Effect of Intra-articular Injection of Injectable Platelet-rich Fibrin on Disc Displacement Without Reduction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Change of pain
研究概览
简要总结
This randomized clinical study was conducted on patients with disc displacement without reduction. Patient was selected one of the two study groups: control group received only arthrocentesis or test group received arthrocentesis + injectable platelet-rich fibrin (i-PRF). As primary outcome variable, pain was recorded at preoperatively and at postoperatively 1, 2, 3, 6 and 12 months. Maximum mouth opening, lateral and protrusive movements were formed as secondary outcome variables.
详细描述
This randomized clinical study was conducted on patients with disc displacement without reduction. Patient was selected one of the two study groups: control group received only arthrocentesis or test group received arthrocentesis + i-PRF. Arthrocentesis procedure was performed for all groups with two needle technique. For test group, intra-articular i-PRF was made. As a primary outcome variable, pain was recorded at preoperatively and at postoperatively 1, 2, 3, 6 and 12 months. Maximum mouth opening, lateral and protrusive movements were formed as secondary outcome variables.
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •unilateral or bilateral disc displacement without reduction
- •localized pain on temporomandibular joint
- •decreased mouth opening, lateral and protrusive movements
排除标准
- •Malignant or inflammatory disorders
- •prior surgical history of temporomandibular joint
结局指标
主要结局
Change of pain
时间窗: at preoperatively, and at 1, 2, 3, 6 and 12 months postoperatively
Pain was measured with a 10-point visual analogue scale which range from 0 meaning no pain to 10 meaning worst pain at preoperatively and at 1, 2, 3, 6 and 12 months postoperatively
次要结局
- Change of maximum mouth opening(at preoperatively, and at 1, 2, 3, 6 and 12 months postoperatively)
- Change of lateral movements(at preoperatively, and at 1, 2, 3, 6 and 12 months postoperatively)
- Change of protrusive movements(at preoperatively, and at 1, 2, 3, 6 and 12 months postoperatively)