Health Condition 1: K135- Oral submucous fibrosis
Conditions
Interventions
Intervention1: Silymarin 1%
Curcumin 10 mg: Topical application, Thrice daily for 6 months
Control Intervention1: Triamcinolone acetonide 0.1 %
: Topical application thrice daily for 6 months
Sponsors
Nil
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with clinical features of Oral submucous Fibrosis (OSMF) such as blanching, palpable vertical fibrotic bands and reduction in the mouth opening 2. No histopathological evidence of dysplastic or malignant changes 3. Patients who are willing to quit the habit and come for regular follow up for 6 months 4. Stage 2 and Stage 3 patients based on Khanna and Andrade functional staging (Mouth opening >15 mm and
Exclusion criteria
Exclusion criteria: 1. Patients who have not given informed consent 2. Patients who have undergone prior treatment for OSMF 3. Stage I and Stage IV OSMF (Mouth opening â?? >35mm and 4. Patients planned for surgical management 5. Patients with no history of cardiac, renal, pulmonary and hepatic diseases 6. History of hypersensitivity to curcumin or silymarin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of burning sensation, Mouth opening measurementTimepoint: 1,3,6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Tongue protrusion measurementTimepoint: 1,3,6 months | — |
Countries
India
Contacts
Public ContactCVDivyambika
Sri Ramachandra Institute of Higher Education and Research (Deemed to be University)
Outcome results
None listed