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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fast-Fix-Enhanced Arthroscopic Disc Repositioning | Experimental |
| |
| Conventional Arthroscopic Suturing Disc Repositioning | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fast-Fix-Enhanced Arthroscopic | Procedure | Device: The FasT-Fix system is a medical device designed for an "all-inside" arthroscopic meniscal repair. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Functional improvement assessed by Maximum Mouth Opening (MIO) | 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. | Baseline (preoperative) to 6 months postoperatively (with assessments at 3 months and 6 months; primary endpoint at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical outcomes , Pain reduction assessed using the Visual Analogue Scale (VAS) • Improvement of joint symptoms, including clicking and tenderness. | Pain intensity assessed using the 10-cm Visual Analogue Scale (VAS), where 0 represents no pain and 10 represents unbearable pain. | Baseline (preoperative), 3 months, and 6 months postoperatively |
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Inclusion Criteria.
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| wajmah Al Sayed, PHD | Contact | 0509560055 | wajmah.sayed@dentistry.cu.edu.eg |
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| (Conventional Arthroscopic Suturing Disc Repositioning) | Procedure | Arthroscopic TMJ discopexy using conventional suturing Minimally invasive surgical intervention |
|
| Joint Symptoms (Clicking and Tenderness) | Clinical evaluation of TMJ joint sounds (clicking) and joint tenderness through physical examination and patient report. | Baseline (preoperative), 3 months, and 6 months postoperatively |
| Surgical outcomes Total surgical time recorded | Total surgical time recorded intraoperatively from incision to completion of disc fixation, measured in minutes | Intraoperative (day of procedure only) |
| surgical outcomes Technical Feasibility | Surgeon's intraoperative assessment of the feasibility of disc fixation using the assigned arthroscopic technique. | Intraoperative (day of procedure only) |