Comparative Study Between Arthroscopic Versus Open Surgical Discopexy for Treatment of Temporomandibular Joint Anterior Disc Displacement Without Reduction (RCT)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- TMJ pain
研究概览
简要总结
Temporomandibular joint dysfunction (TMD) represents a common health problem. A recent systematic review and meta-analysis in 2021 concluded that the prevalence of TMD was 31% for adults and 11% for adolescence.
Many believe that TMD symptoms are related to internal derangement of the temporomandibular joint (TMJ), which is usually in the form of anterior disc displacement(ADD) and it is often associated with pain, clicking, limited range of motion, and even osteoarthritic changes.
Treatment of TMD include non-surgical and surgical modalities. Non-surgical treatment includes instructions, pharmacotherapy, occlusal splints and physiotherapy. Patients who do not respond to non-surgical therapy may require surgical interventions that include minimally invasive procedures (arthroscopy and arthrocentesis) and open surgery.
Arthroscopy of the TMJ was first introduced by Ohnishi in 1975, it involves lysis of adhesions and lavage of the superior joint space, as well as repositioning of a displaced disc.
Open TMJ surgery can be very effective at eliminating symptoms of pain, limited mouth opening and mandibular dysfunction.
详细描述
Patients are assigned randomly into two groups; group (1) for arthroscopic discopexy, and group (2) for open discopexy.
History taking: personal history; name, age, gender and occupation. Patient's complaint(s); as TMJ clicking, pain, locking and limited mouth opening.
Clinical examination: for TMJ clicking and tenderness, measurement of maximum inter-incisal opening (MIO) in mm. Examination of facial symmetry, dental occlusion and dentoskeletal deformity.
Radiological evaluation: Computed Tomography (CT) scan of maxillofacial bones. Magnetic Resonance Imaging (MRI) for TMJ, to confirm anterior disc displacement without reduction.
Operative procedures: will be carried out by the same team, under general anaesthesia, nasotracheal intubation and supine position.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with TMD in the form of anterior disc displacement without reduction
- •Age: 20 - 50 years' old
排除标准
- •Secondary TMD
- •TMJ ankylosis
- •Structural deformity of TMJ
- •Previous surgical intervention to TMJ
- •Patients who are unfit for surgery
结局指标
主要结局
TMJ pain
时间窗: one year
change of pain on a visual analogue scale from 0 to 10 with decreased number means less pain
次要结局
未报告次要终点
研究者
Mohamed Gamal Thabet
Assiut university
Assiut University