Alternating Triamcinolone and Platelet-Rich Plasma Therapy for Oral Submucous Fibrosis
NCT ID: NCT07277998
Last Updated: 2025-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
40 participants
INTERVENTIONAL
2026-03-31
2026-09-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Alternating Triamcinolone + PRP Therapy
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.
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.
Triamcinolone Acetonide
Triamcinolone acetonide 10 mg/mL administered intralesionally once weekly.
Triamcinolone Alone Therapy
Patients will receive intralesional Triamcinolone acetonide (10 mg/mL) once weekly for 6-8 sessions as standard therapy.
Triamcinolone Acetonide
Triamcinolone acetonide 10 mg/mL administered intralesionally once weekly.
Interventions
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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.
Triamcinolone Acetonide
Triamcinolone acetonide 10 mg/mL administered intralesionally once weekly.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
65 Years
ALL
No
Sponsors
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Karachi Medical and Dental College
OTHER
Responsible Party
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Madiha Khan
Principal Investigator
Principal Investigators
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Sufyan Ahmed, BDS, FCPS
Role: STUDY_CHAIR
Karachi Medical and Dental College
Locations
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Abbasi Shaheed Hospital
Karachi, Sindh, Pakistan
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
Related Links
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Published comparative study on PRP and TA therapy for Oral Submucous Fibrosis by the Principal Investigator.
Institutionally developed OSF clinical grading system used in this trial.
Steroid-based management study of Oral Submucous Fibrosis conducted at the same institution.
Other Identifiers
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KMDC/OMFS/OSF-CombTherapy/2025
Identifier Type: OTHER
Identifier Source: secondary_id
MK_OSF_ALTTA_PRP_2025
Identifier Type: -
Identifier Source: org_study_id
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