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

NCT07316673 | Not Yet Recruiting

• 1 other identifier: Fast-Fix-Enhanced Arthroscopic
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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

Conditions

Temporomandibular Joint Internal Derangement

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• 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)

Study Arms (2)

Fast-Fix-Enhanced Arthroscopic Disc Repositioning

EXPERIMENTAL

Procedure: Fast-Fix-Enhanced Arthroscopic

Conventional Arthroscopic Suturing Disc Repositioning

ACTIVE COMPARATOR

Procedure: (Conventional Arthroscopic Suturing Disc Repositioning)

Interventions

Fast-Fix-Enhanced Arthroscopic PROCEDURE

Device: The FasT-Fix system is a medical device designed for an "all-inside" arthroscopic meniscal repair.

Fast-Fix-Enhanced Arthroscopic Disc Repositioning

(Conventional Arthroscopic Suturing Disc Repositioning) PROCEDURE

Arthroscopic TMJ discopexy using conventional suturing Minimally invasive surgical intervention

Conventional Arthroscopic Suturing Disc Repositioning

Eligibility Criteria

• Age: 15 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Central Study Contacts

wajmah Al Sayed, PHD

CONTACT

0509560055; wajmah.sayed@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 19, 2025
• First Posted: January 5, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: January 6, 2026

Record last verified: 2025-12