Rajiv Gandhi University of Health Sciences s129

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE, KARNATAKA. ANNEXURE II PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1. NAME OF THE CANDIDATE Dr. BENIN.P AND ADDRESS (IN BLOCK POSTGRADUATE STUDENT LETTERS) DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS, BAPUJI DENTAL COLLEGE AND HOSPITAL, DAVANGERE – 577 004, KARNATAKA.

2. NAME OF THE INSTITUTION BAPUJI DENTAL COLLEGE AND HOSPITAL, DAVANGERE – 577 004, KARNATAKA.

3. COURSE OF STUDY MASTER OF DENTAL SURGERY AND SUBJECT CONSERVATIVE DENTISTRY AND ENDODONTICS

4. DATE OF ADMISSION TO THE 20/04/2009 COURSE

5. TITLE OF THE DISSERTATION “AN IN VIVO EVALUATION OF THREE ROOT CANAL SEALERS”

6. BRIEF RESUME OF THE INTENDED WORK:

1 6.1 Need for the study:

Searching for the best treatment is the foot step in the growth of science and medicine. Dentistry is no far from it and researches are in progress for the better alternatives. Saving teeth is getting more attention in the eyes of researchers. Cleaning the root canals and maintaining it in a sterile condition with a tight seal with a root canal sealer and obturating material is the most important objective of the root canal therapy.1

Mineral Trioxide Aggregate (MTA), a tricalcium silicate cement was used as a perforation repair material.2 Being biocompatible it gained popularity in pulp capping, pulpotomy, apexification and as root end filling material.3 Recently it is finding its application as a root canal sealer4 and obturating material.5 MTA has ability to form cementum in the main and accessory canals,6 regenerate periodontal ligament and stimulate periapical healing. It also has high push-out bond strength to dentin7 and a better sealing ability. The drawbacks of the handling properties are overcome by the modification of the material8 and techniques employed.9

Epoxy resin sealers have advantages like high radio opacity, low solubility, little shrinkage, better periapical repair,10 and biocompatible. The precursors were genotoxic and cytotoxic. Improvements in this material show no genotoxicity or mutagenicity and regained its popularity as a root canal sealer.11

Studies have been done only in animals using MTA as a root canal sealer and yielded better results and some controversial results in some studies.12 Studies have compared the various aspects of epoxy resin sealer13 but clinical comparative studies are minimal. This study will be an attempt in humans to compare the Clinical and

Radiological outcome of MTA or Epoxy Resin as a root canal sealer compared to Zinc

Oxide Eugenol using Gutta percha as the obturating material.

6.2 Review of literature

2 An in vivo study was conducted in dogs by Holland to observe the apical tissues when MTA or glass ionomer was used as a root canal sealer. Thirty root canals of two dogs were instrumented with irrigation. It is then dressed and sealed for 1 week with temporary filling. In the next treatment, the canals were irrigated, dried and filled with gutta percha and MTA or with glass ionomer. The mixed cements were applied to the walls with lentulospirals and filled by lateral condensation technique. After 180 days, the animals were killed and segments of jaw prepared for histological examination. Closure of the main canals and accessory canals by cementum was observed in all cases with no inflammatory reaction in periodontal ligament in MTA group compared with ketac endo group, which showed partial or no closure of the canals. This suggests MTA has biological properties that recommend it as a root canal material but may need some modification of the physical properties.6

A study was conducted to evaluate the sealing ability of zinc oxide eugenol (Fill

Canal), glass ionomer sealer (Ketac-Endo) and epoxy resin sealer (AH Plus) in extracted teeth. 99 extracted maxillary central incisors were prepared and obturated by lateral condensation of cold gutta-percha using one of the sealers. The teeth were covered with nail varnish to with in 1 mm of the apical foramen and immersed in 2% methylene blue in a reduced pressure environment for 24 hours. Then the teeth were analyzed for leakage. Results showed that all the sealers leaked but AH Plus sealer had a better sealing ability compared with the other two sealers tested.13

An in vitro study was conducted to evaluate the potential of using MTA as a root canal filling material by comparing its sealing ability with that of laterally condensed gutta percha and thermoplasticized gutta percha with sealer in extracted bovine teeth following a standardized procedure. Sealing ability was tested after its immersion in methylene blue for 3 days. The results suggested that, the apical seal produced by

3 traditional gutta percha was superior than that produced by MTA.12

An in vivo study was conduced in dogs to find out the influence of the type of vehicle on periapical tissues after root canal filling with MTA. The study compared the use of distilled water and propylene glycol. Forty roots of incisors and premolars of two dogs were used in the study. Results of all specimens showed newly formed cementum causing biological closure of the canals in the apical data and complete biological closure of main canals in 8 out of 10 specimens. Similar results were observed for both MTA pastes prepared with distilled water or propylene glycol as vehicles. MTA paste prepared with propylene glycol was easily placed into the root canals.14

A study was conducted to find out the dislocation resistance of ProRoot Endo

Sealer from radicular dentin. Sixty single rooted caries free teeth were used in the study.

Canals were prepared using 0.04 taper Profile instruments. The cavities were filled with

ProRoot endo sealer. After setting they were tested for push out bond strength. ProRoot endo sealer exhibited higher push out strengths than the other two sealers used in the study (P<0.001).7

A study was conducted to evaluate physical properties of MTA. MTA was mixed with water at powder/liquid ratios of 4 and 3.33 and an addition of 2 microL to 20 microL of water soluble polymer. The materials were evaluated for flow, film thickness and the optimal quantity of polymer to conform ISO standards. The resulted MTA sealer was tested for radioopacity using standard methods with pulp canal sealer as control. The effect of polymer addition was evaluated by scanning electron microscope. The results suggested that the addition of water-soluble polymer does not affect the hydration process of MTA and had improved properties suitable for use as an endodontic sealer.15

6.3 Objectives of the study:

4  Clinical evaluation of treatment outcome of three different sealers with the help of

visual analogue scale

 To evaluate the radiological outcome of root canal treatment using three different

sealers with the help of Peri Apical Index (PAI)

 To compare the radiological outcome of progression or regression of the

periapical lesion using three different sealers with help of VixWin PRO Dental

image analyzing software (Gendex Dental systems).

7. MATERIALS AND METHODS:

7.1 Source of data:

Patients visiting the Outpatient Department of Conservative Dentistry and

Endodontics in Bapuji Dental College and Hospital, Davangere, Karnataka, with teeth

indicated for root canal treatment and having periapical radiolucency in the age group of

18-50 years.

7.2 Methods of collection of data (Including sampling procedures if any):

Patient’s written consent will be taken before starting the procedure

Materials used are:

Hand and rotary files

Zinc Oxide Eugenol sealer

A H Plus (Dentsply Detrey) root canal sealer

Mineral Trioxide Aggregate (ProRoot MTA, Dentsply, Tulsa Dental)

Propylene glycol IP

VixWin PRO Dental imaging software (Gendex Dental systems)

Inclusion Criteria

5  Teeth indicated for root canal treatment with periapical radiolucency that is

readily visible in the radiographs and more than 1 mm in size

 Single rooted teeth in the age group of 18 to 50 years

 Patients with good systemic health

Exclusion Criteria

 Retreatment cases

 Failure to obtain patients authorization

 Presence of complications during treatment during treatment (Calcified canals,

impossible to obtain apical patency)

 Immuno compromised patients

45 teeth will be randomly selected into 3 groups with 15 teeth in each group

GROUP 1: Zinc Oxide Eugenol as sealer

GROUP 2: Epoxy resin as sealer

GROUP 3: MTA as sealer

Diagnosis will be made based on patient’s history, pulp vitality tests and radiographs. The cases will be assigned randomly into any one of the groups. Isolation, disinfection and sterilization will be obtained with rubber dam application. Access cavity will be prepared with access preparation kit. Pulp tissue and debris will be removed.

Working length will be determined and canals will be prepared with hand and rotary instruments using sodium hypochlorite, hydrogen peroxide and normal saline as irrigants.

The canals will then be obturated according to their groups using gutta-percha as the obturating material.

For Group 1, Zinc Oxide Eugenol sealer will be used. The walls will be coated with the sealer using lentulospirals. The master gutta percha cone will be placed with a little sealer in its tip. The procedure will be completed by filling the lateral spaces with

6 accessory gutta percha cones and sealer by lateral compaction technique.

For Group 2 manufacturers instruction will be followed for mixing and will be

obturated in the same technique as Group 1.

The same methodology will followed for Group 3 except MTA will be used as

the sealer and will be mixed with propylene glycol.14,15 All treated teeth will be reduced to

free occlusal load. Follow-ups will be done using clinical examination, digital and

conventional radiographs for a period of six months.

At each appointment, clinical evaluation for pain or tenderness and radiological

outcome with Peri Apical Index16 will be made. Radiological outcome for progression or

regression of the lesion will be made by morphometric analysis of immediate post

operative and follow-up digital images using VixWin PRO (Gendex Dental Systems)

digital image analyzing software.17

Statistical analysis

The quantitative data will be analyzed by t- test and ANOVA. Ordinal data will

be analyzed by Wilcoxon’s signed rank test, Mann Whitney and Kruskall Wallis test.

7.3 Does the Study require any investigation or interventions to be conducted on

patients or other humans or animals? If so please describe briefly.

Treatment: Root canal treatment in patients using three different root canal sealers (

Mineral Trioxide Aggregate, AH Plus, Zinc Oxide Eugenol root canal sealer)

7.4 Has Ethical clearance been obtained from your institution in case of 7.3?

Yes ( Ethical clearance report attached here with)

8. LIST OF REFERENCES

7 1. Peters OA, Peters CI. Cleaning and shaping of the root canal system. In: Cohen S,

Hargreaves KM. Pathways of the pulp. 9th ed. Missouri: Mosby; 2006. p.290-357.

2. Main C, Mirzayan N, Shabahang S, Torabinejad M. Repair of root perforations

using Mineral Trioxide Aggregate: A long term study. J Endod 2004; 30(2): 80-3.

3. Park JB, Lee JH. Use of mineral trioxide aggregate in the open apex of a maxillary

first premolar. J Oral Sci 2008; 50: 355-58.

4. Gomes-Filbo JE, Watanabe S, Bernabe PF, Costa MT. A Mineral Trioxide

Aggregate sealer stimulated mineralization. J Endod 2009; 35(2): 256-60.

5. Bogen G, Kuttler S. Mineral Trioxide Aggregate obturation: A review and case

series. J Endod 2009; 35: 777-90.

6. Holland R, Souza V, Nery MJ, Filho JA, Bernabe PF et al. Reaction of dog’s teeth

to root canal filling with Mineral Trioxide Aggregate or a Glass Ionomer sealer. J

Endod 1999; 25(11): 728-30.

7. Huffman BP, Mai S, Pinna L, Weller RN, Primus CM et al. Dislocation resistance

of ProRoot Endo sealer, a calcium silicate-based sealer, from radicular dentine. Int

Endon Jol 2009; 42: 34-46.

8. Ber BS, Hatton JF, Stewart GP. Chemical modification of Proroot MTA to improve

handling characteristics and decrease setting time. J Endod 2007; 33: 1231-4.

9. Boutsioukis C, Noula G, Lambrianidis T. Ex vivo study of the efficiency of two

techniques for the removal of mineral trioxide aggregate used as a root canal filling

material. J Endod 2008; 34(10): 1239-42.

10. Leonardo MR, Salgado A, Silva LA, Filho MT. Apical and periapical repair of

dogs’ teeth with periapical lesions after endodontic treatment with different root

canal sealers. Pesqui Odontol Bras 2003; 17(1): 69-74.

11. Leyhausen G, Heil J, Reifferscheid G, Waldmann P, Geurtsen W. Genotoxicity and

8 Cytotoxicity of the Epoxy Resin Based Root Canal Sealer AH Plus. J Endod 1999;

25(2): 109-13.

12. Vizgirda PJ, Liewehr FR, Patton WR, McPherson JC, Buxton TB. A comparison of

laterally condensed Gutta-Percha, Thermoplasticized Gutta-Percha and Mineral

Trioxide Aggregate as root canal filling materials. J Endod 2004; 30(2): 103-6.

13. Almeida WA, Leonardo MR, Filho MT, Silva LA. Evaluation of apical sealing of

three endodontic sealers. Int Endod Jol 2000; 33: 25-27.

14. Holland R, Mazuqueli L, Souza V, Murata SS, Dezan E, Suzuki P. Influence of the

type of vehicle and limit of obturation on apical obturation on apical and periapical

tissue response in dogs teeth after root canal filling with Mineral Trioxide

Aggregate. J Endod 2007; 33(6): 693-7.

15. Camilleri J. Evaluation of selected properties of mineral trioxide aggregate sealer

cement. J Endod 2009; 35(10): 1412-7.

16. Delano EO, Ludlow JB, Orstavik D, Tyndall D, Trope M et al. Comparison

between PAI and quantitative digital radiographic assessment of periapical healing

after endodontic treatment. Oral Surg Oral Med Oral Pathol Oral Radiol Endod

2001; 92: 108-15.

17. Carvalho FB, Gonclaves M, Tanomaru JM, Filho MT. Evaluation of periapical

changes following endodontic therapy: digital substraction technique compared

with computerized morphometric analysis. Dentomaxillofac Radiol 2009; 38: 438-