Evaluation of 3D Guided Botulinum Toxin Type A Injection in Lateral Pterygoid Muscle for Management of Patients With Anterior Disc Displacement With Reduction ( a Randomized Controlled Clinical Trial )
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- • Maximum interincisal opening in millimeters.
研究概览
简要总结
The goal of this study is to evaluate intra-oral botulinum toxin type A injection into lateral pterygoid muscle using a surgical guide synthesized by virtual planning based on CT with soft tissue window.
- To evaluate improvement of maximum interincisal opening (MIO) before and after injection.
- To assess change in disc position before and after injection.
- To evaluate recovery of symptoms as clicking, tenderness of TMJ and tenderness of lateral pterygoid muscle after injection.
Researchers will compare intra-oral botulinum toxin type A injection using a surgical guide synthesized by virtual planning based on CT with soft tissue window to conventional EMG guided botulinum toxin injection into lateral pterygoid muscle in patient with anterior disc displacement with reduction.
Participants will be injected with botulinum toxin type A by intraoral approach.
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
- None
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both sexes that are diagnosed with ADDWR according to DC/TMD.
- •Their age range between 20 and 45 years.
- •Angle class I maxilla-mandibular relation.
排除标准
- •Patients with degenerative joint disease, musculoskeletal, neuromuscular disorders, cardiovascular, bleeding disorders, breathing difficulties, neurological disorders.
- •Pregnancy and lactating women.
- •History of surgical TMJ intervention.
- •Botox hypersensitivity
- •History of tumors or maxillofacial trauma.
- •Posteriorly edentulous saddles or anterior open bite.
- •Patient contraindicated to MRI examination
结局指标
主要结局
• Maximum interincisal opening in millimeters.
时间窗: 6 months
measured in millimeters from incisal edge of uppercentrals to incisal edge of lower incisors by disposable rulers.
clicking
时间窗: 6 months
Any noticeable sound detected temporomandibular joint during opening and closing
temporomandiular joint tenderness
时间窗: 6 months
using visual analogue scale to measure pain intensity diagrammed in a line with two ends representing 0 ( no pain) and 10 ( the worst pain) after lateral and auriculotemporal palpation of temporomandibular joint
lateral pterygoid muscle tenderness
时间窗: 6 months
using visual analogue scale to measure pain intensity diagrammed in a line with two ends representing 0 ( no pain) and 10 ( the worst pain) after intraoral palpation of lateral pterygoid muscle behind tuberosity
次要结局
未报告次要终点
研究者
Mahmoud Akram Khodir
Assistant Lecturer of oral and maxillofacial surgery
Alexandria University