| CTRI Number |
CTRI/2024/11/077002 [Registered on: 19/11/2024] Trial Registered Prospectively |
| Last Modified On: |
13/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Use of AI-based screening over traditional dental screening for oral health |
|
Scientific Title of Study
|
Pilot research study to correlate the artificial intelligence-based oral screening as compared to a traditional dental screening |
| 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 |
| 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
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
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
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,
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 Bhuvana Gurumurthy |
Colgate Clinical Innovation Institute |
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 |
| INDEPENDENT ETHICS COMMITTEE, CLAIMS PVT LTD |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Screening for oral health |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
N/A |
N/A |
| Comparator Agent |
N/A |
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:
Males and Females, between 18-70 years of age;
Informed Consent Form signed and availability for the duration of the study;
Willingness to provide information related to their medical history;
|
|
| ExclusionCriteria |
| Details |
Potential subjects must NOT HAVE ANY of the following conditions:
Subjects that did not sign an informed consent
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of presence or absence of oral conditions such as stains, caries, calculus |
Single time point |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| N/A |
N/A |
|
|
Target Sample Size
|
Total Sample Size="1000"
Sample Size from India="1000"
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)
|
24/11/2024 |
| 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="0"
Days="1" |
|
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 pilot research study is to correlate the artificial intelligence-based oral screening as compared to a traditional dental screening. This is an observational, multi-centered clinical study to assess the oral health status of the Indian population. Up to 1000 subjects will be screened. Subjects who have expressed an interest in participating will be selected based on the inclusion and exclusion criteria. |