| CTRI Number |
CTRI/2025/06/089500 [Registered on: 24/06/2025] Trial Registered Prospectively |
| Last Modified On: |
23/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study and understand the types of bacteria in oral cavity in the Indian population.
|
|
Scientific Title of Study
|
To study and understand the oral microbiome and its diversity in the Indian population.
|
| 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 Abhijit Surwade |
| Designation |
Manager Pharmacovigilance |
| Affiliation |
Colgate-Palmolive India Limited |
| Address |
Colgate-Palmolive India Limited
Colgate Clinical Innovation Institute.
Ground floor, Dental Clinic.
Main Street, Hiranandani Gardens, Powai, Mumbai
Mumbai
MAHARASHTRA
400076
India |
| Phone |
02267096590 |
| Fax |
|
| Email |
abhijit_surwade@colpal.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhijit Surwade |
| Designation |
Manager Pharmacovigilance |
| Affiliation |
Colgate-Palmolive India Limited |
| Address |
Colgate-Palmolive India Limited
Colgate Clinical Innovation Institute.
Ground floor, Dental Clinic.
Main Street, Hiranandani Gardens, Powai, Mumbai
MAHARASHTRA
400076
India |
| Phone |
02267096590 |
| Fax |
|
| Email |
abhijit_surwade@colpal.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhijit Surwade |
| Designation |
Manager Pharmacovigilance |
| Affiliation |
Colgate-Palmolive India Limited |
| Address |
Colgate-Palmolive India Limited
Colgate Clinical Innovation Institute.
Ground floor, Dental Clinic.
Main Street, Hiranandani Gardens, Powai, Mumbai
MAHARASHTRA
400076
India |
| Phone |
02267096590 |
| Fax |
|
| Email |
abhijit_surwade@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,
India |
| Type of Sponsor |
Other [FMCG - Global] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Abhijit Surwade |
Colgate Clinical Innovation Institute, Colgate Palmolive India Limited |
Colgate-Palmolive India Limited
Colgate Clinical Innovation Institute.
Ground floor, Dental Clinic.
Main Street, Hiranandani Gardens, Powai, Mumbai
MAHARASHTRA
400076
India
Mumbai
MAHARASHTRA |
02267096590
abhijit_surwade@colpal.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INDEPENDENT ETHICS COMMITTEE, CLAIMS PVT LTD |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy subjects with tendency to form dental plaque |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Potential subjects must meet ALL of the following criteria:
Males and Females, between age 18 - 55, inclusive.
Good oral health with no evidence of untreated dental decay or active periodontal disease at the point of sample collection.
Subjects will be screened by the dental examiner
Willingness to refrain from oral care hygiene for 12 hours prior to sample collection and refrain from eating, drinking (other than water) 4 hrs prior to sample collection.
Signed Informed Consent Form.
|
|
| ExclusionCriteria |
| Details |
Potential subjects must NOT HAVE ANY of the following conditions:
Hepatitis B or C, HIV infection, oral herpes (cold sore), sinusitis, etc.).
Premedication required for dental procedures.
Pregnant or breastfeeding.
Current or history of infectious disease (i.e.
Current contagious illness (i.e. upper respiratory
Subject allergic to oral care products or their ingredients.
Use of antibiotics any time during or three months prior to entry into the study.
Use of therapeutic oral care products within 1 month prior to entry into the study.
Abnormal salivary function including medication induced dry mouth
Diseases of the soft or hard tissue of the oral cavity
Five (5) or more decayed untreated dental sites at screening
Active periodontal disease (ie purulent exudate or tooth mobility), or having received periodontal treatment (ex: SRP- scaling and root planing) 6 months before entering study
Current smokers or use of tobacco or vaping products
Subjects using anticonvulsants, antihistamines, antidepressants, steroids, 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
Subjects wearing removable retainers, dentures or with fixed orthodontic appliances
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The samples collected will be studied in different phases (genomics and transcriptomics) |
After Donation in Visit 2 samples will be sent to Genotypic for assessment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NA |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
04/07/2025 |
| 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="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 - NO
|
|
Brief Summary
|
This is an observational clinical study to study and understand the oral microbiome and its diversity in the Indian population. Hundred (100) subjects, aged 18-55 years, inclusive, will be entered into the study. Candidates who have expressed an interest in participating will be selected based on the inclusion and exclusion criteria. This is an observational, single-center, single arm clinical study. |