| CTRI Number |
CTRI/2026/02/103850 [Registered on: 13/02/2026] Trial Registered Prospectively |
| Last Modified On: |
13/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing a combination of turmeric and zinc against a steroid to treat fibrosis and burning sensation of oral cavity |
|
Scientific Title of Study
|
Comparative study to evaluate the efficacy of turmizinc and point one percent triamcinolone acetonide oral paste in the treatment of oral submucous fibrosis 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 Vagisha Choudhary |
| Designation |
Post Graduate Student |
| Affiliation |
D Y Patil University School Of Dentistry |
| Address |
DEPARTMENT OF ORAL MEDICINE AND RADIOLOGY D Y Patil University School Of Dentistry Navi Mumbai
Mumbai (Suburban)
MAHARASHTRA
400706
India |
| Phone |
8940729691 |
| Fax |
|
| Email |
vagishac14@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mandavi Waghmare |
| Designation |
Professor and Head of the Department |
| Affiliation |
D Y Patil University School Of Dentistry |
| Address |
DEPARTMENT OF ORAL MEDICINE AND RADIOLOGY D Y Patil University School Of Dentistry Navi Mumbai
Mumbai (Suburban)
MAHARASHTRA
400706
India |
| Phone |
8940729691 |
| Fax |
|
| Email |
mandavi.waghmare@dypatil.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vagisha Choudhary |
| Designation |
Post Graduate Student |
| Affiliation |
D Y Patil University School Of Dentistry |
| Address |
DEPARTMENT OF ORAL MEDICINE AND RADIOLOGY D Y Patil University School Of Dentistry Navi Mumbai
Mumbai (Suburban)
MAHARASHTRA
400706
India |
| Phone |
8940729691 |
| Fax |
|
| Email |
vagishac14@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr VAGISHA CHOUDHARY DEPARTMENT OF ORAL MEDICINE AND RADIOLOGY |
| Address |
Dr Vagisha Choudhary ,
DY Patil University School of Dentistry |
| Type of Sponsor |
Other [SELF SPONSORED ] |
|
|
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 Vagisha Choudhary |
DY Patil University School of Dentistry |
Department Of Oral Medicine and Radiology sector 7 nerul navi mumbai
Mumbai (Suburban)
MAHARASHTRA |
08940729691
vagishac14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL RESEARCH AND ETHICAL BOARD DY PATIL UNIVERSITY SCHOOL OF DENTISTRY NAVI MUMBAI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
patients with osmf |
| Patients |
(1) ICD-10 Condition: K135||Oral submucous fibrosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
0.1 percent triamcinolone acetonide oral paste |
0.1 percent triamcinolone acetonide paste marketed as trioplast to be given for 2 months |
| Intervention |
Turmizinc oral paste |
oral paste containing curcumin along with lycopene and zinc for 2 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients diagnosed with OSMF clinically and histopathologically.
2. Patients with age group: 18 yr - 60 yr
3. Patients with OSMF Stage I and Stage II (More et al. classification 2011)
4. Patients who have not been treated previously for OSMF.
|
|
| ExclusionCriteria |
| Details |
1. Patients with other mucosal lesions other than OSMF
2. Patients with trismus due to other reasons.
3. Patients who have already been given or are currently on any treatment for OSMF
4. Patients with systemic ailments having OSMF.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Increase in mouth opening (interincisal distance)
Reduction in burning sensation (VAS score)
Increase in tongue protrusion which will be assessed at 7 day, 15 days, 30 days and 60 days from the start of treatment
|
Increase in mouth opening (interincisal distance)
Reduction in burning sensation (VAS score)
Increase in tongue protrusion
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
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 3 |
|
Date of First Enrollment (India)
|
11/03/2026 |
| 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="0"
Months="6"
Days="0" |
|
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
|
AIM
To evaluate the efficacy of turmizinc vs 0.1 percentage triamcinolone acetonide in treatment of
oral submucous fibrosis.
Objective
1.
Evaluate
improvement in burning sensation
2.
Evaluate
improvement in mouth opening
3.
Evaluate
improvement in elasticity of the mucosa
4.
Evaluate
improvement in tongue protrusion
5.
Evaluate
adverse effects of the therapy
Intervention
group – Turmizinc
Comparator
group – Triamcinolone acetonide 0.1%
Hypothesis
The null hypothesis (H0) is that there is no difference between the outcomes in turmizinc and triamcinolone acetonide oral paste in treatment of OSMF.
The alternate hypothesis (Ha) is that the efficacy of turmizinc is better when
compared to triamcinolone acetonide in the
treatment of OSMF.
Timeline for data collection—at baseline
7
days after intervention
15
days after intervention
30
days after intervention
60
days after intervention
The present
study will be conducted in the Department of Oral Medicine and Radiology at DY Patil School of Dentistry, Navi Mumbai.
The sample
size is decided to be 30, (n) with n1 being group 1 and n2 being group 2. Each group will have 15 participants.
The
sample size for comparing two means was determined by the following formula
using G*power software 3.1. |