| CTRI Number |
CTRI/2026/03/107015 [Registered on: 27/03/2026] Trial Registered Prospectively |
| Last Modified On: |
26/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to evaluate the effectiveness of DR 32 herbal toothpaste in reducing tooth sensitivity |
|
Scientific Title of Study
|
To evaluate the clinical effectiveness of DR 32 herbal tooth paste in reducing dentinal hypersensitivity A Randomized Controlled Trial |
| 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 Shruthi MS |
| Designation |
Professor |
| Affiliation |
Subbaiah Institiute of Dental Sciences |
| Address |
Department of Periodontology and Implantology
Subbaiah Institiute of Dental Sciences
NH 13 Purle Shimoga
Shimoga
KARNATAKA
577222
India |
| Phone |
9902936899 |
| Fax |
|
| Email |
shruthi.sdoc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Shruthi MS |
| Designation |
Professor |
| Affiliation |
Subbaiah Institiute of Dental Sciences |
| Address |
Department of Periodontology and Implantology
Subbaiah Institiute of Dental Sciences
NH 13 Purle Shimoga
Shimoga
KARNATAKA
577222
India |
| Phone |
9902936899 |
| Fax |
|
| Email |
shruthi.sdoc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
NEHA KOUSAR |
| Designation |
Post graduate |
| Affiliation |
Subbaiah Institiute of Dental Sciences |
| Address |
Department of Periodontology and Implantology
Subbaiah Institiute of Dental Sciences
NH 13 Purle Shimoga
Shimoga
KARNATAKA
577222
India |
| Phone |
8147306735 |
| Fax |
|
| Email |
nehakousar02@gmail.com |
|
|
Source of Monetary or Material Support
|
| PRAKRUTI PRODUCTS PVT LTD
No.71,First floor ,4th main,West of Chord Road,4th stage,3rd Block, Basaveshwara Nagar ,Banglore,560079. |
|
|
Primary Sponsor
|
| Name |
Dr Shruthi MS |
| Address |
Subbaiah Institute of Dental Sciences
NH 13 Purle Shimoga |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Shubha P |
Subbaiah Research Centre
NH 13 Purle Shimoga |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Neha Kousar |
Subbaiah Institute of Dental Sciences |
Department of Periodontology
Subbaiah Institute of Dental Sciences
NH 13 Purle Shimoga
Shimoga
KARNATAKA |
8147306735
nehakousar02@gmail.com |
| Dr Shruthi MS |
Subbaiah Institute of Dental sciences |
Department of Periodontology Subbaiah Institute of Dental sciences
NH 13 Purle Shimoga
Shimoga
KARNATAKA |
9902936899
shruthi.sdoc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of subbaiah Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K031||Abrasion of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
DR 32 Herbal Toothpaste |
0.25 gms twice daily for 2 weeks |
| Comparator Agent |
Potassium Nitrate based toothpaste |
0.25gm twice daily for 2 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Systemically healthy
Minimum of 2 adjacent sensitive teeth
Minimum of 20 residual teeth Patient with good Oral Hygiene
|
|
| ExclusionCriteria |
| Details |
Smokers and Tobacco chewers
Patients with allergy due to materials used in study Participants who develop any signs of irritation or allergic reaction to the study materials during the study period will be withdrawn and provided appropriate care
Patients who have used Analgesic for any systemic illness within 72 hours prior to baseline examination will be excluded
Patients with several dental caries defective restorations
Patients with existing use of toothpaste for sensitive teeth
Patient who went procedures periodontal surgery for root coverage class V resin filling and desensitizing agent application in past 1 month
DH caused by whitening treatment or use of whitening toothpastes
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Dentin hypersensitivity will be assessed and recorded for the three stimuli (air blast, cold, and tactile) before initiating any hypersensitivity treatment using Schiff Sensitivity Score
visual analog scale (VAS). |
0 15 30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patient compliance, acceptability and satisfaction with 0.5% DR – 32 herbal Versus Potassium Nitrate based Toothpaste, will be assessed based on subjective and objective feedback |
30 Day |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 2 |
|
Date of First Enrollment (India)
|
10/04/2026 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 study is a randomized, parallel-group controlled trial conducted at the Department of Periodontology, Subbaiah Institute of Dental Sciences, Shivamogga. The primary purpose of the study is to evaluate the clinical effectiveness and safety of 0.5% DR-32 herbal toothpaste in reducing dentin hypersensitivity. A total of 40 systemically healthy participants with dentin hypersensitivity will be recruited and randomly allocated into two groups (20 per group). All participants will undergo scaling and root planing, followed by assignment to either DR-32 herbal toothpaste or calcium sodium phosphosilicate–based toothpaste for a period of two weeks. Dentin hypersensitivity will be assessed at baseline, 15 days, and 30 days using tactile, air blast, and cold-water tests. Objective assessment will be performed using the Schiff sensitivity scale, and subjective assessment will be recorded using the Visual Analog Scale (VAS). |