Rajiv Gandhi University of Health Sciences, Karnataka Bangalore

ANNEXURE II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1 Name of the Dr. ANANYA RAI candidate DEPARTMENT OF PEDIATRIC AND PREVENTIVE and Address DENTISRY D.A. PANDU MEMORIAL R.V. DENTAL COLLEGE (in block BANGALORE – 560 078 letters) 2 Name of the D.A. Pandu Memorial R.V. Dental College. institution 3 Course of Master of Dental Surgery- Pedodontics and Preventive study and Dentistry. Subject 4 Date of 1st June 2011 admission to the course 5 Title of the “ In Vivo Comparison of the efficacy of fluoridated toothpaste and casein phosphopeptide-amorphous topic calcium phosphate in the prevention and control of white spot lesions in 3-6 year old children”

Brief resume of the intended work: 6 6.1 Need for the study The management of dental caries involves early diagnosis, evaluation of ‘caries risk status’, and treatment of both cavitated and non-cavitated lesions. This has been facilitated by recent advances in diagnostic technology and dental materials. ‘White spot lesions’ (WSL) can be remineralized if the oral ecology is adequately altered. The previous approaches have been to reduce cariogenic bacteria, use of fluorides and reduction in intake of refined carbohydrates. A recent review of remineralization therapies has discussed in detail the use of fluoride, beta tricalcium phosphate, as well as casein phosphopeptide- amorphous calcium phosphate (CPP-ACP) [1]. There is a paucity of clinical studies on evaluation and management of white spot lesions. Therefore, this study seeks to compare the remineralising effect of a CPP-ACP formulation when used with a non fluoridated toothpaste and with a fluoridated kid toothpaste on white spot lesions (WSL) in preschool children using the ICDAS II criteria.

6.2 Review of Literature

1. An in vitro study was done to compare the re mineralizing effects of fluoridated and non fluoridated dentifrices on primary enamel. Surfaces treated with these dentifrices were subsequently exposed to demineralizing solutions. A significant reduction in mean lesion depth was found with application of fluoridated dentifrices as compared to that with non fluoridated dentifrices when observed under polarized light microscope [2]. 2. An in vitro study was done to compare the effect of four dentifrices with varied fluoride content on the remineralization of white spot lesions in bovine and human teeth. The enamel fluoride uptake (EFU), surface micro hardness (SMH) and cross sectional micro hardness (CSM) were evaluated. Statistical analyses revealed significant differences among the four groups. The CSM for both enamel types generated similar profiles for the four groups, SHM and EFU revealed human enamel was more sensitive to 500ppm F dentifrice groups as compared to bovine enamel [3]. 3. A review article has discussed the structure of CPP-ACP,its anti- cariogenicity in rat caries model,its efficacy in situ and its effect on inhibition of demineralization and initiation of remineralisation in vitro. The CPP-ACP (RecaldentTM) technology has shown to remineralize enamel subsurface lesions in vivo and to slow the progression of caries significantly and promote the regression of early caries in randomized,

controlled clinical trials[4]. 4. An in vitro study was done to evaluate the effect of casein phosphopeptide – amorphous calcium phosphate (CPP-ACP) paste on demineralization by observing the treated tooth surface using Field Emission Scanning Electron Microscope (FE-SEM). The control group used a placebo and the negative control was lactic acid. The CPP-ACP specimens showed lesser demineralization of enamel and dentin than both the control and negative control specimens [5]. 5. An in vitro study assessed the effect of CPP-ACP and a fluoridated toothpaste containing 500 ppm of fluoride on artificially created white spot lesions concluded that the CPP-ACP crème increased surface micro hardness( SMH) of the eroded enamel significantly more than 500 ppm NaF solution[6].

6.3 Objective of the Study 1. To assess the effectiveness of fluoridated toothpaste and CPP-ACP when used as adjuncts to oral hygiene instructions and diet counseling. 2. To compare the relative efficacy of fluoridated toothpaste and CPP-ACP in resolving white spot lesions. 3. To provide children with the best strategy for prevention of dental caries depending on the risk status.

7 Materials and Methods:

 Diagnostic instruments  White spot lesion classification using ICDAS-II scale  Digital camera for pre and post intervention photographs  GC Tooth Mousse  Fluoridated kid toothpaste  Non-fluoridated toothpaste

7.1 Source of Data A study of a population comprising of 45 children aged between 3 to 6 years.

Inclusion criteria  Children aged between 3 to 6 years.  Children with the presence of white spot lesions (WSL) with or without concurrent cavitated lesions.

Exclusion criteria  Medically compromised children.  Children with physical and mental disabilities.  Uncooperative children.  Teeth with developmental defects such as enamel hypoplasia, fluorosis, tooth wear (attrition, abrasion and erosion), and extrinsic or intrinsic stains will be excluded.

7.2 Procedure

1. A thorough dental examination of children aged between 3-6 years would be carried out and the clinical data would be recorded. 2. Forty five children with white spot lesions who fall under the inclusion criteria would be selected. 3. The white spot lesions (WSL) would be graded using the ICDAS –II scale and photographed. 4. The children would be given oral hygiene instructions, brushing technique demonstration and diet counseling. 5. The children would then be divided randomly into three groups. Group A would be given fluoridated toothpaste, GroupB would be given non-fluoridated toothpaste with CPP-ACP crème to be used twice daily for a period of 12 weeks, Group C would be given fluoridated kid toothpaste with CPP-ACP crème to be used twice daily for a period of 12 weeks. 6. A follow up would then be carried out at 4 weeks, 8 weeks and 12 weeks to evaluate the effect of the remineralising agents used. 7. The WSL will again be rated with the ICDAS II on subsequent recalls. 8. Post intervention photographs will be taken to document changes in WSL. 9. The results will be statistically analyzed.

7.3 Does this study require any investigation or intervention to be conducted on patients or other humans or animals? Yes, the study requires the participation of children with white spot lesions.

7.4 Has ethical clearance been obtained from your institution in case of being applicable?

8 References 1. Walsh.L. Contemporary technologies for remineralisation therapies a review. International dentistry SA 2009;11(6):6-16. 2. Rirattanapong P, Smutkeeree A, Surairit R, Saaendsirinavin C and Kunanantsak V. Effects of fluoride dentifrice on remineralisation and demineralisation primary enamel. Southeast Asian J Trop Med Public Health 2010;41(1):243-249. 3. Karlinsey RL, Mackey AC ,Walker TJ, Frederick KE, Blanken DD, Flaig

SM and Walker ER. In vitro remineralization of human and bovine white- spot enamel lesions by NaF dentifrices: A pilot study. Journal of Dentistry and Oral Hygiene 2011;3(2):22-29. 4. Reynolds E, Casein phosphopeptide- Amorphous calcium phosphate: The

Scientific Evidence. Adv Dent Res 2009;21:25-29. 5. Oshiro M, Yamaguchi K, Takamizawa T, Inage H, Watanabe T, Irokawa A, Ando S and Miyazaki M. Effect of CPP-ACP paste on tooth mineralization: an FE-SEM study. Journal of Oral Science 2007;49(2):115-129. 6. Zhang Q, Zou J, Yang R, Zhou X. Remineralization effects of casein phosphopeptide - amorphous calcium phosphate crème on artificial early enamel lesions of primary teeth. International Journal of Pediatric Dentistry 2011 Sep;21(5):374-381.

9 Signature of the candidate

10 Remarks of the guide

11 Name and Designation of

11.1 Guide

11.2 Signature

11.3 Co Guide(if any)

11.4 Signature

11.5 Head Of the Department

11.6 Signature

12 12.1 Remarks of the Chairman and Principal

12.2 Signature

PATIENT INFORMATION SHEET

YOU ARE BEING REQUESTED TO TAKE PART IN A STUDY ENTITLED “In vivo comparison of the efficacy of fluoridated toothpaste and casein phosphopeptide-amorphous calcium phosphate in the prevention and control of white spot lesions in 3-6 year old children”. THE STUDY AIMS TO COMPARE THE EFFICACY OF FLOURIDATED TOOTHPASTE AND CASEIN PHOSPHOPEPTIDE-AMORPHOUS CALCIUM PHOSPHATE IN THE PREVENTION AND CONTROL OF INITIAL CARIOUS LESIONS IN 3-6 YEAR OLD(PRE-SCHOOL CHILDREN).

VOLUNTARY PARTICIPATION YOUR PARTICIPATION IN THE PROJECT IS VOLUNTARY. YOU CAN WITHDRAW FROM THE PROJECT AT ANY TIME AND THIS WILL NOT AFFECT YOUR SUBSEQUENT TREATMENT OR RELATIONSHIP WITH THE TREATING DOCTOR.

RISK (IF ANY) TO THE SUBJECTS NONE

CONSENT FORM

I, ……………………………………………… HAVE BEEN PROVIDED BY Dr. Ananya Rai WITH A COPY OF THE PATIENT INFORMATION SHEET FOR TAKING PART IN THE PROJECT ENTITLED“In vivo comparison of the efficacy of fluoridated toothpaste and casein phosphopeptide-amorphous calcium phosphate in the prevention and control of white spot lesions in 3-6 year old children”. AND ALSO BEEN EXPLAINED TO MY SATISFACTION IN THE LANGUAGE KNOWN TO ME. I HEREBY GIVE CONSENT ON BEHALF OF MY MINOR SON/DAUGHTER TO BE ENROLLED IN THE STUDY.

SIGNATURE AND NAME SIGNATURE OF THE OF THE PARENT/GUARDIAN INVESTIGATOR

SIGNATURE OF THE WITNESS DATE