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CTRI Number  CTRI/2025/03/082637 [Registered on: 18/03/2025] Trial Registered Prospectively
Last Modified On: 19/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Is Black Raisin Toothpaste as Effective as Fluoride Toothpaste in Preventing Cavities in Children? 
Scientific Title of Study   EVALUATING THE EFFICACY OF BLACK RAISIN TOOTHPASTE COMPARED TO SODIUM FLUORIDE TOOTHPASTE IN PREVENTING DENTAL CARES IN CHILDREN 
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 VVNKarthik 
Designation  Post Graduate, Paediatrics 
Affiliation  Saveetha Medical College and Hospital 
Address  Dept of Paediatrics, Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Chennai Bengaluru, NH 48, Chennai, Tamil Nadu

Kancheepuram
TAMIL NADU
602105
India 
Phone  9966998047  
Fax    
Email  karthikvelisetty@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vidhyasagar K 
Designation  M.D. Paediatrics 
Affiliation  Saveetha Medical College and Hospital 
Address  Dept of Paediatrics, Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Chennai Bengaluru, NH 48, Chennai, Tamil Nadu

Kancheepuram
TAMIL NADU
602105
India 
Phone  9444139577  
Fax    
Email  dr.kvidhyasagar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Vidhyasagar K 
Designation  M.D. Paediatrics 
Affiliation  Saveetha Medical College and Hospital 
Address  Dept of Paediatrics, Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Chennai Bengaluru, NH 48, Chennai, Tamil Nadu

Kancheepuram
TAMIL NADU
602105
India 
Phone  9444139577  
Fax    
Email  dr.kvidhyasagar@gmail.com  
 
Source of Monetary or Material Support  
Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Chennai Bengaluru, NH 48, Chennai, Tamil Nadu 
 
Primary Sponsor  
Name  Dr VVN Karthik 
Address  Dept of Paediatrics, Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Chennai Bengaluru, NH 48, Chennai, Tamil Nadu 
Type of Sponsor  Other [Self] 
 
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 VVN Karthik  Saveetha Medical College and Hospital  Dept of Paediatrics, Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Chennai Bengaluru, NH 48, Chennai, Tamil Nadu
Kancheepuram
TAMIL NADU 		 9966998047

karthikvelisetty@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Saveetha Medical College and Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  NORMAL 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  BlackRaisin based toothpaste  This group of children will use newly developed blackraisin based toothpaste with natural ingredients for 6months. 
Comparator Agent  Commercially available fluoride toothpaste  This group of children will use their regular fluoride based toothpaste containing chemical ingredients. 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1.Children aged 6 to 12 years.
2.No severe pre-existing dental conditions (e.g., severe dental caries, periodontal disease).
3.Parents or guardians must provide written consent for participation.
4.Children must not have any known allergies to any of the toothpaste ingredients.
 
 
ExclusionCriteria 
Details  1.Children with severe dental conditions (e.g., advanced dental caries, need for orthodontic treatment).
2.Children on systemic medications that might influence oral health (e.g., immunosuppressants).
3.Children who are already enrolled in another clinical trial or using a specialized oral health product.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
The expected outcome of the study is to provide critical evidence regarding the efficacy of natural toothpaste in comparison to traditional fluoride-based commercial options. Specifically, the study will determine if the natural toothpaste can prevent dental caries as effectively as fluoride-based toothpaste, while also assessing secondary outcomes like plaque control, gingival health, safety, and user acceptability.  6months 
 
Secondary Outcome  
Outcome  TimePoints 
To improve overall oral health of children  6months 
 
Target Sample Size   Total Sample Size="392"
Sample Size from India="392" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/03/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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 -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

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

  6. For how long will this data be available start date provided 01-07-2025 and end date provided 30-11-2025?
    Response - Beginning 9 months and ending 36 months following article publication.

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

This study aims to evaluate the effectiveness of a newly developed natural toothpaste in preventing dental caries in children, compared to widely used commercial toothpaste products.

 

The research will focus on children aged 6 to 12, assessing key outcomes such as caries incidence, plaque control, and gum health over a 6-month period. Participants will be randomly assigned to one of two groups: the natural toothpaste, a fluoride-based commercial toothpaste. The study will include regular dental check-ups to monitor oral health and will provide participants with valuable insights into the potential benefits of natural oral care alternatives.

 

In addition to evaluating clinical outcomes, the study will explore the safety and tolerability of the natural toothpaste. The results could provide new evidence on the effectiveness of natural alternatives in children’s oral care, offering a safer or more sustainable option for families. 
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