Comparison of Single-Needle Arthrocentesis and Intravenous Catheter-Assisted Arthrocentesis in the Management of Temporomandibular Joint Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The measurement of pain-free maximum mouth opening (MMO) in millimeters
研究概览
简要总结
The study focused on arthrocentesis performed using a catheter, aiming to assess its effects on pain perception and mouth opening in patients with TMJ disorders.
详细描述
Two groups will be formed consisting of patients who present with complaints of TMJ pain, limited mouth opening and hearing sounds in the joint and are diagnosed with TMJ disorder. After explaining the I-PRF protocol obtained by taking blood to both groups and obtaining the necessary consents, arthrocentesis will be performed on the relevant joint area using a catheter for the patients in the first group and a single needle for the patients in the second group. Patients will be called for check-ups on the 1st day, 1st week and 1st month after the protocols and the current perceived pain level before and after the treatment will be determined by scoring with Visual Analog Scala (VAS) and measuring the mouth opening with a ruler ( mm).
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 其他
- 盲法
- 双盲 (研究者、结局评估者)
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
- Patients included in this study were adult individuals aged 18 years and older who were diagnosed with stage 3 or higher temporomandibular joint (TMJ) disorder according to the Wilkes classification, based on magnetic resonance imaging (MRI) in addition to clinical evaluation. Eligible patients had unilateral internal TMJ disorder and exhibited clinical symptoms such as TMJ-related pain and/or joint sounds, and limited mouth opening. Furthermore, only patients whose symptoms persisted despite at least one month of occlusal splint therapy were included.
排除标准
- were as follows: patients diagnosed with myofascial pain or muscle-related functional limitation; those who had previously undergone intra-articular injection or other invasive procedures involving the TMJ; patients with connective tissue diseases such as rheumatoid arthritis or with neurological disorders; patients with a history of major jaw trauma; and individuals with psychiatric disorders or a history of substance abuse.
研究组 & 干预措施
Catheter group
Patients presenting temporomandibular joint disc displacement without reduction (DDwoR) treated with catheter arthrocentesis. The upper joint space was entered with a 16 gauge 45 mm long branul. The 16 gauge metal cannula was removed and the plastic sheath was left in the upper joint space. The 18 gauge metal cannula, which was 1 size smaller, was placed inside the sheath. The irrigation solution was administered through the 18 gauge metal cannula and the irrigation solution flowed out of the space between the cannula and the sheath + I-PRF
干预措施: Procedure: TMJ Arthrocentesis (Other)
conventional single needle group
Patients presenting temporomandibular joint disc displacement without reduction (DDwoR) treated with single puncture arthrocentesis + I-PRF
干预措施: Procedure: TMJ Arthrocentesis (Other)
结局指标
主要结局
The measurement of pain-free maximum mouth opening (MMO) in millimeters
时间窗: Preopretive, Postoperative 1st day, 1st week and 1st month
Pain-free MMO was measured as the distance between the incisal edges of the upper and lower incisors while patient's mouth is open as possible without any assistance and without pain. Three measurements were performed, and their average is recorded.
Change in post-operative pain assessed
时间窗: Preoperative, Postoperative 1st day, 1st week and 1st month
A visual analog scale (VAS) was used, grading from 1 to 10 (1: no pain, 10: unbearable pain)
次要结局
未报告次要终点
研究者
Gorkem Tekin
Asst.Prof.
Eskisehir Osmangazi University
研究点 (1)
标识符
- NCT 编号
- NCT06766851
- 其他研究编号
- EskisehirOU-TEKIN-002
日期
- 首次提交
- (去年)
- 首次发布
- (去年)
- 主要完成日期
- (6个月前)
- 研究完成日期
- (5个月前)
- 最近核实
- (2个月前)
- 最近更新
- (上个月)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 是否有结果
- 否