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CTRI Number  CTRI/2024/07/069792 [Registered on: 01/07/2024] Trial Registered Prospectively
Last Modified On: 15/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Other 
Public Title of Study   A comparative clinical study on enamel remineralization of children using proanthocyanidin varnish and fluoride varnish 
Scientific Title of Study   Comparative evaluation of effectiveness of non- fluoridated grape seed derived proanthocyanidin varnish and Fluoride varnish in remineralization of enamel caries of permanent teeth in children – A Randomized Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rajeshwari B 
Designation  Post graduate student (M.D.S)  
Affiliation  Chettinad Dental College and Research Institute 
Address  Chettinad Dental College and Research Institute, E Block, Rajiv Gandhi Salai, Kelambakam, Kanchipuram district.

Kancheepuram
TAMIL NADU
603103
India 
Phone  8637421819  
Fax    
Email  meena9thmay1997@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rajeshwari B 
Designation  Post graduate student (M.D.S)  
Affiliation  Chettinad Dental College and Research Institute 
Address  Chettinad Dental College and Research Institute, E Block, Department of Pedodontics, Rajiv Gandhi Salai, Kelambakam, Kanchipuram district.


TAMIL NADU
603103
India 
Phone  8637421819  
Fax    
Email  meena9thmay1997@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Daya Srinivasan 
Designation  Professor and Head 
Affiliation  Chettinad Dental College and Research Institute 
Address  Chettinad Dental College and Research Institute, E Block, Department of Pedodontics, Rajiv Gandhi Salai, Kelambakam, Kanchipuram district.

Kancheepuram
TAMIL NADU
603103
India 
Phone  9884476385  
Fax    
Email  dayaswathi@gmail.com  
 
Source of Monetary or Material Support  
Chettinad Dental College and Research Institute, E block, Department of Pedodontics Rajiv Gandhi Salai, Kelambakkam, Kancheepuram district, TN - 603103 
 
Primary Sponsor  
Name  Chettinad Dental College and Research Institute 
Address  Chettinad Dental college and Research Institute, E Block, Rajiv Gandhi Salai, Kelambakkam, Kancheepuram district, TN - 603103. 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Daya Srinivasan  Chettinad Dental College and Research Institute  Chettinad Dental College and Research Institute, E block, Department of Pedodontics, Rajiv gandhi salai, kelambakkam, TN -603103 Kancheepuram TAMIL NADU
Kancheepuram
TAMIL NADU 		 9884476385

dayaswathi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human Ethics Committee Chettinad Dental College and Research Institute (IHEC - CDCRI)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K025||Dental caries on pit and fissure surface,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Fluoride varnish   Commercially available as Ivoclar Vivadent Fluor Protector S Fluoride Varnish gel containing 0.9% difluorosilane. Application 3 months once upto 9 months 
Intervention  Proanthocyanidin(PAC) varnish   Formulated from Indegenous grape seed extract by maceration method. 20μg/mL Concentration of proanthocyanidin is used for the formulation. Application 3 months once upto 9 months 
 
Inclusion Criteria  
Age From  7.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  1. Helathy Children aged 7-10 years.
2. Presence of early enamel caries (ICDAS II scores 1, 2, and 3) in occlusal surfaces of permanent molars on left and right quadrants.
3. Parental/guardian consent to participate in the study.
 
 
ExclusionCriteria 
Details  1. Children with systemic illnesses or children with special healhcare needs
2. Allergies to any of the study materials.
3. Tooth surfaces with proximal restorations;
4. Surfaces with evident proximal caries
5. Previous caries treatment on the selected teeth.
6. Use of fluoride supplements or professional fluoride treatments within the past six months
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Change in ICDAS II scores from baseline to 9 months, comparing the effectiveness of fluoride varnish and PAC varnish application every 3 months.  At 4 points
Baseline
3 months
6 months
9 months 
 
Secondary Outcome  
Outcome  TimePoints 
Change in (CIE) Lab color scores of digital photographs from baseline to 9 months.  At 4 points
Baseline
3 months
6 months
9 months 
 
Target Sample Size   Total Sample Size="56"
Sample Size from India="56" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="56" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   01/08/2024 
Date of Study Completion (India) 09/05/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 09/05/2025 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [dayaswathi@gmail.com ].

  6. For how long will this data be available start date provided 25-11-2025 and end date provided 25-11-2026?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

This is a double-blinded, split-mouth randomized clinical trial, consisting of 56 children aged 7-10 years with early enamel caries (ICDAS II scores 1, 2, and 3) in permanent 1st molars of both quadrants . Fluoride varnish (control) will be applied to one quadrant, and PAC gel (test) to the other every 3 months. The ICDAS II scores and Commission Internationale de l’Eclairage (CIE) Lab color scores using digital photographs will be determined at baseline, 3,6, 9 and 12 months and will be subjected to statistical analysis using repeated measures ANOVA to evaluate the remineralization potential of the test and control groups.

 
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