Ultrasound-guided Versus Arthroscopic Guided PRF Injection for TMJ Disc Displacement.

Официальное название

Ultrasound Guided Versus Arthroscopic Guided PRF Injection in Management of Temporomandibular Joint Disc Displacement With Reduction: A Randomized Controlled Clinical Trials

Обзор

To compare the clinical effectiveness of ultrasound-guided versus arthroscopic guided platelet rich fibrin injection in the management of anterior disc displacement with reduction of the temporomandibular joint, in terms of pain reduction, improvement of mandibular function, and patient-reported outcomes.

Подробное описание

Internal derangements of the temporomandibular joint, particularly disc displacement with reduction, represent a significant proportion of temporomandibular disorders. Conventional conservative treatments may not always achieve satisfactory symptom resolution, leading to increased interest in minimally invasive interventions. PRF has gained attention for its ability to promote tissue regeneration, reduce inflammation, and enhance healing through the sustained release of growth factors. Image-guided injection techniques are essential for ensuring accurate delivery of PRF into the targeted joint structures. Arthroscopic-guided injection allows direct visualization of intra-articular anatomy but is invasive, technically demanding, and associated with higher cost and procedural complexity. In contrast, ultrasound-guided injection is a non-invasive, radiation-free, and cost- effective technique that enables real-time visualization of soft tissues and needle placement. Despite these advantages, the comparative clinical efficacy of ultrasound-guided versus arthroscopic-guided PRF injection remains inadequately explored, particularly in patients with TMJ disc displacement with reduction.

Вмешательства

• Устройство ultrasound guided platelet rich fibrin injection
  1. A high-frequency linear ultrasound probe will be used to identify the TMJ space. 2. A sterile syringe containing 1 mL of PRF will be inserted into the superior joint space under real-time ultrasound guidance. 3. PRF will be injected slowly with continuous confirmation of needle position.
• Устройство Arthroscopic guided platelet rich Fibrin injection
  1. TMJ arthroscopy will be performed under local or general anesthesia following standard aseptic preparation. 2. The superior joint space will be visualized using a 1.9 mm arthroscope. 3. A sterile syringe containing 1 mL of PRF will be introduced through a lateral portal under direct arthroscopic visualization. 4. PRF will be injected slowly into the superior joint space.

Первичные конечные точки

• Maximum mouth opening [Срок оценки: 6 months]

Вторичные конечные точки (1)

• Pain intensity [Срок оценки: 6 months]

Критерии участия

Критерии включения

• Patients aged 18-60 years.
• Clinically and radiographically diagnosed temporomandibular joint disc displacemet with reduction.
• Presence of TMJ pain exacerbated by mandibular movement.
• Limited mandibular function and/or reduced maximum mouth opening.
• Symptoms persisting for at least 3 months.
• Failure of conservative treatment (e.g. occlusal splint, physiotherapy, NSAIDs). -Ability to understand the study protocol and provide informed consent.

Критерии исключения

• Previous TMJ surgery or arthroscopic intervention.
• Intra-articular injection in the TMJ within the last 6 months.
• Systemic inflammatory or autoimmune joint diseases.
• Coagulation disorders or current anticoagulant therapy.
• Active local infection at the injection site.
• Pregnancy or lactation.
• Severe degenerative joint disease (advanced osteoarthritis).
• Known allergy or contraindication to ( PRF) preparation.

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

Двойное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Gonzalez LV, Lopez JP, Diaz-Baez D, Orjuela MP, Chavez M. Clinical outcomes of operative arthroscopy and temporomandibular medical infiltration with platelet-rich fibrin in upper and lower articular space. J Craniomaxillofac Surg. 2021 Dec;49(12):1162-1168. doi: 10.1016/j.jcms.2021.07.001. Epub 2021 Aug 3. PMID 34384651
• Chaudhary FA, Ahmad B, Butt DQ, Hameed S, Bashir U. Normal range of maximum mouth opening in Pakistani population: A cross-sectional study. J Int Oral Health. 2019;11(6):353-356. doi:10.4103/jioh.jioh_127_19.

Идентификаторы

NCT: NCT07535073 · OMFS-TMJ-PRF-RCT01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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