EFFICACY OF ENDODONTIC DEBRIDEMENT ON POSTOPERATIVE PAIN IN SYMPTOMATIC TEETH WITH PULPAL NECROSIS
A Thesis
Presented in Partial Fulfillment of the Requirements for
the Degree of Master of Science in the
Graduate School of The Ohio State University
By
Raquel D. Sebastian, D.D.S.
Graduate Program in Dentistry
The Ohio State University 2014
Master’s Examination Committee:
Melissa Drum, D.D.S., M.S., Advisor
Al Reader, D.D.S., M.S.
John Nusstein, D.D.S., M.S.
Sara Fowler D.M.D., M.S.
F. Michael Beck, D.D.S., M.A Copyright by
Raquel D. Sebastian, D.D.S.
2014
ABSTRACT
Patients without a general dentist or access to dental care often present to a hospital emergency department with painful teeth. These patients are typically prescribed pain medication and an antibiotic until they can be evaluated and treated by a dentist.
There are currently no studies to demonstrate if initial root canal debridement is better than just placing the patient on medications for pain relief during this symptomatic period. The purpose of this study was to compare initial endodontic treatment versus no initial endodontic treatment for postoperative pain in patients with symptomatic teeth with a pulpal diagnosis of necrosis and associated periapical area. Ninety-five patients presenting for emergency endodontic treatment experiencing moderate to severe pain were analyzed in the study. The patients were randomly divided into two groups: an initial debridement group who received anesthetic and emergency endodontic treatment, and a second non-debridement group who received anesthetic, but no initial debridement.
At the end of the appointment, patients were given ibuprofen (600mg q6h) and acetaminophen (500mg q6h) and a prescription for an antibiotic. Patients also received a
5-day diary to record their pain level and the amount of pain medication taken.
Postoperative data was analyzed using multiple Mann-Whitney-Wilcoxon tests and the
Step-down Bonferroni method of Holm. Results showed that for both the debridement and the non-debridement groups, the level of pain reported decreased over the course of
ii the five days. However, there were no significant differences between the two groups until day 5. Both groups showed a decrease in medication usage over the 5-day period.
There was no significant difference between the two groups with respect to escape drug use. Twenty percent of patients in the debridement group and 12% of patients in the non- debridement group utilized an escape drug.
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DEDICATION
To my Mom, who I am convinced prayed me through this residency. You inspire me every day with your strength and wisdom. Thank you for teaching me the important things in life and for being not only a mother, but a friend.
To my Dad, whose endless love and encouragement is unmatched. Thank you for everything you do. You are appreciated more than you know.
And to Rocky, whose unwavering support throughout the years leaves me forever grateful. You believed in me, even when I didn’t believe in myself. Thank you.
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ACKNOWLEDGEMENTS
Dr. Drum – I didn’t think it could be done, but we did it! Thank you for lending your incredible knowledge to this thesis and for your unrelenting commitment to this program. Your dedication to your students, residents and the field of endodontics is truly amazing.
Dr. Reader – I am so lucky to have had the opportunity to train under you. You bring excitement and energy to the program. Thank you for your dedication to educating the next generation of endodontists. I will never forget the lessons you taught me, in both endodontics and life.
Dr. Nusstein – You are an incredible educator. I am so grateful I had the opportunity to work with you. Thank you for teaching me the value of thinking critically. I will never read the JOE the same again.
Dr. Fowler – I am so glad that you have chosen to pursue education. It is the perfect fit for you! You are a wonderful teacher, and future students and residents will be lucky to have you.
Dr. Beck – I’m sure the last thing you wanted to see at 6:30 a.m. each day was me in your office, but you always had a smile on your face. Thank you for taking the time and having the patience to walk me through the realm of statistics.
Taryn, Ryan & Jared – From our first trip to Philadelphia, to our last trip to D.C., I’ve really enjoyed being your co-resident and friend. We’ve laughed together (mostly at each other), learned together and practiced endo together. There is no one else I would have rather gone through this residency with than you three! For your friendship and support, in and out of school, I thank you.
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VITA
April 10, 1987.……………………………………...Born: Royal Oak, MI
May 2011………………………………………...... Bachelor of Science, Biology University of Detroit Mercy Detroit, MI
Doctor of Dental Surgery, University of Detroit Mercy School of Dentistry Detroit, MI
August 2014……………...…………………………Specialization in Endodontics Post-Doctoral Certificate, The Ohio State University College of Dentistry, Columbus, Ohio
FIELD OF STUDY
Major Field: Dentistry
Specialization: Endodontics
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TABLE OF CONTENTS
Page
Abstract…………………………………………………………………………...………ii
Dedication……………………………………………………………………………..….iv
Acknowledgments………………………………………………………………….…….v
Vita…………………………………………………………………………………....…..vi
Table of Contents………………………………………………………………....…...... vii
List of Tables………………………………………………………………………...…...ix
List of Figures……………………………………………………………….………...….xi
Chapters:
1. Introduction………………………………………………………….…………….1
2. Materials and Methods…………………………………………….……………..28
3. Results……………………………………………………………….………..….37
4. Discussion…………………………………………………………….……..…...43
5. Summary and Conclusions………………………………………….………...... 86
List of References………………..……………………………..…………..………...….88
Appendices
A. Tables…………………………………………………...……………………96
B. Figures……………………………………………………...……………….115 vii
C. Consent Form…………………………………………………...…………..119
D. Privacy Form………………………………………………………...…...…126
E. Corah’s Dental Anxiety Scale………………………………...……...….….131
F. Health History Questionairre ………………………………………………133
G. Initial Visual Analog Scale...……………………...…………………...…...136
H. Anesthetic Injection Visual Analog Scale………………………………….138
I. Emergency Treatment Visual Analog Scale…………………………….….140
J. Supplemental Injection Visual Analog Scale………………………………142
K. Post-supplemental Injection Visual Analog Scale………………….………144
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LIST OF TABLES
Table Page
1. Preliminary Data of Debridement and Non-Debridement Groups………..…...... 97
2. Pre-Operative Statistics by Jaw and Tooth Type.………..………...... 98
3. Pre-Operative Statistics by Treatment Type.………………………………..…...99
4. Injection Pain………………………....…………………………………….…..100
5. Injection Pain by Stage Using Categorical Values of the VAS.…………....…..101
6. Emergency Treatment Pain…………..……………………………………..…..102
7. Emergency Treatment Pain by Stage Using Categorical Values of the
VAS……………………………………………………………………....…….103
8. Escape Drug Utilization……………... ………………………………………...104
9. Non-Escape Group Post-Operative Pain by Day…………………..………..…105
10. Non-Escape Group Post-Operative Pain by Stage Using Categorical Values of the
Visual Analog Scale ………………………………………………..……..……106
11. Escape Group Post-Operative Pain by Day ……………………………………107
12. Escape Group Post-Operative Pain by Stage Using Categorical Values of the
Visual Analog Scale…………………....……………………………………….108
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13. Total Number of Pain Medication Tablets by Day ………...…………………..109
14. Number of Patients Utilizing No Medication by Day …….…….………...…..110
15. Total Number of Patients Utilizing an Escape Drug by Day ……………..……111
16. Escape Group Number of Narcotic Tablets Taken by Day…………………….112
17. Non-Escape Group Post-Operative Drug Use by Day……………………….…113
18. Escape Group Post-Operative Drug Use by Day……………………………….114
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LIST OF FIGURES
Figure Page
1. Post-Operative Pain by Group and Day ………….………………………….....116
2. Medication Use by Group and Day…………...... 117
3. Escape Drug Use……………………………………………………………..…118
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CHAPTER 1
INTRODUCTION
Symptomatic teeth with a pulpal diagnosis of necrosis are frequently treated in a
specialty endodontic practice (1-4). Usually, accessing the tooth and performing canal debridement is completed at the initial emergency visit. However, many general dental practitioners do not access a tooth or perform initial canal debridement when the patient is symptomatic. Rather, they prescribe pain medications and antibiotics and then reappoint the patient when the symptoms have subsided.
In addition, there are many patients without a general dentist or access to dental care that present to a hospital emergency room with symptomatic teeth. These patients presenting to the emergency room with severe odontogenic pain are also typically prescribed pain medication and antibiotics until they can be evaluated and treated by a dentist (5). According to the National Hospital Ambulatory Medical Care Survey, dental emergency room visits in the United States increased by 1 million from 2000 to 2010 (6).
In an article published in the ADA News, a community dental health coordinator was interviewed and asked about dental emergency room visits. She stated that she sees patients daily who have waited too long for dental treatment. “Often, they’ve visited the emergency room and received antibiotics as a temporary treatment but haven’t followed up with a dentist to completely resolve their problem.” (6) In a study conducted by Shah et al., a retrospective analysis was conducted of patients admitted to the emergency room
1 with a diagnosis of periapical abscess. Over 9 years, there were 61,439 hospitalizations due to periapical abscess in the United States. Additionally, the number of hospitalizations increased 41% from 2000 to 2008 (7). Another similar study was conducted by Nalliah et al. in 2006 to assess the prevalence of and costs associated with emergency department visits. The number of emergency visits was determined by analyzing the usage of the medical code associated with pulpal and periapical diseases.
Results showed that there were 403,149 emergency department visits that year associated with this code totaling $163,692,957 in hospital charges (8).
In a study conducted by Lewis et al., dental emergency room visits were evaluated and described from 1997 to 2000. There were 2.95 million dental emergency department visits in total. According to the study, at least one prescription was given in more than 80% of visits. Antibiotics were prescribed in 49.5% of visits, while 72.4% of patients presenting to the emergency department received analgesics. Of those prescribed analgesics, 37.8% received a narcotic. In addition, a referral to another doctor or clinic other than their regular physician occurred 72.3% of the time. It was also found that dental emergency department visits were more likely to occur on the weekend when many dental offices are not open (5).
Although many emergency room physicians recommend more definitive follow- up care, it is not known how many of these patients follow through with this recommendation. A study conducted by Davis et al. investigated dental related emergency room visits from five major hospital systems in Minneapolis over 1 year.
Results showed that over 10,000 visits were related to dental problems. Of these 10,000
2
visits, 2,499 were second or additional repeat visits for a dental problem. Therefore,
about 20% of the dental related emergency room visits were repeat visits. A major
concern with the treatment of dental problems in a hospital setting is the lack of follow-
up and definitive dental treatment. According to the previous study, although dental pain
and infection are treated by emergency room physicians, the underlying problem is not
addressed (9). A telephone survey was conducted by Cohen et al. in which low-income adults were questioned regarding a history of tooth pain within the last year. Participants were asked if they had visited a hospital or emergency department for the tooth pain.
Results indicated that 8.5% visited an emergency room, and interestingly, 80.5% of those subsequently visited a dentist for more definitive dental treatment (10).
Although it is known that patients are commonly prescribed antibiotics and pain
medication for dental pain in the emergency room, it is not known what happens to these
patients once they leave the hospital setting (5). Does their pain improve over the course of the next few days? Or does their pain worsen until they finally seek traditional dental care?
There are currently no studies to demonstrate if initial root canal debridement is better than just placing the patient on medications. Our hypothesis was that initial debridement will lead to less postoperative pain and less medication use.
Postoperative Pain
Pain following root canal therapy has been studied in order to understand its
incidence, causes and predictors. In addition, different methods for reducing the amount
3 of postoperative endodontic pain have been studied such as prescribing pre and postoperative pain medications and/or antibiotics.
Several studies have been conducted in order to analyze the incidence of post- operative endodontic pain. Many factors seem to have an effect on the percentages reported, and studies have frequently reported conflicting data. A systematic review of the research was conducted by Sathorn et al., and it was found that the overall incidence of postoperative endodontic pain ranged from 3-58%. However, of the 16 studies included, the majority did not differentiate preoperative pulpal and periapical status (11).
According to a study published by Arias et al, post-endodontic pain was present in 47.3% of single-visit vital and non-vital cases (12). Siqueira et al. studied the incidence of postoperative pain in teeth diagnosed with pulpal necrosis. Results showed that the overall incidence of postoperative pain, including mild, moderate and severe pain, was
15.2%. The incidence of severe pain, or a flare-up, was 1.9% (13).
A study conducted by Genet et al. also investigated factors associated with pain following endodontic instrumentation. A total of 443 patients were treated with root canal therapy using the step-back technique, irrigation with 2% sodium hypochlorite solution, and obturation with gutta percha. Overall, there was a 22% incidence of moderate postoperative pain and a 5% incidence of severe pain. Furthermore, a positive correlation was detected between postoperative pain level and teeth diagnosed with a non-vital pulp presenting with preoperative pain. Postoperative pain was reported twice as often in symptomatic teeth with a pulpal diagnosis of necrosis compared to teeth with a pulpal diagnosis of asymptomatic or symptomatic irreversible pulpitis (14).
4
Harrison et al. conducted a study of 229 patients who were treated with root canal therapy of asymptomatic teeth. Interappointment pain was evaluated at the second visit, which was between two and ten days later and recorded as none, slight or moderate to severe. Moderate to severe pain was reported in 15.7% of cases with slight pain in 28.8% and no pain in 55.5% of cases. In addition, no significant difference in level of pain was found between vital and non-vital teeth (15). Similarly, a study conducted by Fox et al. also found no difference in postoperative pain between vital and necrotic teeth (16).
A study conducted by Henry et al. evaluated the effect of penicillin on postoperative endodontic pain in symptomatic necrotic teeth. Results showed that there was no statistically significant difference in the level of postoperative pain reported or amount of medication tablets taken over the 7 day period between the patients who received penicillin versus the placebo group (3).
Houck et al. led a study investigating the effect of trephination on postoperative pain and swelling in symptomatic necrotic teeth. Results showed no significant difference in pain level, swelling or amount of pain medication taken between the two groups.
However, it was noted that the majority of patients had significant postoperative pain requiring analgesics (1).
A similar study was conducted by Nist et al. who also evaluated the effect of apical trephination on postoperative pain and swelling in symptomatic necrotic teeth.
Results showed no significant reduction in pain, swelling or the amount of ibuprofen taken over 7 days. However, there was a significant reduction in the amount of acetaminophen with codeine taken in the trephination group (2). 5
A study conducted by Wells et al. compared the use of ibuprofen alone versus the combination of ibuprofen and acetaminophen on postoperative pain in symptomatic patients with a pulpal diagnosis of necrosis. Results showed no statistically significant difference between the ibuprofen group and the ibuprofen and acetaminophen group (17).
Nusstein et al. studied the effect of drainage upon access on postoperative endodontic pain and swelling in symptomatic necrotic teeth. Results showed that drainage on access did not significantly reduce pain, swelling or the amount of pain medication taken. Both groups used the most pain medication on days 1 and 2 following treatment, and a decrease in the amount taken was seen starting on day 3 for the remainder of the study period (4).
Several causes of postoperative pain have been proposed including mechanical and chemical injury to periapical tissues, and extrusion of debris and bacteria beyond the apex (13, 18). Some practitioners even assert that maintaining apical patency can cause severe postoperative pain by inducing a periapical inflammatory response. Arias et al. conducted a study using 236 patients to determine the effect of maintaining apical patency on postoperative pain. No significant difference was found in postoperative pain between the teeth with patency maintained using a #10K file and those without patency.
However, it was found that in non-vital teeth, the incidence of postoperative pain was significantly higher when patency was not maintained (19). This highlights the importance of thoroughly cleaning and shaping the root canal system in necrotic teeth as remaining tissue and debris may have a deleterious effect on postoperative pain.
6
In a subsequent study conducted by Alves, maintaining patency had no relationship to the amount of flare-ups reported. This was attributed to the use of the crown-down technique. All instrumentation techniques likely cause apical extrusion of debris to some extent. However, the crown-down technique using rotary instrumentation has been demonstrated to cause less extrusion of debris due to the auger effect of the files, which may lessen the probability of postoperative pain (13, 20, 21).
There are several proposed predictors for postoperative endodontic pain including age, gender, amount of preoperative pain, presence of periapical radiolucency and tooth type. Mandibular teeth in particular have been shown to be associated with a higher frequency of postoperative pain following endodontic cleaning and shaping procedures
(18).
Patient age and gender have also been evaluated as factors associated with postoperative pain. O’Keefe found that patients over the age of 20 reported more postoperative pain than those under the age of 20, which is in agreement with studies conducted by Seltzer, Bender and Ehrenreich (22). Torabinejad et al. noted that “patients in the 40 to 59 year range were more susceptible to developing interappointment emergencies than other age categories” (18). Arias et al. also noted that the age of the patient was a significant predictive factor of postoperative pain and attributed this to the decrease in pulp size often seen in older patients (12). However, Genet et al., Fox et al.,
Clem, Maddox et al. and Mulhern et al. did not find any association between patient age and postoperative pain (14).
7
Female gender has also been associated with an increase in postoperative pain in some studies. According to a study conducted by Torabinejad et al., which evaluated factors associated with interappointment emergencies of teeth with necrotic pulps, female patients over the age of 40 had more postoperative complications than males (18). This finding was substantiated by both Genet et al. and Fox et al. who found that females reported more postoperative pain than males following endodontic treatment (14, 16).
According to Arias et al., the main factor in predicting postoperative endodontic pain lasting more than 2 days is gender with females reporting a longer duration of pain (12).
The level of preoperative pain has also been associated with a higher incidence of postoperative pain in endodontic treatment. Torabinejad et al. conducted a study utilizing
400 teeth requiring endodontic therapy treated in five different endodontic offices over a period of 3 years. It was determined that “the presence of preoperative complaint is an excellent predictor for intrerappointment emergencies” (18). O’Keefe found similar results when studying the effect of preoperative pain on post-operative pain. He determined that the level of postoperative pain was directly proportional to the severity of the preoperative pain. “Patients with moderate or severe preoperative pain were five times more likely to have moderate or severe operative or postoperative pain than were patients with mild or no preoperative pain.” In this study, pulp status had no effect on postoperative pain (22). However, Genet et al. found that a “tooth with a non-vital pulp and preoperative pain on the day of treatment caused about four times the incidence of postoperative pain as teeth with a non-vital pulp and no preoperative pain and twice as often as teeth with a vital pulp with or without preoperative pain” (14). In addition,
8
Siqueira et al. found an increased incidence of postoperative pain in patients with symptomatic teeth and a periapical radiolucency (13).
Another factor that may contribute to postoperative pain is the presence or absence of a periapical radiolucency. According to Torabinejad et al., teeth without periapical radiolucencies have a higher incidence of interappointment emergencies. This was attributed to the lack of space for pressure release in the absence of a periapical radiolucency (18). In addition, Fox et al. and Frank et al. also found more postoperative pain in patients without a periapical radiolucency (16, 18). According to Fox et al., tooth vitality had little effect on postoperative pain, but teeth without radiolucencies were associated with more postoperative pain than those with a radiolucency (16). Similarly,
Siqueira et al. found more postoperative pain in association with previously symptomatic teeth without periapical radiolucencies. Again, this was postulated to be due to the buildup of pressure in the absence of bone resorption (12). Similarly, Arias et al. found that teeth with periapical radiolucencies were associated with less postoperative pain
(12). Conversely, Harrison et al. found no difference in interappointment pain between teeth with a periapical radiolucency and those without one (15).
Microbiology
Bacteria have been found to be the major microorganisms involved in endodontic infections and apical periodontitis. The benchmark study conducted by Kakehashi et al. illustrated this brilliantly through their use of germ-free rats versus conventional rats. In this study, pulps were exposed on 21 germ-free rats and 15 conventional control animals. 9
The animals were then sacrificed and the pulpal tissue evaluated for inflammation and
necrosis. In the control group, complete pulpal necrosis with abscess formation occurred
after the eighth day. In contrast, the germ-free rats showed no sign of pulpal necrosis or
abscess formation and pulpal inflammation was minimal. This study therefore proved the
vital role bacteria play in the pathogenesis of pulpal and periapical inflammation (23).
Sundqvist was one of the first to use anaerobic techniques in order to identify
specific bacteria associated with necrotic teeth. Most of the strains isolated were found to
be obligate anaerobes. In a preliminary study conducted by Sundqvist, teeth were
evaluated for the presence of bacteria. Bacteroides melaninogenicus, an anaerobic, gram-
negative rod, was found in all teeth with painful symptoms and in none of the
asymptomatic teeth (24).
In a subsequent study by Sundqvist, the prevalence of black-pigmented
Bacteroides in teeth with apical periodontitis was evaluated. Of the 72 canals evaluated,
22 contained black-pigmented Bacteroides. The most commonly found bacteria included
Fusobacterium nucleatum, B. intermedius, Peptostreptococcus micros,
Peptostreptococcus anaerobius, Eubacterium lentum,and Eubacterium alactolyticum.
Overall, more than ninety percent of the bacteria present were found to be anaerobic (25).
As anaerobic culturing techniques improved, strict anaerobes were found to be the
predominant bacteria involved in infected root canals. Baumgartner et al. conducted a
study of 10 teeth with pulpal necrosis and periapical lesions in order to identify the
predominant bacteria present in the apical 5mm. Using anaerobic and aerobic culturing
techniques, 50 bacteria were isolated from the 10 teeth. Sixty-eight percent of the bacteria
10
isolated were strict anaerobes. The most common species isolated included Actinomycyes,
black-pigmented Bacteroides including B. intermedius and Non-pigmented Bacteroides
including Lactobacillus, Peptostreptococcus, Veilonella, Fusobacterium, E. faecalis and
S. mutans (26).
Dougherty et al. specifically studied black- pigmented Bacteroides in 18 teeth with a periapical radiolucency. The teeth were extracted, sectioned and a file was used to obtain a microbial sample. The samples were cultured and examined for growth every 3-4 days. Of the 18 samples, black-pigmented Bacteroides were isolated from 12.
Furthermore, P. nigrescens was isolated from the coronal and apical segments in seven roots, and P. melaninogenica was detected in five coronal segments and three apical segments. Several other variables were evaluated in conjunction with the type of bacteria present. However, no statistically significant relationship was found between growth of black-pigmented Bacteroides, level of pain, or association with apical infection (27).
It has been suggested that some bacteria are associated with an increased probability of symptomatic apical periodontitis. However, many studies have found no difference in the number and type of bacteria present in symptomatic and asymptomatic teeth. Bacterial synergism, differences in virulence, bacterial load and environmental factors may all affect the development of symptomatic apical periodontitis (28).
More recently, the most prevalent gram-negative species to be found in primary infections include Fusobacterium, Dialister, Porphyromonas, Prevotella, Tannerella,
Treponema, Campylobacter and Veilonella. Gram-positive bacteria frequently found in primary infections include Peptostreptococcus, Parvimonas, Filifactor,
11
Pseudoramibacter, Actinomyces, Streptococcus, Propionibacterium, Eubacterium and
Olsenella (28).
Secondary infections are caused by bacteria that, although not present initially,
gain access to the tooth subsequent to endodontic initiation. Once the bacteria have
penetrated the tooth, they colonize the canals leading to a secondary infection. These
bacteria may gain access to the canal during treatment, between appointments or
following obturation. There is no single species that has been found to persist following
treatment, but gram-negative bacteria are typically eliminated and gram-positive bacteria are most often present. Gram-negative bacteria are typically found in primary infections.
Conversely, gram-positive facultative and anaerobic bacteria such as Streptococci, P. micra, Actinomyces, Propionibacterium, Lactobacilli, E. faecalis, Olsenella uli and P. alactolyticus are often detected post-treatment (28).
Advances in microbial identification continued to occur through the 1990’s and
2000’s, and the complexity and diversity of endodontic microbiota was further recognized. We are now more aware than ever of the vast amount of bacteria that are uncultivable, with some studies estimating this number to be as high as 40%. For example, Siqueira et al. conducted a study to investigate the prevalence of 11 bacteria in the apical third of infected root canals with an associated periapical lesion using the
Polymerase Chain Reaction. Molecular methods were utilized because some species chosen were notoriously difficult to grow in a culture. Siqueira et al. identified this apical third as the critical zone for endodontic success and stressed the importance of recognizing its bacterial composition. Twenty three extracted teeth were used in the study
12
and PCR amplification was performed on each. Of the bacteria evaluated, P. alactolyticus
was found in 10 cases, T. denticola in 6, F. nucleatum in 6, P. endodontalis in 4 and T.
forsythensis in 1 case. The study illustrates that a culture cannot definitively rule out the
presence of these bacteria and molecular methods often provide a better picture of the
composition of endodontic microbiota (29).
Although bacteria remain the primary contributors to endodontic infection, viruses and fungi have recently been found to play a role as well. According to Slots et al., herpes viruses including human cytomegalovirus and Epstein-Barr virus have been
connected with periapical pathosis. A subsequent study was conducted to determine the
role HCMV and EBV play in symptomatic periapical lesions. The study was conducted
using 25 symptomatic teeth and 19 asymptomatic teeth previously treated endodontically
with the presence of a non-healing periapical lesion. An apicoectomy was performed and
samples taken from the area. HCMV was found in all 25 symptomatic teeth, but was only
found in 37% of asymptomatic teeth. HCMV and EBV co-infection was found in 76% of symptomatic teeth and 26% of asymptomatic teeth (30).
The role of fungi has also been studied in regards to endodontic infection. Sen et al. conducted a study of ten molars with periapical lesions using a scanning electron microscope, and found that 4 of the 10 were heavily invaded by yeasts (31). In addition,
Baumgartner et al. studied the presence of Candida albicans in infected root canals.
Samples were taken from 24 root canals and C. albicans was detected in 5 samples or
21% (32). Waltimo et al. also conducted a study of 967 teeth with persistent endodontic infections. Samples were collected from general practitioners in Finland and cultured
13 aerobically. Forty-seven samples or 7% showed yeast growth. Twenty yeast strains were identified with all but one belonging to the Candida genus (33).
Calcium Hydroxide
Calcium hydroxide was first introduced in 1920 by Hermann, and has continued to be widely used in endodontics. It is commonly used in apexification, root perforation repair, pulp capping and as an intracanal medicament. It is typically used as a slurry in a water or saline base at which point it dissolves into calcium and hydroxyl ions (34).
There have been several proposed mechanisms of action of calcium hydroxide.
Calcium hydroxide has been shown to have a high pH of about 12.5. This high pH in combination with the release of hydroxyl ions exerts a lethal effect on bacterial cells. The high pH disrupts cell metabolism, while the hydroxyl ions inhibit DNA replication and induce potentially lethal mutations (35).
Several studies have illustrated the effectiveness of calcium hydroxide as an intracanal medicament. It has been shown to be highly effective in reducing levels of bacteria (36-41) and endotoxin (38). Furthermore, it has been shown by some authors to be effective in reducing postoperative pain (39,42). Other authors, however, have shown no significant difference in bacterial reduction between those teeth treated with calcium hydroxide and those treated without the medicament (43, 44). Furthermore, several authors have also shown that two visit endodontic treatment using calcium hydroxide did not result in a decrease in postoperative pain compared to single visit endodontics (45-
48).
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Ibuprofen
Pain management in endodontic therapy is of critical importance. The most
commonly prescribed drugs include non-steroidal anti-inflammatories (NSAIDs), acetaminophen and opiates including codeine and tramadol (49).
Pulpal inflammation and necrosis ultimately lead to periradicular changes and the release of inflammatory mediators that activate peripheral nociceptors (50). Ibuprofen is a non-steroidal anti-inflammatory drug with analgesic, anti-inflammatory and anti-pyretic
properties. Due to these properties, ibuprofen has been shown to be very effective in
managing odontogenic pain associated with inflammation (51). NSAIDs act peripherally
by inhibiting cyclo-oxygenase, which prevents the formation and release of
prostaglandins, thromboxanes and prostacyclins (51, 52). Both COX-1 and COX-2 are
inhibited reversibly by NSAIDs. When prostaglandins are released, inflammation, pain
and fever may result (52). In addition to preventing the release of prostaglandins,
NSAIDs may also inhibit free radical formation, cytokine synthesis and other major
pathways involved in inflammation (49).
Ibuprofen is generally prescribed in formulations ranging from 200-800mg. For
moderate pain, 400-600mg every six hours is recommended with a maximum daily dose
of 3200mg (49). However, ibuprofen and other NSAIDs have a ceiling effect. Despite
increasing the dose of the drug, increased pain relief may not occur. Therefore,
supplementing ibuprofen with an additional medication may be necessary to achieve
sufficient analgesia (53). A commonly prescribed combination includes 600mg of
ibuprofen with 1000mg of acetaminophen every six hours (49, 53).
15
Although short-term use of ibuprofen and other NSAIDs is associated with few side effects, there are some associated adverse drug interactions. Gastrointestinal (GI) bleeding is the most common serious side effect of NSAIDs. It is caused by damage to the gastric mucosa in addition to the inhibition of platelet function by NSAIDs.
Additional GI effects include pain, nausea, vomiting, diarrhea and constipation.
Ibuprofen and other NSAIDs should therefore be used with caution in patients with a history of gastric ulcer or GI bleeding (54).
Adverse drug interactions of NSAIDs include warfarin, antihypertensives, lithium, methotrexate and alcohol. Due to the antiplatelet effect of NSAIDs, patients receiving anticoagulant therapy such as warfarin, or those at risk for bleeding should avoid the use of NSAIDs. Furthermore, those taking antihypertensives including angiotensin-converting-enzyme inhibitors, diuretics and beta blockers should use
NSAIDs with caution. These drugs depend on renal prostaglandins to exert their antihypertensive effect, and NSAIDs inhibit renal prostaglandin synthesis (54). In addition to the aforementioned interactions, NSAIDs also interact with lithium, methotrexate and alcohol. These drugs are protein bound, and because NSAIDs are also highly protein bound, they have the ability to displace these drugs (52, 54).
Anaphylactic reactions associated with NSAIDs can be found in patients with a history of sensitivity to aspirin or aspirin induced asthma (52). Therefore, all NSAIDs should be avoided in patients describing aspirin intolerance.
Several clinical studies and systematic reviews recommend NSAIDs as the drug of choice for postoperative endodontic pain (49). Additionally, new research has focused
16
on combination analgesic therapy for reducing post-operative endodontic pain. In a study
conducted by Menhinick et al., 57 patients with spontaneous pain requiring root canal
treatment were treated with endodontic therapy and prescribed either a placebo, 600mg
ibuprofen or 600mg ibuprofen with 1000mg of acetaminophen. Patients were then asked
to record their pain level on a visual analog scale (VAS) for the next eight hours. A
significant difference was found between the ibuprofen and combination drug group, and
between the placebo and combination drug group. No significant difference was found
between the placebo and ibuprofen group (53). Therefore, the combination of ibuprofen
and acetaminophen may be more effective than ibuprofen alone in managing endodontic
pain.
A study conducted by Wells et al. compared the use of ibuprofen alone versus the
combination of ibuprofen and acetaminophen on postoperative pain in symptomatic
patients with a pulpal diagnosis of necrosis. Seventy- one patients with moderate to severe pain were included in the study. Endodontic therapy was initiated and patients were then prescribed either 600mg of ibuprofen or 600mg ibuprofen with 1000mg acetaminophen. Patients were asked to record their pain level on a VAS for 6 days. Pain levels and analgesic use decreased over time for both groups. However, there was no statistically significant difference between the ibuprofen group and the ibuprofen and acetaminophen group. On day 1, 9% of patients in the ibuprofen plus acetaminophen group reported severe pain, with 43% reporting moderate and 31% reporting mild pain.
By day 2, only 6% reported severe pain, 37% reported moderate pain and mild pain was reported in 34%. By day 5, none reported severe pain and 6% reported moderate pain
17
with 40% reporting mild pain. The average number of ibuprofen tablets taken was 7.1 on
day 1, 3.7 on day 2, 2.9 on day 3, and 1.4 on days 4 and 5. In the ibuprofen plus
acetaminophen group, the mean number of tablets taken was 5.7 on day 1, 4.5 on day 2,
3.9 on day 3, 1.6 on day 4 and 1.4 on day 5 (17).
Moore et al. conducted a systematic review to evaluate the combination of
ibuprofen and acetaminophen for acute pain management after third-molar extractions.
Quantitative systematic reviews published by the Cochrane Collaboration were evaluated.
Results suggested that the combination of ibuprofen and acetaminophen may be more
effective than either drug alone and lead to fewer side effects than opioid containing
medications (55).
Acetaminophen
Use of acetaminophen dates back to the late 1800’s, but it was not commercially
available until the mid-1900’s. Acetaminophen is an analgesic and antipyretic with very
weak anti-inflammatory properties. Its mechanism of action is still unclear, but it seems
to involve inhibition of prostaglandin synthesis similar to NSAIDs. However, its actions
are concentrated on the central nervous system as opposed to the periphery (52).
Acetaminophen is well absorbed orally with a half-life of 2-4 hours. It is metabolized in the liver resulting in mostly inactive metabolites. However, one metabolite, N-acetyl-p-benzoquinoneimine (NAPQI), is highly reactive and hepatotoxic.
Generally, this metabolite is inactivated by glutathione. However, in acetaminophen overdose, NAPQI accumulates resulting in liver cell damage (51, 52, 54). In fact,
18 acetaminophen use has become the most common cause of acute liver failure (51).
Because chronic alcohol use can also lead to hepatotoxicity, acetaminophen should be used with caution in this patient population. Chronic alcohol use leads to the induction of
CYP2E1, which promotes the conversion of acetaminophen to NAPQI. Furthermore, glutathione normally inactivates this highly reactive metabolite. However, in alcoholics, hepatic glutathione is generally depleted leading to a further increase in NAPQI.
Therefore, acetaminophen should be used with caution in those who consume alcohol regularly (52).
Acute and chronic overdoses of acetaminophen are typically the only cause of adverse effects. Unlike NSAIDs, nausea, gastric irritation, and inhibition of platelet aggregation are not associated with acetaminophen use. Furthermore, allergy to the drug is rare (52).
Acetaminophen is commonly prescribed in dentistry for postoperative pain and is often found in combination with opioids. The recommended dose for acetaminophen alone is 500-1000mg every 4-6 hours with a maximum daily dose of 4000mg (49).
Studies have shown that higher doses are more effective than lower doses (49, 56).
Several studies have been conducted to evaluate the safety and efficacy of acetaminophen as an analgesic for postoperative pain. Two Cochrane Reviews have been published using an oral surgery model. The first review was conducted by Weil and investigated the optimal dose of acetaminophen and optimal time for drug administration to provide pain relief. Randomized, placebo controlled, double blind clinical trials of acetaminophen for acute pain following third molar surgery were included in this review.
19
Twenty-one studies were included with a total of 1,968 patients. Acetaminophen was
administered following surgical removal of wisdom teeth and pain levels were
subsequently assessed. Acetaminophen was found to be significantly better than the
placebo at both 4 and 6 hours following the administration of the drug. There was also a
statistically significant difference found between doses of less than 1000mg and doses of
1000mg with the higher dose providing more pain relief at 4 and 6 hours. Furthermore,
there was no statistically significant difference between the number of patients
experiencing side-effects between the acetaminophen and the placebo groups (56).
A second Cochrane Review by Bailey et al. investigated the use of ibuprofen and
acetaminophen for pain relief following the surgical removal of lower wisdom teeth.
Seven randomized, controlled, double-blinded clinical trials were included in the study with a total of 2,241 participants. The optimal doses of ibuprofen alone, acetaminophen alone and of a combination of the two drugs were evaluated. Ibuprofen was found to provide enhanced pain relief compared to acetaminophen with evidence indicating
400mg ibuprofen is superior to 1000mg of acetaminophen. Only two of the clinical trials compared the combination drug of acetaminophen 1000mg and ibuprofen 400mg to each of the drugs alone. At two hours post-surgery, there was no significant difference in pain relief in the combination group compared to the single drugs. However, six hours following surgery, the combination drug was more effective than either drug alone (57).
Mitchell et al. also investigated the use of acetaminophen plus ibuprofen compared to codeine plus caffeine following outpatient general surgery. A double-blind, randomized controlled trial was performed on 146 patients. Patients were randomly given
20
300mg acetaminophen plus 30mg codeine plus 15mg caffeine (Tylenol #3) or 325mg acetaminophen plus 400mg ibuprofen every 6 hours. Pain levels were recorded four times daily using the visual analog scale (VAS). Results showed that the acetaminophen plus ibuprofen combination provided similar pain relief to Tylenol #3. The acetaminophen plus ibuprofen group also exhibited fewer side-effects and was associated with a higher patient satisfaction. Mean daily VAS for the acetaminophen plus ibuprofen group was
37.1mm on day 1, 35.6mm on day 2, 30.6mm on day 3, 27.2mm on day 4 and 26mm on day 5. In the Tylenol #3 group, mean daily VAS was 39.7mm on day 1, 44.4mm on day
2, 36.6mm on day 3, 29.6mm on day 4 and 27.5mm on day 5 (58).
In a similar study also conducted by Mitchell et al., acetaminophen plus ibuprofen was compared to acetaminophen plus codeine plus caffeine after outpatient breast surgery. A total of 71 patients were included in this double-blind randomized trial.
Patients were randomly prescribed either 650mg of acetaminophen plus 400mg of ibuprofen or 600mg acetaminophen, 30mg of caffeine and 60mg of codeine. Patients were instructed to take the medication four times daily and asked to record pain levels on a visual analog scale (VAS). No significant differences were found between either of the treatment groups. Furthermore, there was no difference detected in the incidence of adverse events. However, discontinuation of the study medication was more common in the Tylenol #3 group due to adverse effects. Patient satisfaction was found to be 92% in the acetaminophen plus ibuprofen group compared to 89% in the Tylenol #3 group with no significant difference between the two groups. Mean daily VAS in the acetaminophen plus ibuprofen group was 21.7mm on day 1, 19.6mm on day 2, 17.3mm on day 3,
21
15.3mm on day 4 and 14.7mm on day 5. In the Tylenol #3 group, mean daily VAS was
24.2mm on day 1, 20.4mm on day 2, 17.5mm on day 3, 17.1mm on day 4 and 14.8mm on
day 5 (59).
Hydrocodone
Hydrocodone is a class of opioid analgesic similar to morphine used for moderate
to severe pain (52). Opioids act on three receptors: mu, kappa and delta. All pure agonists
including morphine and hydrocodone principally act on mu receptors located on neurons
in the central nervous system and peripheral nervous system. The two subtypes of mu
receptor provide supraspinal analgesia and spinal analgesia (52). Through G-protein activation, voltage-gated calcium channels are inhibited resulting in a decrease in the release of excitatory neurotransmitters. In addition, potassium conductance is also altered resulting in the hyperpolarization of neurons (52, 60).
Opioid receptors are located on neurons present in the spinal cord and on primary afferents. They exert their effect by inhibiting the release of neurotransmitters from primary afferent neurons and by blocking pain transmission from the brainstem to the spinal cord by inhibiting the dorsal horn (52, 60). When these neurons are inhibited, descending inhibitory neurons are activated, which ultimately inhibits pain transmission
(60). Opioids also exert effects on neurons in the brain that are not associated with the descending pain pathway. These receptors affect the interpretation and emotional response to pain rather than the pain threshold itself. Finally, opioids have been found to act peripherally on receptors located on A-delta and C-fibers, which lead directly to the
22
CNS (52). Therefore, opioids act at several sites which collectively produce analgesia
through the combination of their spinal, supraspinal and peripheral actions (52).
Opioids are often associated with many side effects, but have few adverse drug interactions. Side-effects include respiratory depression, sedation, constipation, nausea and pruritus (54, 60). Respiratory depression is dose related and their use with other CNS depressants should be avoided. Constipation is also a problematic effect of opioids due to the high concentration of receptors located in the gastrointestinal tract. In addition, therapeutic doses of opioids may cause pruritis and flushing of the skin. This is caused by effects on the CNS along with the release of peripheral histamine associated with opioid administration (60).
Contraindications to opioid use include impaired pulmonary function, impaired renal or hepatic function and use in patients with endocrine diseases or who are pregnant.
Respiratory depression is a major concern with opioid analgesics. Respiratory failure can occur in those with impaired pulmonary function such as chronic obstructive pulmonary disease, asthma or cor pulmonale (60). Therefore, opioids should be used with caution in this patient population. Furthermore, opioids should not be administered in combination with other drugs that can cause respiratory depression as their combination will produce increased sedation (54). Metabolization of opioids occurs primarily in the liver and their half-life can be prolonged extensively in those with impaired renal function. Therefore, the dosage may need to be decreased in patients with liver or kidney disease. In addition, those with adrenal insufficiency or hypothyroidism may have an exaggerated response to opioids so they should be used with caution in this patient population (52).
23
An additional area of concern with opioid use is the development of tolerance and
physical dependence. With frequent, long-term use, a gradual loss of effectiveness is observed requiring an increase in dose to reproduce the original effect. In addition, physical dependence can occur producing withdrawal symptoms when the drug is stopped (60).
In order to minimize side effects and reduce the likelihood of tolerance and physical dependence, a common practice is to combine opioids with NSAIDs or acetaminophen (51, 52). This is beneficial because opioids exert their main effect in the
CNS, while ibuprofen and acetaminophen mainly act peripherally at the site of injury.
However, although these drugs have complementary actions, they are not synergistic.
Therefore, the total effect of the two drugs in combination will never exceed the sum of the individual effects of each drug. However, due to the ceiling effect of NSAIDs and acetaminophen, there is a benefit to combining either of those drugs with an opioid, which can provide additional analgesia beyond this ceiling effect (52).
The usual therapeutic dosage of hydrocodone is 5-10mg given orally every 4-6
hours. It is equipotent to oxycodone and about 2.5 times more potent than codeine as an
antitussive (52). It is often prescribed in combination with acetaminophen in doses of
5/500mg, 5/325mg and 5/300mg (61).
A study conducted by Litkowksi et al. investigated the analgesic efficacy of 5mg
oxycodone plus 400mg ibuprofen compared to 5mg oxycodone plus 325mg
acetaminophen and 7.5mg hydrocodone plus 500mg acetaminophen following third
molar extraction. Participants in the study included those greater than 12 years old
24
undergoing removal of at least two third molars. Two hundred forty-nine patients were
included in this randomized, double-blind, placebo-controlled study. Patients were required to have moderate to severe pain within 5 hours after surgery to receive medication. Patients were randomly assigned to one of four groups. The combination of oxycodone 5mg/ibuprofen 400mg was found to provide more pain relief than any other combination or the placebo group. However, the hydrocodone 7.5mg/acetaminophen
500mg and oxycodone 5mg/acetaminophen 325mg groups also showed higher pain relief than the placebo group. In addition, patients who received oxycodone 5mg/ibuprofen
400mg experienced significantly less nausea and vomiting compared to either the oxycodone 5mg/acetaminophen 325mg group or the hydrocodone 7.5mg/ acetaminophen
500mg group. A decrease in opioid adverse effects when combined with ibuprofen has been found in previous studies as well, but the reason for this is unclear (62).
In a Cochrane Review by Gaskell et al., a single dose of oxycodone 15mg was compared to oxycodone 10mg with acetaminophen 650mg for acute postoperative pain.
Twenty studies with 2,641 participants were included in the review. Results showed that the combination of oxycodone and acetaminophen was more effective at relieving pain than oxycodone alone, and analgesia lasted up to 10 hours. Both treatment groups were associated with more adverse effects compared to the placebo group. However, they were described as mild to moderate. In conclusion, oxycodone 10mg plus acetaminophen
650mg provides analgesic efficacy that is similar to NSAIDs, but with a longer duration of action (63).
25
Marco et al. conducted a prospective, double-blind, randomized controlled trial comparing oxycodone 5mg plus acetaminophen 325mg versus hydrocodone 5mg plus acetaminophen 325mg. Eighty eight patients were included in the study and randomly assigned to one of two groups. Pain ratings were assessed at 30 and 60 minutes following drug administration and adverse effects were recorded. Although pain relief was achieved in both groups, results showed no statistically significant difference between the two treatment groups at either 30 and 60 minutes. In addition, the rate of adverse effects was similar. Therefore, Marco et al concluded that oxycodone and hydrocodone are both equally effective in treatment acute pain (64).
White et al. compared the efficacy of ketorolac versus hydrocodone/acetaminophen following surgery. Two hundred fifty-two patients underwent arthroscopic or laparoscopic surgery and experiencing moderate to severe pain were randomly assigned to receive oral ketorolac 10mg every 6 hours or hydrocodone
7.5mg plus acetaminophen 750mg every 6 hours. Patients recorded their pain level on a
VAS at 30 min and at every hour for 6 hours after the first dose. They were then provided a pain diary to record their pain level at bedtime for 3 days. In those patients who underwent atheroscopy, no statistically significant difference was found between ketorolac and hydrocodone/acetaminophen. In the laparascopic group, there was no difference in pain level between the two treatment groups or the placebo group indicating ineffective anesthesia. In addition, ketorolac tolerability was rated higher than the hydrocodone/acetaminophen group by patients and postoperative dizziness was the only
26 side effect found to be significantly higher in the hydrocodone/acetaminophen group
(65).
In general, the evidence suggests that the management of acute pain should begin with acetaminophen or ibuprofen for mild to moderate pain and progress to the use of narcotics in combination with ibuprofen or acetaminophen for the relief of severe pain
(66).
Therefore, the purpose of this prospective, randomized study was to compare the efficacy of initial endodontic treatment versus no initial endodontic treatment on postoperative pain in patients with symptomatic teeth with a pulpal diagnosis of necrosis who are experiencing moderate-to-severe pain.
27
CHAPTER 2
MATERIALS AND METHODS
One hundred and eight patients who presented to The Ohio State University
College of Dentistry for emergency treatment participated in this study. Each patient was required to be 18 years or older, able to provide informed consent, and be in good health with an ASA classification of I or II. Patients were excluded from the study if they were allergic to ibuprofen, acetaminophen or codeine or if they reported a history of gastrointestinal problems, angioedema or bronchospastic activity to aspirin or other
NSAIDs. In addition, patients taking chronic pain medications or those unable to give informed consent were also excluded. All female patients were questioned regarding pregnancy and were not allowed to participate if pregnant or suspected pregnancy, trying to conceive, or nursing. Prior to participating in the study, females suspecting pregnancy were asked to take a urine pregnancy test. Patients with contraindications to the use of
2% lidocaine with 1:100,000 epinephrine were also excluded from the study. One patient was excluded from the study for not initially disclosing the daily use of Percocet® for chronic back pain.
Approval for this study was obtained from The Ohio State University Human
Subjects Review Committee and written consent was obtained from each participant. All
28 study medications were kept in a locked cabinet only accessible by the supervising investigator.
Each subject participating in the study had a radiolucency at the apex of a symptomatic tooth with pulpal necrosis. A periapical image was taken of the tooth, using a paralleling device and digital radiographic imaging software (Schick, Long Island City,
NY), to determine the presence of the radiolucency. Each patient’s tooth also had a negative response to an electric pulp tester (Analytic Technology Corp., Redmond, WA) and to Endo-Ice™ (Hygenic Corp., Akron, OH). However, if the tooth was crowned, electric pulp testing was not completed. If any vital tissue was encountered upon endodontic access, the patient was excluded from the study. One patient was excluded due to the presence of vital tissue within the pulp chamber, and a second patient was excluded due to the presence of a fracture deeming the tooth non-restorable. For the non- debridement group, patients were not treated by the same operator when root canal treatment was initiated at the subsequent appointment following the study. Therefore, there was no definitive diagnosis recorded for patients participating in the non- debridement group. Patients were also required to have no/mild swelling, no fever above
100°F, and no draining sinus tract.
Each patient rated his or her initial pain on a Heft Parker Visual Analog Scale
(VAS) (83). The VAS was divided into four categories. No pain corresponded to 0 mm.
Mild pain was defined as greater than 0 mm and less than or equal to 54 mm. Mild pain also included the descriptors of “faint”, “weak”, and “mild” pain. Moderate pain was defined as greater than 54 mm and less than 114 mm. Moderate pain had the descriptor
29
of “moderate”. Severe pain was defined as equal to or greater than 114 mm. Severe
pain included the descriptors of “strong”, “intense” and “maximum possible”. To qualify
for the study, patients had to present with moderate to severe pain as rated on the VAS
(Appendix G). Each subject also completed the Corah’s Dental Anxiety Scale
questionnaire (Appendix E).
Each of the patients received two cartridges of 2% lidocaine with 1:100,000
epinephrine (Xylocaine, AstraZeneca LP, Dentsply, York, PA) by infiltration or inferior
alveolar nerve block. For the maxillary teeth, a standard maxillary infiltration injection
was administered. The target site was centered over the maxillary tooth apex using a 27-
gauge 1¼ -inch needle (Monoject; Sherwood Services AG) attached to a standard aspirating syringe. Two cartridges of 2% lidocaine with 1:100,000 epinephrine were administered on the buccal or labial aspects of the tooth. For the mandibular teeth, two cartridges of 2% lidocaine with 1:100,000 epinephrine were administered utilizing a conventional inferior alveolar injection with a 27 gauge 1¼- inch needle (Monoject;
Sherwood Services AG) attached to a standard aspirating syringe. Before both the mandibular and maxillary injections, topical anesthetic (20% benzocaine; Patterson
Brand Dental Supply, Inc.) was placed on a cotton swab and placed passively at the injection sites for 60 seconds.
For the inferior alveolar nerve block injection, after initial needle penetration, the needle was advanced over a time period of approximately 10 seconds to the target site. The needle was then withdrawn 1mm, aspiration performed, and one cartridge of the anesthetic solution deposited over a period of 1 minute. After deposition was
30
complete, the needle was removed. For maxillary infiltration injections, after initial
needle penetration, the needle was advanced over a time period of approximately 3
seconds to the target side. Aspiration was performed, and one cartridge of the anesthetic
solution deposited over a period of 1 minute. After deposition was complete, the needle
was removed. Prior to insertion of the needle and deposition of the anesthetic solution,
each subject was informed of the rating scales to be utilized for rating pain of needle
insertion, needle placement, and deposition of the anesthetic solution. Each subject was
told that three words would be said during the anesthetic injection and they should
remember the way they felt when each word was said. The word “insertion” was said
immediately upon inserting the needle into the mucosa, “placement” was said as the
needle was advanced to the target site and “deposition” was stated as anesthetic was
being deposited into the mucosa. Following the injection of the first cartridge of 2%
lidocaine with 1:100,000 epinephrine, each subject was asked to rate each of the above
procedures utilizing the VAS described earlier. Pain ratings were obtained from subjects
for the first injection given prior to treatment as well as for supplemental injections given
during the procedure when deemed necessary. Pain ratings were not obtained for the
injection of the second cartridge of anesthetic given prior to the initiation of treatment.
However, the administration of the second cartridge followed the same regimen as
administration of the first cartridge.
Before the experiment, the two regimens (initial endodontic access opening and
tissue debridement or no debridement) were randomly assigned five-digit numbers from a random number table created on the website www.random.org. Each patient was
31
randomly assigned to each of the two regimens to determine which regimen would be
administered at the appointment. Each assignment and any alterations to the assignment were determined at the beginning of the appointment for endodontic treatment (prior to the patient being seen by the operator). Only the random numbers were recorded on the data collection sheets to blind the experiment.
In the debridement group, after achieving soft tissue anesthesia and following application of the rubber dam, endodontic treatment was initiated. All subjects were given ten minutes following the second anesthetic injection to achieve soft tissue anesthesia (77). The patient was advised to raise his/her hand if any discomfort was felt at any time during endodontic treatment. A VAS (as described earlier) was used to record any pain felt during initial access into dentin, upon accessing the pulp chamber, or while instrumenting canals during the entire debridement procedure. Even if the patient did not raise his/her hand during the procedure, treatment was stopped after each of the previous three phases to allow the patient to record any discomfort on the VAS. If the patient rated the pain as moderate to severe, treatment was completed by giving additional anesthetic using the same technique as previously described. All supplemental injections were given using 1 cartridge of 4% articaine with 1:100,000 epinephrine. Following the supplemental injection, subjects were asked to record, on the VAS, any pain felt during needle insertion, needle placement and deposition of the anesthetic solution.
Canal preparation was completed using K-type hand files (Tulsa Dentsply, Tulsa
OK) and rotary files. Initially, a #10 K-file was used to explore the canal. Working length was established by exposing a radiograph with either #10 or #15 K-file in place.
32
Each canal was then filed to a size #20 K-file and Vortex rotary instruments (Tulsa
Dentsply, Tulsa OK) were used to enlarge the canals utilizing a crown down technique.
Canals were enlarged until sufficiently cleaned and shaped most often to a size between
30/.04 and 40/.04 depending on the tooth and canal treated.
The tooth was irrigated with 10ml of 3% NaOCl (Clorox, Clorox Company,
Oakland, CA) upon access, during the debridement, and after the final file. The canals were then dried with paper points. Calcium hydroxide (Multi-Cal™, Pulpdent Corp,
Watertown, MA) was placed into each canal (1.2mL) with the manufacturer’s syringe by placing a capillary tip (0.014” Diameter Capillary Tip, Ultradent Products Inc., South
Jordan, Utah) to length and backfilling. Then the Ca(OH)2 was worked into the canals with K-type hand files. A cotton pellet was placed and the tooth was temporized with
Cavit (Cavit G, 3M ESPE, Seefeld, Germany). During canal instrumentation, five subjects continued to record moderate to severe pain even after supplemental injections were given. One of these five patients chose to stop endodontic treatment following instrumentation to size 15/.02 due to pain. The tooth being treated was a mandibular molar. The other four patients chose to continue working through the pain even though adequate anesthesia had not been obtained. The tooth being treated was a mandibular molar in three of the four patients and a maxillary anterior tooth in one patient. Irrigation with 3% NaOCl, placement of calcium hydroxide and temporization of the teeth was then completed as previously described.
33
For the non-debridement group, once the diagnosis was made, local anesthesia
was administered using two cartridges of 2% lidocaine with 1:100,000 epinephrine as
described above. This completed the treatment phase.
Subjects in each group were given the same local anesthesia and pain medications. Each patient received a prescription for an appropriate antibiotic (500mg penicillin; if allergic – 300mg clindamycin) to be taken every six hours until gone. A total of 7 patients were prescribed clindamycin due to a penicillin allergy. Six of these patients were in the debridement group and one patient was in the non-debridement group. Many patients are prescribed an antibiotic by their general dentist or a hospital emergency room prior to presenting for emergency endodontic treatment. If the patient presented to the clinic already taking an antibiotic, they were instructed to finish their current regimen.
The patient was also given a 5-day supply of 600mg ibuprofen (Amneal Pharma. of NY, Hauppage, NY) with instructions to take 1 tablet every 6 hours as needed for pain.
In addition, each patient also received a 5-day supply of 500mg acetaminophen (Amneal
Pharma. of NY, Hauppage, NY ) with instructions to take 2 tablets every 6 hours as needed for pain. Each of the pain medications were placed in separate 30 dram bottles.
The bottles were affixed with labels containing the drug information including the name, dose, quantity and medication instructions. If the ibuprofen/acetaminophen given to the patient was not managing their pain, the patients were instructed to call an assigned cell phone number that was carried by the investigator. The patients were instructed not to take any other pain or antibiotic medications. After speaking with the investigator, if an
34
escape medication was needed, hydrocodone/acetaminophen (5/500mg 20 tabs 1 tab
every 6 hours) was prescribed for the patient. Due to the recent changes to the drug
formulation, some patients may have received hydrocodone/acetaminophen 5/325 or
hydrocodone/acetaminophen 5/300 based on pharmacy availability. The patient was
instructed to stop taking the acetaminophen once starting the escape medication to avoid
taking multiple doses. The patient was seen emergently in the clinic if the need arose.
Patients received a diary for the day of the appointment and 5-days
postoperatively to record any pain they were having and the amount of pain
(ibuprofen/acetaminophen or escape) medication they took (Appendix L). On the day of
the appointment, patients were asked to record the time of day when the anesthesia wore
off and then record any pain or discomfort utilizing a VAS. They were then asked to
record the number of pain medications taken within each 24-hour period. Instructions in
the pain diary asked patients to record each night before bed any pain they were feeling
on a VAS, as described earlier. There was also a place for patient comments in the diary.
Patients were asked to return all unused medications upon completion of the study to
verify diary input. The patients received $50 at the end of the debridement appointment
or non-debridement appointment for participation in the study. Upon the completion and
return of the survey and all unused medications, subjects received another $50. The
patients were allowed to return the survey and all unused medications at their next
scheduled appointment or at another time determined by the patient and the investigator.
The patients assigned to the non-debridement group were allowed to return for treatment
5 days later or at the earliest convenient appointment.
35
Patients were instructed to complete a 5-day pain diary at home. However, 10 patients never returned their postoperative surveys. Eight of these patients were in the debridement group, while 2 were in the non-debridement group. These 10 patients were dropped from the study.
Between group differences in pain and medication use were analyzed using the multiple Mann-Whitney-Wilcoxon tests and the Step-down Bonferroni method of Holm.
Escape drug utilization was analyzed using the Chi-square test.
With a non-directional alpha risk of 0.05 and assuming an escape-drug utilization rate of 20% (17) a sample size of 50 patients per group was required to demonstrate a difference in utilization rate of ±30% with a power ≥0.89. For VAS pain scores, assuming a standard deviation of 50.3 (17), a difference of ±30 mm could be detected with a power of 0.84 with 50 patients per group. However, because of potential withdrawal by subjects, the total number was set to 110.
36
CHAPTER 3
RESULTS
A total of 108 subjects were enrolled in this study. Thirteen subjects were
disqualified for various reasons including: one due to the presence of vital pulp tissue
upon access, one due to a fracture detected upon access, ten for not returning
postoperative surveys and one for not disclosing the use of Percocet® daily for chronic
back pain. Ultimately, 10 patients were disqualified from the debridement group and 3
patients were disqualified from the non-debridement group. The total number of subjects
analyzed was 46 in the debridement group and 49 in the non-debridement group. In the
debridement group, 44% of subjects treated were female and 56% were male. In the non-
debridement group, 51% of subjects were female, while 49% were male. There was no
statistically significant difference in the ratio of females to males between the two groups
(Table 1). The mean age in the debridement group was 36.3 +/- 12.1 years, and the mean age in the non-debridement group was 39.1 +/- 16.1 years. There was no statistically significant difference between the two groups with respect to age (Table 1). Results from the Corah Dental Anxiety Questionnaire can also be found in Table 1. The median score was 9 for both the debridement and non-debridement groups with no statistically significant difference between the two groups. Each patient participating in
37
the study was required to have moderate to severe pain. The mean initial pain score for
the debridement group was 118 +/- 26.8mm on a 170mm VAS. Similarly, the mean initial pain score for the non-debridement group was 119 +/- 27.3mm. There was no
statistically significant difference between the two groups (Table 1).
Table 2 shows the preoperative statistics by jaw and tooth type. In the
debridement group, 24 teeth were maxillary and 22 mandibular, which equates to 52.2%
and 47.8%, respectively. In the non-debridement group, 25 (51%) of the teeth were
maxillary and 24 (49%) were mandibular. There was no statistically significant difference
between the two groups. The tooth type was also recorded in Table 2. In the debridement
group, 31 teeth were molars, 12 teeth were premolars and 3 teeth were anteriors. In the
non-debridement group, 35 teeth were molars, 8 teeth were premolars and 6 teeth were
anteriors. There was no statistically significant difference between the two groups with respect to tooth type.
Patients were included in this study if they required either initial root canal
therapy or if root canal therapy had already been initiated, but not obturated and the teeth
were re-infected and symptomatic. Table 3 shows the preoperative statistics by treatment
type. In the debridement group, 33 teeth required initial root canal therapy, while 13 teeth
were re-cleanouts of previously initiated teeth. In the non-debridement group, 41 teeth
required initial root canal therapy, while 8 teeth were re-cleanouts. There was no
statistically significant difference between the two groups.
38
Tables 4 and 5 illustrate the pain of injection. Both the debridement and non-
debridement groups had similar mean pain values for needle insertion, and needle
placement. However, mean anesthetic solution deposition pain was 65.1mm in the non-
debridement group compared to 84.8 mm in the debridement group. Despite this
difference, the mean pain value for both groups still fell into the moderate pain category.
There was no statistically significant difference between the two groups for pain of
needle insertion, needle placement or solution deposition.
Tables 6 and 7 show the pain reported during emergency treatment of the
debridement group. After the initial anesthetic injection, the highest pain levels were
reported during canal instrumentation. Patients were given a supplemental anesthetic
injection if they reported a pain level of moderate or higher at any point during treatment.
Following administration of the supplemental injection, pain levels were again recorded
as post-supplemental injection pain. Fourteen patients required a post-supplemental injection. The mean pain values found during access of the dentin or pulp chamber and during canal instrumentation post-supplemental injection all fell into the moderate category. During canal instrumentation, 5 subjects continued to report moderate to severe pain even after supplemental injections were given. One of these 5 patients chose to stop endodontic treatment following instrumentation to a size 15/.02 due to pain. The other 4 patients chose to continue working through the pain even though adequate anesthesia had not been obtained.
Table 8 shows the number of patients in each group who utilized an escape drug.
In the debridement group, a total of 9 patients, or 19.6%, used an escape drug, while 6 39 patients, or 12.2%, utilized an escape drug in the non-debridement group. There was no statistically significant difference between the two groups.
Tables 9 and 10 show the postoperative pain levels reported by the patients who did not use an escape medication. Postoperative pain was recorded on the day of treatment when the anesthesia wore off as well as that night before going to bed. These values are reported as post-anesthesia and day 0 in the tables, respectively. In the debridement group, moderate pain was reported only post-anesthesia and on day 0 at which point it fell to mild on day 1 with the lowest pain reported on day 5. In the non- debridement group, moderate pain was reported through day 2 and fell to mild at day 3. A significant difference was detected on day 5 between the debridement and non- debridement groups. On day 5, the mean was 19.8 +/- 27.5mm for the debridement group and 47.1 +/- 39.5mm for the non-debridement group. Pain levels were reported as moderate to severe in the debridement group in 62% on day 0, 50% on day 1, 36% on day
2, 23% on day 3, 17% on day 4, and 14% on day 5 (Table 10). Conversely, in the non- debridement group, moderate to severe postoperative pain was reported in 52% on day 0,
67% on day 1, 58% on day 2, 44% on day 3, 48% on day 4 and 38% on day 5 (Table 10).
Tables 11 and 12 show the postoperative pain level reported in the patients who used an escape medication. A total of 9 patients went to an escape medication in the debridement group and 6 patients were included in the non-debridement group, which is a very small sample. The majority of pain was reported on days 0 and 1 in both the debridement and non-debridement groups. In the debridement group, mean pain values were in the moderate category on day 0 and fell to mild at day 5. In the non-debridement 40
group, mean pain values were in the severe category on day 0, but also fell to mild at day
5. There was no statistically significant difference in pain levels reported between the two
groups.
Table 13 shows the total drug utilization for the patients that did not use an escape
medication in the debridement and non-debridement groups. The most tablets were taken on days 0 through 3. Over the 5-day study period, the total number of tablets taken
decreased with the least amount being taken on day 5. Although there was no statistically
significant difference in the number of tablets taken between the two groups, the non-
debridement group had a higher number of mean tabs and a higher median number of
tabs taken.
Table 14 shows the number of patients who took no pain medication. The highest
number of patients taking pain medication was found on day 1. Over the course of the 5
days, the number of patients taking no pain medication increased until its peak at day 5.
In general, there was a higher percentage of patients in the debridement group taking no
pain medication compared to the non-debridement group on each day. On day 1, only 5% of patients in the debridement group and 7% of patients in the non-debridement group were taking no medications. By day 5, 59% of patients in the debridement group were taking no medication compared to 23% of patients in the non-debridement group.
Table 15 shows the total number of patients utilizing an escape drug by day. The highest number of patients reporting escape drug use was found on day 1 in both the debridement and non-debridement groups. This number dropped from 78% on day 1 to
41
59% on day 5 in the debridement group and from 83% on day 1 to 33% on day 5 in the non-debridement group.
Table 16 shows the mean number of narcotic tablets taken per day. The highest number of tablets was taken on day 1. Over the next four days, this number continued to drop until it reached a mean of 1.4 tablets in the debridement group and 1.5 tablets in the non-debridement group on day 5.
Tables 17 and 18 show the mean number of ibuprofen and acetaminophen tablets taken per day in the patients not taking an escape medication (Table 17) and patients taking an escape medication (Table 18).
Figure 1 illustrates the mean postoperative pain levels by group and day. As is shown in the Figure, pain levels started higher at days 0 and 1 and continued to drop through day 5.
Figure 2 illustrates the total medication use (mean number of tabs) by group and by day. Medication usage was highest on day 1 and then continued to fall over the duration of the 5 days.
Figure 3 illustrates the percentage of patients utilizing an escape medication in each group. There was a similar number of patients requiring an escape medication in both the debridement and non-debridement groups.
42
CHAPTER 4
DISCUSSION
Patients are commonly prescribed antibiotics and pain medication for dental pain in the emergency room. However, it is not known what happens to these patients once they leave the hospital setting (5). Does their pain improve over the course of the next few days? Or, does their pain worsen until they finally seek traditional dental care?
There are currently no studies to demonstrate if initial root canal debridement is better than just placing the patient on medications. Our hypothesis was that initial debridement would lead to less postoperative pain and less medication use. Bacteria have been shown to be the prominent cause of endodontic infections and apical periodontitis
(28). Debriding the tooth using chemomechanical instrumentation effectively reduces the bacterial load (34). In addition, the placement of calcium hydroxide has been shown in some studies to further reduce the bacterial level after instrumentation has been completed (36-41).
There have been several proposed mechanisms of action for calcium hydroxide.
Siqueira and Lopes published a critical review highlighting the different mechanisms of antimicrobial activity that have been proposed over the years. Calcium hydroxide is known to have a pH of about 12.5, which makes bacterial survival difficult. This high pH and the release of hydroxyl ions are known to exert lethal effects on bacterial
43
cells. Hydroxyl ions destroy phospholipids on the bacterial cell membrane by removing
hydrogen atoms from unsaturated fatty acids. This inevitably leads to the production of
peroxides and the subsequent removal of additional hydrogen atoms from unsaturated
fatty acids. Another consequence of the high pH found in calcium hydroxide is protein
denaturation, or the breakdown of bonds that maintain the tertiary structure of proteins.
Once this bond is lost, cell metabolism is disrupted which is critical for proper cell function. Finally, hydroxyl ions are known to inhibit DNA replication and induce potentially lethal mutations (35).
Several studies have been conducted to determine the efficacy of calcium hydroxide as an intracanal medicament (36-41). Sjogren et al. conducted a study utilizing
30 necrotic teeth with periapical lesions in order to compare the effectiveness of a 10 minute versus 7 day application of calcium hydroxide. All teeth were instrumented to a size 40 or larger using 0.5% sodium hypochlorite as an irrigant. Calcium hydroxide paste was then placed into the canal and left for either 10 minutes or 7 days. Pre- and post- instrumentation samples were taken from each canal and examined. Following the one week dressing with calcium hydroxide, bacteria were not found in any samples. Samples were taken again after 1-5 weeks with no dressing present and again, bacteria were not found to be present. On the other hand, 6 samples showed bacteria following the 10 minute application of calcium hydroxide. Therefore, calcium hydroxide was shown to be highly effective in eliminating bacteria when used for 7 days. A 10 minute application, however, was ineffective at destroying all bacteria (36).
44
Vera et al. also conducted a study comparing one-visit and two-visit endodontic therapy in teeth with apical periodontitis. Thirteen teeth were divided into one-visit and two-visit treatment groups. All teeth were instrumented to a size 40/.06 and irrigated with
5% NaOCl and 17% EDTA. Canals in the two-visit group were medicated with calcium hydroxide for one week. The pH of the paste was also measured to ensure a pH of 12.5 or higher. Following seven days, root canals in the two-visit group were re-instrumented and obturated. All teeth were extracted after one week and evaluated histologically. Results showed that no teeth in the one-visit group were free of bacteria. In the two-visit group, 2
teeth were found to be free of bacteria and no bacteria were found in the main root canals of 5 of the 7 roots studied. Additionally, no bacteria were found in the dentinal tubules surrounding the main canals in all 7 roots. Therefore, a two-visit protocol with calcium
hydroxide as an intracanal medicament for seven days resulted in a reduction of bacteria
compared with a one-visit protocol. Bacteria remaining in the one-visit group were more
frequently found in isthmuses, ramifications and dentinal tubules. Therefore, according to
Vera et al., “the use of an antibacterial interappointment agent is necessary to maximize
bacterial reduction before filling” (37).
Xavier et al. conducted a study to determine the effectiveness of one- versus two-
visit root canal treatment on the removal of endotoxins and cultivable bacteria. Forty-
eight infected root canals were divided into single-visit treatment and two-visit treatment
groups with the placement of calcium hydroxide for fourteen days. Results showed that
two-visit treatment was more effective in reducing endotoxins compared to the single-
visit treatment group (38).
45
Furthermore, both Gama et al. and Yoldas et al. studied the effect of intracanal medicaments on postoperative pain. Gama et al. found no statistically significant difference between the use of chlorhexidine and calcium hydroxide with camphorated paramonochlorophenol paste on postoperative pain. All teeth included in the study were asymptomatic with either a diagnosis of pulpal necrosis or requiring retreatment. Results showed that 84% of the patients treated reported no pain following treatment. Gama et al. therefore recommended that an intracanal medicament be placed in two-visit endodontic treatment due to the low incidence of postoperative pain and the antimicrobial effectiveness of the medicaments (39). Similarly, Yoldas et al. found that a calcium hydroxide and chlorhexidine combination for one week reduced postoperative pain of previously symptomatic teeth and led to a decrease in the number of flare ups. All teeth included in this study were endodontic retreatment cases (42).
In contrast, Beus et al. conducted a study comparing the effect of two different irrigation protocols and interappointment calcium hydroxide on the elimination of bacteria from the root canal system. Fifty patients were included in the study, and endodontic therapy was performed in two visits with calcium hydroxide as the intracanal medicament. Teeth were instrumented and passive ultrasonic irrigation or non-ultrasonic irrigation was used depending on the group assigned followed by the placement of calcium hydroxide. A bacterial sample was taken at the second appointment, which was scheduled no sooner than 7 days following the initial appointment. Results showed the overall negative culture rate of the entire sample was 82% for the first visit compared to
87% after medication with calcium hydroxide at the second appointment. After
46
instrumentation and irrigation at the second appointment, 91% showed a negative culture
rate. However, there was no statistically significant difference between any of the three
groups (43).
El Mubarak et al. evaluated postoperative pain in multiple visit and single visit
endodontic treatment. The study included 234 patients with various pulpal diagnoses
treated endodontically by undergraduate dental students. The incidence of postoperative
pain was higher in patients reporting preoperative pain compared to those presenting
asymptomatically. In addition, 13.7% of nonvital teeth exhibited postoperative pain
compared to only 7.8% of vital teeth. No pain was reported in 90.6% of those treated in a single visit compared to 88.6% of those treated in multiple visits. There was no statistically significant difference detected between the two groups (48).
A Cochrane Review was conducted by Figini et al. comparing single versus
multiple visit endodontic treatment. Twelve studies were included in the review.
Outcomes assessed in the study included radiographic success, postoperative pain and
analgesic use. No difference in postoperative pain was detected between the single visit
treatment group and the multiple visit group. In addition, no difference was detected
between the groups with regard to radiographic success. However, the single visit
treatment group resulted in significantly more analgesic use compared to the multiple
visit treatment group (45).
In addition, both Walton et al. and Trope et al. showed no significant difference in
incidence or severity of postoperative pain in teeth treated with calcium hydroxide
compared to other intracanal medicaments (46, 47). Walton et al. compared the use of
47
calcium hydroxide to a dry cotton pellet inside the tooth and found that calcium
hydroxide did not decrease the amount of postoperative pain. One hundred-forty patients
were treated in this study, of which 31% of teeth were vital and 69% of teeth treated were diagnosed with pulpal necrosis. Results showed a 30% incidence of moderate to severe pain at 4 hours post treatment, 16% at 24 hours and 8% at 48 hours (46).
Siqueira et al. conducted a study investigating the effects of chemomechanical
preparation with 2.5% sodium hypochlorite and intracanal medication with calcium
hydroxide on cultivable bacteria in infected root canals. Bacterial samples were collected
from 11 teeth at baseline, after cleaning and shaping using 2.5% NaOCl as an irrigant and
following calcium hydroxide placement for one week. A significant reduction in bacteria
was seen between the baseline and following cleaning and shaping, but no difference was
detected between bacterial levels after cleaning and shaping and levels following one
week of a calcium hydroxide dressing. Therefore, the seven day calcium hydroxide
protocol did not significantly reduce bacterial counts in infected root canals (44).
Although Siqueira et al. showed no significant difference in bacterial levels in the
previous study, two subsequent studies showed an increase in the number of negative-
culture cases when a seven day dressing with calcium hydroxide was used (40).
According to Siqueira and Lopes, the efficacy of calcium hydroxide as an
intracanal medicament is dependent on its ability to maintain an alkaline pH. However,
pH values are often lower at more distant areas from the root canal creating a varying pH.
This may allow the subsequent survival or growth of some bacteria that thrive in that type
of environment. According to Atlas, some strains of E. coli, P. vulgaris, E. aerogenes
48
and P aeruginosa survive in a pH of 8 or 9. Additionally, fungi have been found to live in
a range of pH 5-9 (35). Recent findings have suggested that calcium hydroxide is not effective against some of these strains of bacteria, most notably E. coli and C. albicans
(34, 67). Therefore, its efficacy as an intracanal medicament has been called into
question.
The previous studies show conflicting evidence for the effectiveness of calcium
hydroxide as an intracanal medicament and its effect on postoperative pain. However,
most of these studies compared one-visit to two-visit endodontic treatment whereas our
study is comparing no initial treatment to two-visit endodontic treatment. Although
calcium hydroxide may not kill all bacteria involved, it is an antibacterial medicament
commonly used to reduce bacterial load. Theoretically, by reducing the bacterial level
inside the tooth whether through chemomechanical debridement alone or in conjuction
with the use of calcium hydroxide, healing and/or a decrease in pain levels may be
achieved sooner than if the tooth is not debrided initially. Therefore, patients treated with
an initial debridement of a symptomatic tooth diagnosed with pulpal necrosis should get
better faster than those in whom treatment is delayed. However, even when patients are
treated endodontically initially, they do not feel immediate relief of their pain (28). Part
of this is due to the inflammation/infection present periapically, which takes time to
resolve in symptomatic teeth with pulpal necrosis and periapical areas. This condition
may present as an exacerbation of an asymptomatic tooth with pulpal necrosis- or a flare-
up.
49
The endodontic flare-up is a somewhat controversial topic. Different authors have
different definitions and criteria for the term. However, it is most commonly defined as
an acute exacerbation after root canal treatment resulting in significant pain and/or
swelling. Typically, a flare-up results in an unscheduled visit to the dental office for the
management of patient symptoms (68).
According to Walton and Fouad, a flare-up consists of pain or swelling or both that requires an unscheduled visit to the office followed by endodontic treatment in the form of incision and drainage, re-instrumentation of the canals, or an opening of the tooth to allow for drainage (59). In comparison, Trope simply defines a flare-up as intolerable pain and/or swelling (70). Due to the varying definitions of flare-up by different authors, it is difficult to compare studies. Therefore, each study must be viewed in light of the proposed definition of a flare-up by each author, and the requirements for a “flare-up” should not be assumed.
Flare-up incidence has been extensively studied. However, findings have been highly variable likely due to the difference in definition among different authors. A meta- analyses of the literature was completed by Tsesis et al. to determine flare-up frequency.
The results of six different studies were pooled in order to increase the sample size and power. The studies included defined a flare up as “strong pain with or without swelling that occurs after initiation or continuation of root canal treatment” within 24-48 hours following treatment as dictated by a VAS. A total of 982 patients were included in the meta-analyses with the incidence of flare-ups found to be 8.4% (71). Trope completed a similar study of 226 patients where a flare-up was defined as intolerable pain and/or
50
swelling. The overall incidence was 1.8% with all cases occurring in teeth previously
diagnosed with apical periodontitis. Flare-ups were most commonly seen in retreatment
cases at 13.6% or 3 out of 22 cases (70).
Pickenpaugh et al. conducted a study investigating the effect of prophylactic
amoxicillin on endodontic flare-up in asymptomatic, necrotic teeth. Seventy patients were
included in the study and were randomly given either 3 grams of amoxicillin or 3 grams
of placebo. Following endodontic treatment, each patient received ibuprofen and
acetaminophen with codeine. Patients were asked to record their pain level and amount of
pain medication taken. In this study, a flare-up was defined as moderate to severe postoperative pain and/or swelling. Results showed a flare up rate of 10%. Flare-ups
began on average 30 hours after treatment and lasted for approximately 74 hours. In
addition, prophylactic amoxicillin did not reduce the rate of flare-ups (72).
Other authors define a flare-up as pain and/or swelling requiring an unscheduled visit and active treatment of the offending tooth (69, 73). Walton and Fouad completed a study of 946 patients, in which 30 flare-ups occurred with an overall incidence of 3.17%
(69). Imura and Zuolo, utilizing the same definition for flare-up, studied 1,012 teeth and
found an overall incidence of 1.58% (73). Mor et al. referred to the flare-up phenomenon
as an interappointment emergency, but the criteria were the same as that used by Walton
and Fouad and Imura and Zuolo. Three hundred thirty-four patients were included in the
study and an incidence of 4.2% was detected (74). Additionally, a study completed by
Alves of 266 patients and 408 teeth found a flare-up rate of 1.71% (20).
51
Several factors have been associated with flare-ups including tooth type and
location, gender, age, pulp vitality, presence of periapical lesion and history of pre-
operative pain. In Walton and Fouad’s study of flare-ups in 946 patients, no statistically significant difference was found in gender, age or number of treatment visits. However, those who presented with severe preoperative pain and swelling had flare-up incidences of 19% and 15%, respectively. In addition, fewer flare-ups were seen in teeth with vital pulps compared to those with pulpal necrosis (69).
In the study completed by Mor et al. evaluating interappointment emergencies of
334 patients, no statistically significant differences were detected between gender, age group, tooth location and presence of periapical radiolucency. However, a higher incidence was noted in nonvital teeth compared to vital teeth. In addition, it was found that swelling was present in 50% of interappointment emergencies (74).
Torabinejad et al. conducted a retrospective study comparing patients with no complications following endodontic treatment to those reporting pain or swelling and requiring a nonscheduled emergency visit. Several factors were assessed to determine those associated with interappointment emergencies (IAE), but only necrotic teeth were evaluated in the study. Factors associated with higher rates of IAE were found to be female gender, patients in the 40 to 59 year age range, mandibular teeth, absence or small size periapical radiolucency, and presence of preoperative pain (18).
Iqbal et al. defined a flare-up as an acute exacerbation of an asymptomatic tooth follow endodontic treatment. In their study, records were taken from an electronic database and analyzed for the occurrence of flare-ups. A flare-up was diagnosed when
52
patients presented for an unscheduled visit for treatment due to pain and/or swelling after
endodontic treatment had been initiated. A total of 6,580 patients were treated from 2000
to 2005 with a total of 26 patients diagnosed with a flare-up. Therefore, in this
retrospective study, the incidence of flare-up was 0.395%. There was no statistically
significant difference found between gender, age groups, amount of preoperative pain,
periapical diagnosis, tooth type or instrumentation technique. However, it was found that
teeth with a periapical radiolucency were 9 times more likely to have a flare-up compared
to those without a radiolucency (75). Other studies have found an increased rate of flare-
up with periapical radiolucencies as well including those conducted by Trope, Imura &
Zuolo and Alves (20, 70, 73).
Causes of endodontic flare-ups have been attributed to the apical extrusion of
debris, changes in the environment or microbiota present, and secondary infections from
bacteria or viruses allowed to penetrate canals during or after instrumentation. Several
preventive measures have been suggested including the selection of instruments and
techniques that extrude the least amount of debris, completion of procedures in one visit,
the use of intracanal medicaments between appointments, never leaving the tooth open
for drainage, and maintaining an aseptic technique during procedures (76).
Even after root canal therapy has been initiated in patients requiring endodontic
treatment, they may still experience significant postoperative pain, and their pain is not
eliminated immediately (28). In contrast, some patients with a symptomatic tooth with
pulpal necrosis may not have the ability to obtain emergency endodontic treatment either due to access to care issues or because their general dentist is unable to provide treatment.
53
Therefore, this study was proposed in order to determine the efficacy of endodontic debridement on postoperative pain in patients with symptomatic teeth with a pulpal diagnosis of necrosis.
Table 1 demonstrates the total number of patients participating in this study, 46 in the debridement group and 49 in the non-debridement group. There was no statistically significant difference between the two groups with respect to age, gender, initial pain or
Corah score.
Female gender has been associated with an increase in postoperative pain in some studies. According to a study conducted by Torabinejad et al., which evaluated factors associated with inter-appointment emergencies of teeth with necrotic pulps, female patients over the age of 40 had more postoperative complications than males (18). This finding was substantiated by both Genet et al. and Fox et al. who found that females reported more postoperative pain than males following endodontic treatment (14, 16).
According to Arias et al., the main factor in predicting postoperative endodontic pain lasting more than 2 days is gender, with females reporting a longer duration of pain (12).
In our study, there was no statistically significant difference among the gender of the patients in each group. Therefore, the effect of gender on our results is minimal.
Another variable analyzed in our study was patient age. Table 1 shows that there was no statistically significant difference for the two groups with respect to age (Table 1).
This is important because age has been found by some authors to be a predictive factor for postoperative pain. O’Keefe found that patients over the age of 20 reported more postoperative pain than those under the age of 20, which is in agreement with studies
54 conducted by Seltzer, Bender and Ehrenreich (22). Torabinejad et al. noted that “patients in the 40 to 59 year range were more susceptible to developing interappointment emergencies than other age categories” (18). Arias et al. also noted that the age of the patient was a significant predictive factor of postoperative pain and attributed this to the decrease in pulp size often seen in older patients (12). However, Genet et al., Fox et al.,
Clem, Maddox et al. and Mulhern et al. did not find any association between patient age and postoperative pain (14).
In our study, the majority of subjects were under the age of 40. A total of 35 out of 95 subjects were age 40 or over, which is about 36.8%. Nineteen of these patients were in the non-debridement group, while sixteen were in the debridement group. Therefore, both groups not only had patients of a similar age range, but also had a similar number of patients over the age of 40. Of those patients that ultimately used an escape medication, five were age 40 or older with three being in the debridement group and two in the non- debridement group. Interestingly, this equates to 2/6 or 33% of subjects in the non- debridement group and 3/9 or 33% of patients in the debridement group that were age 40 or older and required an escape medication. Although it is not known for certain the effect of age on postoperative pain, it appears that it did not play a major role in postoperative pain levels in our study as only 33% of patients 40 or older resorted to an escape drug. Nonetheless, any possible effects of patient age have been minimized in our investigation due to the similarity of the age range between the two groups.
In order to qualify for the study, patients were required to be experiencing moderate to severe pain as reported on a 170mm VAS. There was no significant
55 difference between the two groups with respect to preoperative pain level. This is important because the level of preoperative pain reported has been associated with a higher incidence of postoperative pain following endodontic treatment. Torabinejad et al. conducted a study utilizing 400 teeth requiring endodontic therapy treated in five different endodontic offices over a period of 3 years. It was determined that “the presence of preoperative complaint is an excellent predictor for interappointment emergencies” (18). O’Keefe found similar results when studying the effect of preoperative pain on postoperative pain. He determined that the level of postoperative pain was directly proportional to the severity of the preoperative pain. “Patients with moderate or severe preoperative pain were five times more likely to have moderate or severe operative or postoperative pain than were patients with mild or no preoperative pain” (22). Genet et al. found that preoperative pain in association with a non-vital tooth was associated with a four times higher incidence of postoperative pain than the same teeth without preoperative pain (14). In our study, the mean level of initial pain reported in each of the groups was in the severe range and only varied by a few millimeters with the standard deviation taken into account. Therefore, due to the similarity in initial pain scores between the two groups, the results in our study were not affected by this variable.
In addition to preoperative pain levels affecting post-operative pain, pulpal diagnosis has also been reported to affect postoperative pain levels. Genet et al. found that teeth with a non-vital pulp and preoperative pain were associated with an incidence of postoperative pain twice as high as teeth with a vital pulp either with or without preoperative pain (14). Furthermore, Siqueira et al. found an increased incidence of
56 postoperative pain in symptomatic teeth diagnosed with pulpal necrosis and no periapical radiolucency compared to teeth with a periapical radiolucency present(13). All teeth included in our study were diagnosed with pulpal necrosis and associated with a periapical radiolucency. Therefore, any potential differences in postoperative pain due to pulpal diagnosis and presence of a periapical lesion were eliminated.
Only patients experiencing moderate to severe pain were included in the study in order to reduce the effect of varying preoperative pain levels on postoperative pain.
However, the length of time patients were experiencing pain when they presented to the clinic was not taken into account. Therefore, patients presenting for our study may have been experiencing pain for different lengths of time and were likely in different phases of their flare-up. Some patients may have already hit the peak of their flare-up, while others may have been on the ascent. This could have conceivably affected the levels of postoperative pain reported over the next five days.
The Corah Dental Anxiety Questionnaire was used to determine the preoperative anxiety level. Table 1 demonstrates that the median number for both the debridement and non-debridement groups was 9. There was no significant difference between the two groups. This is important because anxiety has been associated with reduced pain tolerance and difficulty achieving anesthesia (77). In a study by Stanley et al., the effect of nitrous oxide on the success of the inferior alveolar nerve block was evaluated. It was found that in mandibular teeth diagnosed with symptomatic irreversible pulpitis, nitrous oxide significantly increased the success of the IAN block. However, this could have been attributed to the analgesic effect of the nitrous oxide and not necessarily its sedative
57 properties (79). Lindemann et al. found that conscious sedation using sublingual triazolam was not associated with an increase in success of the IAN block (80).
Therefore, the effect of anxiety on the ability to achieve anesthesia is controversial. In our study, both groups had the same Corah score, which was low to moderate. Thus, we can assert that anxiety did not play a large role in the outcome of this study.
A total of 13 patients were disqualified in our study (Table 1). Ten of these patients did not return their postoperative surveys following the 5 day postoperative period. Due to the lack of data, they were excluded from the study. In addition, one patient was excluded from the study for not initially disclosing the daily use of Percocet® for chronic back pain. This patient had been included in the non-debridement group and therefore received only an anesthetic injection. He informed the operator of his
Percocet® use upon dismissal and was subsequently disqualified from the study. The use of Percocet® daily was part of the exclusion criteria as it may have interfered with the level of pain reported and the ability to take the study medications.
One patient was excluded from the study due to the presence of vital tissue upon access. Each tooth included in the study had a negative response to cold and EPT as well as a periapical radiolucency present. However, in this patient, vital tissue was found upon access, and the patient was disqualified. One limitation of this study is that the diagnosis of pulpal necrosis was never confirmed in the non-debridement group. The patients in this group were not scheduled for root canal treatment at a set time, but at their own convenience. This meant that the patients were not always treated by the operator upon their return to the clinic for treatment. However, the operator did follow up with the
58 treating practitioner to ensure the diagnosis was correct upon access whenever possible.
Furthermore, if there was any doubt as to the vitality of the tooth at the initial appointment, the patient was placed in the debridement group by the lead investigator, not the operator, in order to achieve confirmation of the pulpal diagnosis.
Finally, one patient was disqualified from the study due to the presence of a fracture upon access ultimately deeming the tooth non-restorable. The fracture was detected internally and found to extend down the distal canal as well as externally down the distal aspect of the distal root. This type of fracture could have had an effect on postoperative pain levels, and since the tooth was also non-restorable, the patient was disqualified from the study.
Table 2 shows the pre-operative statistics for jaw and tooth type. The number of maxillary and mandibular teeth as well as the number of molars, premolars and anteriors treated was not statistically different between the two groups.
Mandibular teeth have been shown to be associated with a higher frequency of postoperative pain following endodontic cleaning and shaping procedures (12, 18). In a study conducted by Torabinejad et al., mandibular bicuspids followed by mandibular anteriors caused the most postoperative pain subsequent to cleaning and shaping. This was attributed to the diverse anatomy often seen in these teeth (18). Conversely, Arias et al. found that teeth with three or more canals, especially mandibular teeth, were found to be associated with increased postoperative pain (12). Similarly, Genet et al. found that teeth with “three or more canals treated caused postoperative pain nearly twice as frequently as teeth with two canals and three times as often as teeth with a single canal”. 59
One possibility for this finding is that practitioners may not be cleaning and shaping teeth with three or more canals as effectively as those with only a single canal (14).
In our study, there was no statistically significant difference between the debridement and non-debridement groups with regard to jaw or tooth type. This is important as some authors have asserted an increase in postoperative pain associated with mandibular teeth and with molars. Furthermore, pain during treatment may also be affected by tooth or jaw type. Molar teeth have more canals compared to anterior or premolar teeth and are typically more difficult to treat. In addition, it usually takes more time to treat a molar compared to an anterior or premolar tooth. A longer treatment time could mean a loss of anesthesia contributing to an increase in pain during treatment. In addition, anesthetic failure is reported more often with inferior alveolar nerve block injections in the mandible compared to a local maxillary infiltration. There are several theories for the high failure rate of the inferior alveolar nerve block including the additional layer of complexity involved in inferior alveolar nerve block injections compared to infiltrations with respect to varying patient anatomy and operator knowledge of anatomical structures. However, in a study by Bukhari et al., anesthetic success of the inferior alveolar block and the maxillary infiltration was evaluated in patients diagnosed with pulpal necrosis and experiencing moderate to severe pain. Success was determined by the need for a supplemental injection. The success rate in the mandible was 96% and in the maxilla was 91%. There was no statistically significant difference between the two groups (81). In our study, a total of 14 patients required supplemental anesthetic during treatment. The success rate, therefore, was 70% overall. Of the patients requiring
60 supplemental anesthesia, 6 teeth were maxillary, while 8 teeth were mandibular.
Therefore, our results appear to be similar to that of Bukhari et al. in that there was similar anesthetic failure rates between the maxillary and mandibular teeth treated (81).
Despite this fact, it is still important to have a similar number of teeth per jaw in each group in order to reduce the chance of results being skewed due to the use of different injection techniques. Furthermore, due to the association of mandibular teeth and increased postoperative pain as well as the possibility of treatment pain levels differing by tooth type due to number of canals, complexity and treatment time required, including a similar number and type of teeth per jaw in each group will minimize the effect of these variables on the study results.
Table 3 demonstrates the number of teeth in each group that required initial root canal therapy as opposed to teeth with endodontic therapy that had been previously initiated and had become re-infected. There was a similar number of re-cleanouts compared to teeth requiring initial treatment in each group with no statistically significant difference between the two. Ideally, we would have liked to include only teeth requiring initial root canal treatment. However, due to the difficulty in finding patients to qualify for this study, we included those with previously initiated root canals who reported to the clinic in moderate to severe pain. Furthermore, in an educational environment, this patient population is frequently treated as endodontic therapy is often completed in two appointments, and patients later return experiencing pain after not following through with treatment in a timely fashion.
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It is possible that the bacteria involved in the two different types of teeth treated
were different. A primary infection involves bacteria that initially invade the tooth
leading to pulpal necrosis. Mixed anaerobic/aerobic gram negative bacteria are typically
involved in a primary infection. Secondary infections, on the other hand, are caused by
bacteria that, although not present initially, gain access to the tooth subsequent to
endodontic initiation. Once the bacteria have penetrated the tooth, they colonize the
canals leading to a secondary infection. There is no single species that has been found to
persist following treatment, but gram-positive facultative and anaerobic bacteria such as
Streptococci, P. micra, Actinomyces, Propionibacterium, Lactobacilli, E. faecalis,
Olsenella uli and P. alactolyticus are most often detected. (28). Therefore, bacteria present in the re-cleanout group would have likely been gram-positive facultative and anaerobic compared to the gram-negative aerobic and anerobic bacteria that would have likely been found in the teeth requiring initial root canal treatment. Despite the different
bacteria likely present in these teeth, only teeth with a diagnosis of pulpal necrosis that
were symptomatic were treated, which is likely more predictive of pain during treatment
and postoperatively. Furthermore, there were was no statistically significant difference
between the number of re-cleanouts and teeth requiring initial root canal therapy in each
group. Therefore, the difference in a re-cleanout versus an initial start should not have
had significant bearing on our results.
Tables 4 and 5 illustrate the pain reported during the three phases of anesthetic
injection, needle insertion, needle placement and solution deposition. There were no
statistically significant differences in the level of pain reported for each of the three
62 injection phases in the debridement and non-debridement groups. For the debridement group, all three phases of the injection had similar mean pain ratings, which fell into the moderate category. Subjects in the non-debridement group reported similar mean pain ratings to the debridement group in each of the three phases except solution deposition.
Solution deposition mean pain was lower in the non-debridement group with a mean of
65.1mm compared to 84.8mm in the debridement group. Nonetheless, there was no statistically significant difference between the two groups with respect to solution deposition, and the pain ratings for both groups were in the moderate category.
A study conducted by Wells et al. also reported on maxillary infiltration and mandibular inferior alveolar nerve block injection pain in patients with symptomatic teeth with a diagnosis of pulpal necrosis. Moderate to severe pain was reported during needle insertion in 60%, during needle placement in 65% and during solution deposition in 52%
(17). In our study, the debridement group reported moderate to severe pain during needle insertion 79% of the time and during placement 81% and deposition 74% of the time. The non-debridement group reported moderate to severe pain during insertion 69% of the time and during placement and deposition 67% and 53% of the time respectively. Our numbers were slightly higher than that found by Wells et al., however still comparable.
In our study, injection pain ratings were separated by the debridement and non- debridement groups and not by injection type: maxillary infiltration or mandibular inferior alveolar nerve block. The purpose of our study was not to compare injection pain ratings, but to look at pain levels overall and differences between the debridement and non-debridement groups. Therefore, injection pain was evaluated only to compare how
63 the patients in each group reacted to pain. If one group had reacted more severely to the injection, this would have implied the groups may not have responded in the same way to pain making it difficult to form definitive conclusions from our postoperative findings.
However, since there was no statistically significant difference between the two groups with respect to pain of injection, we know that patients in both groups responded similarly to pain. Furthermore, had we separated the data by injection type in addition to group, we would have compromised the power necessary for our primary purpose in the study. It was more important to us to have the power in the pain and medication use as opposed to the injection pain because those variables were the focus of our study.
Although we did not evaluate injection pain by injection type, there may have been differences in pain reported in maxillary infiltrations versus mandibular inferior alveolar nerve blocks. Our study focused on symptomatic teeth with a pulpal diagnosis of necrosis. The teeth involved were typically very tender to percussion and had significant periapical inflammation/infection present. Injecting into an area that is already painful and exhibiting inflammation is likely more painful than injecting into an area further from the source of pain. The nerve block is administered further away from the site of inflammation and source of pain as compared to the maxillary infiltration. Therefore, I believe the patients with maxillary teeth requiring a local infiltration likely experienced more injection pain compared to those with mandibular teeth requiring an inferior alveolar nerve block. However, this cannot be supported by our data.
Pain during emergency treatment of the debridement group was measured during access of the dentin, access of the pulp chamber and during canal instrumentation. Canal
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instrumentation was found to be the most painful process with 35% reporting moderate
pain and 3% reporting severe pain. Furthermore, 14 patients reported moderate to severe
pain during treatment and required supplemental anesthesia. One patient chose to stop
treatment during canal instrumentation due to pain, and two others reported moderate to
severe pain during canal instrumentation, but chose to continue treatment.
A study of symptomatic teeth with a pulpal diagnosis of necrosis was also
completed by Wells et al. In their study, pain during access and instrumentation was also measured and similar results were found. Canal instrumentation was found to be the most painful compared to the other stages of treatment (17). In teeth diagnosed with pulpal necrosis, there is no vital tissue to anesthetize. Pain is encountered when teeth are symptomatic due to the extensive inflammation of the periapical tissues around the tooth.
Although pressure is exerted on the periapical tissues during access, there may be more pressure exerted periapically during the instrumentation phase due to the torque-like forces transmitted from hand and rotary instruments.
In our study, 14 patients out of the 46 total in the debridement group required supplemental anesthesia. Therefore, the success rate, as determined by the number of patients not requiring additional anesthesia, was 70%. In a study by Bukhari et al., anesthetic success of the inferior alveolar block and the maxillary infiltration in symptomatic patients with a diagnosis of pulpal necrosis was determined. The success rate in the mandible was 96%, while teeth in the maxilla had a success rate of 91% (81).
There was no statistically significant difference between the two groups. It is clear that
65 our success rate was much lower than that encountered by Bukhari et al. This is likely due to the small sample size of the latter study.
Thirty percent of patients required supplemental anesthesia at some point during the procedure. Thirty-eight percent of these patients reported moderate to severe pain during canal instrumentation. One patient opted to discontinue treatment due to pain during instrumentation, and two more reported moderate to severe pain during treatment, but chose to continue treatment. Therefore, it is clear that a significant number of patients in the debridement group experienced enough pain to be uncomfortable during treatment.
This knowledge should be taken into consideration when determining whether or not to treat a patient presenting with a necrotic tooth and moderate to severe pain. With the exception of day 5, there were no significant differences in postoperative pain or medication use reported between the two groups. Furthermore, pain levels dropped over the course of the 5 days ultimately ending in the mild range. Therefore, based on the previously stated statistics, it may be prudent to delay treatment in this patient population until pain levels taper down so as to avoid significant pain during treatment.
Table 8 and Figure 3 illustrate the number of patients who utilized an escape drug in both the debridement and non-debridement groups. Only 19.6% of patients in the debridement group and 12.2% of patients in the non-debridement group utilized an escape drug. There was no statistically significant difference between the two groups.
The results of our study are similar to the results found by Wells et al. with respect to percent of patients utilizing an escape drug following endodontic treatment of a symptomatic, necrotic tooth. In the previous study, 20% of patients resorted to the use of 66 an escape drug. These patients were part of the group treated endodontically, which were subsequently given a combination of ibuprofen and acetaminophen postoperatively for pain similar in concentration to the medication used in our study (17).
Patients in our study were not given a prescription for an escape drug (narcotic) at the treatment appointment. Instead, they were required to contact the investigator if their pain was not being managed by the combination ibuprofen and acetaminophen that was provided, similar to Wells et al (17). This may have deterred some patients with inadequate pain control from obtaining an escape medication due to the extra steps involved. However, there is always a concern with giving an escape drug immediately for use only in the event of inadequate pain control because patients may not follow study protocol in using the non-escape medication first. Furthermore, the ability to prescribe narcotics may be changing soon for all practitioners. New legislation action creating an opioid task force with the purpose of reducing the numbers of narcotics prescribed in the medical community may have effects in the future. Therefore, in order to ensure patients adhered as closely as possible to the study protocol and only took narcotics if necessary, an escape medication was given only in the event that the patient reached out to the investigator with pain unmanageable by the study drugs.
There was no statistically significant difference between the two groups with respect to number of patients utilizing an escape medication. Therefore, we can assert that a similar number of patients experienced pain unmanageable by non-narcotics in each group. The number of patients requiring a narcotic is important because of the increased risks and side effects associated with narcotic use. Side effects include
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respiratory depression, sedation, constipation, nausea and pruritus (54, 60). These side
effects can interfere with daily activities including driving and caring for children due to
the drowsiness and sedation these medications can cause. Therefore, it is imperative to
know the number of patients requiring a narcotic for adequate pain management not only
because it indicates which procedure is associated with less pain, but also because these
drugs can be associated with significant lifestyle alterations.
As practitioners, we want our patients to experience as little pain as possible.
However, the level of pain experienced by patients who did not require an escape
medication was not enough for them to request a narcotic. If the level of pain had been
unmanageable at home with the over-the-counter pain medication supplied, the patients understood they could have called the operator or presented to the clinic complaining of pain. None of the patients enrolled in the study returned before the end of the 5 days due to pain. Therefore, we can feel confident that the pain level was manageable with over-
the-counter pain medication for most patients. This is significant not only for the patients
with respect to side effects, lifestyle alterations, and the inconvenience associated with
having to contact their doctor for narcotics, but also for the practitioner. As practitioners,
our concern is less with the exact millimeter of pain patients record on the VAS as long
as it is manageable with over-the-counter medications.
Postoperative pain was analyzed by day by evaluating those subjects who used an
escape drug separately. This was done because the escape drug would likely have
affected the overall pain level reported by the remaining participants. Tables 9 and 10 and
Figure 1 show the level of postoperative pain by day in the non-escape groups. In both
68 the debridement and non-debridement groups, the most pain was reported post-anesthesia and on days 0 and 1. Over the remaining five days, pain levels continued to decrease. The only significant difference between the two groups was found on day 5. Pain levels were reported as moderate to severe in the debridement group in 62% on day 0, 50% on day 1,
36% on day 2, 23% on day 3, 17% on day 4, and 14% on day 5. Conversely, in the non- debridement group, moderate to severe post-operative pain was reported in 52% on day
0, 67% on day 1, 58% on day 2, 44% on day 3, 48% on day 4 and 38% on day 5.
Throughout the study analysis, p-values were adjusted from the original raw numbers in order to take into account the number of tests run on the data. When multiple tests are run on the same data or data that is correlated, error can be introduced.
Significance may be found when the event really occurred by chance. Therefore, in order to eliminate this possibility, we were conservative with the data and adjusted the raw p- values for the multiple tests we were running. Although this can cause us to miss a significant event, we would rather find significances we know to be true than find significances that may be erroneous.
The debridement group reported significantly less pain on day 5 than the non- debridement group. It is to be expected that the pain level will decrease over time, which it did in our study. However, our original hypothesis was that the debridement group would report less pain and require less medication than the non-debridement group.
Looking strictly at the numbers in Table 9, it seems clear that the non-debridement group had mean pain level numbers that were higher than the debridement group. In fact, on days 4 and 5, the mean pain levels reported in the non-debridement group were more than
69 double that of the debridement group. In addition, the pain level fell to mild by day 1 in the debridement group, whereas it took until day 3 to fall to mild in the non-debridement group. Although the only significant difference was found on day 5, the debridement group may have gotten better faster. This could have been due to the fact that these teeth were treated endodontically and the bacterial load reduced. However, both groups continued to experience pain even though one group was debrided because although the bacterial load was reduced, other factors likely play a role. We know from previously published studies that bacteria are not the only cause of pain otherwise antibiotics would be effective in reducing pain postoperatively (3, 72, 78). Similarly, endodontic pain is also not solely caused by immunological components as illustrated by Bramy et al (82).
Therefore, post-operative pain is mediated by a complex interaction between bacteria, viruses and other various immunological components.
Although bacteria remain the primary contributors to endodontic infection, viruses and fungi have recently been found to play a role as well. According to Slots et al., herpesviruses including HCMV and EBV have been connected with periapical pathosis. A subsequent study was conducted to determine the role HCMV and EBV play in symptomatic periapical lesions. The study was conducted using 25 symptomatic teeth and 19 asymptomatic teeth previously treated endodontically with the presence of a non- healing periapical lesion. An apicoectomy was performed and samples taken from the area. HCMV was found in all 25 symptomatic teeth, but was only found in 37% of asymptomatic teeth. HCMV and EBV co-infection was found in 76% of symptomatic teeth and 26% of asymptomatic teeth (30).
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The role of fungi has also been studied in regard to endodontic infection. Sen et
al. conducted a study of ten molars with periapical lesions using SEM, and found that 4
of the 10 were heavily invaded by yeasts (31). In addition, Baumgartner et al. studied the
presence of Candida albicans in infected root canals. Samples were taken from 24 root
canals and C. albicans was detected in 5 samples or 21% (32). Waltimo et al. also
conducted a study of 967 teeth with persistent endodontic infections. Samples were
collected from general practitioners in Finland and cultured aerobically. Forty-seven samples or 7% showed yeast growth. Twenty yeast strains were identified with all but one belonging to the Candida genus (33).
In our study, there was no statistically significant difference in the number of patients experiencing pain unmanageable by over –the-counter medications and requiring a narcotic between the two groups. In other words, whether the tooth was debrided or not, patients experienced similar pain levels with the only significant difference on day 5.
However, in the debridement group, pain levels dropped to mild at day 1, while it took until day 3 in the non-debridement group to reach mild levels. The difference in pain levels reported by each group was about 18mm on the VAS on day 1, 18mm on day 2 and 22mm on day 3. Thus, the question arises, what does approximately 20mm on the
VAS equate to clinically? This could mean that the debridement group did not need to take pain medication after day 1 because their mean pain level was mild, while the non- debridement group stayed in the moderate category longer and therefore required pain medication longer. However, in my opinion, this 20mm difference is not significant because regardless of whether the pain experienced at home was mild or moderate, it was
71 still being managed by over-the-counter medications in most patients with no group requiring an escape medication more than the other. What is clinically significant, however, is that patients in the debridement group experienced a significant level of pain during treatment. Therefore, although it takes longer for patients to reach mild pain in the non-debridement group, this group may experience less pain during treatment when root canal therapy is eventually initiated. As previously discussed, the level of preoperative pain is significantly associated with the level of postoperative pain. Therefore, if treatment is delayed, patients may experience less operative pain than if root canal therapy is initiated when patients are in moderate to severe pain.
The only statistically significant difference found in postoperative pain levels between the two groups was on day 5. However, the non-debridement group pain levels may have continued to drop in the days following, but it just takes longer for the pain levels to drop when the tooth is not debrided compared to when a full debridement is completed. Although pain levels dropped at a slower rate in the non-debridement group compared to the debridement group, they did decrease nonetheless over the 5 days. It is not known how long it would take for another flare-up to occur in the non-debridement group. Therefore, in future studies, it would be interesting to lengthen the amount of time postoperative pain is evaluated in order to determine what may happen after day 5.
Tables 11 and 12 illustrate the level of pain reported by subjects in the escape group. Subjects in both the debridement and non-debridement groups requiring an escape medication reported the most pain post-anesthesia and on days 0 and 1. Pain levels continued to decrease over the remaining five days. Although the pain scores for the non-
72 debridement escape group appear higher than the debridement escape group, we must keep in mind the number of subjects per group. Because the escape drug users were separated from those participating in the rest of the study, the sample size was much smaller. On days 0 and 1, there were 7 and 8 subjects of 9 reporting moderate to severe pain in the debridement group, respectively. In the non-debridement group, all 6 subjects reported moderate to severe pain on day 0 and five reported moderate to severe pain on day 1. Therefore, although the level of pain reported in the non-debridement escape group appears higher, it is really a matter of only one or two subjects reporting more pain that has skewed the numbers due to the extremely small sample size.
One of the exclusion criteria in this study was the presence of swelling. Patients were included if mild or no swelling was present, but excluded with the presence of anything greater. Swelling is commonly seen concomitantly with a diagnosis of pulpal necrosis in a symptomatic tooth. Therefore, by excluding this group, the results could have been affected. Patients with swelling typically report more pain during anesthesia, during treatment and postoperatively. In a study by Walton and Fouad, preoperative swelling was associated with a flare-up rate of 15% (69). Therefore, these patients may also be at a higher risk for a flare-up. Excluding this group may have led to lower pain levels reported during the injection, during emergency treatment for the debridement group and also postoperatively.
Many patients presenting to our clinic had already visited either their general dentist or the emergency department and been started on a round of antibiotics. In order to minimize any differences between patients and groups, we prescribed each study
73 participant an antibiotic. However, research has shown that antibiotic use following root canal therapy on a necrotic tooth does not affect postoperative pain or analgesic use. A study conducted by Henry et al. evaluated the effect of penicillin on postoperative endodontic pain in symptomatic necrotic teeth. Root canal treatment was initiated on 41 patients with a pulpal diagnosis of symptomatic necrosis. Patients were given a 7-day dose of either penicillin or a placebo along with ibuprofen and acetaminophen with codeine (30mg) and asked to record their pain level each day for 7 days. Results showed that there was no statistically significant difference in the level of postoperative pain reported or amount of pain medication tablets taken over the 7 day period between the penicillin and placebo group (3). In addition, Fouad et al. evaluated the effect of penicillin on teeth with a diagnosis of pulpal necrosis and associated periapical pain with or without localized swelling. The teeth were all treated with conventional endodontic therapy, and patients were given ibuprofen in combination with penicillin, a placebo, or no second medication. Results showed no significant difference in postoperative pain between the three groups (78).
The effect of antibiotics on untreated symptomatic teeth with a pulpal diagnosis of necrosis has never been studied. However, in our study, there was no significant difference between the two groups with respect to pain level or analgesic use apart from day 5. Therefore, we can assert that antibiotics also do not affect postoperative pain levels in an untreated symptomatic tooth with a pulpal diagnosis of necrosis. Prescribing an antibiotic for this patient population is only warranted if significant swelling or systemic
74 effects are present. However, none of the patients in this study returned to the clinic with swelling or unmanageable pain.
Table 13 and Figure 2 show the total amount of pain medication taken per group.
The largest number of tablets was taken on days 1 and 2. Over the 5 day study period, the total number of tablets taken decreased with the least amount being taken on day 5.
Although there was no statistically significant difference in the number of tablets taken between the two groups, the non-debridement group took a higher number of tablets than the debridement group on days 1 through 5.
It is important to recognize that medication use on day 0 was different for each patient depending on when they were treated that day. Some patients were treated first thing in the morning, and therefore, had the opportunity to take more pain medication throughout the remainder of the day than those patients treated at 4 p.m. Due to the difference in the number of hours remaining in the day based on what time the patients were treated, there was a large variance in the number of tablets taken. In addition, less tablets were taken day 0 compared to day 1 because day 1 was the first full day evaluated, while day 0 began at different times for different patients.
Patients in the study were instructed to take one 600mg tablet of ibuprofen and two 500mg tablets of acetaminophen together every 6 hours for the management of their pain. This should be taken into consideration when evaluating the total number of tablets taken in Table 13. The two pain medications were not supposed to be taken in a 1:1 ratio, but rather a 2:1 ratio of acetaminophen to ibuprofen. To help ensure patient understanding, the bottles of ibuprofen were marked with a white label instructing
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patients to take 1 tablet every 6 hours. The acetaminophen bottle, on the other hand, was
marked with a yellow label and instructed patients to take 2 tablets every 6 hours for
pain. Patients were verbally instructed to take both medications together at the same time
during their appointment. However, as evidenced by the postoperative pain surveys, not
all patients were compliant with the instructions given. Furthermore, even if the patients
were taking the appropriate study medication, they may not have accurately reported their
pain level or medication use on the pain diary provided.
Patient compliance is always an issue with studies of this design. The only way to
ensure patients strictly follow study protocol and accurately report their pain and
medication use is to create a hospital-based study where these variables are closely monitored. However, this study was interested in clinically significant results. In other words, we were interested in knowing the results as they relate to the general population, where compliance is typically an issue. Therefore, although patients may not have strictly adhered to the study protocol with respect to medication usage and the accurate reporting of pain levels, the results obtained were clinically significant as these are common issues faced by private practice practitioners.
Henry et al. evaluated the effect of penicillin on postoperative endodontic pain in
symptomatic necrotic teeth. Root canal treatment was initiated on 41 patients diagnosed
with symptomatic pulp necrosis. Patients were then given a 7-day dose of either penicillin
or placebo along with ibuprofen and acetaminophen with codeine (30mg). Patients were
asked to record their pain level each day for 7 days in a pain diary that was given
following treatment. Results showed that there was no statistically significant difference
76 in level of postoperative pain reported or amount of medication tablets taken over the 7 day period between the patients who received penicillin versus the placebo group.
Moderate to severe pain was reported on day 1 in 53% and 68% of penicillin and placebo groups, respectively. By day 2, this number dropped to 48% and 27% followed by 26% and 23% on day 3, 16% and 4% on day 4, and 26% and 9% on day 5. Moderate to severe pain was reported the most through day 3 and then decreased over the remaining days.
The number of patients taking ibuprofen compared to acetaminophen with codeine was also recorded. In the penicillin group, on day 1, 74% of patients took ibuprofen. This number continued to fall over the remainder of the study with 74% taking ibuprofen day
2, 53% day 3, 37% day 4, and 21% day 5. Total medication usage was highest through day 3 and then decreased over the remaining 4 days, but more than 20% of patients continued to take pain medications through day 7 (3).
Houck et al. investigated the effect of trephination on postoperative pain and swelling in symptomatic necrotic teeth. Fifty patients with a tooth diagnosis of symptomatic necrosis and a periapical radiolucency were included in the study.
Following root canal treatment, patients received either trephination or a mock procedure.
Patients were prescribed ibuprofen 400mg and acetaminophen with codeine (30mg) and asked to record their pain level and the amount of pain medication taken for the next 7 days. Results showed no significant difference in pain level, swelling or amount of pain medication taken between the two groups. However, it was noted that the majority of patients had significant postoperative pain requiring analgesics. In the mock trephination group, 4% recorded severe pain and 52% recorded moderate pain on day 1 following
77 endodontic treatment. No severe pain was reported day 2 with 20% reporting moderate pain. By day 3, only 16% reported moderate pain, while 40% recorded mild pain. On days 4 and 5 only mild pain was reported 32% and 16% of the time, respectively. In the study, the amount of analgesic medication taken was also recorded. On day 1, 76% of the patients in the mock treatment group reported taking ibuprofen followed by 72% on day
2, 64% on day 3, 32% on day 4, and 28% on day 5 (1).
A similar study was conducted by Nist et al. who also evaluated the effect of apical trephination on postoperative pain and swelling in symptomatic teeth with a pulpal diagnosis of necrosis. Fifty patients were included in the study, and apical trephination or mock trephination was completed following endodontic treatment. Patients were given ibuprofen 400mg and acetaminophen with codeine (30mg) and asked to record their pain level and amount of pain medication taken over the next 7 days. Results showed no significant difference in pain level, amount of swelling or the amount of ibuprofen taken over 7 days between the two groups. However, there was a significant reduction in the amount of acetaminophen with codeine taken in the trephination group. In the mock trephination group on day 1, severe pain was reported in 16% of patients with moderate pain reported in 44% and mild pain in 36%. Day 2 pain levels were reported as severe in
12%, moderate in 24% and mild in 48%. By day 3, severe pain was not reported in any patients with moderate pain reported falling to 24%. The pain levels reported continued to decrease over the remainder of the study and by day 5, severe pain was not reported in any patients, with moderate pain reported in 4% of patients and mild pain reported in
28%. The amount of ibuprofen taken was also recorded in this study. On day 1, 84% of
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patients in the mock trephination group took ibuprofen followed by 80% on day 2, 64%
on day 3, 44% on day 4, and 44% on day 5 (2).
A study conducted by Wells et al. compared the use of ibuprofen alone versus the
combination of ibuprofen and acetaminophen on postoperative pain in symptomatic
patients with a pulpal diagnosis of necrosis. Seventy-one patients with moderate to severe pain were included in the study. Endodontic therapy was initiated and patients were then prescribed either 600mg of ibuprofen or 600mg ibuprofen with 1000mg acetaminophen.
Patients were asked to record their pain level on a VAS for 6 days. Results showed no statistically significant difference between the ibuprofen group and the ibuprofen and acetaminophen group. On day 1, 9% of patients in the ibuprofen plus acetaminophen group reported severe pain, with 43% reporting moderate and 31% reporting mild pain.
By day 2, only 6% reported severe pain, 37% reported moderate pain and mild pain was reported in 34%. By day 5, none reported severe pain and 6% reported moderate pain with 40% reporting mild pain (17).
Nusstein et al. studied the effect of drainage upon access on postoperative
endodontic pain and swelling in symptomatic necrotic teeth. In this retrospective study,
124 symptomatic patients with a diagnosis of pulp necrosis and a periapical radiolucency
were included. The occurrence of drainage on access was timed and recorded. Following
endodontic treatment, patients were given ibuprofen 400mg or 600mg and Tylenol #3.
Results showed that drainage on access did not significantly reduce pain, swelling or the
amount of pain medication taken. Both groups used the most pain medication on days 1
and 2 and a decrease in the amount taken was seen starting on day 3 for the remainder of
79 the study period. On day 1, 15% of patients in the nondrainage group reported severe pain, 40% reported moderate pain and 34% reported mild pain. By day 3, only 4% reported severe pain, 21% reported moderate pain and 39% reported mild pain. The amount of analgesic medication taken was also recorded in the study. On day 1, 84% of patients in the nondrainage group took ibuprofen followed by 78% on day 2, 53% on day
3, 38% on day 4, 31% on day 5 and 29% on day 6 (4).
There are currently no studies that assess the level of pain over time in a group of patients requiring endodontic therapy when treatment is not immediately initiated. In all of the previously listed studies , moderate to severe pain levels were the highest on day 1 and continued to drop over the remaining 4 days, similar to the results of our study. The overall level of pain reported was similar to what was found in the debridement group in our study and slightly less than that found in the non-debridement group. In the study conducted by Henry et al., moderate to severe pain was reported the most through day 3, which is similar to the debridement group in our study (3). However, the non- debridement group in our study continued to report moderate to severe pain through day
5 about 38% of the time.
In the study by Henry et al., the highest percentage of patients using medication was seen through day 3. In addition, at day 7, more than 20% of patients were still using medication (3). In our study, the percentage of patients taking medication per day in the debridement group was 92% on day 0, 95% on day 1, 84% on day 2, 76% on day 3, 51% on day 4 and 41% on day 5. For the non-debridement group, the numbers were similar except days 4 and 5, which remained high at 77% both days. The study conducted by
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Houck et al. reported a smaller percentage of patients taking pain medication particularly on days 4 and 5 compared to the debridement group in our study (1). However, Nist et al. reported similar percentages of patients taking medications per day compared to our study (2). In all of the previously mentioned studies, medication use was highest on day 1 and dropped over the remaining days of the study.
Table 14 shows how many patients took no pain medication each day. The highest number of patients taking pain medication was found on day 1. Over the course of the 5 days, the number of patients taking no medication increased until its peak at day 5. In general, there were more patients in the debridement group taking no medication compared to the non-debridement group on each day. On day 1, only 5% of patients in the debridement group and 7% of patients in the non-debridement group were taking no medications. By day 5, 59% of patients in the debridement group were taking no medication compared to 23% of patients in the non-debridement group.
Over the course of the 5 days, the use of pain medication decreased. However, at day 5, 41% of patients in the debridement group and 77% of patients in the non- debridement group were still taking pain medication. As previously discussed, the percent reported in the debridement group is similar to that found by Nist et al., but higher than that found by Houck et al (1, 2). The percentage in the non-debridement group seems particularly high. However, there was no statistically significant difference in the amount of pain medication used between the two groups. It is unknown when pain levels dissipate completely in this patient population. Henry et al. reported greater than
20% of patients continued to take pain medication at day 7 (3). Therefore, future studies
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to determine when pain levels dissipate completely should evaluate postoperative pain for
at least 7 days, if not more.
Table 15 shows the total number of patients utilizing an escape drug by day. A
total of 15 patients utilized an escape medication during this study. The highest number
of patients reporting escape drug use was found on day 1 in both the debridement and
non-debridement groups with 12 of the 15 patients total utilizing a narcotic by day 1. This
number dropped from 78% on day 1 to 59% on day 5 in the debridement group and from
83% on day 1 to 33% on day 5 in the non-debridement group. However, because the number of subjects in each group is so small, definitive conclusions cannot be drawn about differences between the two groups.
Although the number of narcotic tablets taken between the two escape groups was not statistically different, it is interesting to note that fewer patients utilized an escape medication in the non-debridement group compared to the debridement group on days 3,
4 and 5. This indicates that patients in the debridement group requiring an escape medication needed to use the medication longer than those in whom endodontic therapy was not initiated.
Table 16 shows the mean number of narcotic tablets taken per day. The highest number of tablets was taken on day 1. Over the next four days, this number continued to drop until it reached a mean of 1.4 tablets in the debridement group and 1.5 tablets in the non-debridement group on day 5. There was no statistically significant difference between the two groups.
82
Tables 17 and 18 show the mean number of ibuprofen and acetaminophen tablets
taken per day adjusted to exclude the escape group. This was done because the escape
group was receiving a stronger pain medication, which would likely alter the data
collected with respect to postoperative pain and pain medication utilization. It is
interesting to note that the non-escape debridement group took less pain medications on
average compared to the non-debridement group, while the escape debridement group
took more pain medications compared to the escape non-debridement group. However, in
Table 11 we see that the non-debridement escape group actually had more pain than the
debridement group. This may have been due to the fact that the group as a whole took
less pain medication, and their pain was not being managed effectively.
Ultimately, the results of this study should be viewed in light of one’s own definition of clinical success. Performing a debridement of these teeth may lead to a decrease in pain to a mild level sooner. However, if one is concerned with the patient experiencing the least amount of pain possible during treatment, consider delaying the debridement for a few days until pain levels subside. Finally, if one wants to do whatever one can to prevent these patients from needing/using a narcotic, either option will suffice as there was no statistically significant difference in escape drug use between the two groups.
Generally, as endodontists, we are capable of managing most pain during
treatment, and are mainly concerned with achieving a mild pain level faster. In this case,
a debridement should be completed initially taking into consideration effective anesthesia
may be difficult to achieve. If, however, one is a general dentist with limited endodontic
83
experience, managing these patients can be extremely difficult. In order to make the
patient as comfortable as possible during treatment, one may opt to wait a few days for
the pain to drop to a mild level. Alternatively, if endodontic treatment has already been
initiated and effective anesthesia cannot be achieved, one can feel comfortable in
terminating treatment. These patients will basically be considered non-debridement patients, and are no more likely to experience postoperative pain than those in which a thorough debridement was completed. As an emergency room physician confronted with an access to care issue, one can feel confident in discharging these patients with instructions to visit their local dentist within the next few days knowing that their pain level will not be significantly different from those who have had their teeth treated endodontically. In addition, these patients will not need narcotic pain medication any more than those in whom endodontic therapy was initiated. Emergency room physicians, therefore, may discharge these patients with nothing more than an antibiotic if necessary and instructions to take over-the-counter pain medication as needed.
Future studies should assess post-operative pain for a period of time longer than 5 days, especially in the non-debridement group. Since the only statistically significant difference in pain levels between the two groups was found on day 5, it would be interesting to know what would happen in the following days. However, it could also just take longer for pain levels to drop in this group compared to the debridement group.
Future studies should also investigate pain levels during emergency treatment of the non- debridement group after day 5. It would be interesting to compare pain levels during treatment of the debridement group to the non-debridement group after pain levels have
84 dropped to mild. If pain levels during treatment are significantly less when treatment is delayed, practitioners may want to consider postponing root canal therapy as achieving effective anesthesia in symptomatic teeth with this diagnosis can be notoriously difficult.
85
CHAPTER 5
SUMMARY AND CONCLUSIONS
The purpose of this prospective, randomized study was to compare the efficacy of initial endodontic treatment versus no initial endodontic treatment on postoperative pain in patients with symptomatic teeth with a pulpal diagnosis of necrosis and associated periapical area.
Ninety-five adult patients presenting for emergency treatment and experiencing moderate to severe pain were analyzed in this study. Patients were randomly assigned to one of two treatment regimens. The first group received anesthetic and an initial endodontic debridement using hand and rotary instruments. The second group received anesthetic, but no initial endodontic debridement. Following administration of the anesthetic, patients were asked to rate the level of pain they experienced on a visual analog scale during needle insertion, needle placement and anesthetic deposition. Initial endodontic debridement was then completed in the debridement group, while the non- debridement group received no further treatment. At the end of the appointment, patients were given ibuprofen 600mg to be taken every 6 hours and acetaminophen 500mg to be taken every 6 hours. Patients were also prescribed an antibiotic if not already taking one and given a 5 day diary to be completed after anesthesia wore off and every night for five days. Patients were instructed to record their level of pain on a visual analog scale each night as well as the amount of pain medications taken in a 24 hour period. If the 86 ibuprofen/acetaminophen given to the patient was not managing their pain, patients were instructed to call an assigned cell phone number that was carried by the investigator.
After speaking with the investigator, an escape medication (hydrocodone/acetaminophen
5/500mg q6h) was prescribed, if needed.
Results showed no statistically significant difference in postoperative pain or medication use between the two groups except on day 5. The debridement group had significantly less pain on day 5 compared to the non-debridement group. Furthermore, the debridement group reached a mild pain level on day 1 compared to day 3 in the non- debridement group. There was no statistically significant difference in escape medication usage between the two groups. Approximately 15% of patients in both groups required escape medication.
In conclusion, initial endodontic debridement of symptomatic necrotic teeth did not lead to a statistically significant difference in postoperative pain or medication use.
87
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95
APPENDIX A
TABLES
96
DEBRIDEMENT NON- P-VALUE DEBRIDEMENT Total Enrolled 56 52 Total Disqualified 10 3 Total Analyzed 46 49 Gender Female 20/46 (44%) Female 25/49 (51%) 0.4616* Male 26/46 (56%) Male 24/49 (49%) Age 36.3 +/- 12.1 39.1 +/- 16.1 0.3615** (Mean +/- SD) yrs. Corah 9 9 0.3952*** (Median) Initial Pain (Mean +/- SD) 118 +/- 26.8 119 +/- 27.3 0.9088** mm
Table 1. Preliminary Data of Debridement and Non-Debridement Groups.
*Chi-square test **ANOVA ***Mann-Whitney-Wilcoxon test
97
GROUP JAW N PERCENT P-VALUE
Debridement Maxillary 24 52.2 0.9105* Mandibular 22 47.8
Non-Debridement Maxillary 25 51.0 Mandibular 24 49.0
GROUP TOOTH N PERCENT P-VALUE TYPE
Debridement Anterior 3 6.5 0.3914** Premolar 12 26.1 Molar 31 67.4
Non-Debridement Anterior 6 12.2 Premolar 8 16.3 Molar 35 71.4
Table 2. Pre-Operative Statistics by Jaw and Tooth Type.
*Chi-square test **Fisher exact test
98
GROUP TREATMENT N PERCENT P-VALUE TYPE
Debridement Re-Cleanout 13 28.3 0.1601* Initial Root Canal 33 71.7
Non-Debridement Re-Cleanout 8 16.3 Initial Root Canal 41 83.7
Table 3. Pre-Operative Statistics by Treatment Type.
*Chi-square test
99
P- P- GROUP STAGE N MEAN SD MEDIAN MIN MAX VALUE VALUE (raw)* (adj)**
DBMT Insertion 46 80.1 42.8 82.5 0 170 0.7335 1.0000 Placement 46 83.9 42.0 89.5 0 170 0.6717 1.0000 Deposition 46 84.8 45.4 86.5 0 170 0.0274 0.0822
NODBMT Insertion 48 84.5 47.9 83.5 0 170 Placement 48 81.7 47.0 83.0 0 170 Deposition 48 65.1 46.2 58.0 0 170
Table 4. Injection Pain.
DBMT= Debridement NODBMT=Non-Debridement *Mann-Whitney-Wilcoxon test **Step-down Bonferroni method of Holm
100
MILD MOD. NONE SEVERE GROUP STAGE N (>0 mm, (>54 mm, (0mm*) (≥114 mm) ≤54 mm) <114 mm)
2/46 8/46 26/46 DBMT Insertion 46 10/46 (22%) (4%) (17%) (57%) 1 /46 8/46 28/46 9/46 Placement 46 (2%) (17%) (61%) (20%) 2/46 10/46 25/46 9/46 Deposition 46 (4%) (22%) (54%) (20%) 1/48 14/48 21/48 NODBMT Insertion 48 12/48 (25%) (2%) (50%) (44%) 2/48 14/48 22/48 Placement 48 10/48 (21%) (4%) (50%) (46%) 4/48 19/48 18/48 7/48 Deposition 48 (8%) (40%) (38%) (15%)
Table 5. Injection Pain by Stage Using Categorical Values of the Visual Analog Scale.
DBMT= Debridement NODBMT=Non-Debridement
101
STAGE N MEAN SD MEDIAN MIN MAX Dentin 45 28.9 37.1 11 0 112
Chamber 41 19.2 28.3 4 0 102
Canal 40 41.2 42.0 21.5 0 139
Post supp. Dentin 1 69.0 . 69 69 69 Post supp. Chamber 6 85.7 44.8 83 37 165 Post supp. Canal 13 63.2 55.7 59 0 170
Table 6. Emergency Treatment Pain Debridement Group. Post Supp.= Post-Supplemental Injection
102
MILD MOD. NONE SEVERE STAGE N (>0 mm, ≤54 (>54 mm, (0mm*) (≥114 mm) mm) <114 mm)
0/45 Dentin 45 15/45 (33%) 18/45 (40%) 12/45 (27%)
Chamber 41 17/41 (42%) 17/41 (42%) 7/41 (17%) 0/41 Canal 40 8/40 (20%) 17/40 (43%) 14/40 (35%) 1/40 (3%)
Post. Supp. Dentin 1 0 0 1/1 (100%) 0 Post. Sup. Chamber 6 0 2/6 (33%) 3/6 (50%) 1/6 (17%) Post. Sup. Canal 13 1/13 (8%) 5/13(38%) 4/13 (31%) 3/13 (23%)
Table 7. Emergency Treatment Pain by Stage Using Categorical Values of theVisual Analog Scale.
103
GROUP ESCAPE DRUG COUNT PERCENT P-VALUE* Debridement Yes 9 19.6 0.3218 No 37 80.4
Non-Debridement Yes 6 12.2 No 43 87.8
Table 8. Escape Drug Utilization.
*Chi-square test
104
P- P- DAY GROUP N MEAN SD MEDIAN MIN MAX VALUE VALUE (raw)* (adj)** Post- DBMT 37 83.5 41.2 84 0 165 0.6189 1.0000 Anesthesia NODBMT 43 79.1 40.0 84 0 171
0 DBMT 37 62.4 38.2 58 0 153 0.9295 1.0000 NODBMT 42 64.0 40.8 57.5 0 145
1 DBMT 36 51.7 37.8 52 0 151 0.0682 1.0000 NODBMT 43 69.4 40.1 59 0 168
2 DBMT 36 40.0 33.8 36 0 142 0.0490 0.7840 NODBMT 41 58.2 38.9 58 0 140
3 DBMT 35 29.2 32.7 22 0 121 0.0150 0.3748 NODBMT 41 51.6 41.9 46 0 166
4 DBMT 36 23.8 26.7 20.5 0 111 0.0070 0.1885 NODBMT 42 47.0 38.8 45.5 0 138
5 DBMT 35 19.8 27.5 3 0 97 0.0012 0.0345 NODBMT 39 47.1 39.5 38 0 143
Table 9. Non-Escape Group Post-Operative Pain by Day.
DBMT= Debridement NODBMT=Non-Debridement N excludes narcotic users and patients who did not record data. *Mann-Whitney-Wilcoxon test **Step-down Bonferroni method of Holm
105
MILD MOD. NONE SEVERE GROUP STAGE N (>0 mm, ≤54 (>54 mm, (0mm) (≥114 mm) mm) <114 mm)
Post- DBMT 37 2 (5.4%) 5 (13.5%) 22 (59.5%) 8 (21.6%) Anesthesia 0 37 1 (2.7%) 13 (35.1%) 20 (54.1%) 3 (8.1%) 1 36 3 (8.3%) 15 (41.7%) 17 (47.2%) 1 (2.8%) 2 36 2 (5.6%) 21 (56.3%) 12 (33.3%) 1 (2.8%) 3 35 11 (31.4%) 16 (45.7%) 7 (20.0%) 1 (2.9%) 4 36 9 (25.0%) 21 (58.3%) 6 (16.7%) 0 5 35 15 (42.3%) 15 (42.3%) 5 (14.3%) 0
Post- NODBMT 43 2 (4.7%) 11 (25.6%) 23 (53.5%) 7 (16.3%) Anesthesia 0 42 4 (9.5%) 16 (38.1%) 16 (38.1%) 6 (14.3%) 1 43 3 (7.0%) 11 (25.6%) 26 (60.5%) 3 (7.0%) 2 41 4 (9.8%) 13 (31.8%) 21 (51.2%) 3 (7.3%) 3 41 6 (14.6%) 17 (41.5%) 16 (39.0%) 2 (4.9%) 4 42 6 (14.3%) 16 (38.1%) 18 (42.9%) 2 (5.1%) 5 39 6 (15.4%) 18 (46.2%) 13 (33.3%) 2 (5.1%)
Table 10. Non-Escape Group Post-Operative Pain by Stage Using Categorical Values of the Visual Analog Scale.
DBMT= Debridement NODBMT=Non-Debridement N excludes narcotic users and patients who did not record data
106
P- DAY GROUP N MEAN SD MEDIAN MIN MAX VALUE (adj)** Post- DBMT 9 84.4 52.1 85 0 169 1.0000 Anesthesia NODBMT 6 118.0 28.8 124 68 142
0 DBMT 9 90.6 52.5 91 1 169 1.0000 NODBMT 6 121.7 34.2 124.5 83 170
1 DBMT 9 96.3 36.7 109 21 150 1.0000 NODBMT 6 111.0 48.6 118.5 35 170
2 DBMT 9 78.6 34.1 81 22 142 1.0000 NODBMT 6 78.8 59.5 85 4 141
3 DBMT 9 64.8 31.9 76 0 112 1.0000 NODBMT 6 67.0 66.2 58.5 0 170
4 DBMT 8 58.8 34.5 63 0 112 1.0000 NODBMT 5 67.8 72.7 58 0 170
5 DBMT 9 54.4 37.3 58 0 111 1.0000 NODBMT 4 50.3 77.3 19 0 163
Table 11. Escape Group Post-Operative Pain by Day. DBMT= Debridement NODBMT=Non-Debridement *Mann-Whitney-Wilcoxon test **Step-down Bonferroni method of Holm
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MOD. MILD (>54 SEVERE NONE GROUP STAGE N (>0 mm, mm, (≥114 (0mm*) ≤54 mm) <114 mm) mm)
DBMT Post-Anesthesia 9 1 (11.1%) 1 (11.1%) 5 (55.6%) 2 (22.2%) 0 9 0 2 (22.2%) 4 (44.4%) 3 (33.3%) 1 9 0 1 (11.1%) 5 (55.6%) 3 (33.3%) 2 9 0 1 (11.1%) 7 (77.8%) 1 (11.1%) 3 9 1 (11.1%) 1 (11.1%) 7 (77.8%) 0 4 8 1 (12.5%) 1 (12.5%) 6 (75.0%) 0 5 9 2 (22.2%) 2 (22.2%) 5 (55.6%) 0
NODBMT Post-Anesthesia 6 0 0 3 (50.0%) 3 (50.0%) 0 6 0 0 3 (50.0%) 3 (50.0%) 1 6 0 1 (16.7%) 2 (33.3%) 3 (50.0%) 2 6 0 2 (33.3%) 2 (33.3%) 2 (33.3%) 3 6 1 (16.7%) 2 (33.3%) 2 (33.3%) 1 (16.7%) 4 5 1 (20.0%) 1 (20.0%) 2 (40.0%) 1 (20.0%) 5 4 2 (50.0%) 1 (25.0%) 0 1 (25.0%)
Table 12. Escape Group Post-Operative Pain by Stage Using Categorical Values of the Visual Analog Scale.
CAT.= Pain Category Mod.= Moderate DBMT= Debridement NODBMT=Non-Debridement
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P- P- VALUE VALUE DAY GROUP N Mean SD MEDIAN MIN MAX (raw)* (adj)**
0 DBMT 37 4.89 2.75 6 0 12 0.3701 0.3701 NODBMT 43 4.40 3.09 6 0 12
1 DBMT 37 6.38 3.78 6 0 14 0.0698 0.1484 NODBMT 43 7.84 3.93 9 0 15
2 DBMT 37 4.97 3.85 4 0 12 0.0495 0.1484 NODBMT 43 6.77 3.99 8 0 12
3 DBMT 37 3.65 3.62 2 0 12 0.0183 0.0916 NODBMT 43 5.88 4.10 6 0 12
4 DBMT 37 2.92 3.98 1 0 12 0.0243 0.0974 NODBMT 43 4.53 3.56 6 0 12
5 DBMT 37 2.32 3.86 0 0 12 0.0087 0.0521 NODBMT 40 4.05 3.69 3 0 12
Table 13. Total Number of Pain Medication Tablets by Day.
DBMT= Debridement NODBMT=Non-Debridement N excludes narcotic users and patients who did not report data. *Mann-Whitney-Wilcoxon test **Step-down Bonferroni method of Holm
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DAY DBMT NODBMT
3/37 6/43 0 (8%) (14%) 2/37 3/43 1 (5%) (7%) 6/37 5/43 2 (16%) (12%) 9/37 7/43 3 (24%) (16%) 18/37 10/43 4 (49%) (23%) 22/37 10/43 5 (59%) (23%)
Table 14. Number of Patients Utilizing No Medication by Day.
DBMT= Debridement NODBMT= Non-Debridement
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N GROUP DAY (%)
2/9 Debridement 0 (22%) 7/9 1 (78%) 3/9 2 (33%) 4/9 3 (44%) 4/9 4 (44%) 5/9 5 (56%)
2/6 Non-Debridement 0 (33%) 5/6 1 (83%) 3/6 2 (50%) 1/6 3 (17%) 1/6 4 (17%) 2/6 5 (33%)
Table 15. Total Number of Patients Utilizing an Escape Drug by Day.
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P-VALUE DAY GROUP N MEAN SD MEDIAN MIN MAX (adj)** 0 DBMT 9 0.6 1.1 0 0 3 1.0000 NODBMT 6 0.7 1.0 0 0 2
1 DBMT 8 2.5 2.0 2.5 0 6 1.0000 NODBMT 6 2.8 2.0 2.5 0 6
2 DBMT 8 2.1 2.1 2 0 5 1.0000 NODBMT 6 2.2 1.8 2.5 0 4
3 DBMT 8 1.4 1.6 1 0 4 1.0000 NODBMT 6 1.5 1.8 1 0 4
4 DBMT 8 1.3 1.6 0.5 0 4 1.0000 NODBMT 6 1.0 2.4 0 0 6
5 DBMT 8 1.4 1.4 1.5 0 4 1.0000 NODBMT 6 1.5 2.5 0 0 6
Table 16. Escape Group Number of Narcotic Tablets Taken by Day.
DBMT= Debridement NODBMT= Non-Debridement N includes all patients who reported data in the escape group including those who took no medications *Mann-Whitney-Wilcoxon test **Step-down Bonferroni method of Holm
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P- P- DRUG DAY GROUP N MEAN SD MEDIAN MIN MAX VALUE VALUE (raw)* (adj)** Acet. 0 DBMT 37 2.9 1.9 4 0 6 0.5770 1.0000 NODBMT 43 2.8 2.1 3 0 8 1 DBMT 37 3.8 2.6 4 0 8 0.0378 0.6993 NODBMT 43 5.0 2.9 6 0 9 2 DBMT 37 2.9 2.6 2 0 8 0.0251 0.5781 NODBMT 43 4.3 2.9 5 0 9 3 DBMT 37 2.2 2.5 1 0 8 0.0193 0.4639 NODBMT 43 3.7 2.9 4 0 8 4 DBMT 37 1.7 2.6 0 0 8 0.0368 0.6993 NODBMT 43 2.7 2.4 3 0 8 5 DBMT 37 1.4 2.5 0 0 8 0.0331 0.6611 NODBMT 40 2.4 2.7 1.5 0 8
Ibu. 0 DBMT 37 2.0 1.1 2 0 6 0.1346 1.0000 NODBMT 43 1.6 1.1 2 0 4
1 DBMT 37 2.6 1.5 3 0 7 0.2548 1.0000 NODBMT 43 2.8 1.3 3 0 6
2 DBMT 37 2.1 1.4 2 0 5 0.1866 1.0000 NODBMT 43 2.4 1.4 3 0 4
3 DBMT 37 1.5 1.3 1 0 4 0.0275 0.6046 NODBMT 43 2.2 1.4 3 0 4
4 DBMT 37 1.2 1.6 1 0 6 0.0389 0.6993 NODBMT 43 1.9 1.7 2 0 8
5 DBMT 37 1.0 1.6 0 0 6 0.0079 0.2055 NODBMT 40 1.7 1.4 2 0 4
Table 17. Non-Escape Group Post-Operative Drug Use by Day.
DBMT= Debridement NODBMT= Non-Debridement Acet.= Acetaminophen Ibu.= Ibuprofen N includes all patients who reported data in the non-escape group including those who took no medications. *Mann-Whitney-Wilcoxon test **Step-down Bonferroni method of Holm
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P- DRUG DAY GROUP N MEAN SD MEDIAN MIN MAX VALUE (adj)** Acet. 0 DBMT 9 4.0 1.9 4 1 8.0 1.0000 NODBMT 5 3.6 2.2 4 0 6.0 1 DBMT 9 4.3 2.3 4 1 8.0 1.0000 NODBMT 6 2.0 1.8 2 0 4.0 2 DBMT 8 3.1 2.7 2 0 8.0 1.0000 NODBMT 6 1.3 2.1 0 0 4.0 3 DBMT 8 2.1 2.7 0.5 0 6.0 1.0000 NODBMT 6 1.7 2.7 0 0 6.0 4 DBMT 8 2.4 2.3 2.5 0 6.0 1.0000 NODBMT 6 2.3 3.2 1 0 8.0 5 DBMT 8 1.8 2.3 1 0 6.0 1.0000 NODBMT 6 1.5 2.0 0.5 0 4.0
Ibu. 0 DBMT 9 2.4 1.2 2 1 5.0 1.0000 NODBMT 5 2.4 0.5 2 2 3.0 1 DBMT 9 4.0 1.7 4 2 8.0 1.0000 NODBMT 6 3.5 1.0 3.5 2 5.0 2 DBMT 8 3.3 1.3 3.5 1 5.0 1.0000 NODBMT 6 2.8 1.6 3.5 0 4.0 3 DBMT 8 2.5 2.2 3 0 6.33 1.0000 NODBMT 6 3.0 1.5 3.5 0 4.0 4 DBMT 8 3.1 1.5 3.5 0 4.66 1.0000 NODBMT 6 2.3 1.9 2.5 0 4.0 5 DBMT 8 2.3 1.9 3 0 4.0 1.0000 NODBMT 6 1.5 1.8 1 0 4.0
Table 18. Escape Group Post-Operative Drug Use by Day.
DBMT= Debridement NODBMT= Non-Debridement Acet.= Acetaminophen Ibu.= Ibuprofen N includes all patients who reported data in the escape group including those who took no medications. *Mann-Whitney-Wilcoxon test **Step-down Bonferroni method of Holm
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APPENDIX B
FIGURES
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Post-Operative Pain 170 150 130 110 90 Mean VAS (mm) Debridement 70 Non-Debridement 50 30 10
-10 0 1 2 3 4 5 Day
Figure 1. Post-Operative Pain by Group and Day.
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Medication Usage 15
13
11
9 Mean # Tablets 7 Debridement Non-Debridement 5
3
1 0 1 2 3 4 5 Day
Figure 2. Medication Use by Group and Day.
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Escape Drug Use 100.0
90.0
80.0
70.0
60.0 Percent (%) 50.0 Non-Escape 40.0 Escape
30.0
20.0
10.0
0.0 Debridement Non-Debridement
Figure 3. Escape Drug Use.
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APPENDIX C
CONSENT FORM
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The Ohio State University Consent to Participate in Research
Effect of initial endodontic treatment on postoperative pain in Study Title: symptomatic teeth with pulpal necrosis Principal Investigator: Dr. Melissa Drum
Sponsor: Not Applicable
• This is a consent form for research participation. It contains important information about this study and what to expect if you decide to participate. Please consider the information carefully. Feel free to discuss the study with your friends and family and to ask questions before making your decision whether or not to participate. • Your participation is voluntary. You may refuse to participate in this study. If you decide to take part in the study, you may leave the study at any time. No matter what decision you make, there will be no penalty to you and you will not lose any of your usual benefits. Your decision will not affect your future relationship with The Ohio State University. If you are a student or employee at Ohio State, your decision will not affect your grades or employment status. • You may or may not benefit as a result of participating in this study. Also, as explained below, your participation may result in unintended or harmful effects for you that may be minor or may be serious depending on the nature of the research. • You will be provided with any new information that develops during the study that may affect your decision whether or not to continue to participate. If you decide to participate, you will be asked to sign this form and will receive a copy of the form.You are being asked to consider participating in this study for the reasons explained below.
1.Why is this study being done? The purpose of this study is to evaluate patients with emergency pain and a sore tooth to determine if immediate root canal therapy is better at reducing pain, when compared to initial treatment with antibiotic and pain medication followed by root canal therapy.
2.How many people will take part in this study? One hundred people (100) will take part in this study.
3.What will happen if I take part in this study?
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You have a tooth, which is hurting (painful), and you are aware that it needs a root canal. If you decide to participate in this study, you will be required to complete a medical history questionnaire and HIPAA authorization and consent form. If you are a female and pregnant or nursing, you will not be able to participate. If you are a woman able to have children, you will be required to take a urine pregnancy test before participation. You will be randomly assigned a number, which will determine if you will receive initial endodontic treatment today or at a later date. Each participant will receive an anesthetic injection, pain medication and a prescription for an antibiotic today. You will be asked to keep a diary to record your pain level after the injection and record your pain and the amount and type of pain medication taken each day for the next 5 days.
4. How long will I be in the study?
You will have an initial appointment that may last up to 90 minutes. If root canal treatment is started at the first appointment, you will be required to return after 5 days to return the pain diary. Patients not receiving immediate endodontic treatment will be scheduled for the procedure 5 days later or at the earliest convenient appointment.
5. Can I stop being in the study?
You may leave the study at any time. If you decide to stop participating in the study, there will be no penalty to you, and you will not lose any benefits to which you are otherwise entitled. Your decision will not affect your future relationship with The Ohio State University.
6.What risks, side effects or discomforts can I expect from being in the study? The research risks with ibuprofen would be: an allergic reaction (rash, difficulty breathing) which is very rare, upset stomach, nausea, heartburn, diarrhea, gastric bleeding, and increased bleeding.
The research risks with acetaminophen would be: an allergic reaction (rash, difficulty breathing) which is very rare, upset stomach, nausea and liver trouble.
The risks with standard root canal treatment would include: You may have pain associated with the local anesthetic (numbing solution) or soreness at the site of the injections (shots) for approximately two days. Where you receive the injection, you may have swelling (hematoma-a collection of blood in my mouth) or a bruise may develop. You may experience a feeling of anxiety, lightheadedness or fainting, and/or a temporary increase in your heart rate. Your toothache may stay the same or worsen 121
during the study. The tingling sensation and/or slight discomfort (pain) produced by the cold ice spray may be uncomfortable to you. You may have an unexpected infection (rare) which could result in permanent nerve damage. You may have soreness of your gum tissue for a few days or a possible altered sensation of your lip or tongue that may last up to a few weeks. Your tooth may feel sore to bite on for a few days.
7.What benefits can I expect from being in the study? You may not directly benefit from this study. Patients receiving root canal therapy at the first appointment may have reduced pain compared to the group not receiving the root canal therapy. Conversely, patients not receiving the root canal therapy today may also experience less pain.
8. What other choices do I have if I do not take part in the study?
You may choose not to participate without penalty or loss of benefits to which you are otherwise entitled.
9.Will my study-related information be kept confidential?
Efforts will be made to keep your study-related information confidential. However, there may be circumstances where this information must be released. For example, personal information regarding your participation in this study may be disclosed if required by state law.
Also, your records may be reviewed by the following groups (as applicable to the research): • Office for Human Research Protections or other federal, state, or international regulatory agencies; • U.S. Food and Drug Administration; • The Ohio State University Institutional Review Board or Office of Responsible Research Practices; • The sponsor supporting the study, their agents or study monitors; and • Your insurance company (if charges are billed to insurance).
If this study is related to your medical care, your study-related information may be placed in your permanent hospital, clinic, or physician’s office records. Authorized Ohio State University staff not involved in the study may be aware that you are participating in a research study and have access to your information.
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. law. This website will not include information that can identify 122
you. At most, the website will include a summary of the results. You can search the website at any time.
You may also be asked to sign a separate Health Insurance Portability and Accountability Act (HIPAA) research authorization form if the study involves the use of your protected health information.
10.What are the costs of taking part in this study? The study will pay for the cost of study drugs (ibuprofen and acetaminophen) and a urine pregnancy test when indicated. Costs associated with routine endodontic treatment (emergency fees, root canal treatment, antibiotics) will be billed to the patient and/or dental insurance.
11.Will I be paid for taking part in this study?
Yes. You will receive up to $100 to participate in this study. If you complete the first visit, you will receive $50. You will receive an additional $50 upon completion and return of the 5-day diary and return of all unused study medications. By law, payments to subjects are considered taxable income.
12.What happens if I am injured because I took part in this study?
If you suffer an injury from participating in this study, you should notify the researcher or study doctor immediately, who will determine if you should obtain medical treatment at The Ohio State University Medical Center.
The cost for this treatment will be billed to you or your medical or hospital insurance. The Ohio State University has no funds set aside for the payment of health care expenses for this study.
13.What are my rights if I take part in this study?
If you choose to participate in the study, you may discontinue participation at any time without penalty or loss of benefits. By signing this form, you do not give up any personal legal rights you may have as a participant in this study.
You will be provided with any new information that develops during the course of the research that may affect your decision whether or not to continue participation in the study.
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You may refuse to participate in this study without penalty or loss of benefits to which you are otherwise entitled.
An Institutional Review Board responsible for human subjects research at The Ohio State University reviewed this research project and found it to be acceptable, according to applicable state and federal regulations and University policies designed to protect the rights and welfare of participants in research.
14. Who can answer my questions about the study?
For questions, concerns, or complaints about the study you may contact Dr. Melissa Drum or Dr. Raquel Sebastian at 614-292-5399.
For questions about your rights as a participant in this studyor to discuss other study- related concerns or complaints with someone who is not part of the research team, you may contact Ms. Sandra Meadows in the Office of Responsible Research Practices at 1-800-678-6251.
If you are injured as a result of participating in this study or for questions about a study-related injury, you may contact Dr. Melissa Drum or Dr. Raquel Sebastian at 614-292-5399.
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Signing the consent form
I have read (or someone has read to me) this form and I am aware that I am being asked to participate in a research study. I have had the opportunity to ask questions and have had them answered to my satisfaction. I voluntarily agree to participate in this study.
I am not giving up any legal rights by signing this form. I will be given a copy of this form.
Printed name of subject Signature of subject
AM/PM Date and time
Printed name of person authorized to consent for Signature of person authorized to consent for subject subject (when applicable) (when applicable)
AM/PM Relationship to the subject Date and time
Investigator/Research Staff
I have explained the research to the participant or his/her representative before requesting the signature(s) above. There are no blanks in this document. A copy of this form has been given to the participant or his/her representative.
Printed name of person obtaining consent Signature of person obtaining consent
AM/PM Date and time
Witness(es) - May be left blank if not required by the IRB
Printed name of witness Signature of witness
AM/PM Date and time
Printed name of witness Signature of witness
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APPENDIX D
PRIVACY FORM
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THE OHIO STATE UNIVERSITY AUTHORIZATION TO USE PERSONAL HEALTH INFORMATION IN RESEARCH
Title of the Study: Efficacy of initial endodontic treatment on postoperative pain in symptomatic teeth with pulpal necrosis
Protocol Number: 2013H0001
Principal Investigator: Melissa Drum DDS, MS
Subject Name______
Before researchers use or share any health information about you as part of this study, The Ohio State University is required to obtain your authorization. This helps explain to you how this information will be used or shared with others involved in the study.
• The Ohio State University and its hospitals, clinics, health-care providers, and researchers are required to protect the privacy of your health information. • You should have received a Notice of Privacy Practices when you received health care services here. If not, let us know and a copy will be given to you. Please carefully review this information. Ask if you have any questions or do not understand any parts of this notice. • If you agree to take part in this study your health information will be used and shared with others involved in this study. Also, any new health information about you that comes from tests or other parts of this study will be shared with those involved in this study. • Health information about you that will be used or shared with others involved in this study may include your research record and any health care records at The Ohio State University. For example, this may include your medical records, x-rays, or laboratory results. Psychotherapy notes in your health records (if any) will not, however, be shared or used. Use of these notes requires a separate, signed authorization.
Please read the information carefully before signing this form. Please ask if you have any questions about this authorization, the university’s Notice of Privacy Practices or the study before signing this form.
Those Who May Use, Share, and Receive Your Information as Part of This Study
• Researchers and staff at The Ohio State University will use, share, and receive your personal health information for this research study. Authorized Ohio State staff not involved in the 127 study may be aware that you are participating in a research study and have access to your information. If this study is related to your medical care, your study-related information may be placed in your permanent hospital, clinic, or physician’s office records.
Initials/Date: ______
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• Those who oversee the study will have access to your information, including the following: • Members and staff of The Ohio State University’s Institutional Review Boards, including the Western Institutional Review Board • The Ohio State University Office of Responsible Research Practices • University data safety monitoring committees • The Ohio State University Office of Research.
• Your health information may also be shared with federal and state agencies that have oversight of the study or to whom access is required under the law. These may include the following: • Food and Drug Administration • Office for Human Research Protections • National Institutes of Health • Ohio Department of Job and Family Services.
• These researchers, companies and/or organization(s) outside of The Ohio State University may also use, share and receive your health information in connection with this study: • NONE
The information that is shared with those listed above may no longer be protected by federal privacy rules.
Authorization Period
This authorization will not expire unless you change your mind and revoke it in writing. There is no set date at which your information will be destroyed or no longer used. This is because the information used and created during the study may be analyzed for many years, and it is not possible to know when this will be completed.
Initials/Date______
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Signing the Authorization
• You have the right to refuse to sign this authorization. Your health care outside of the study, payment for your health care, and your health care benefits will not be affected if you choose not to sign this form. • You will not be able to take part in this study and will not receive any study treatments if you do not sign this form. • If you sign this authorization, you may change your mind at any time. Researchers may continue to use information collected up until the time that you formally changed your mind. If you change your mind, your authorization must be revoked in writing. To revoke your authorization, please write to: Dr. Melissa Drum at the College of Dentistry, 305 w 12th avenue, the Ohio State University, Columbus, Ohio 43218 or Dr. Fonda Robinson at the College of Dentistry, 305 w 12th avenue, the Ohio State University, Columbus, Ohio 43218. • Signing this authorization also means that you will not be able to see or copy your study- related information until the study is completed. This includes any portion of your medical records that describes study treatment.
Contacts for Questions
• If you have any questions relating to your privacy rights, please contact: Dr. Fonda Robinson at the College of Dentistry, 305 w 12th avenue, the Ohio State University, Columbus, Ohio 43218 • If you have any questions relating to the research, please contact: Dr. Melissa Drum at the College of Dentistry, 305 W. 12th Ave., The Ohio State University, Columbus, OH 43210
Signature
I have read (or someone has read to me) this form and have been able to ask questions. All of my questions about this form have been answered to my satisfaction. By signing below, I permit Dr. Melissa Drum and the others listed on this form to use and share my personal health information for this study. I will be given a copy of this signed form.
Signature______(Subject or Legally Authorized Representative)
Print Name ______Date______Time ______AM/PM
______(If legal representative, also print relationship to subject)
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APPENDIX E
CORAH’S DENTAL ANXIETY SCALE
131
Code______Pre-Injection Questionnaire
PLEASE ANSWER THE FOLLOWING QUESTIONS BY CIRCLING THE ANSWER THAT BEST DESCRIBES HOW YOU FEEL.
1. If you had to go to the dentist tomorrow, how would you feel about it? a) I would look forward to it as a reasonably enjoyable experience. b) I wouldn't care one way or the other. c) I would be a little uneasy about it. d) I would be afraid that it would be unpleasant and painful. e) I would be very afraid of what the dentist might do.
2. When you are waiting in the dentist's office for you turn in the chair, how do you feel? a) Relaxed. b) A little uneasy. c) Tense. d) Anxious. e) So anxious that I sometimes break in a sweat or almost feel physically sick.
3. When you are in the dentist's chair waiting while she/he gets her/his drill ready to begin working on your teeth, how do you feel? a) Relaxed. b) A little uneasy. c) Tense. d) Anxious. e) So anxious that I sometimes break in a sweat or almost feel physically sick.
4. You are in the dentist's chair to have your teeth cleaned. While you are waiting and the dentist is getting out the instruments, which she/he will use to scrape your teeth around your gums, how do you feel? a) Relaxed. b) A little uneasy. c) Tense. d) Anxious. e) So anxious that I sometimes break in a sweat or almost feel physically sick.
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APPENDIX F
HEALTH HISTORY QUESTIONAIRRE
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THE OHIO STATE UNIVERSITY Subject # ______COLLEGE OF DENTISTRY Date ______Date of Birth ______
Medical History
1. Do you have or have you had any of the following?
a. rheumatic fever or rheumatic heart disease…………………. NO YES b. heart murmur or mitral valve prolapse……………………… NO YES c. heart disease or heart attack………………………………… NO YES d. artificial heart valve………………………………………… NO YES e. irregular heart beat………………………………………….. NO YES f. pacemaker…………………………………………………… NO YES g. high blood pressure…………………………………………. NO YES h. chest pains or angina………………………………………… NO YES i. stroke………………………………………………………… NO YES j. artificial joint………………………………………………… NO YES k. hepatitis/liver disease……………………………………….. NO YES l. tuberculosis………………………………………………….. NO YES m. thyroid problem……………………………………………. NO YES n. kidney disease………………………………………………. NO YES o. diabetes (sugar)……………………………………………… NO YES p. asthma………………………………………………………. NO YES q. HIV or other immunosuppressive disease………………….. NO YES r. radiation or cancer therapy………………………………….. NO YES
2. Do you or have you had any disease, condition, or problem not listed here?NO YES
3. Have you ever been hospitalized? NO YES
4. Have you had excessive or prolonged bleeding requiring special treatment? NO YES
5. Have you had an allergic reaction to any drugs or medications? (Circle all that apply: penicillin; codeine; aspirin; anesthetics; other)NO YES
6. Are you currently under the care of a physician (M.D., D.O.)? NO YES When were you last seen by a physician?______Name of Physician______Street address______City, State, and Zip Code______Phone______
7. Are you pregnant or nursing? Estimated date of delivery______NO YES
8. Have you had any trouble associated with previous dental treatment? NO YES
9. How often do you have dental check ups? ______Date of last Exam______134
10. Do you have any lumps or sores in your mouth now? NO YES
11. Do you smoke or use smokeless tobacco? NO YES
12. Are you currently taking any drugs or medications (such as antibiotics, heart medicine, birth control pills?) NO YES
Current Medications
Trade Name Generic Name Dose/Frequency Reason
Summary of Patient’s Medical Status:______Medical Risk Assessment
ASA I (healthy individual) ASA III (severe disease but not incapacitating) ASA II (mild systemic disease) ASA IV (incapacitating systemic disease)
Medical Consultation Required
No (healthy and/or stabilized disease)
Yes (ASA III or IV; cardiac murmur; vague hx; recent major disease; recent diagnosis/operation; uncontrolled disease; blood pressure; etc.)
To the best of my knowledge, the above information is correct and complete.
______Patient’s Signature Date
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APPENDIX G
INITIAL VISUAL ANALOG SCALE
(Note: VAS not drawn to scale)
136
Code Number:______
Initial Pain Rating Appointment 1
Mark an “X” on the point on the line that best describes your pain.
None Faint Weak Mild Moderate Strong Intense Maximum Possible
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APPENDIX H
ANESTHETIC INJECTION VISUAL ANALOG SCALE
(Note: VAS not drawn to scale)
138
Code Number:______
Anesthetic Injection Pain Rating Insertion
Mark an “x” on the point on the line that best describes your pain.
None Faint Weak Mild Moderate Strong Intense Maximum Possible
Anesthetic Injection Pain Rating Placement
Mark an “x” on the point on the line that best describes your pain.
None Faint Weak Mild Moderate Strong Intense Maximum Possible
Anesthetic Injection Pain Rating Deposition
Mark an “x” on the point on the line that best describes your pain.
None Faint Weak Mild Moderate Strong Intense Maximum Possible
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APPENDIX I
EMERGENCY TREATMENT VISUAL ANALOG SCALE
(Note: VAS not drawn to scale)
140
Code Number:______
Emergency Treatment Access Dentin
Mark an “x” on the point on the line that best describes your pain.
None Faint Weak Mild Moderate Strong Intense Maximum Possible
Emergency Treatment Pulp Chamber
Mark an “x” on the point on the line that best describes your pain.
None Faint Weak Mild Moderate Strong Intense Maximum Possible
Emergency Treatment Instrument Canals
Mark an “x” on the point on the line that best describes your pain.
None Faint Weak Mild Moderate Strong Intense Maximum Possible
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APPENDIX J
SUPPLEMENTAL INJECTION VISUAL ANALOG SCALE
(Note: VAS not drawn to scale)
142
Code Number:______
Supplemental Anesthetic Injection Pain Rating Insertion
Mark an “x” on the point on the line that best describes your pain.
None Faint Weak Mild Moderate Strong Intense Maximum Possible
Anesthetic Injection Pain Rating Placement
Mark an “x” on the point on the line that best describes your pain.
None Faint Weak Mild Moderate Strong Intense Maximum Possible
Anesthetic Injection Pain Rating Deposition
Mark an “x” on the point on the line that best describes your pain.
None Faint Weak Mild Moderate Strong Intense Maximum Possible
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APPENDIX K
POST-SUPPLEMENTAL INJECTION SURVEY
(Note: VAS not drawn to scale)
144
Code Number:______
Post Supplemental Injection Emergency Treatment Pain Rating Access Dentin
Mark an “X” on the point on the line that best describes your pain.
None Faint Weak Mild Moderate Strong Intense Maximum Possible
Emergency Treatment Pulp Chamber
Mark an “X” on the point on the line that best describes your pain.
None Faint Weak Mild Moderate Strong Intense Maximum Possible
Emergency Treatment Instrument Canals
Mark an “X” on the point on the line that best describes your pain.
None Faint Weak Mild Moderate Strong Intense Maximum Possible
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