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| ID | Type | Description | Link |
|---|---|---|---|
| KMDC/OMFS/OSF-CombTherapy/2025 | Other Identifier | Karachi Medical and Dental College |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alternating Triamcinolone + PRP Therapy | Active Comparator | Patients will receive alternating-week intralesional Triamcinolone (10 mg/mL) and Platelet-Rich Plasma therapy. Triamcinolone is given in Week 1, PRP in Week 2, and alternated weekly for a total of 6-8 sessions. |
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| Triamcinolone Alone Therapy | Active Comparator | Patients will receive intralesional Triamcinolone acetonide (10 mg/mL) once weekly for 6-8 sessions as standard therapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Platelet-Rich Plasma (PRP) Injections | Biological | Autologous Platelet-rich plasma (PRP) injected intralesionally at standard volume for Oral submucous fibrosis (OSF) treatment, administered every alternate week. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mouth Opening (Interincisal Distance in mm) | 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. | Baseline, Week 4, Week 8, Week 12 |
| Change in Burning Sensation (VAS Score 0-10) | Burning sensation will be assessed using the Visual Analog Scale (VAS), where 0 indicates no burning and 10 indicates the worst possible burning. | Baseline, Week 4, Week 8, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Clinical Grade of OSMF | 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 |
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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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Madiha Khan, BDS, MS | Contact | +923350-250691 | Dr.khanmadiha@gmail.com | |
| Aisha Faraz, BDS, MS | Contact | +92333096619 | Aishazafar212@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Sufyan Ahmed, BDS, FCPS | Karachi Medical and Dental College | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abbasi Shaheed Hospital | Karachi | Sindh | 71510 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Khan M, Ahmed S, Faraz A, Ali Z, Khan S, Iqbal M. Comparison Between Treatment of Oral Submucous Fibrosis with Intralesional Triamcinolone Injection Versus Platelet-Rich Plasma. Journal of Population Therapeutics and Clinical Pharmacology. 2025;32(4):166-172. | ||
| Result | Alsousou J, Thompson M, Hulley P, Noble A, Willett K. The biology of Platelet-Rich Plasma and regenerative potential in tissue healing. Am J Sports Med. 2009;37(11):2259-2272. PMID: 19088268. | ||
| Result | Tilakaratne WM, Klinikowski MF. Intralesional corticosteroid injection as a treatment modality for oral submucous fibrosis. J Oral Pathol Med. 2016;45(3):162-168. PMID: 27422421. | ||
| Result | Saraf K, Gaur A, Thomas R. Efficacy of Platelet-Rich Plasma injections in Oral Submucous Fibrosis: A Prospective Clinical Study. Dent Res Dent Clin Dent Prospects. 2021;15(4):275-280. PMID: 34912641. | ||
| Result | OSF Singh S, Misra N. Comparative evaluation of intralesional platelet-rich plasma and intralesional corticosteroid in management of oral submucous fibrosis. J Oral Maxillofac Pathol. 2020;24(1):121-126. PMID: 33584414. | ||
| Result | Ali H, Ahmed S, Raza SH. Effect of intralesional injection of triamcinolone acetonide in oral submucous fibrosis. Journal of Surgery Pakistan. 2019;24(4):181-185. |
| Label | URL |
|---|---|
| Published comparative study on PRP and TA therapy for Oral Submucous Fibrosis by the Principal Investigator. | View source |
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Individual participant data (IPD) will not be shared because the dataset will be used for future analyses, internal audits, and subsequent publications by the study team. Data will remain confidential and securely stored according to institutional policy.
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| ID | Term |
|---|---|
| D009914 | Oral Submucous Fibrosis |
| D005355 | Fibrosis |
| D010292 | Paresthesia |
| D014313 | Trismus |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007267 | Injections |
| D014222 | Triamcinolone Acetonide |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D014221 | Triamcinolone |
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Two-arm parallel assignment comparing alternating-week Triamcinolone + PRP therapy vs standard single-agent therapy
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| Triamcinolone Acetonide | Drug | Triamcinolone acetonide 10 mg/mL administered intralesionally once weekly. |
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| Baseline and Week 12 |
| Change in Cheek Flexibility (mm) | Cheek flexibility will be measured using Mathur and Jha method at baseline and follow-up visits. | Baseline, Week 8, Week 12 |
| Incidence of Treatment-Related Adverse Events | All adverse events such as swelling, pain, ulceration, infection, or allergy will be recorded throughout the study period. | Up to 12 weeks |
| Result | Haider SM, Merchant A, Fida M. Clinical grading of oral submucous fibrosis: A practical classification for patient severity assessment. Journal of Pakistan Dental Association. 2016;25(4):147-152. |
| Institutionally developed OSF clinical grading system used in this trial. | View source |
| Steroid-based management study of Oral Submucous Fibrosis conducted at the same institution. | View source |
| D020886 | Somatosensory Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013035 | Spasm |
| D020879 | Neuromuscular Manifestations |
| D011245 |
| Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |