| CTRI Number |
CTRI/2024/07/071276 [Registered on: 25/07/2024] Trial Registered Prospectively |
| Last Modified On: |
25/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study to evaluate safety, in-use tolerability and efficacy of a toothpaste in adult subjects. |
|
Scientific Title of Study
|
A clinical study to evaluate safety, in-use tolerability and efficacy of a toothpaste in healthy adult subjects with plaque, oral malodor and bleeding gums. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| C3B04629, Version: 01, Dated 28 Jun 24 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Parth Joshi |
| Designation |
Principal Investigator |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department,
Corporate House 17, Sigma 1 Corporate House,
BH. Rajpath Club, Off. Sindhubhavan Road,
Nr. Mann Party Plot Cross Road, Bodakdev,
Ahmedabad-380054-India
Ahmadabad
GUJARAT
380054
India |
| Phone |
8000085049 |
| Fax |
|
| Email |
pjoshi@cliantha.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Simran Sethi |
| Designation |
Director-Consumer Research |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department,
Corporate House 17, Sigma 1 Corporate House,
BH. Rajpath Club, Off. Sindhubhavan Road,
Nr. Mann Party Plot Cross Road, Bodakdev,
Ahmedabad-380054-India
Ahmadabad
GUJARAT
380054
India |
| Phone |
9825784942 |
| Fax |
|
| Email |
ssethi@cliantha.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Parth Joshi |
| Designation |
Principal Investigator |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department,
Corporate House 17, Sigma 1 Corporate House,
BH. Rajpath Club, Off. Sindhubhavan Road,
Nr. Mann Party Plot Cross Road, Bodakdev,
Ahmedabad-380054-India
Ahmadabad
GUJARAT
380054
India |
| Phone |
8000085049 |
| Fax |
|
| Email |
pjoshi@cliantha.com |
|
|
Source of Monetary or Material Support
|
| Cliantha Research
Corporate House 17, Sigma 1 Corporate House,
BH. Rajpath Club, Off Sindhubhavan Road,
Nr. Mann Party Plot Cross Road,
Bodakdev, Ahmedabad-380054, Gujarat. |
| Patanjali Ayurved Ltd.
Patanjali Food & Herbal Park,
Laksar Road, Padartha,
Haridwar, Uttrakhand - 249404 India |
|
|
Primary Sponsor
|
| Name |
Patanjali Ayurved Ltd. |
| Address |
Patanjali Food & Herbal Park,
Laksar Road, Padartha,
Haridwar, Uttrakhand - 249404 India |
| Type of Sponsor |
Other [FMCG] |
|
|
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 Parth Joshi |
Cliantha Research |
Consumer Research Department,
Corporate House 17, Sigma 1 Corporate House,
BH. Rajpath Club, Off. Sindhubhavan Road,
Nr. Mann Party Plot Cross Road, Bodakdev,
Ahmedabad-380054-India
Ahmadabad
GUJARAT |
8000085049
pjoshi@cliantha.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| OM - Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K055||Other periodontal diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Patanjali Dantkanti Red Toothpaste (Pan Flavor) |
Apply approx. 1 gm of toothpaste on the affected area twice a day with a cleaned fingertip and massage gently for a minute followed by 1-min brushing by moving brush up-down and side wise
movement fashion followed by
rinsing mouth with water for 30 days. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects with mild, moderate or severe plaque with plaque index of 2, 3 and 4.
2. Subjects with gingivitis and having extrinsic dental stains.
3. Subjects having T-VSC reading (total volatile sulphur compounds) of ≥140 ppb (parts per billion).
4. Subjects should be willing to come to the test site without brushing their teeth in the morning of screening visit.
5. Subjects should be willing to not consume anything except water after meal of previous night. |
|
| ExclusionCriteria |
| Details |
1. Subjects with plaque index of 0, 1 and 5.
2. Subject with orthodontic bands.
3. Subject with partial removable dentures.
4. Subject having tumor (s) of the soft or hard tissues of the oral cavity.
5. Subject with advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone).
6. Subject with five or more carious lesions requiring immediate restorative treatment. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the effect of the test product on the
reduction in gingivitis using Gingival index |
Comparison of baseline readings i.e. Day 01 (before brushing) with Day 15 (plus 2 days) and Day 30 (plus 2 days). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the effect of the test product on the reduction in plaque by using plaque index and disclosing agents |
Comparison of baseline readings i.e. Day 01 (before brushing) with Day 15 (plus 2 days) and Day 30 (plus 2 days). |
| To assess the effect of the test product on the reduction in T-VSC reading (total volatile sulfur compounds) using a Halimeter: |
Comparison of baseline (before brushing) with 0 hour (plus 15 mins) after brushing and with 4 hours (plus 15 mins), 8 hours (plus 15 mins) and 12 hours (plus 15 mins) after brushing but before having meals at each time point on Day 01. |
| To assess the effect of the test product on Germ Protection by microbial analysis for S. mutans |
Comparison of baseline (before brushing) with 0 hour (plus 15 mins) after brushing and with 4 hours (plus 15 mins), 8 hours (plus 15 mins), and 12 hours (plus 15 mins) after brushing but before having meals at each time point on Day 01. |
| To assess the effect of the test product on Number of carious tooth by dental examination |
Comparison of baseline readings i.e. Day 01 (before brushing) with Day 15 (plus 2 days) and Day 30 (plus 2 days). |
| Subjective evaluation questionnaire |
Comparison of baseline readings i.e. Day 01 (before brushing) with Day 15 (plus 2 days) and Day 30 (plus 2 days). |
| Subjects’ perception questionnaires |
0 mins (plus 5 mins), 30 mins (plus 5 mins) and 60 mins (plus 5 mins)on Day 01 and Day 30 (plus 2 days). |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "31"
Final Enrollment numbers achieved (India)="31" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
09/08/2024 |
| Date of Study Completion (India) |
05/10/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="2" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 open label,
non-randomized, single-centre, single-arm clinical study to evaluate safety,
in-use tolerability and efficacy of a toothpaste in healthy adult subjects with
plaque, oral malodor and bleeding gums.
The potential subjects will be
screened as per the inclusion and exclusion criteria only after obtaining
written informed consent from the subjects.
All eligible subjects will undergo clinical
evaluation by a Dentist, instrument evaluation and subjective evaluation. Safety will be assessed throughout
the study by monitoring adverse events. |