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
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Cairo University
- Enrollment
- 50
- Primary Endpoint
- Functional improvement assessed by Maximum Mouth Opening (MIO)
Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 15 Years to 75 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Fast-Fix-Enhanced Arthroscopic Disc Repositioning
Intervention: Fast-Fix-Enhanced Arthroscopic (Procedure)
Conventional Arthroscopic Suturing Disc Repositioning
Intervention: (Conventional Arthroscopic Suturing Disc Repositioning) (Procedure)
Outcomes
Primary Outcomes
Functional improvement assessed by Maximum Mouth Opening (MIO)
Time Frame: 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 Outcomes
- 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))
Investigators
Wajmah Sayed Karim Al Sayed
Principal Investigator
Cairo University