Ultrasound-Guided Vs Non-Guided Prolotherapy for Internal Derangement of Temporomandibular Joint. a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- visual analogue scale
研究概览
简要总结
Ultrasound Guided Versus Non-Guided Prolotherapy for Treatment of Internal Derangement of Temporomandibular joint.
Rationale for conducting the research:
The most critical cause for guided prolotherapy is to specify the accurate location of glenoid fossa and the disc space while prolotherapy procedure, and to adjust the needle insertion to according to articular eminence, mandibular condyle, and intra-articular space as anatomical variations. The vibration of ultrasound waves generates a heat so there is a thermal effective for prolotherapy effusion in the TMJ space.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with TMD - internal derangement with symptomatic clicking pain, according to RDC (Research diagnostic criteria for TMJD) sheet .
- •Muscles spasm causing TMDs.
- •Patients who failed to improve on conservative measures or highly hyperactivity patients.
- •Female and male patients age range from 20 to 60 years old.
排除标准
- •Patients who refused to be included in the research.
- •Patients with a systemically diseases or inflammation whether local or generalized.
- •Patients with bleeding disorders.
- •Patients with unknown dextrose allergy.
研究组 & 干预措施
Ultrasound Guided Prolotherapy forTreatment of Internal Derangement of TMJD.
Injection procedure in TMJ Space guided by ultrasound probe the injection materials will be composition of ( !0% Dextrose ) + (Saline ) + (2% Lidocaine, plain anesthesia ).
The intervention procedure will done after TMJ MRI assessment for patients who have anterior disc displacement with reduction (DDWR)
干预措施: Prolotherapy (Procedure)
Non-Guided Ultrasound ( Blind) Prolotherapy for Treatment of Internal Derangement of TMJD.
Injection procedure in TMJ Space by anatomical land mark (blindly), and we also call it ( conventional prolotherapy ) the injection materials will be composition of ( !0% Dextrose ) + (Saline ) + (2% Lidocaine, plain anesthesia ).
The intervention procedure will done after TMJ MRI assessment for patients who have anterior disc displacement with reduction (DDWR)
干预措施: Prolotherapy (Procedure)
结局指标
主要结局
visual analogue scale
时间窗: VAS change at 2 months ( lower score means better outcome )
psychometric measuring instruments designed to document the characteristics of disease-related symptom severity in individual patients
visual analogue scale
时间窗: Change from Baseline VAS at 4 weeks ( lower score means better outcome)
psychometric measuring instruments designed to document the characteristics of disease-related symptom severity in individual patients
次要结局
未报告次要终点
研究者
Mohammad Bader AL-Haj Kheder
Oral & Maxillofacial Surgeon
Cairo University