Health Condition 1: O- Medical and Surgical
Conditions
Interventions
Intervention1: Placentrex: Injection Placentrex 2ml administered intramuscosally once weekly for total duration of 6 weeks
Intervention2: Platelet Rich Plasma (PRP): Injection Platelet Rich Plasma (PR
Sponsors
Self-sponsored
Eligibility
Inclusion criteria
Inclusion criteria: Patients with stage II and III oral submucous fibrosis grading based on mouth opening ranging from 15mm to 35mm Patients having oral submucous fibrosis due to tobacco chewing habit Patients who have already quit the tobacco chewing habit
Exclusion criteria
Exclusion criteria: Patients with stage I and IV OSMF grading based on mouth opening (less than 15mm and more than 35mm) Patients who have already undergone surgeries/ medicinal treatment for oral submucous fibrosis in the past Patients with systemic sclerosis or oral submucous fibrosis due to any other systemic condition
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in interincisal mouth opening (in mm) measured using vernier calliper between upper and lower central incisorsTimepoint: Baseline (Week 0),Week 2, Week 4, Week 6, 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Reduction in burning sensation in oral mucosa using Visual Analog Scale(VAS)Timepoint: Baseline (Week 0),Week 2, Week 4, Week 6, 3 months;Change in blanching of oral mucosa assessed by clinical grading (subjective scale)Timepoint: Baseline (Week 0),Week 2, Week 4, Week 6, 3 months | — |
Countries
India
Contacts
Public ContactDr Shreeya Sharma
All India Institute of Medical Sciences, Rajkot, Gujarat
Outcome results
None listed