NCT07277998

Alternating Triamcinolone and Platelet-Rich Plasma Therapy for Oral Submucous Fibrosis

Clinical Efficacy of Alternating Intralesional Triamcinolone Acetonide and Platelet-Rich Plasma Compared to Triamcinolone Alone in Patients With Oral Submucous Fibrosis: A Two-Arm Interventional Clinical Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Karachi Medical and Dental College · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Oral Submucous Fibrosis (OSF) is a chronic, irreversible fibro-elastic disorder of the oral mucosa associated with restricted mouth opening, burning sensation, impaired mastication, and decreased quality of life. Traditional management approaches include intralesional corticosteroids, physiotherapy, antioxidants, and more recently, regenerative therapies such as Platelet-Rich Plasma (PRP). Triamcinolone Acetonide (TA) provides anti-inflammatory and anti-fibrotic effects by suppressing fibroblast activity and collagen deposition. PRP, an autologous concentrate of platelets and growth factors, has demonstrated potential in promoting angiogenesis, collagen remodeling, and mucosal regeneration. Alternating TA and PRP may theoretically combine the immediate anti-inflammatory benefits of TA with the long-term regenerative benefits of PRP, resulting in more effective improvement of OSF symptoms. This study consists of two arms. In the control arm, participants will receive weekly intralesional Triamcinolone injections for 6 weeks. In the experimental arm, participants will receive Triamcinolone in Week 1, PRP in Week 2, followed by alternating TA and PRP injections for a total of 6 weeks. All participants will be instructed to perform standardized jaw physiotherapy exercises during the study period. Primary outcomes include change in interincisal mouth opening (millimeters) and reduction in burning sensation using a Visual Analog Scale (VAS). Secondary outcomes include mucosal flexibility score, cheek rigidity grading, functional improvement during mastication and speech, and patient satisfaction. This clinical trial aims to generate high-quality comparative evidence regarding whether an alternating TA-PRP protocol offers superior therapeutic outcomes compared to conventional corticosteroid therapy alone, thereby supporting advancement of regenerative treatment protocols for OSF within oral and maxillofacial clinical practice.

Conditions

• Oral Submucous Fibrosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-03-01
• Primary completion: 2026-07-01
• Completion: 2026-09-01
• First posted: 2025-12-11
• Last updated: 2025-12-11

Locations

1 site across 1 country: Pakistan