| CTRI Number |
CTRI/2026/03/106190 [Registered on: 13/03/2026] Trial Registered Prospectively |
| Last Modified On: |
13/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Screening
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study to Evaluate the Effect of Antioxidants and Curcumin on Mouth Opening and Quality of Life in Patients with Oral Submucous Fibrosis. |
|
Scientific Title of Study
|
Validation of clinical parameters and oral health quality of life in patients with Oral Submucous Fibrosis using combination of antioxidants and curcumin: A Comparative Prospective Study |
| 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 Smruti Shephalika Dey |
| Designation |
MDS (PGT) |
| Affiliation |
Institute of Dental Sciences, Bhubaneswar |
| Address |
Institute of Dental Sciences, Kalinga Nagar, K8, Khordha, Bhubaneswar, Odisha- 751003
Roon Number: 101, Department of Oral Medicine and Radiology, Institute of dental Sciences, Kalinga Nagar, K8, Khordha, Bhubaneswar
Khordha
ORISSA
751003
India |
| Phone |
7008477720 |
| Fax |
|
| Email |
smrutisdey@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhishek Ranjan Pati |
| Designation |
Professor and Guide |
| Affiliation |
Institute of Dental Sciences, Bhubaneswar |
| Address |
Institute of Dental Sciences, Kalinga Nagar, K8, Khordha, Bhubaneswar
Room No: 101, Department of Oral Medicine and Radiology, Institute of Dental Sciences, Kalinga Nagar, K8, Khordha, Bhubaneswar
Khordha
ORISSA
751003
India |
| Phone |
8763429793 |
| Fax |
|
| Email |
patiabhi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhishek Ranjan Pati |
| Designation |
Professor and Guide |
| Affiliation |
Institute of Dental Sciences, Bhubaneswar |
| Address |
Institute of Dental Sciences, Kalinga Nagar, K8, Khordha, Bhubaneswar
Room No: 101, Department of Oral Medicine and Radiology, Institute of Dental Sciences, Kalinga Nagar, K8, Khordha, Bhubaneswar
Khordha
ORISSA
751003
India |
| Phone |
8763429793 |
| Fax |
|
| Email |
patiabhi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Dental Sciences, Kalinga Nagar, K8, Khordha, Bhubaneswar, Odisha- 751003 |
|
|
Primary Sponsor
|
| Name |
Dr Smruti Shephalika Dey |
| Address |
Institute of Dental Sciences, Kalinga Nagar, K8, Khordha, Bhubaneswar, Odisha-751003 |
| Type of Sponsor |
Other [SELF] |
|
|
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 Smruti Shephalika Dey |
Institute of Dental Sciences |
Room No: 101, Department of Oral Medicine and Radiology, Institute of Dental Sciences, Kalinga Nagar, K8, Khordha, Bhubaneswar
Khordha
ORISSA |
7008477720
smrutisdey@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-INSTITUTE OF DENTAL SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C148||Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CURCUFLEX
(Curcumin-Piperine) |
One tablet once daily for 6 months after food |
| Intervention |
VCOR GOLD
(Co Enzyme Q10, L- Arginine, L- Carnitine, Lycopene, Omega 3 Fatty Acids providing Eicosapentaenoic Acid, Docosahexaenoic Acid, Natural Mixed Carotenoids, Wheat Germ Oil, Calcium L- Ascorbate, Vitamin B12 as Cyanocobalamin, Sodium Selenite, Zinc Sulphate Monohydrate, Piperine) |
One capsule once daily for 6 months after food |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients diagnosed with OSMF clinically Stage II ( Pindborg’s classification, 1989)
2) Who have already quit gutkha/arecanut chewing habit or have effectively quit after counseling.
3) Not received any treatment for OSMF in the past.
4) Age between 25 years to 55 years of any gender.
|
|
| ExclusionCriteria |
| Details |
1) Patient with any systemic disorder like hypertension, diabetes mellitus, respiratory, cardiovascular or renal disorder.
2) Patient having other oral mucosal disease, pericoronal infections and temporomandibular joint dysfunctions.
3) Pregnant or breast-feeding women.
4) Other adverse habits such as alcohol use, smoking, vaping, or e-cigarette use with or without gutkha chewing.
5) Patients not willing to be a part of the study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Change or improvement in maximal interincisal distance & severity in burning sensation.
2) Post- treatment discomfort or pain as a result of the intervention.
|
6 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Oral health quality of life assessed by validated questionnaire. (Tadakamadla et al., 2017)
2) Complete clinical resolution of the lesion and remission.
|
6 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
26/03/2026 |
| 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="1"
Months="6"
Days="10" |
|
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
|
This study is proposed to determine the validation of clinical parameters and oral health quality of life in patients with Oral Submucous Fibrosis using Antioxidants and Curcumin. After complete clinical examination of oral submucous fibrosis (inclusion & exclusion criteria) will be done. Patients will be informed about the study and consent form will be provided. Antioxidant and Curcumin combination will be given in systemic form (oral) and are instructed to perform mouth opening exercises. Then follow up will be done at an interval of 6 months followed by data tabulation and interpretation. |