Alternating Triamcinolone and Platelet-Rich Plasma Therapy for Oral Submucous Fibrosis
NCT07277998 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2025-12-11
Summary
Oral Submucous Fibrosis (OSF) is a chronic, progressive, potentially malignant disorder characterized by mucosal stiffness, trismus, and burning sensation. This interventional clinical trial evaluates the therapeutic effectiveness of alternating weekly intralesional Triamcinolone Acetonide (TA) and Platelet-Rich Plasma (PRP) injections compared to standard Triamcinolone therapy alone. The purpose is to determine whether sequential anti-inflammatory (TA) and regenerative (PRP) stimulation can produce superior clinical improvement in mouth opening, burning sensation, and mucosal flexibility compared to corticosteroid therapy alone.
Conditions
- Oral Submucous Fibrosis
Interventions
- BIOLOGICAL
-
Platelet-Rich Plasma (PRP) Injections
Autologous Platelet-rich plasma (PRP) injected intralesionally at standard volume for Oral submucous fibrosis (OSF) treatment, administered every alternate week.
- DRUG
-
Triamcinolone Acetonide
Triamcinolone acetonide 10 mg/mL administered intralesionally once weekly.
Sponsors & Collaborators
-
Karachi Medical and Dental College
lead OTHER
Principal Investigators
-
Sufyan Ahmed, BDS, FCPS · Karachi Medical and Dental College
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-03-31
- Primary Completion
- 2026-07-31
- Completion
- 2026-09-30
Countries
- Pakistan
Study Locations
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