Health Condition 1: M728- Other fibroblastic disorders
Conditions
Interventions
Intervention1: Topical Pirfenidone Hydrogel: Patients will be instructed and guided to apply the Pirfenidone hydrogel intraorally in one finger unit using clean and dry finger after gently drying the
Sponsors
PGIMER Chandigarh
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients clinically diagnosed with Oral Submucous Fibrosis (OSMF) showing symptoms like burning sensation of buccal mucosa, palpable fibrotic bands, reduced mouth opening (Khanna and Andrade s Stage I, II, III and IV)(3) 2.Participants willing to discontinue harmful oral habits and agree to adhere to regular follow-up protocol.
Exclusion criteria
Exclusion criteria: 1.Patients who had received any treatment for OSMF within the past 6 months. 2.Pregnant women. 3.Patients presenting with coexisting premalignant or malignant oral lesions. 4.Individuals with a known case of systemic sclerosis, endocrine, metabolic, skeletal disorders, or other malignancies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine if pirfenidone improves interincisal distance (mouth opening) at 12 weeks.Timepoint: Baseline 15 days 1 month 2 months 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate symptom relief (burning sensation pain stomatitis or mucositis). To evaluate the cheek flexibility pallor & blanching. Measure QoL improvement. To assess the safety issues if any. Timepoint: Pre treatment (T0) After 15 days (T1) After 30 days (T2) After 60 days (T3) After 90 days (T4) | — |
Countries
India
Contacts
Public ContactDr. Satnam Singh Jolly
PGIMER Chandigarh
Outcome results
None listed