| CTRI Number |
CTRI/2024/12/077856 [Registered on: 09/12/2024] Trial Registered Prospectively |
| Last Modified On: |
09/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
A clinical study to evaluate the effect of a test product (Toothpaste) on subjects with periodontitis / gingivitis (gum disease). |
|
Scientific Title of Study
|
An open label, prospective, multicenter, comparative, randomized, controlled, 2-arm study to assess the safety and efficacy of Zn citrate based Dental Gel in subjects with periodontitis / gingivitis. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| C3B04902;DRL-IND-GGI-073-STOL/2024;Ver: 01,Dated : 08 Nov 24 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Parth Joshi |
| Designation |
Overall Trial Coordinator |
| 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, Gujarat.
Ahmadabad
GUJARAT
380054
India |
| Phone |
8000085049 |
| Fax |
|
| Email |
pjoshi@cliantha.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kriti Kaushik |
| Designation |
Medical Advisor |
| Affiliation |
Dr Reddys Laboratories Limited |
| Address |
Dr Reddys Laboratories Limited,
Global Generics India 7-1-27,
Ameerpet, Hyderabad, 500016. Telangana. India.
Hyderabad
TELANGANA
500016
India |
| Phone |
9811566259 |
| Fax |
|
| Email |
kritikaushik@drreddys.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sagar Katare |
| Designation |
Medical Cluster Head Ideation and CR Medical Affairs |
| Affiliation |
Dr Reddys Laboratories Limited |
| Address |
Dr Reddys Laboratories Limited,
Global Generics India 7-1-27,
Ameerpet, Hyderabad, 500016. Telangana. India.
Hyderabad
TELANGANA
500016
India |
| Phone |
9223772427 |
| Fax |
|
| Email |
sagarkatare@drreddys.com |
|
|
Source of Monetary or Material Support
|
| Dr Reddy’s Laboratories Ltd., Medical Affairs Department, 7-1-27, Ameerpet, Hyderabad, Telangana – 500016, India. |
|
|
Primary Sponsor
|
| Name |
Dr. Reddys Laboratories Ltd. |
| Address |
7-1-27, Ameerpet, Hyderabad, Telangana - 500016 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Henil Shah |
Tatva Dental Care (Site 1) |
31, Kajal-Kiran Complex,
B/S Parthesh Appt.,
Navrangpura Jain Derasar,
Navrangpura, Ahmedabad.
Ahmadabad
GUJARAT |
9924289809
Shahhenil29@yahoo.com |
| Dr Harsh Shah |
Vijay Dental Clinic (Site 2) |
Shop#01, Shreeji Park,
Bhavik School Road,
Near Arbuda Nagar,
Chandlodiya, Ahmedabad.
Ahmadabad
GUJARAT |
9825010184
drharshomfs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| OM Institutional Ethics Committee |
Approved |
| OM Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Subjects with plaque, gingivitis/periodontitis and oral malodor. |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Marketed Toothpaste |
Pea sized product to be used twice a day as per modified Bass technique for brushing for duration of 1 month. |
| Intervention |
Test Toothpaste |
Pea sized product to be used twice a day as per modified Bass technique for brushing for duration of 1 month. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Age: 18 to 60 years (both inclusive) at the time of consent.
2) Gender: Males and Non-pregnant /Non-Lactating females.
3) For Group 1:
a. Healthy subjects as determined by the Investigator based on medical history and vital signs.
AND
For Group 2:
a. Subjects with Type 2 Diabetes Mellitus, reported HbA1c level between 6.5 to 8 in past 3 months.
b. Subjects with physician diagnosed type 2 diabetes of more than three months duration and who are currently under the care of a physician for diabetes management.
4) Subjects with moderate to severe (3 to 4) plaque as determined by Plaque Index System.
5) Subjects with mild to moderate (1 to 2) gingivitis/periodontitis.
6) Subjects having slight to strong oral malodor / bad breath (2 to 4) associated with periodontal disease as determined by Organoleptic Scoring Scale.
7) Subjects who are willing to come to the test site without brushing their teeth in the morning of visit 01 [Screening, Enrollment and Baseline Visit (Day 01)].
8) Subjects who are willing to participate in the study and give a signed consent.
9) Subjects should be willing and able to follow the study protocol to participate in the study. |
|
| ExclusionCriteria |
| Details |
1) Pregnant or breastfeeding or planning pregnancy during the study period.
2) Subjects not willing to follow all the acceptable forms of contraception as applicable.
3) Subjects with orthodontic bands and partial removable dentures.
4) Subjects having tumor(s) of the soft or hard tissues of the oral cavity.
5) Subject with advanced periodontal disease (purulent exudate, tooth mobility with grade 3, and/or extensive loss of periodontal attachment or alveolar bone).
6) Subjects having history of acute cardiac and circulatory diseases, HIV, hepatitis, uncontrolled hypertension and Hyperthyroidism.
7) Subjects who are receiving chronic treatment with systemic corticosteroids, cyclosporine or other systemic immunosuppressive drugs.
8) Subjects who are undergoing chronic treatment with systemic antibiotics
9) Subjects who are currently receiving dialysis.
10) Subjects who are at increased risk of bleeding complications from dental treatment, based on medical history.
11) Subjects who require Essential Dental Care (e.g., treatment for grossly decayed teeth, broken teeth, dental abscesses, peri-apical infections, other dental infections, extractions, impactions, implant placement, irreversible pulpitis, surgical removal of cysts and tumors, mucositis due to radiotherapy/chemotherapy).
12) Heavy alcohol consumption (on average more than 2 drinks/day for women and more than 3 drinks/day for men).
13) Subjects smoking cigarette or consume any other form of tobacco.
14) Participation in a similar clinical study within the previous 30 Days.
15) Any other condition which could warrant exclusion from the study, as per the investigator’s discretion. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of reduction in gingivitis assessed using gingival index between 2 products. |
Day 30 (+ 02 days) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of gingivitis assessed using gingival index |
Day 01, Day 07, Day 15 and Day 30 and Day 60 |
| Assessment of plaque formation using plaque index and disclosing agent |
Day 01, Day 07, Day 15 and Day 30 and Day 60 |
| Assessment of pocket depth or clinical level attachment using a periodontal probe |
Day 01, Day 07, Day 15 and Day 30 and Day 60 |
| Assessment of bleeding gums using WHO probe |
Day 01, Day 07, Day 15 and Day 30 and Day 60 |
| Assessment of halitosis using Organoleptic Scoring Scale. |
Day 01, Day 07, Day 15 and Day 30 and Day 60 |
| Assessment of overall gum health by dental examination |
Day 01, Day 07, Day 15 and Day 30 and Day 60 |
| Subjective questionnaires |
Day 01, Day 07, Day 15 and Day 30 and Day 60 |
|
|
Target Sample Size
|
Total Sample Size="108"
Sample Size from India="108"
Final Enrollment numbers achieved (Total)= "108"
Final Enrollment numbers achieved (India)="108" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
27/12/2024 |
| Date of Study Completion (India) |
11/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
|
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, prospective, prospective, multicenter, comparative, randomized, controlled, 2-arm study to assess the safety and efficacy of Stolin-R Toothpaste in subjects with periodontitis / gingivitis. The potential subjects will be screened as per the inclusion and exclusion criteria only after obtaining written informed consent from the subjects. Subjects will be divided into 04 groups. Group 1a: Healthy Subjects using Test Product (Zn citrate based Dental Gel) Group 1b: Healthy Subjects using Comparator Product (Colgate Strong Teeth) Group 2a: Subjects with Type 2 Diabetes Mellitus using Test Product (Zn citrate based Dental Gel) Group 2b: Subjects with Type 2 Diabetes Mellitus using Comparator Product (Colgate Strong Teeth) All eligible subjects will undergo dental assessment and subjective evaluation. Safety will be assessed throughout the study by monitoring adverse events. |