Rajiv gandhi university of health sciences karnataka, bangalore



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RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES KARNATAKA, BANGALORE.






ANNEXURE-II
PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERATION



1


NAME OF THE

CANDIDATE AND

ADRESSS


Dr. KAVYA SHREE. B. S

POST GRADUATE STUDENT

DEPARTMENT OF PEDODONTICS & PREVENTIVE DENTISTRY,

V.S.DENTAL COLLEGE & HOSPITAL K.R. ROAD

V.V.PURAM. BANGALORE-560004


2


NAME OF THE INSTITUTION


V.S.DENTAL COLLEGE AND HOSPITAL, K.R ROAD, V.V.PURAM. BANGALORE-560004


3


COURSE AND STUDY OF SUBJECT


M.D.S PEDODONTICS AND PREVENTIVE DENTISTRY


4


DATE OF ADMISSION TO THE COURSE


JUNE 2013


5


TITLE OF THE TOPIC

COMPARATIVE ASSESSMENT OF SUCCESS RATE OF INDIRECT PULP CAPPING WITH CALCIUM HYDROXIDE AND 2% CHLORHEXIDINE GLUCONATE DISINFECTING SOLUTION WITH RESIN MODIFIED GLASS IONOMER LINER IN PRIMARY TEETH .”




6. BRIEF RESUME OF THE INTENDED WORK

6.1 NEED FOR THE STUDY-

Preservation of the primary teeth until natural exfoliation is essential for normal oral function and facial growth. Guidelines from the American Academy of Pediatric Dentistry [AAPD] state that maintenance of tooth integrity and preservation of surrounding tissues remain key strategies in the treatment of primary teeth affected by injury or bacterial contamination. This objective is achieved through vital pulp therapy1.

Currently pulpotomy is most frequently used vital pulp therapy for cariously involved primary teeth but now indirect pulp treatment [IPT] emerging as a viable and potentially preferable alternative1,8.

In indirect pulp treatment, upper layer of infected dentin is removed and a thin layer of affected dentin is left behind to avoid pulp exposure1,5. Then a biocompatible liner is placed over the remaining carious dentin which stimulates healing and repair of the dentin pulp complex and the tooth is sealed with restoration that prevents microleakage2.

Calcium hydroxide plays an important role through its ability to induce hard tissue formation, moderate antibacterial action and tissue dissolving capacity. It also acts as a physical barrier by preventing root canal reinfection and intercept the nutrient supply to remaining bacteria. Its high pH has a destructive effect on cell membrane and protein structure3.

Chlorhexidine gluconate is a chemical antiseptic commonly used as an oral antimicrobial therapy in the form of oral rinses, dentifrices, varnishes and gels. It is active against wide range of micro organisms including gram positive and gram negative bacteria and used as both an irrigant and an intracanal medicament2,3.

Studies have been done on calcium hydroxide4,11 and resin modified glass ionomer6 for indirect pulp capping. Studies have been reported comparing 2% chlorhexidine with calcium hydroxide3 and comparing resin system with calcium hydroxide for indirect pulp capping5. Till date there is no reported studies on comparing calcium hydroxide and 2% chlorhexidine gluconate with resin modified glass ionomer liner in indirect pulp capping of primary molars. Thus this study is undertaken to assess the success rate of calcium hydroxide and 2% chlorhexidine gluconate disinfecting solution with resin modified glass ionomer liner in indirect pulp treatment of primary molars.
6. 2. Review of literature

A prospective study conducted in indirect pulp treatment using resin-modified glass ionomer and 2% chlorhexidine gluconate in primary molars of 12- month follow up and concluded its effectiveness in indirect pulp treatment of primary molars, although appropriate case selection and adequate marginal seal were essential for a successful outcome1.


A study assessed retrospectively the clinical and radiographic success of indirect pulp treatment (IPT) on primary posterior teeth and concluded that Indirect pulp treatment is a successful technique and an alternative pulp therapy procedure in deeply carious primary posterior teeth with a use of base over liner in addition to stainless steel crown dramatically increases the success of an IPT 2.
A study evaluated the effectiveness of 2% chlorhexidine gluconate gel and calcium hydroxide [Ca(OH)2] as an intracanal medicaments against Enterococcus faecalis and they found that, 2% chlorhexidine gel alone was more effective against E.faecalis than calcium hydroxide(p<0.05) 3.
An in vitro study evaluated a possible remineralization of human carious dentin by calcium hydroxide and concluded that Qualitative microradiographs showed a qualitative increase in radiopacity of the calcium hydroxide in treated samples. Quantitative microradiography showed a statistically significant increase in total mineral content in the experimental samples compared to the control samples4.

An in vivo study conducted to compare the clinical and radiographic outcomes of an adhesive resin system vs a calcium hydroxide liner in indirect pulp treatment and concluded that an adhesive resin system showed similar clinical and radiographic 2-year outcomes as compared to calcium hydroxide when indirect pulp treatment was performed in class 1 composite restorations5.


A study evaluated the biocompatibility of resin-modified glass-ionomer material on

Monkey pulps and concluded that resin-modified glass-ionomer material showed an acceptable bio-compatibility in exposed and nonexposed cavities6 .


6.3 OBJECTIVE OF THIS STUDY:

  • To assess the success rate of calcium hydroxide in indirect pulp treatment of primary teeth.

  • To assess the success rate of 2% chlorhexidine gluconate disinfecting solution with resin modified glass ionomer liner in indirect pulp treatment of primary teeth.

  • To compare the success rate of calcium hydroxide and 2% chlorhexidine gluconate disinfecting solution with resin modified glass ionomer liner in indirect pulp treatment of primary molars.



7. MATERIALS AND METHODS:
7.1 SOURCE OF DATA: V. S. Dental College and Hospital, Bangalore
7.2 METHODS AND COLLECTION OF DATA:
SAMPLE SIZE: 60 primary teeth in children between age 3 to 10 years with control group comprises of 30 primary teeth and study group comprises of 30 primary teeth , visiting the Department of Pedodontics and Preventive Dentistry , V S Dental College and Hospital , Bangalore.
STUDY DESIGN: Randomized clinical study.

STUDY DURATION: 1 ½ Years.
SAMPLE DESIGN: Random sampling.
PROPOSED STATISTICAL ANALYSIS: Chi-square test.
INCLUSION CRITERIA:

  1. Children within the age of 3 years to 10 years.

  2. No history of spontaneous pain.

  3. No tenderness to palpation or percussion

  4. Radiographic evidence of an intact lamina dura.

  5. Not expected to exfoliate within the year.

  6. Possess sufficient remaining tooth structure to allow placement of a rubber dam.


EXCLUSION CRITERIA:

  1. Fistulas, abscess, swelling of the periodontal tissues.

  2. Enhanced mobility .

  3. Radio graphically the diagnosis of inter radicular or periapical radiolucency or internal / external root resorption, that is not related to the normal exfoliation process.


METHODOLOGY-

Carious primary molars indicated for indirect pulp treatment in children between 3 to 10 years will be randomly selected. Standardized periapical and posterior bitewing radiographs are taken and children are treated under local anesthesia and rubber dam isolation. All carious infected dentin will be excavated and a layer of affected dentin is left behind to prevent pulp exposure. Then the cavity will be washed and dried. A sable seek caries indicator is placed to see whether all infected dentin has been removed from the pulpal floor and washed with water after 15 seconds. The preparation is then air- dried to assess the color of the dye. This procedure is repeated until the infected dentin is completely removed from pulpal floor. At this point photograph is taken for future reference.

Teeth will be randomly assigned for study group and control group. In the study group 2% chlorhexidine gluconate solution with resin modified glass ionomer will be placed and the control group will receive calcium hydroxide. Composite restorations and a full coverage restoration consisting of a stainless steel crown is placed. Follow up visits at 3. 6 and 12 months intervals will be done. Children will be evaluated clinically at 3 month interval while both clinical and radiographic evaluation will be done on 6 and 12 months intervals. The results of the study are statistically evaluated.


MATERIALS:


  • Diagnostic instruments.

  • Local anesthesia

  • Rubber dam

  • Airotor and burs

  • Spoon excavators

  • Sable seek caries indicator.

  • 2% chlorhexidine gluconate disinfecting solution.

  • resin modified glass ionomer liner

  • Calcium hydroxide

  • Composite

  • Stainless steel crown

  • Intraoral radiographs


7.3 DOES THE STUDY REQUIRE ANY INVESTIGATIONS OR INTERVENTIONS TO BE CONDUCTED ON PATIENTS OR OTHER HUMANS OR ANIMALS IF SO, PLEASE DESCRIBE BRIEFLY


  • Preoperative periapical and bitewing radiographs and postoperative periapical and bitewing radiographs required at 6 and 12 month recall intervals .

7.4 HAS ETHICAL CLEARANCE BEEN OBTAINED FROM YOUR INSTITUTION IN CASE OF 7.3.


8. LIST OF REFERENCES

  1. Linda Rosenberg, Michael Atar, Marcia Daronch et al , Prospective study of Indirect Pulp Treatment in primary molars using Resin-modified Glass Ionomer and 2% Chlorhexidine Gluconate: A 12- month follow up. Pediatr Dent 2013;35:13-17




  1. Mohammed A. Al-Zayer, Lloyd H. Straffon, Robert J. Feigal, Kathleen B. Welch. Indirect pulp treatment of primary posterior teeth: a retrospective study. Pediatr Dent. 2003;25:29-36




  1. Gomes BP, Souza SF, Ferraz CC, et al. Effectiveness of 2% chlorhexidine gel and calcium hydroxide against Enterococcus faecalis in bovine root dentine in vitro. Int Endod J 2003;36:267-75




  1. Carlos Alberto CONRADO. Remineralization of Carious Dentin.I: In Vitro Microradiographic Study in Human Teeth Capped by Calcium Hydroxide. Braz Dent J (2004) 15(1): 59-62




  1. Caline A. Falster, Fernando B. Araujo, Lloyd H. Straffon, Jacques E. Nör. Indirect pulp treatment: in vivo outcomes of an adhesive resin system vs calcium hydroxide for protection of the dentin-pulp complex. Pediatr Dent 24:241-248, 2002




  1. Berna Tarim, Abeer A. Hafez, Charles F. Cox. Pulpal response to a resin-modified glass ionomer material on nonexposed and exposed monkey pulps. Quititesserice Int 1998;29:5 35-542




  1. Andréa Cruz Câmara1, Miracy Muniz de Albuquerque2, Carlos Menezes Aguiar3,Ana Cristina Regis de Barros Correia4. Antimicrobial activity of chlorhexidine in root canals instrumented with the ProTaper Universal™ System. Braz J Oral Sci July/September 2010 - Volume 9, Number 3




  1. Seale NS, Glickman GN, Contemporary perspectives on vital pulp therapy; views from the endodontists and pediatric dentists. Pediatr Dent 2008;50:261-7




  1. James A. Coll, Is the Primary Tooth Pulpotomy Out of Indirect Pulp Capping and Primary Teeth Date? JOE—Volume 34, Number 7S, July 2008




  1. Branimir Bebek1, Ivona Bago2, Greta [kaljac3, Vanda Ple~ko4, Ivana Mileti}3 and Ivica Ani}3 . Antimicrobial Effect of 0.2%chlorhexidine in Infected Root Canals. Coll. Antropol. 33 (2009) 4: 1159–1163




  1. HC. Sathorn, P. Parashos & H. Messer. Antibacterial efficacy of calcium hydroxide intracanal dressing: a systematic review and meta-analysis. International Endodontic Journal, 40, 2–10,




9. SIGNATURE OF THE CANDIDATE






10. REMARKS OF THE GUIDE






11.NAME AND DESIGNATION OF GUIDE (IN BLOCK LETTERS)


DR. VENKATESH BABU,

PROFESSOR AND HEAD OF DEPARTMENT,

DEPARTMENT OF PEDODONTICS &

PREVENTIVE DENTISTRY, V.S DENTAL COLLEGE & HOSPITAL

K.R. ROAD V.V.PURAM,

BANGALORE-560004.




11.1 SIGNATURE






11.2 CO-GUIDE IF ANY






11.3 SIGNATURE








11.4 HEAD OF THE DEPARTMENT



DR.VENKATESH BABU

PROFESSOR & HOD DEPARTMENT OF PEDODONTICS &

PREVENTIVE DENTISTRY,

V.S DENTAL COLLEGE & HOSPITAL

K.R. ROAD V.V.PURAM,

BANGALORE-560004.




11.5 SIGNATURE






12.1 REMARKS OF THE CHAIRMAN AND PRINCIPAL






12.2 SIGNATURE





CONSENT FORM
DEPARTMENT OF PEDODONTICS AND PREVENTIVE DENTISTRY
VOKKALIGARA SANGHA DENTAL COLLEGE AND HOSPITAL
V.V. PURAM, K.R ROAD, BANGALORE- 500040
‘ I _______________________________________ residing in ___________________________________________________________ _____________________have been informed about involvement of my child_____________________________, aged ___________ , by

Dr. ________________________________ in the study in the language that I can understand.’

I agree to give my child’s personal details and will co- operate and follow the instructions given by the dentist during the study. If for any reason my child is unable to participate in the study, for reasons unknown, I can withdraw from the study.
Place: Parent’s signature

Date:


Dentist’s signature

consent form kannada


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