NCT06205667已完成不适用
Computer Guided Versus Conventional Arthrocentesis in Management of Internal Derangements: A Randomized Clinical Study
适应症
干预措施
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
- Operation time started from first needle insertion.
研究概览
简要总结
The aim of the study is to evaluate the applicability, accuracy, benefits and the efficacy of 3-dimensional, printed, patient-specific guides to direct TMJ access for arthrocentesis when performed in contrast with conventional arthrocentesis of TMJ.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who complain from signs and symptoms of internal derangements and were diagnosed by the RDC/TMD as having disc displacement with/ without reduction with / without limitation associated with arthralgia or as having disc displacement with reduction associated with arthralgia in a presence or absence of joint sounds.
- •Patients who did not responded to conservative treatment for a minimum of 3 months.
- •Obtaining written informed consents signed by the patients.
排除标准
- •Patients suffering from any muscular disorders as myofascial pain or myofascial pain with limitations
- •If the disc was not visible in the MRI examination.
- •Patients who previously received intra-articular injection of any medication or exposed to any other TMJ invasive procedure.
- •Patients who suffer from any connective tissue diseases as rheumatoid arthritis or neurologic disorders.
- •Patients with history of major jaw trauma, bisphosphonate-derived drug use, pregnancy, alcohol or drug dependence.
- •Patients with gross mechanical restrictions or history of adhesion (fibrous or bony).
- •Patients with psychiatric disease or substance abuse or have an allergy to the substance used in the study.
研究组 & 干预措施
Computer Guided Arthrocentesis
Experimental
a study group injected intra-articularly through TMJ using a computer-guided template.
干预措施: Computer Guided Arthrocentesis (Procedure)
Conventional Arthrocentesis
Active Comparator
a control group which injected intra-articular through TMJ using conventional method based on anatomical landmark determination
干预措施: Conventional Arthrocentesis (Procedure)
结局指标
主要结局
Operation time started from first needle insertion.
时间窗: intaoperative
Attempts number of needle puncture
时间窗: intraoperative
次要结局
- Maximum mouth opening(1week, 1, 3 and 6)
- Pain reduction(1week, 1, 3 and 6)
研究者
研究点 (1)
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