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CTRI Number  CTRI/2025/09/095106 [Registered on: 19/09/2025] Trial Registered Prospectively
Last Modified On: 18/09/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A study to test the benefits of a specialized toothpaste on dental health of adults 
Scientific Title of Study   Clinical research study to evaluate the efficacy of a stannous fluoride toothpaste on established dental plaque and gingivitis in adults 
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 Ashish Kakar 
Designation  Director Dental Research 
Affiliation  GLOBAL HEALTH RESERCH GROUP  
Address  DENTAL RESEARCH DEPARTMENT DIVISION ROOM NO. B1 H-8 MASJID MOTH GREATER KAILASH PART-2 NEW DELHI

South
DELHI
110048
India 
Phone  9811081052  
Fax    
Email  ashish@ghrg.org  
 
Details of Contact Person
Scientific Query  
Name  Dr Bhuvana Gurumurthy 
Designation  Assistant Manager, Clinical Innovation 
Affiliation  Colgate-Palmolive India Limited 
Address  Ground Floor, Colgate Research Centre, India Global Technology Center, Main Street, Hiranandani Gardens, Powai, Mumbai

Mumbai
MAHARASHTRA
400076
India 
Phone  02267096165  
Fax    
Email  bhuvana_gurumurthy@colpal.com  
 
Details of Contact Person
Public Query  
Name  Dr Bhuvana Gurumurthy 
Designation  Assistant Manager, Clinical Innovation 
Affiliation  Colgate-Palmolive India Limited 
Address  Ground Floor, Colgate Research Centre, India Global Technology Center, Main Street, Hiranandani Gardens, Powai, Mumbai

Mumbai
MAHARASHTRA
400076
India 
Phone  02267096165  
Fax    
Email  bhuvana_gurumurthy@colpal.com  
 
Source of Monetary or Material Support  
Colgate Palmolive Company 909 River Rd, Piscataway, NJ 08854, USA 
 
Primary Sponsor  
Name  Colgate-Palmolive Company 
Address  909 River Rd, Piscataway, NJ 08854, USA 
Type of Sponsor  Other [FMCG - Global] 
 
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 Ashish Kakar  GLOBAL HEALTH RESEARCH GROUP   H-8 MASJID MOTH DENTAL RESEARCH DEPARTMENT DIVISION ROOM NO. B1 GREATER KAILASH PART-2 NEW DELHI 110048
South
DELHI 		 9811081052

ashish@ghrg.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
GOOD SOCIETY ETHICAL RESEARCH   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K051||Chronic gingivitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Commercially available toothpaste  Whole mouth brushing with a toothpaste, 2 times/day for 1 minute each time for the duration of the study 
Intervention  Test product with active  Whole mouth brushing with a toothpaste, 2 times/day for 1 minute each time for the duration of the study 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Potential subjects must meet ALL of the following criteria:
Males and females, between 18-70 years of age;
Informed Consent Form signed and availability for the duration of the study;
Good general health (absence of any condition that, in the opinion of the Principal Investigator, might constitute a risk to the subject while participating in the study. Examples include heart problems, valve/hip replacements, etc);
Willingness to provide information related to their medical history;
Minimum of 15 uncrowned permanent natural teeth (excluding third molars);
Initial mean gingivitis index of at least 1 as determined by the use of the Loe and Silness Gingival Index and mean Plaque Index score of at least 1.5 determined by the Turesky modification of the Quigley-Hein Plaque Index;
Availability for the duration of the study.
 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Gingivitis (Loe and Silness Index)  Baseline, 3 months and 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Plaque (Turesky modification of the Quigley-Hein Plaque Index)  Baseline, 3 months and 6 months 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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 3 
Date of First Enrollment (India)   29/09/2025 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - NO
Brief Summary  
The objective of this clinical research study is to evaluate the efficacy of a specialized toothpaste on established dental plaque and gingivitis in adults. This is a phase III, single center, randomized, parallel and double blinded study conducted on about 100 subjects in the age group between 18 to 70 years.

The subjects will be exposed to either of 2 different test products for a period of 6 months with a treatment regimen of whole mouth brushing twice daily for 2 minutes.
 
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