Health Condition 1: K135- Oral submucous fibrosis
Conditions
Interventions
Intervention1: Topical Pirfenidone gel (8%): Topical Pirfenidone gel (8%) to be applied thrice daily on affected mucosa for 4 months
Control Intervention1: Topical Curcumin Gel (1%): Topical Curcumin
Sponsors
Maulana Azad Institute of Dental Sciences
Eligibility
Inclusion criteria
Inclusion criteria: Clinically & histopathologically proven cases of OSMF Any subject of age group18 to 50 years. Both males and females. A positive history of chewing areca nut or one of its commercial preparation, difficulty in swallowing and chewing, and burning sensation on eating spicy foods. Restricted mouth opening and changes in the oral mucous membrane including the presence of palpable vertical fibrous bands, stiffness and blanching.
Exclusion criteria
Exclusion criteria: Subjects with mouth opening less than 15mm. Subjects with severe systemic disease. Pregnant and nursing women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of effectiveness of different treatment modalities through clinical outcome and its comparison among different subgroups. Pre and Post treatment evaluation of expression of JNK, ATF2 and TGF ââ?¬â?? Ã?²Timepoint: Pre - treatment, Every 4 weeks upto 4 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Reporting of any adverse effects during the trial period. The monitoring of the adverse effects of the topical drugs being used which include burning sensation at the site of application, anorexia, loss of appetite and gastrointestinal reflux.Timepoint: Every 4 weeks upto 4 months | — |
Countries
India
Contacts
Public ContactDr Sunita Gupta
Maulana Azad Institute of Dental Sciences
Outcome results
None listed