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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

Cairo University (CU) logo

Cairo University (CU)

Status

Not yet enrolling

Conditions

Temporomandibular Joint Internal Derangement

Treatments

Procedure: Fast-Fix-Enhanced Arthroscopic
Procedure: (Conventional Arthroscopic Suturing Disc Repositioning)

Study type

Interventional

Funder types

Other

Identifiers

NCT07316673
Fast-Fix-Enhanced Arthroscopic

Details and patient eligibility

About

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

Enrollment

50 estimated patients

Sex

All

Ages

15 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

50 participants in 2 patient groups

Fast-Fix-Enhanced Arthroscopic Disc Repositioning
Experimental group
Treatment:
Procedure: Fast-Fix-Enhanced Arthroscopic
Conventional Arthroscopic Suturing Disc Repositioning
Active Comparator group
Treatment:
Procedure: (Conventional Arthroscopic Suturing Disc Repositioning)

Trial contacts and locations

0

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Central trial contact

wajmah Al Sayed, PHD

Data sourced from clinicaltrials.gov

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