Application of Injectable Platelet-Rich Fibrin for the Treatment of Temporomandibular Joint Osteoarthritis: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Change of Pain Level
研究概览
简要总结
The authors designed a randomized, controlled, double-blind clinical trial after the ethical approval by the University Ethics Committee. The patients with temporomandibular joint osteoarthritis (TMJ-OA) randomly assigned one of the two treatment groups: intra-articular injection of injectable platelet-rich fibrin (i-PRF) after arthrocentesis procedure as i-PRF group and arthrocentesis procedure alone as control group. The primary outcome variable was pain levels at preoperatively, and postoperatively at 1st, 2nd, 3rd, 6th and 12th month. The secondary outcome variables included maximum mouth opening (MMO), lateral and protrusive movements.
详细描述
The authors designed a randomized, controlled, double-blind clinical trial after the ethical approval by the University Ethics Committee. The patients with TMJ-OA randomly assigned one of the two treatment groups: intra-articular injection of i-PRF after arthrocentesis procedure as i-PRF group and arthrocentesis procedure alone as control group. All treatment procedures were completed by the same experienced surgeon under the local anesthesia. The procedure of arthrocentesis was performed using the standard technique and after arthrocentesis procedure, the i-PRF injection was performed in the test group.
The primary outcome variable was pain levels at preoperatively, and postoperatively at 1st, 2nd, 3rd, 6th and 12th month. The secondary outcome variables included maximum mouth opening (MMO), lateral and protrusive movements.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients with osteoarthritis (OA) of one or two temporomandibular joint (TMJ)
- •maximum mouth opening less than 35 mm
- •impeded protrusive and lateral movements
- •localized pain of the affected joint
排除标准
- •systemic or malignant diseases affecting TMJ-OA assessment
- •previous invasive or surgical treatments of TMJ unrelated to OA
- •edentulous patients
- •pregnancy
结局指标
主要结局
Change of Pain Level
时间窗: at preoperatively, and postoperatively at 1st, 2nd, 3rd, 6th and 12th month
Pain level was measured with a visual analog scale (VAS) before treatment, and at postoperative follow-up (1st, 2nd, 3rd, 6th and 12th month).
次要结局
- Change of maximum mouth opening(at preoperatively, and postoperatively at 1st, 2nd, 3rd, 6th and 12th month)
- Change of lateral movement(at preoperatively, and postoperatively at 1st, 2nd, 3rd, 6th and 12th month)
- Change of protrusive movement(at preoperatively, and postoperatively at 1st, 2nd, 3rd, 6th and 12th month)
研究者
Gözde Işık
Principal Investigator
Ege University