FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2021/12/038624 [Registered on: 15/12/2021] Trial Registered Prospectively
Last Modified On: 14/12/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda
Dentistry 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Clinical study of herbal toothpaste to check the efficacy against gum problems 
Scientific Title of Study   ​Clinical research study is to evaluate the efficacy of a​ toothpaste containing herbal ingredients on established ​dental ​plaque and gingivitis in adults 
Trial Acronym   
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 Department 
Affiliation  Global Health Research Group 
Address  Global Health Research Group, H-8, Masjid Moth, Greater Kailash II, New Delhi, India.

South
DELHI
110048
India 
Phone    
Fax    
Email  ashish@ghrg.org  
 
Details of Contact Person
Scientific Query
 
Name  Ms Neelima Utgikar 
Designation  Technology Manager 
Affiliation  Colgate Palmolive India Ltd 
Address  Colgate Palmolive India Ltd., Colgate Research Centre Hiranandani Gardens, Main Street, Powai, Mumbai

Mumbai (Suburban)
MAHARASHTRA
400076
India 
Phone  02267096145  
Fax    
Email  neelima_utgikar@colpal.com  
 
Details of Contact Person
Public Query
 
Name  Ms Neelima Utgikar 
Designation  Technology Manager 
Affiliation  Colgate Palmolive India Ltd 
Address  Colgate Palmolive India Ltd., Colgate Research Centre Hiranandani Gardens, Main Street, Powai, Mumbai

Mumbai (Suburban)
MAHARASHTRA
400076
India 
Phone  02267096145  
Fax    
Email  neelima_utgikar@colpal.com  
 
Source of Monetary or Material Support  
Colgate Palmolive Company 909 River Rd, Piscataway, NJ 08854, USA 
 
Primary Sponsor  
Name  Colgate Palmolive 
Address  Colgate Palmolive Company, Piscataway, New Jersey, USA 
Type of Sponsor  Other [FMCG] 
 
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, Greater Kailash II, New Delhi - 110048
South
DELHI 
91981140353

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. Ayurveda Condition: शीतादः (Gingivitis / Spongy Gums),  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Herbal Toothpaste, Reference: NA, Route: Topical, Dosage Form: , Dose: 2.5(g), Frequency: bd, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information:
(2) Medicine Name: 6 Months, Reference: NA, Route: , Dosage Form: , Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information:
(3) Medicine Name: 6 Months, Reference: NA, Route: , Dosage Form: , Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information:
2Comparator Arm (Non Ayurveda)-Fluoridated toothpaste The comparator product is a fluoridated toothpaste which is to be used to brush the teeth twice daily for 6 months
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Potential subjects must meet ALL of the following criteria:
Males and females, between 25-70 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 and a negative Covid-19 test via RT PCR or a Rapid Antigen test within 48 hours prior to site visits;
Minimum of 10 uncrowned permanent natural teeth (excluding third molars);
Initial mean gingivitis index of at least 1.5 as determined by the use of the Loe and Silness Gingival Index and at least 10% of bleeding sites;
Availability for the duration of the study.
 
 
ExclusionCriteria 
Details  Potential subjects must NOT HAVE ANY of the following conditions:
Oral pathology, chronic disease, or a history of allergy to testing products;
Subject using anticonvulsants, antihistamines, antidepressants, sedatives, tranquilizers, anti-inflammatory medication or daily analgesics within one month prior to the start of the study or scheduled to start such intake during the course of the study;
Subject participating in any other clinical study that might interfere with the main study outcome;
Subject pregnant or breastfeeding;
Subject allergic to oral care products, personal care consumer products, or their ingredients;
Extended use of antibiotics or therapeutic mouthwash any time during the three months prior to entry into the study;
Ongoing use of medications known to affect the gingival tissues (i.e. calcium channel blockers, phenytoin, cyclosporine);
Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone). Pocket depth greater than 4 mm, periodontal abscess(es), teeth with mobility > 1;
Current smokers, tobacco users and subjects with a history of alcohol or drug abuse;
An existing medical condition which prohibits eating or drinking for periods up to 4 hours.
 
 
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 Gingival Index and Ayurveda 3 parameters)  Baseline, 3 months and 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
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)   27/12/2021 
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   NA 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Summary: 


The objective of this clinical research study is to evaluate the efficacy of a​ toothpaste containing herbal ingredients on established ​dental ​plaque and gingivitis in adults. This is a phase III, single center, randomised, parallel and double blinded study conducted on about 100 subjects in the age group between 25 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.

 
Close