A Randomized Controlled Trial Evaluating the Efficacy of Conventional Two-Needle Arthrocentesis Versus Surgery-Guided Arthrocentesis in the Management of Temporomandibular Joint Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Total Duration of Arthrocentesis Procedure
研究概览
简要总结
The goal of this clinical trial is to compare two methods of arthrocentesis in treating temporomandibular joint (TMJ) disorders. The main questions it aims to answer are:
Is surgery-guided arthrocentesis more efficient in terms of operation time compared to traditional two-needle arthrocentesis? Does the use of surgical guides lead to less postoperative pain and better patient comfort?
Participants will:
Undergo either the traditional two-needle arthrocentesis or the surgery-guided arthrocentesis.
Be monitored for operation time, postoperative pain, and overall patient comfort.
Researchers will compare the outcomes of patients who underwent traditional two-needle arthrocentesis with those who had surgery-guided arthrocentesis to see if the latter can shorten operation time and improve patient comfort.
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 (Outcomes Assessor)
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 diagnosed with Wilkes stage II, III, or IV Temporomandibular Joint (TMJ) internal derangement.
- •Presence of pain, sound, or both in the TMJ.
- •Limitation or locking in mouth opening, or both.
- •Patients who have not responded to symptoms after a minimum of three months of splint therapy.
排除标准
- •Presence of infection in the puncture area.
- •Presence of osteomyelitis in the neighboring region.
- •Patients with uncontrolled coagulopathies.
- •Patients experiencing limitation in maximum mouth opening without disk disorder.
- •Patients with severe degenerative joint disease (e.g., deformed condylar contour, osteophyte findings in MRI).
- •History of TMJ surgery.
- •History of muscle-originated mandibular hypomobility.
结局指标
主要结局
Total Duration of Arthrocentesis Procedure
时间窗: Immediately following the completion of each arthrocentesis procedure, anticipated to occur on the day of the surgery.
he primary outcome measure of the study is the total time duration required to complete the arthrocentesis procedure. This duration will be measured from the time local anesthesia is administered to the time when the arthrocentesis is completed. In addition, the number of intraoperative repositions of the needles will also be recorded.
次要结局
- Volume of Ringer's Solution Used for Joint Irrigation(Immediately following the completion of each arthrocentesis procedure, anticipated to occur on the day of the surgery.)
- Change in Postoperative Pain(7 days)
- Change in Mouth Opening(7 days)
- Change in Facial Swelling(7 days)
研究者
Ferit Bayram
Principal Investigator
Marmara University