Evaluation Study of Retro Discal Tissue Injection Arthroscopically Versus Ultrasound Guide Injection

Официальное название

Comparative Evaluation Study of Retro Discal Tissue Injection Arthroscopically Versus Ultrasound Guide Injection

Обзор

A comparative evaluation study of arthroscopic retrodiscal tissue injection versus ultrasound-guided injection in temporomandibular joint disorders aims to assess differences in pain relief, functional improvement, and clinical outcomes between an invasive and a minimally invasive delivery technique. Arthroscopic injection allows direct visualization of intra-articular structures, accurate targeting of the retrodiscal tissues, and simultaneous management of associated pathology such as synovitis or adhesions, which may enhance therapeutic outcomes in advanced internal derangement. In contrast, ultrasound-guided injection offers a less invasive, cost-effective, and outpatient-based approach with improved accuracy over blind techniques, making it suitable for early or moderate cases. While both methods are effective in reducing pain and improving mouth opening and jaw function, arthroscopic injection may provide superior results in patients requiring diagnostic confirmation and mechanical intervention, whereas ultrasound-guided injection offers comparable symptomatic improvement with lower procedural morbidity and resource utilization.

Вмешательства

• Процедура Arthroscopic retrodiscal tissue injection
  Arthroscopic retrodiscal tissue injection
• Процедура Ultrasound-guided retrodiscal tissue injection
  Ultrasound-guided retrodiscal tissue injection

Первичные конечные точки

• Pain intensity (VAS) [Срок оценки: Baseline → 2 months (early outcome) Baseline → 6 months (mid-term outcome)]

Критерии участия

Критерии включения

• Adults aged 18-60 years with symptomatic TMJ disorder/internal derangement (unilateral or bilateral)
• TMJ pain at rest and/or during function for ≥ 3 months
• Clinical diagnosis consistent with disc displacement with or without reduction (with or without MRI confirmation, if included in the protocol)
• Baseline pain intensity ≥ 4/10 on VAS or NRS
• Limitation of mouth opening or functional impairment (e.g., maximum mouth opening ≤ 35 mm or pain-related limitation)
• Failed or insufficient response to conservative therapy for ≥ 4-6 weeks (e.g., soft diet, NSAIDs, splint therapy, physiotherapy)
• Ability to provide informed consent and comply with scheduled follow-up visits

Критерии исключения

• Previous TMJ surgery (arthroscopy or arthrotomy) on the study side or TMJ injection within the last 3-6 months
• TMJ ankylosis, fracture, tumor, or active infection
• Primary inflammatory arthropathy (e.g., rheumatoid arthritis, gout, psoriatic arthritis) or systemic connective tissue disease affecting the TMJ
• Significant degenerative joint disease (advanced osteoarthritis) if the study focuses on internal derangement or soft tissue pathology
• Severe skeletal or dentofacial deformity requiring orthognathic surgery during the study period
• Pregnancy or lactation
• Bleeding disorders, platelet disorders, or anticoagulant therapy that cannot be safely managed (particularly relevant for PRP injections)
• Known allergy or contraindication to the planned injectate or local anesthetic
• Severe uncontrolled systemic disease (ASA III-IV) or inability to tolerate anesthesia or sedation (for arthroscopy arm)
• Active psychiatric or neurologic condition that may impair accurate pain reporting or follow-up compliance

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• facility of Dentistry — Cairo

Публикации

• Cha YH, O J, Park JK, Yang HM, Kim SH. Ultrasound-guided versus blind temporomandibular joint injections: a pilot cadaveric evaluation. Int J Oral Maxillofac Surg. 2019 Apr;48(4):540-545. doi: 10.1016/j.ijom.2018.09.002. Epub 2018 Oct 2. PMID 30287106
• Lopez JP, Orjuela MP, Gonzalez LV, Peraza-Labrador AJ, Diaz-Baez D. Comparison of the Clinical Effectiveness of Intra-Articular Injection with Different Substances After TMJ Arthroscopy: A Systematic Review and Meta-Analysis. J Maxillofac Oral Surg. 2024 Apr;23(2):261-270. doi: 10.1007/s12663-023-02047-7. Epub 2023 Dec 12. PMID 38601255

Идентификаторы

NCT: NCT07316790 · arthroscope versus ultrasound

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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