To study effects of two different drugs in treatment of Oral Submucous Fibrosis
Phase 4
Completed
- Conditions
- Health Condition 1: null- Oral Submucous Fibrosis
- Registration Number
- CTRI/2017/09/009671
- Lead Sponsor
- Maulana Azad Institute Of Dental Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 45
Inclusion Criteria
Clinically and histopathologically proven cases of OSMF
1) Positive history of chewing areca nut or one of its commercial preparation, difficulty in swallowing and chewing, and burning sensation on eating spicy food.
2) Restricted mouth opening and changes in the oral mucous membrane including the presence of vertical fibrous bands , stiffness and blanching.
30 positive history of tobacco, smoking, betel quid and alcohol.
Exclusion Criteria
1) Those who were not willing to participate.
2)Patients who were already undertaking some treatment for existing potentially malignant disorder.
3)Patients with severe systemic disease.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation of burning sensation score, mouth opening, tongue protrusion and cheek flexibility between groups and within groupsTimepoint: At the time of first visit, every month till a period of 9 months.
- Secondary Outcome Measures
Name Time Method Reporting of malignant transformation over period of 9 months.Timepoint: Individuals were assessed every 4 weeks for 9 months. In case of any suspicion, biopsy was done.