Comparative Study Between the Outcome of Intra-articular Injection of Platelet Rich Plasma Versus Hyaluronic Acid in Arthroscopic Management of Temporomandibular Degenerative Joint Diseases: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Maximum Interincisal Opening (MIO) Measurements
研究概览
简要总结
The aim of this study is to evaluate the efficacy of intra-articular injection of platelet rich plasma versus hyaluronic acid following diagnostic arthroscopy in the management of patients suffering from degenerative temporomandibular joint (TMJ).
This is a prospective randomized study of 20 patients with TMJ degenerative joint diseases Wilkes IV, V.
Patients will be divided into two groups; Group A: will be treated with operative arthroscopy plus intra-articular platelet rich plasma.
Group B: will be treated with operative arthroscopy plus intra-articular hyaluronic acid.
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
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- All patients with reduced mouth opening and/or painful maximum mouth opening.
- •Joint pain.
- •Patients with radiological evidence of degenerative joint disease.
- •Patients with unsuccessful medical conservative treatment for at least two months.
- •Unilateral or bilateral temporomandibular joint involvement.
- •Wilkes stages IV and V
排除标准
- •- Patients with bony ankylosis .
- •Patients with advanced resorption of the glenoid fossa.
- •Patients with infection or tumors around joint area
- •Patients unfit for intervention medically.
- •Patients who refused to share in the study
结局指标
主要结局
Maximum Interincisal Opening (MIO) Measurements
时间窗: change from baseline maximum interincisal mouth opening in millimeters at 6 months postoperative
change in maximum inter-incisal mouth opening will be measured in millimeters between preoperative and postoperative at 1 week,3 weeks, the every month till 6 months
Pain Intensity Measurements
时间窗: change from preoperative pain intensity according to 100 -point visual analogue scale at 6 months postoperative
A 100 -point visual analogue scale (VAS) for the assessment of pain intensity with 0 as the absence of pain and 100 as the worst pain imaginable With filled standardized charts.
次要结局
未报告次要终点
研究者
Ahmad Mohammad Abd-elmoniem
Principal Investigator
Sohag University