Microfragmented Adipose Tissue Injection Compared to Hyaluronic Acid for Treatment of Temporomandibular Joint Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 28
- 主要终点
- VAS
研究概览
简要总结
Internal derangement and osteoarthritis are the most common degenerative temporomandibular joint diseases and initial treatment for such conditions relies on arthrocentesis.
Micro fragmentation of adipose tissue has been proven in orthopedic literature to represent a more effective method to preserve stem cells, but no application has ever been reported in the temporomandibular joint.
详细描述
Rationale for conducting the research:
The rationale of this procedure is to remove inflammatory mediators, reduce friction, stimulate the production of new synovial fluid, eliminate suction-cup effect.
The purpose of this study was to evaluate the hypothesis that TMJ arthrocentesis with intraarticular injection of autologous micro fragmented adipose tissue leads to better clinical outcomes in terms of reducing pain and improving function
compared with arthrocentesis and intraarticular injection of hyaluronic acid (HA) in patients with TMJ internal derangement and osteoarthritis.
Preliminary results of this clinical trial show that the injection of micro fragmented adipose tissue can significantly improve outcomes of pain and function compared with the standard treatment and encourage to pursue research on this topic.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •* TMJ osteoarthritis assessed by clinical examination and MRI imaging
- •Presence of TMJ-related symptoms including at least limited mouth opening and joint pain
- •Previously failed conservative treatment
- •Age superior to 14 years
- •No previous TMJ surgical procedures
- •Acquisition of informed consent;
- •Complete availability of the data acquired preoperatively and during each follow-up
- •Patients free from any systemic disease that may affect the procedure.
排除标准
- •* Previously diagnosed hematological and neurological conditions;
- •Previous malignant head and neck neoplasms;
- •Contraindication to fat harvesting.
- •Uncooperative patients.
结局指标
主要结局
VAS
时间窗: 3 months
by Vas measurement scale OF PAIN
次要结局
- mouth opening(3 months)
研究者
Mutaz Alkhair Hamad Elsayed
principle investigator
Cairo University