A Prospective Randomized Clinical Trial Comparing a Fast Fix Enhanced Arthroscopic System Versus Conventional Arthroscopic Suturing for Temporomandibular Disc Repositioning in Internal Derangement: Clinical, Functional, and Surgical Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Functional improvement assessed by Maximum Mouth Opening (MIO)
研究概览
简要总结
This prospective randomized clinical trial evaluates the effectiveness of a Fast Fix-enhanced arthroscopic system compared with conventional arthroscopic suturing for temporomandibular joint disc repositioning in patients with TMJ internal derangement. Patients are randomly allocated into two groups and assessed for functional improvement (maximum mouth opening), pain reduction, joint symptoms, and surgical performance outcomes over a 6-month follow-up period. The study aims to determine whether the Fast Fix-enhanced technique provides superior clinical, functional, and surgical outcomes compared to conventional arthroscopic suturing
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
- 15 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •Both sexes.
- •Patients with TMJ internal derangement (disc displacement without reduction).
- •Patients indicated for arthroscopic disc repositioning following failure of conservative management.
排除标准
- •Previous TMJ surgery on the affected joint.
- •Rheumatoid arthritis, systemic inflammatory joint disease, or other TMJ pathology (tumor, fracture, infection)
- •Severe degenerative joint disease (osteoarthritis grade V) or ankylosis.
- •Patients are unable to comply with follow-up assessments or MRI evaluation.
- •Patients with TMDS are secondary to malocclusion.
研究组 & 干预措施
Fast-Fix-Enhanced Arthroscopic Disc Repositioning
干预措施: Fast-Fix-Enhanced Arthroscopic (Procedure)
Conventional Arthroscopic Suturing Disc Repositioning
干预措施: (Conventional Arthroscopic Suturing Disc Repositioning) (Procedure)
结局指标
主要结局
Functional improvement assessed by Maximum Mouth Opening (MIO)
时间窗: Baseline (preoperative) to 6 months postoperatively (with assessments at 3 months and 6 months; primary endpoint at 6 months
MIO is measured as the maximal interincisal distance (in millimeters) using a ruler or digital caliper, with the primary endpoint being the change from baseline to 6 months postoperatively.
次要结局
- Clinical outcomes , Pain reduction assessed using the Visual Analogue Scale (VAS) • Improvement of joint symptoms, including clicking and tenderness.(Baseline (preoperative), 3 months, and 6 months postoperatively)
- Joint Symptoms (Clicking and Tenderness)(Baseline (preoperative), 3 months, and 6 months postoperatively)
- Surgical outcomes Total surgical time recorded(Intraoperative (day of procedure only))
- surgical outcomes Technical Feasibility(Intraoperative (day of procedure only))
研究者
Wajmah Sayed Karim Al Sayed
Principal Investigator
Cairo University