Clinical and Magnetic Resonance Imaging Evaluation of Micro Fragmented Adipose Tissue Injection Combined With Bone Marrow Stem Cells on Healing of Temporomandibular Joint Internal Disc Derangement Without Reduction (Randomized Control Pilot Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Mandibular mouth opening
研究概览
简要总结
Arthrocentesis of TMJ then injection of micro fragmented adipose tissue mixed with bone marrow aspirate on healing of TMJ internal disc derangement without reduction.
详细描述
Arthrocentesis of TMJ then injection of intra and periarticular of 2 mm of micro fragmented adipose tissue mixed with Bone marrow aspirate extracted from 20 mm of bone marrow using gradient separation method in one group and use of Bone marrow aspirate injection only in another group and injection of intra and periarticular of 2 mm hyaluronic acid gel in control group on healing of TMJ internal disc derangement without reduction.
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 (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with TMDs not previously surgically treated.
- •Patients with TMJ osteoarthritis assessed by clinical examination and magnetic resonance imaging.
排除标准
- •Patients refuse to be enrolled in this study.
- •Patients with uncontrolled systemic disease.
结局指标
主要结局
Mandibular mouth opening
时间窗: 6 Months
Measuring Maximum interincisal opening measured by plastic scale ruler in millimeter
次要结局
- Joint sound(six months follow-up)
- Post-operative pain(six months follow-up)
- Lateral and protrusive movements(six months follow-up)
研究者
Mohamed Talaat Abbas Hassan
Principle investigator
Cairo University