| CTRI Number |
CTRI/2025/11/097807 [Registered on: 21/11/2025] Trial Registered Prospectively |
| Last Modified On: |
19/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Research on Tooth Stains Chemistry Using Donated Extracted Human Teeth |
|
Scientific Title of Study
|
Extracted Human Teeth samples collection for ex-vivo research testing of tooth stains composition. |
| 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 Chaitra Mastud |
| Designation |
Professor, Department of Orthodontics and Dentofacial Orthopedics |
| Affiliation |
Dr. D. Y. Patil Dental College & Hospital |
| Address |
Department of Orthodontics and Dentofacial Orthopedics
Dr. D. Y. Patil Dental College & Hospital
Sant Tukaram Nagar,Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
02067116419 |
| Fax |
|
| Email |
chaitra.mastud@dpu.edu.in |
|
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 (India) Limited, Main Street, Hiranandani Gardens, Powai, Mumbai, MH 400076, India |
|
|
Primary Sponsor
|
| Name |
Colgate-Palmolive |
| Address |
Main Street, Hiranandani Gardens, Powai, Mumbai, Maharashtra 400078 |
| 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 Chaitra Mastud |
Dr. D. Y. Patil Dental College and Hospital |
Department of Orthodontics and Dentofacial Orthopedics, Dr. D. Y. Patil Dental College & Hospital Sant Tukaram Nagar, Pimpri, Pune
Pune MAHARASHTRA
411018
India
Pune
MAHARASHTRA |
02067116419
chaitra.mastud@dpu.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE, Dr.D.Y. Patil VIDYAPEETH, PUNE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K039||Disease of hard tissues of teeth,unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with an indication for
teeth extraction
Subjects willing for donation of extracted
teeth |
|
| ExclusionCriteria |
| Details |
Tooth with cracks, defective restorations and
cavities, excess staining and excess damage |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assess molecular changes of tooth stains composition |
Baseline (Single time point) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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)
|
02/12/2025 |
| 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="8"
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
|
This is a single centered cross-sectional clinical study for ex-vivo evaluation of molecular changes in tooth stains of newly extracted 1000 human teeth. Subjects with an indication for teeth extraction will be invited to donate their newly extracted teeth. Extracted teeth will be further processed for evaluation of stains composition. |