Does Intra-articular Injection of Platelet-Rich Fibrin After Arthrocentesis Followed by Lateral Pterygoid Muscle Injection With Botulinum Toxin Type A Improve Clinical Outcomes for Anterior Disc Displacement?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Maximum Mouth Opening
研究概览
简要总结
Aim of Study : To evaluate the efficacy of TMJ arhtrocentesis followed by injection of liquid platelet rich fibrin (I-PRF ) in addition to intramuscular injection of lateral pterygoid muscle with botulinum toxin on clinical outcomes of painful TMJ , maximum mouth opening , joint sounds and range of lateral movement in patients with TMJ anterior disc displacement with reduction
Hypothesis : Intramuscular injection of lateral pterygoid muscle with botulinum toxin plus TMJ intra-articular injection of liquid platelet rich fibrin after arthrocentesis are more effective than TMJ arthrocentesis followed by intra-articular injection of ( I-PRF ) or TMJ arthrocentesis only .
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with painful tmj during jaw movements
- •Patients with joint sounds ( clicking ) during jaw opening and mastication
- •Patients age range from 16 years old to 45 years old
- •Patients with Class I maxillo-mandibular relationship
- •Patients with reduced mouth opening
- •All patients diagnosed clinically and radiographically by MRI as TMJ anterior disc displacement with reduction
排除标准
- •Patient with history of recent trauma
- •Patients with malocclusion
- •Patients with systematic condition that affect bone and joints such as osteoarthritis , systemic lupus and epilepsy .
- •Patients allergic to botox injection
- •Pregnant or lactating females
- •Patients with non-reducible disc on MRI
- •Patients contraindicated to exposure to MRI
- •Patients with previous tmj arthrocentesis , arthroscopy or TMJ surgery
- •Significant mechanical obstruction that prevents mouth opening, acute capsulitis, benign or malignant temporomandibular joint lesions.
- •Patients with blood diseases, and coagulation disorders
研究组 & 干预措施
TMJ arthrocentesis + (I-PRF) injection & injection of Botox to lateral pterygoid muscle
干预措施: TMJ Arthrocentesis Followed By Injectable Platelet Rich Fibrin And Botulinum Toxin Type A (Drug)
TMJ arthrocentesis
干预措施: TMJ Arthrocentesis (Drug)
TMJ arthrocentesis followed by intra-articular injection of liquid platelet rich fibrin ( I-PRF )
干预措施: TMJ Arthrocentesis Followed By Injectable Platelet Rich Fibrin (Drug)
结局指标
主要结局
Maximum Mouth Opening
时间窗: 6 months
Maximum mouth opening will be measured as the distance from incisal edges of the upper and lower central incisors using a ruler and will be evaluated preoperatively , immediately after the procedure , 1month , 3 months and 6 months postoperative .
次要结局
- Lateral movement(6 months)
- Clicking(6 months)
研究者
Ahmed Taha Ahmed Mohamed
Master student of oral and maxillofacial surgery
Fayoum University