| CTRI Number |
CTRI/2024/10/075020 [Registered on: 09/10/2024] Trial Registered Prospectively |
| Last Modified On: |
02/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical Procedures for Training and Calibration |
|
Scientific Title of Study
|
Clinical Procedures for Training and Calibration in the Use of the Tooth Stain and Color Indices |
| 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 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
Public Query
|
| 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 |
|
|
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 |
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 |
| Patients |
(1) ICD-10 Condition: K037||Posteruptive color changes of dental hard tissues, |
|
|
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 |
1. Signed Informed Consent Form.
2. Male and female subjects aged 18-70 years, inclusive.
3. Good general health and good oral health.
4. Availability for the duration of the study.
5. Present twelve (12) scorable natural anterior teeth (free of large restorations or prosthetics).
6. A minimum mean Composite Lobene Index score of 1 or greater.
7. 50% of subjects are current tobacco users.
8. Clinical evidence of a tendency to form extrinsic stains on anterior teeth.
|
|
| ExclusionCriteria |
| Details |
1. Presence of orthodontic appliances or any anterior tooth with a prosthetic crown or veneer.
2. Presence of partial removable dentures.
3. Tumors or significant pathology of the soft or hard tissues of the oral cavity.
4. Presence of anterior teeth with severe or atypical staining, which include tetracycline or hypo-calcification.
5. Use of antibiotics or stain inducing medications any time during the one month prior to entry into the study.
6. Dental prophylaxis received in the past four weeks prior to baseline examinations or usage of whitening toothpaste.
7. History of alcohol or drug abuse.
8. Exposed to a tooth whitening procedure during the last 3 months.
9. Moderate periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone).
10. Five or more carious lesions requiring immediate restorative treatment.
11. History of allergy to consumer or personal care products as determined by the dental professional monitoring the study.
12. Participation in any other clinical study or test panel within the 30-day period prior to entering into the study.
13. Pregnant women or women who are breast-feeding.
14. Medical conditions that the investigator considers significant which may compromise the subject’s safety as well as the quality of the study results.
15. Restorations on the teeth to be scored which may interfere with scoring procedures.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Inter and intra examiner reproducibility |
Inter examiner reproducibility - Visit 1 and 2
Intra examiner reproducibility - Visit 3 and 4 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| N/A |
N/A |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
14/10/2024 |
| 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="5" |
|
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 study titled, "Clinical Procedures for Training and Calibration in the Use of the Tooth Stain and Color Indices" 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 20 healthy subjects in the age group of 18-70 years with tooth stains for training and calibration of dental examiners for future clinical research studies. |