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临床试验/NCT07535073
NCT07535073尚未招募不适用

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

Cairo University0 个研究点目标入组 18 人开始时间: 2026年5月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
18
主要终点
Maximum mouth opening

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Ultrasound guided platelet rich fibrin injection.

Experimental

Patient receive PRF injection under ultrasound guidance

干预措施: ultrasound guided platelet rich fibrin injection (Device)

Arthroscopic guided platelet-rich fibrin injection.

Experimental

Patient receive PRF injection under arsothscopic guidance

干预措施: Arthroscopic guided platelet rich Fibrin injection (Device)

结局指标

主要结局

Maximum mouth opening

时间窗: 6 months

Maximum interincisal distance measured using digital caliper in millimeters (mm) between upper and lower central incisors, Unit of measure: millimeters (mm). Minimum value: 0 mm. Maximum value: 60 mm. Higher values represent a better outcome.

次要结局

  • Pain intensity(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sami faiz kahwaji

Principal investigator, postgraduate researcher

Cairo University

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