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CTRI Number  CTRI/2024/06/068516 [Registered on: 06/06/2024] Trial Registered Prospectively
Last Modified On: 06/06/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Clinical study to screen and evaluate the oral health in an adult population in India 
Scientific Title of Study   Oral Health Assessment of an Adult Population in India 
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 Bhuvana Gurumurthy 
Designation  Assistant Manager, Clinical Innovation and Lead, India Dental-Dermal Health Unit 
Affiliation  Colgate-Palmolive India Limited 
Address  Main Street, Hiranandani Gardens, Powai, Mumbai

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

bhuvana_gurumurthy@colpal.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Kelkar Educational Trusts Institutional Scientific & Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K05||Gingivitis and periodontal diseases, (2) ICD-10 Condition: K02||Dental caries, (3) ICD-10 Condition: K08||Other disorders of teeth and supporting structures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  N/A 
Comparator Agent  NIL  N/A 
 
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:
1. Males and Females, between 18-70 years of age;
2. Informed Consent Form signed and availability for the duration of the study;
3. 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.);
4. Willingness to provide information related to their medical history;
5. Minimum of 10 uncrowned permanent natural teeth (excluding wisdom teeth);
 
 
ExclusionCriteria 
Details  Potential subjects must NOT HAVE ANY of the following conditions:
1. Oral pathology, chronic disease, or a history of allergy to oral care products, teeth whitening products, hydrogen peroxide, personal care consumer products, or their ingredients;
2. Presence of orthodontic appliances;
3. Obvious signs of periodontal disease, rampant caries, or any condition that the dental examiner considers exclusionary from the study;
4. Subject using anticonvulsants, antihistamines, antidepressants, sedatives, tranquilizers, anti-inflammatory medication or daily analgesics;
5. Subject participating in any other clinical study that might interfere with the main study outcome;
6. Subject pregnant or breastfeeding;
7. Ongoing use of medications known to affect the gum tissues (i.e. calcium channel blockers, phenytoin, cyclosporine);
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Oral health status, risk assessment, oral wellness, digital images
 		 Baseline
 
 
Secondary Outcome  
Outcome  TimePoints 
N/A  N/A 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
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)   15/06/2024 
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="3"
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 - NO
Brief Summary  

The study titled, "Oral Health Assessment of an Adult Population in India" is a single-centered observational study that will be conducted at the Colgate Clinical Innovation Institute, India Global Technology Center of Colgate-Palmolive (India) Limited in Mumbai, India. The study aims to enroll 300 healthy subjects in the age group of 18-70 years, where oral health screening and clinical research evaluations will be carried out to assess their oral health status, perform risk assessment, determine oral wellness and gather digital images. 

 
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