Topical Intrapocket Anesthesia During Scaling and Root Planing
Total Page:16
File Type:pdf, Size:1020Kb
Brazilian Dental Journal (2015) 26(1): 26-32 ISSN 0103-6440 http://dx.doi.org/10.1590/0103-6440201300131 1Dental School, Franciscan University Topical Intrapocket Anesthesia Center, Santa Maria, RS, Brazil 2Postgraduate Program in Dentistry, During Scaling and Root Planing: UFSM - Federal University of Santa Maria, Santa Maria, a Randomized Clinical Trial RS, Brazil 3Postgraduate Program in Dentistry, ULBRA - Lutheran University of Brazil, Canoas, RS, Brazil Raquel Pippi Antoniazzi1, Bruna Cargnelutti1, Daniela Napoleão Freitas2, Magáli Beck Guimarães1, Fabricio Batistin Zanatta2, Carlos Alberto Feldens3 Correspondence: Dra. Raquel Pippi Antoniazzi, Rua Silva Jardim, 1175, 97010-491 Santa Maria, RS, Brasil. Tel: +55-55-3025-1202. e-mail: [email protected] Although the use of injectable anesthesia prior to subgingival scaling and root planing (SRP) reduces pain, many patients report fear and prolonged numbness of adjacent tissues. The aim of the present study was to compare the effects of a eutectic mixture containing 25 mg/g of lidocaine and 25 mg/g of prilocaine, injectable 2% lidocaine, topical 2% benzocaine and a placebo substance on reducing pain during SRP. In this randomized, split-mouth, masked clinical trial, thirty-two patients presenting more than two teeth with probing depth and clinical attachment level ≥5 mm in at least 4 sextants were randomly allocated to four groups: EMLA®; injectable 2% lidocaine; topical 2% benzocaine and placebo. Pain and discomfort were measured using a visual analogue scale (VAS) and verbal scale (VS). Repeated-measures analysis of variance and Poisson regression were used for analysis. Patient satisfaction with the anesthesia was determined at the end of each treatment session. VAS and VS scores did not differ between injectable 2% lidocaine and EMLA (p>0.05) and both substances showed significantly better pain control compared to 2% benzocaine and placebo (p<0.05). 93.7% and 81.2% of the individuals were satisfied with the injectable anesthetic and EMLA, respectively (p=0.158). Dissatisfaction with benzocaine and placebo was approximately 10 times greater than injectable anesthesia (p=0.001). In conclusion, EMLA showed an equivalent effect on pain control when compared to the injectable anesthesia and performed better than 2% benzocaine in SRP. Thus, EMLA is a viable anesthetic option during scaling and root Key Words: local anesthesia, planning, despite the frequent need for second application. periodontitis, root planing, pain. Introduction lower cost. To date, no studies have compared the efficacy It is often necessary to use anesthesia during of EMLA to another inexpensive, commonly used anesthetic subgingival scaling and root planing (SRP) to control pain (2% benzocaine) during subgingival SRP procedures. and discomfort (1). An injectable anesthetic is considered Moreover, few studies have compared the effects of EMLA the gold standard in such cases and may or may not be to injectable anesthesia using pain scores for the purposes used in conjunction with a topical anesthetic (2). While of evaluation. injectable anesthetics are effective in controlling pain, many The study hypothesis is that topical anesthetics are patients report fear of the needle, long-lasting effects and equivalent to injectable anesthetic regarding the control the prolonged numbness of adjacent tissues, such as the of pain during SRP. The aim of the present study was to lips and tongue (3-5). The need for painless, noninvasive, compare the effects of EMLA, injectable 2% lidocaine, fast-acting anesthetics with effectiveness only during topical 2% benzocaine and a placebo substance on reducing the procedure has led to the investigation of the use of pain during subgingival scaling and root planing. substances with topical application during SRP (3,6-11) and periodontal maintenance (12). It has recently been Material and Methods demonstrated that the use of a topical anesthetic does Study Design and Subjects not compromise subgingival treatment and offers similar A masked, randomized clinical trial with a split-mouth benefits to pocket probing and clinical attachment gain design was carried out. Forty-one patients were recruited to an injectable anesthetic (13). from the Dental School of the Franciscan University Center, Oraqix® is a topical anesthetic containing lidocaine Santa Maria, RS, Brazil, from June 2010 to March 2012. This (25 mg/g) and prilocaine (25 mg/g) that is commercially study received approval from the Human Research Ethics available as an anesthetic for subgingival SRP. This product Committee of the university and all participants signed a has proven to be a reliable alternative to injectable statement of informed consent. The registration number anesthesia (7-9). A eutectic mixture denominated EMLA® is NCT01860235 (www.clinicaltrials.gov). has the same composition as Oraqix, but is offered at a For gingivitis treatment, all patients received two Braz Dent J 26(1) 2015 to four supragingival scaling and polishing sessions and procedures being conducted during the first four sessions. meticulous self-care oral hygiene training. After treatment Therefore all patients received the four interventions. and the achievement of the goal of a low percentage of The two teeth with the deepest PD were selected from visible plaque and gingival bleeding (<15%), an examination each sextant. Following the treatment of those teeth and was performed for the assessment of probing depth (PD), administration of the pain scales, SRP was performed on clinical attachment level (CAL) and bleeding on probing other teeth in the sextant that required the procedure (BOP) at six sites per tooth to determine the sites that using the same type of anesthetic. required SRP treatment. Eligible individuals were selected Randomization was conducted by a researcher not from those requiring SRP with at least two teeth in four involved in the eligibility and entry of subjects into the sextants with ≥1 site with PD and CAL ≥5 mm and BOP study to warrant treatment allocation concealment. following treatment for gingivitis (without marginal Block randomization was performed for the allocation bleeding). The other inclusion criteria were aged 18 years or of the participants to the different groups: injectable 2% older, adequate understanding of the pain scales employed lidocaine with epinephrine 1:100,000 (Alphacaine; DFL, and no history of previous periodontal treatment. The Rio de Janeiro, RJ, Brazil); topical 5% eutetic mixture of following were the exclusion criteria: history of allergies 25 mg/g of lidocaine and 25 mg/g of prilocaine (EMLA; or sensitivity reaction to any amide or ester anesthetic; AstraZeneca, Cotia, SP, Brazil); topical 200 mg/g of 2% having received anesthesia or sedation 12 h prior to SRP; benzocaine (Benzotop; DFL) or a placebo substance with be using pain medication (i.e., sedative, muscle relaxant, same appearance and viscosity as the topical anesthetics. anti-inflammatory medication, and narcotic analgesic); One set of opaque envelopes contained a card stipulating ulcerations or abscesses in the oral cavity; oral disease the sextant to undergo treatment and a second set with immediate need for surgery; history of alcohol of envelopes contained a card stipulating the type of abuse; current pregnancy; uncontrolled hypertension; and anesthesia to be administered. Each participant received participation in a clinical trial of an investigational drug an envelope from each set immediately prior to the start within four months after the onset of the present study. of the subgingival SRP session. The technique used for injectable anesthesia was Experimental Design nerve block with at most two anesthetic cartridges per Figure 1 displays the flow chart of the study. After the session SRP. When a topical substance was administered, clinical parameters had been recorded, the four sextants the patient was masked to the type. All anesthetics were containing teeth with the deepest PD were chosen to administered by the same operators (BC and DNF). Prior Topical intrapocket anesthesia intrapocket Topical participate in the experiment. Treatment with SRP was to administration, relative isolation was performed with performed over six weekly sessions with the experimental cotton rolls. The selected anesthetic was applied to the Figure 1. Study flow chart. 27 Braz Dent J 26(1) 2015 two teeth with a deepest PD and BOP (regardless of the kappa (K) statistic. K values for intra-examiner agreement severity of PD). For topical anesthetics, the maximum dose regarding PD and CAL were 0.79 and 0.76 for Examiner 1 used in the sextant was 2.5 mL. The anesthetic was applied and 0.74 and 0.80 for Examiner 2, respectively. K values for directly into the periodontal pocket of each tooth with a inter-examiner agreement were 0.75 and 0.78 for PD and millimeter syringe and a blunt needle and inserted until CAL, respectively. Both intra-examiner and inter-examiner overflowing the gingival margin. reliability were determined a second time eight months Different operators performed the subgingival SRP after the onset of the study and all K values were ≥0.8. and assessment of the main outcome. The operator who performed the subgingival SRP was blinded to the type of Sample Size anesthesia to ensure that the procedure was performed The sample size was calculated based on a clinically similarly in all groups. For the operators masked were relevant difference in VAS scores (15 mm) between groups put under the clinic table all anesthetic types and it was with a standard deviation (SD) of 25 mm. Considering a requested him/her to walked away from dental chair until significance level of 5%, 90% study power and the paired that was completed the anesthesia so that operator does design, it was determined that a minimum of 31 patients not know the type of anesthesia that was administered. were needed for each group. This number was increased to Two minutes after administration of the anesthetic 41 patients to compensate for a possible 25% dropout rate. administration, the operator began the SRP procedure in the sextant using curettes and periodontal files (Neumar, Data Analysis São Paulo, SP, Brazil).