A Prospective Randomized Clinical Trial Comparing a Fast-Fix-Enhanced Arthroscopic System Versus Conventional Arthroscopic Suturing for Temporomandibular Disc Repositioning in Internal Derangement: Functional, Clinical, and Surgical Outcomes

N/ANot Yet RecruitingNCT07316673

Cairo University50 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Temporomandibular Joint Internal Derangement

Interventions

Eligibility

Sex: ALLMin age: 15 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: Baseline (preoperative) to 6 months postoperatively (with assessments at 3 months and 6 months; primary endpoint at 6 months

Secondary Outcomes

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.

Time frame: Baseline (preoperative), 3 months, and 6 months postoperatively

Joint Symptoms (Clicking and Tenderness)

Clinical evaluation of TMJ joint sounds (clicking) and joint tenderness through physical examination and patient report.

Time frame: 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

Time frame: Intraoperative (day of procedure only)

surgical outcomes Technical Feasibility

Surgeon's intraoperative assessment of the feasibility of disc fixation using the assigned arthroscopic technique.