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CTRI Number  CTRI/2026/02/104386 [Registered on: 20/02/2026] Trial Registered Prospectively
Last Modified On: 19/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive
Screening
Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Study done on Two Toothpastes Available in the Market to Check its Effectiveness in Controlling Tooth Decay by Checking pH of Saliva in Children 
Scientific Title of Study   Comparative Evaluation of Anticariogenic Effect of Two Dentifrices on Salivary pH In the Paediatric Population: A Triple-Blinded 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 Sakshi Sharan 
Designation  Senior Resident 
Affiliation  Rungta College Of Dental Sciences And Research 
Address  Royal Green Society, Near Shubham K Mart, Smriti Nagar, Bhilai

Durg
CHHATTISGARH
490020
India 
Phone  8319772096  
Fax    
Email  sakshisharan123@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Lumbini Pathivada 
Designation  Professor and HOD 
Affiliation  Rungta College Of Dental Sciences And Research 
Address  Surya Vihar, Opposite to Milestone Academy, Bhilai

Durg
CHHATTISGARH
490020
India 
Phone  7830508856  
Fax    
Email  drlumbinip@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sakshi Sharan 
Designation  Senior Resident 
Affiliation  Rungta College Of Dental Sciences And Research 
Address  Royal Green Society, Near Shubham K Mart, Smriti Nagar, Bhilai


CHHATTISGARH
490020
India 
Phone  8319772096  
Fax    
Email  sakshisharan123@gmail.com  
 
Source of Monetary or Material Support  
Infrastructure Support By Rungta College of Dental Sciences and Research, Rungta knowledge city, R2, Kohka-Kurud, Bhilai, Chhattisgarh, India. PIN: 490024 
 
Primary Sponsor  
Name  Dr Sakshi Sharan 
Address  Royal Green Society, Smriti Nagar, Near Shubham K Mart, Bhilai, Chhattisgarh, India. PIN:490020  
Type of Sponsor  Other [Principal Investigator (self)] 
 
Details of Secondary Sponsor  
Name  Address 
Rungta College of Dental Sciences and Research  Kohka-Kurud, Bhilai 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sakshi Sharan  Rungta College Of Dental Sciences And Research  205, Department of Pediatric and Preventive Dentistry, RCDSR Rungta Knowledge City R2, Kohka-Kurud
Durg
CHHATTISGARH 		 08319772096

sakshisharan123@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee- Rungta College of Dental Sciences and Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Preventative care and screening for Dental Caries  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Fluoride Toothpaste  Commercially Available Toothpaste with Long Data of History and Successful use in Pediatric Population 
Intervention  Probiotic Toothpaste with Hydroxyapatite  Commercially Available Toothpaste that claims to prevent Dental Caries 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  14.00 Year(s)
Gender  Both 
Details  1)Healthy middle school Children.
2)Children with DMFT index lesser than 5.
3)Children agreeing to follow the instructions for the given duration of study. 
 
ExclusionCriteria 
Details  1)Children taking probiotic supplements or have used them in last three months.
2)Children who have used xylitol or fluoride containing products in the last three months.
3Children undergoing periodontic or orthodontic therapy.
4)Children undergoing antibacterial/antimicrobial therapy in last 3 months.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
Both the toothpastes claim to have inhibitory action against dental caries but due to microbial influence, probiotic toothpaste might show better results  baseline, 1 month, 3 months and 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Probiotic toothpaste might show better periodontal health   baseline, 1 month, 3 months and 6 months 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   Phase 4 
Date of First Enrollment (India)   02/03/2026 
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="1"
Months="0"
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 - Informed Consent Form
    Response - Clinical Study Report

  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 - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sakshisharan123@gmail.com].

  6. For how long will this data be available start date provided 30-06-2027 and end date provided 30-06-2030?
    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   NEED FOR STUDY
Primary teeth play a vital role in children’s oral and overall development, making their maintenance essential. Oral diseases like dental caries contribute significantly to the global disease burden, affecting individuals of all ages. Conventional preventive strategies such as fluoride treatments and antibacterial mouth rinses have limitations. Fluoride, while effective in remineralization, can cause dental and skeletal fluorosis if overused. Antibacterial rinses, on the other hand, indiscriminately eliminate both harmful and beneficial bacteria, creating an imbalance in the oral microbiota. Probiotics have emerged as a promising approach in caries prevention, demonstrating the ability to selectively inhibit cariogenic bacteria such as Streptococcus mutans, a primary pathogen in dental caries. Given the limitations of conventional methods and the growing body of evidence supporting probiotics, there is a compelling need to evaluate their efficacy in pediatric populations prone to dental caries. This study aims to assess the impact of fluoride and probiotic-fluoride dentifrices on gingival health and salivary pH as indicators of their anticariogenic potential in paediatric population.
 
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