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A Study to Evaluate the Effect of Antioxidants and Curcumin on Mouth Opening and Quality of Life in Patients with Oral Submucous Fibrosis.

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 - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/03/106190
Enrollment
100
Registered
2026-03-13
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx

Interventions

Intervention1: 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, Calc

Sponsors

Dr Smruti Shephalika Dey
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
1) Change or improvement in maximal interincisal distance & severity in burning sensation. 2) Post- treatment discomfort or pain as a result of the intervention. Timepoint: 6 months

Secondary

MeasureTime frame
1) Oral health quality of life assessed by validated questionnaire. (Tadakamadla et al., 2017) 2) Complete clinical resolution of the lesion and remission. Timepoint: 6 months

Countries

India

Contacts

Public ContactDr Abhishek Ranjan Pati

Institute of Dental Sciences, Bhubaneswar

patiabhi@gmail.com8763429793

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Apr 4, 2026