| CTRI Number |
CTRI/2024/11/076685 [Registered on: 12/11/2024] Trial Registered Prospectively |
| Last Modified On: |
05/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy of a whitening vs non-whitening toothpaste for removal of teeth stains |
|
Scientific Title of Study
|
Proof-of-concept clinical study to evaluate the stain removal efficacy of a commercially available as compared to negative control toothpaste |
| 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 |
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
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
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, Colgate Palmolive India Limited |
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 |
| Patients |
(1) ICD-10 Condition: K039||Disease of hard tissues of teeth,unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Non-whitening toothpaste group |
14 days of brushing with the product twice daily for two minutes |
| Intervention |
Whitening toothpaste group |
14 days of brushing with the product twice daily for two minutes
|
|
|
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:
Signed Informed Consent Form;
Male and female subjects aged 18-70 years, inclusive;
Good general health and good oral health based on the opinion of the study investigator;
Present twelve (12) scorable natural anterior teeth (free of large restorations or prosthetics).
Availability for the duration of the study;
Self reported consumption of tea, coffee or tobacco ≥ 2 times a day.
A minimum mean Composite Lobene Index score of 1 or greater.
Clinical evidence of a tendency to form stains on anterior teeth.
|
|
| ExclusionCriteria |
| Details |
Potential subjects must NOT HAVE ANY of the following conditions:
Presence of orthodontic appliances or any anterior tooth with a prosthetic crown or veneer.
Presence of partial removable dentures.
Tumors or significant pathology of the soft or hard tissues of the oral cavity.
Presence of anterior teeth with severe or atypical staining, which include tetracycline or hypo-calcification.
Use of antibiotics or stain inducing medications any time during the one month prior to entry into the study.
Dental prophylaxis received in the past four weeks prior to baseline examinations or usage of whitening toothpaste.
History of alcohol or drug abuse.
Exposed to a tooth whitening procedure during the last 3 months.
Moderate periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone) or any other condition that the dental examiner considers would exclude you from participation.
Five or more carious lesions requiring immediate restorative treatment.
History of allergy to consumer or personal care products as determined by the dental professional monitoring the study.
Participation in any other clinical study or test panel within the 30-day period prior to entering into the study.
Pregnant women or women who are breast-feeding.
Medical conditions that the investigator considers significant which may compromise the subject’s safety as well as the quality of the study results.
Restorations on the teeth to be scored which may interfere with scoring procedures.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in Tooth stain determined by examiner use Lobene Stain |
Baseline, 7 days and 14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| N/A |
N/A |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 4 |
|
Date of First Enrollment (India)
|
16/11/2024 |
| 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="15" |
|
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 proof-of-concept clinical study to evaluate the stain removal efficacy of a commercially available toothpaste as compared to negative control toothpaste. Thirty (30) subjects, aged 18-70 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 a Phase IV, single-center, two cell, parallel-group and double-blinded clinical study. |