Oral Submucous Fibrosis
Conditions
Keywords
Triamcinolone acetonide, Platelet-rich plasma, Regenerative therapy, Oral mucosal disorders, Fibrosis, OSF, Intralesional therapy, Oral and maxillofacial surgery, Steroid injection, Mouth opening, Burning sensation, Oral precancerous lesions, Stem cell mediated healing, Collagen remodeling, Areca nut, Trismus, Limited mouth opening, LMO, BMS, OMFS, Regenerative dentistry, Oral surgery, PRP
Brief 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.
Interventions
BIOLOGICALPlatelet-Rich Plasma (PRP) Injections
Autologous Platelet-rich plasma (PRP) injected intralesionally at standard volume for Oral submucous fibrosis (OSF) treatment, administered every alternate week.
DRUGTriamcinolone Acetonide
Triamcinolone acetonide 10 mg/mL administered intralesionally once weekly.
Sponsors
Karachi Medical and Dental College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Two-arm parallel assignment comparing alternating-week Triamcinolone + PRP therapy vs standard single-agent therapy
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Clinically diagnosed Oral Submucous Fibrosis (OSF), Stage II-IV using Haider et al. classification. Age 18-65 years. Mouth opening ≤ 30 mm. Persistent burning sensation (VAS ≥ 3). Able and willing to comply with weekly therapy sessions. Provided written informed consent.
Exclusion criteria
Previous treatment with PRP, Platelet-rich Fibrin (PRF), corticosteroid, or combination therapy in the last 6 months. Systemic diseases affecting wound healing (e.g., uncontrolled diabetes, severe anemia). Current steroid therapy or immunosuppressive therapy. Oral lesions suspicious for malignancy or recurrent Oral Squamous cell carcinoma (OSCC). Bleeding disorders or platelet count \<150,000. Pregnant or breastfeeding women. Known allergy to local anesthetics or triamcinolone. Patients unwilling to stop areca nut/tobacco habits.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mouth Opening (Interincisal Distance in mm) | Baseline, Week 4, Week 8, Week 12 | Mouth opening will be measured using a digital caliper from incisal edge to incisal edge at baseline and at each follow-up visit. The primary endpoint is the change in interincisal distance from baseline to 8 weeks and 12 weeks. |
| Change in Burning Sensation (VAS Score 0-10) | Baseline, Week 4, Week 8, Week 12 | Burning sensation will be assessed using the Visual Analog Scale (VAS), where 0 indicates no burning and 10 indicates the worst possible burning. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Clinical Grade of OSMF | Baseline and Week 12 | Oral Submucous Fibrosis (OSF) severity will be assessed using a standardized clinical grading system that evaluates mouth opening, fibrous banding, mucosal texture, and burning sensation. Grades range from Grade I (mild) to Grade IV (severe). Higher grades indicate more advanced disease. Improvement or worsening will be determined by comparing baseline and Week 12 assessment |
| Change in Cheek Flexibility (mm) | Baseline, Week 8, Week 12 | Cheek flexibility will be measured using Mathur and Jha method at baseline and follow-up visits. |
| Incidence of Treatment-Related Adverse Events | Up to 12 weeks | All adverse events such as swelling, pain, ulceration, infection, or allergy will be recorded throughout the study period. |
Countries
Pakistan
Contacts
Primary ContactMadiha Khan, BDS, MS
Backup ContactAisha Faraz, BDS, MS
Outcome results
None listed