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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Биопрепарат 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.
• Препарат Triamcinolone Acetonide
  Triamcinolone acetonide 10 mg/mL administered intralesionally once weekly.

Первичные конечные точки

• Change in Mouth Opening (Interincisal Distance in mm) [Срок оценки: Baseline, Week 4, Week 8, Week 12]
• Change in Burning Sensation (VAS Score 0-10) [Срок оценки: Baseline, Week 4, Week 8, Week 12]

Вторичные конечные точки (3)

• Change in Clinical Grade of OSMF [Срок оценки: Baseline and Week 12]
• Change in Cheek Flexibility (mm) [Срок оценки: Baseline, Week 8, Week 12]
• Incidence of Treatment-Related Adverse Events [Срок оценки: Up to 12 weeks]

Критерии участия

Критерии включения

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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Пакистан · 1 центр

• Abbasi Shaheed Hospital — Karachi

Публикации

• 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.

Идентификаторы

NCT: NCT07277998 · MK_OSF_ALTTA_PRP_2025 · KMDC/OMFS/OSF-CombTherapy/2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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