Rajiv Gandhi University of Health Sciences s94

Rajiv Gandhi University of Health Sciences Bangalore, Karnataka. ANNEXURE - II PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION.

Dr. Poojari Manohar Sham 1. Name of the candidate PG Dept. of Pediatric dentistry, and address SDM College of Dental Sciences and Hospital, Sattur, Dharwad 580009.

2. Name of the Institution SDM College of Dental Sciences and Hospital, Sattur, Dharwad 580009.

3. Course of study and M.D.S in Pediatric Dentistry subject 4. Date of Admission to the course 31.05.2007

Clinical and Radiographic evaluation of efficacy of Sodium 5. Title of the topic Hypochlorite compared with Ferric Sulfate and Formocresol as a pulpotomy medicament: an in vivo study.

6. Brief resume of the study intended work 6.1. Need for the study Over the past 20 years, the use of Formocresol as a pulpotomy medicament has been challenged due to its systemic distribution, cytotoxicity, carcinogenic potential and pulpal inflammatory

response and thus concerns have been raised for finding a suitable alternatives to it to maintain pulp vitality.1,2 These include Glutaraldehyde, Ferric Sulfate, Electrosurgery, Laser and Enriched Collagen Solution.3 Ferric Sulfate has been used recently, due to its hemostatic effect.4 Salako et al. found that there was complete pulpal destruction with Ferric Sulfate and pulpal necrosis with Formocresol pulpotomies performed on rat molars.1,2 Even though high clinical success rates have been found using both Formocresol and Ferric Sulfate, histologic studies have shown that both produce severe inflammatory responses.1 Recently Sodium Hypochlorite (NaOCl) has been tried as a pulpotomy medicament due to its hemostatic and antimicrobial property without being a significant pulpal irritant.1,6 Rosenfeld et al. showed that placement of 5% NaOCl on noninstrumented vital pulp tissue acted only at the surface, thus exerts a digestive effect on diseased tissues and has a limited effect on normal healthy tissues.1,5,7 Thus Sodium Hypochlorite can be tried as an alternative to Formocresol as a pulpotomy agent as being a good hemostatic agent, economical and exerting minimal effect on normal healthy pulpal tissues. Objective of the study was as follows:

1. Evaluate clinically the efficacy of Sodium Hypochlorite when compared with Formocresol and Ferric Sulfate as pulpotomy medicament when followed up for one year at an interval of 1,3,6,9 and 12 months. 6.2. Objectives of the study 2. Evaluate radiographically the efficacy of Sodium Hypochlorite when compared with Formocresol and Ferric Sulfate as pulpotomy medicament when followed up for one year at an interval of 1,3,6,9 and 12 months using standardized paralleling technique.

6.3. Review of the 1. Vargas K. G, Packham Brett, Lowman David (2006)1 literature Compared the effectiveness of 5% NaOCl to that of ferric sulfate as a pulpotomy medicament in decayed primary molars. Results obtained from this study were as follows: 100% clinical success with intact restorations in both groups and no signs/symptoms of pain at 6 and 12 months recall respectively. Radiographic success for ferric sulfate was 68% and 91% for sodium hypochlorite with internal resorption was the most common finding. Based on this study’s results the following conclusions can be made 1). Preliminary evidence shows that NaOCl is superior to ferric sulfate as a pulpotomy medicament in primary molars. 2). Internal resorption is the most common radiographic finding at 6 and 12 months for both ferric sulfate and NaOCl.

2.Vargas K. G, Packham Brett (2004)2 Purpose of this retrospective study was to evaluate the radiographic findings with formocresol and ferric sulfate pulpotomies in relation to early tooth loss. The study concluded that both ferric sulfate and formocresol pulpotomies can lead to premature exfoliation of primary teeth, with the subsequent need for orthodontic space maintainance. Therefore radiographic criteria should be taken into consideration when evaluating pulpotomized teeth at recall visits.

3. Hegde A. H., Naik S (2005)3 Evaluated the efficacy of MTA as a pulpotomy medicament when compared with formocresol for a period of 6 months. Conclusion drawn from this study was that there was no statistical difference between the success rates of Formocresol or MTA.

4. Huth K C et al. (2004)4 Conducted a study to compare the relative effectiveness of the Er:YAG laser, calcium hydroxide and ferric sulfate techniques with that of dilute formocresol in retaining symptom free molars. After 24 months the clinical success rates determined as follows: formocresol 96%, laser 93%, calcium hydroxide 87% and ferric sulfate 100%. In conclusion calcium hydroxide was less appropriate for pulpotomies than formocresol.

5. Cox Charles F, Tarim Berna, Otsuki Masayuki, Akimoto Naotake, Hafez Abeer A (2002)5 Evaluated the biologic ability of sodium hypochlorite to control hemorrhage via chemical amputation of the coagulum, to remove dentin chips, to assist healing, and to facilitate formation of dentinal bridge under two adhesive systems. The conclusion drawn from the experiment was that the normal soft tissue reorganization and dentinal bridge formation were observed in 86% of pulp treated with NaOCl and either adhesive system.

6. Cox Charles F, Kopel Hugh M, Hafez Abeer A (2000)6 Conducted a study to compare the healing response of permanent primate pulps to pulpotomy procedures following hemorrhage control and adhesive hybridization to their response after conventional treatment. In this study 3% NaOCl was used as a hemostatic agent. From this study they concluded that permanent pulps without periapical radiolucencies may survive pulpotomy, provided hemorrhage was properly controlled with NaOCl and the pulp restoration interface was hybridized to exclude all microleakage.

7. Tang H.-M, Nordbo H, Bakland L. K.(1999)7 Conducted a study to examine the effect of undiluted NaOCl on vital pulp tissue when applied to freshly cut dentin. From this experimental study he concluded that under the conditions of the experiment, the use of NaOCl in a freshly cut cavity in an intact tooth of a dog, with exposed dentinal tubules, does not appear to cause additional pulpal damage to that caused by the physical contact in cutting tooth structure. Materials and Methods Source of data: Participants selected will be healthy individuals aged below 10 years of age visiting the OPD of Department of Pediatric Dentistry of SDM College of Dental Sciences needing pulpotomy of atleast 1 restorable primary molar with a cariously exposed vital pulp.

Clinical exclusion criteria were: a) spontaneous pain, b) swelling, c) tenderness on percussion, d) pathological mobility, e) sinus tract opening and f) initially unsuccessful hemorrhage control.

Radiographic exclusion criteria were : a) teeth with interradicular radiolucency, b) widened periodontal ligament space, c) physiologic root resorption of more than one-third. Treatment: The possible discomfort, risks and benefits will be explained to the parents / guardians regarding the procedure and informed consent will be obtained prior to the participation in this study. The study comprises of total 60 teeth which will be divided into three groups: Group-A, Group-B and Group C. Group A: 20 teeth evaluation for Formocresol (1:5 Buckley’s solution) pulpotomy. Group B: 20 teeth evaluation for 15.5% Ferric Sulfate pulpotomy. Group C: 20 teeth evaluation for 5% Sodium Hypochlorite pulpotomy.

Procedure : The selected molars will be clinically and radiographicaly evaluated. Pulpotomy procedure will be carried out under local anesthesia and rubber dam isolation. Access to coronal pulp will be gained and followed by amputation of the coronal pulp and leaving behind vital radicular pulp tissue. Initial hemorrhage control will be done by placing sterile no. 4 cotton pellet on the radicular pulp stumps under slight pressure for no more than 5 minutes. In Group-A a cotton pellet moistened with 20% Formocresol (Buckley’s solution) will be placed for 5 minutes on the vital pulp stumps. In group-B a cotton pellet moistened with 15.5% Ferric Sulfate will be placed for 15 seconds on the vital pulp stumps. In group-C cotton pellet moistened with 5% Sodium Hypochlorite will be placed for 30 seconds on the vital pulp stumps. All the selected teeth will be restored with Zinc Oxide Eugenol and finally restored with stainless steel crown. Post operative clinical and radiographical evaluation will be done at an interval of three months i.e. 1, 3, 6, 9 and 12 months respectively.

Parameters to be used for comparison: Post operative clinical evaluation based on: (a) Pain symptoms, (b) Tenderness to percussion, (c) Swelling, (d) Sinus opening, and (e) Pathologic mobility.

Post operative radiographic evaluation for: (a) Inter radicular radiolucency, (b) Internal or external root resorption and (c) Widening of periodontal ligament space.

After collection of data, it will be statistically analyzed by using Fisher’s exact test/Chi-square test. 7.2 Does your study require any investigation to be Yes on Humans conducted on humans or animals. 7.3. Has Ethical clearance been obtained from your Yes institution. 8. List of references 1. Vargas Kaaren G., Packham Brett, Lowman David. 2006 “Preliminary Evaluation of Sodium Hypochlorite for pulpotomies in primary molar.”Pediatric Dentistry; 28: 511- 517.

2. Vargas Kaaren G., Packham Brett. 2005 “Radiographic success of ferric sulphate and formocresol pulpotomies in relation to early exfoliation.” Pediatric Dentistry; 27: 233-237.

3. Hegde A. H., Naik S. 2005 “Mineral trioxide aggregate as a pulpotomy agent in primary molars: An in vivo study.” Journal of Indian Society of Pediatric and Preventive Dentistry;13- 16.

4. Huth K.C et al. 2005 “Effectiveness of four pulpotomy techniques- Randomised controlled trial.” Journal of dental research 84 (12): 1144-1148.

5. . Cox Charles F, Tarim Berna, Otsuki Masayuki, Akimoto Naotake, Hafez Abeer A. 2002 “Invivo evaluation of hemorrhage control using sodium hypochlorite and direct capping with a one- or two- component adhesive system in exposed non human primate pulps.”Quintessence International; 33: 261-27.

6. Cox Charles F, Kopel Hugh M, Hafez Abeer A. 2000 “Pulpotomy reconsidered: Application of an adhesive system to pulpotomized permanent primate pulps.” Quintessence International; 31: 579-589.

7. Tang H.-M, Nordbo H, Bakland L. K. 2000 “Pulpal response to prolonged dentinal exposure to sodium hypochlorite.”International Endodontic Journal, Vol. 33, 505- 508.

9. Signature of the Candidate

10. Remarks of the Guide

11. Name and Designation (in block letters) DR. ANAND TAVARGERI READER 11.1 Guide DEPT. OF PEDIATRIC DENTISTRY S.D.M. DENTAL COLLEGE, DHARWAD.

11.2 Signature

11.3 Co-Guide (if any)

11.4 Signature

11.5 Head of the Department DR. RAJESH T. ANEGUNDI PROFESSOR AND H.O.D. DEPT OF PEDIATRIC DENTISTRY S.D.M. DENTAL COLLEGE, DHARWAD.

11.6 Signature

12. Remarks of Chairman and Principal

12.1 Signature