Temporomandibular Joint Internal Derangement
Conditions
Brief summary
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
Interventions
PROCEDUREFast-Fix-Enhanced Arthroscopic
Device: The FasT-Fix system is a medical device designed for an all-inside arthroscopic meniscal repair.
PROCEDURE(Conventional Arthroscopic Suturing Disc Repositioning)
Arthroscopic TMJ discopexy using conventional suturing Minimally invasive surgical intervention
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
15 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
. * 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional improvement assessed by Maximum Mouth Opening (MIO) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Pain intensity assessed using the 10-cm Visual Analogue Scale (VAS), where 0 represents no pain and 10 represents unbearable pain. |
| Joint Symptoms (Clicking and Tenderness) | Baseline (preoperative), 3 months, and 6 months postoperatively | Clinical evaluation of TMJ joint sounds (clicking) and joint tenderness through physical examination and patient report. |
| Surgical outcomes Total surgical time recorded | Intraoperative (day of procedure only) | Total surgical time recorded intraoperatively from incision to completion of disc fixation, measured in minutes |
| surgical outcomes Technical Feasibility | Intraoperative (day of procedure only) | Surgeon's intraoperative assessment of the feasibility of disc fixation using the assigned arthroscopic technique. |
Contacts
Primary Contactwajmah Al Sayed, PHD
Outcome results
None listed