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RecruitingNCT05938257Updated Jul 10, 2023

Comparative Study Between Arthroscopic Versus Open Surgical Discopexy for Treatment of Temporomandibular Joint Anterior Disc Displacement Without Reduction (RCT)

An interventional study of TMJ discopexy in Efficacy of TMJ Arthroscopy, sponsored by Mohamed Gamal Thabet. Recruiting at 1 site in Egypt. Open to participants aged 20 Years to 50 Years. Per ClinicalTrials.gov, last updated 2023-07-10.

Sponsored by Mohamed Gamal Thabet · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jul 2025, 1 year 3 months ago, but the record still lists the study as recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
20 Years to 50 Years
Sex
All
01

Study summary

Temporomandibular joint dysfunction (TMD) represents a common health problem. A recent systematic review and meta-analysis in 2021 concluded that the prevalence of TMD was 31% for adults and 11% for adolescence.

Many believe that TMD symptoms are related to internal derangement of the temporomandibular joint (TMJ), which is usually in the form of anterior disc displacement(ADD) and it is often associated with pain, clicking, limited range of motion, and even osteoarthritic changes.

Treatment of TMD include non-surgical and surgical modalities. Non-surgical treatment includes instructions, pharmacotherapy, occlusal splints and physiotherapy. Patients who do not respond to non-surgical therapy may require surgical interventions that include minimally invasive procedures (arthroscopy and arthrocentesis) and open surgery.

Arthroscopy of the TMJ was first introduced by Ohnishi in 1975, it involves lysis of adhesions and lavage of the superior joint space, as well as repositioning of a displaced disc.

Open TMJ surgery can be very effective at eliminating symptoms of pain, limited mouth opening and mandibular dysfunction.

Read the detailed description

Patients are assigned randomly into two groups; group (1) for arthroscopic discopexy, and group (2) for open discopexy.

History taking: personal history; name, age, gender and occupation. Patient's complaint(s); as TMJ clicking, pain, locking and limited mouth opening.

Clinical examination: for TMJ clicking and tenderness, measurement of maximum inter-incisal opening (MIO) in mm. Examination of facial symmetry, dental occlusion and dentoskeletal deformity.

Radiological evaluation: Computed Tomography (CT) scan of maxillofacial bones. Magnetic Resonance Imaging (MRI) for TMJ, to confirm anterior disc displacement without reduction.

Operative procedures: will be carried out by the same team, under general anaesthesia, nasotracheal intubation and supine position.

Group (1) for arthroscopic discopexy: using 1.9 mm diameter - 30-degree scope. The procedure is performed through three ports and a suture-passing spinal needle 18 gauge. One port for the scope, second port for manipulation and reduction of the displaced disc and third port for retrieval of the suture used for discopexy. The suture used is 2-0 polypropylene, which is tied down in the extra-capsular tissue.

Group (2) for open discopexy: through pre-auricular incision. Exposure of the temporomandibular joint capsule, incision is made through the lateral capsule into the superior joint space and the disc is repositioned. Discopexy is done using 2-0 polypropylene suture.

Follow up will be at intervals of 1, 3, 6 and 12 months after the operation for clinical assessment of pain by Visual Analogue Scale (VAS), MIO in mm, joint clicking and complications.

MRI of TMJ is performed after one month of surgery to evaluate position of the articular disc.

02

Conditions studied

  • Efficacy of TMJ Arthroscopy
03

In context

Lead sponsor

Mohamed Gamal Thabet is the lead sponsor of 4 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients with TMD in the form of anterior disc displacement without reduction
  • Age: 20 - 50 years' old

Exclusion criteria

Exclusion Criteria:

  • Secondary TMD
  • TMJ ankylosis
  • Structural deformity of TMJ
  • Previous surgical intervention to TMJ
  • Patients who are unfit for surgery
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    TMJ dysfunction

    TMJ discopexy

    Procedure: TMJ discopexy

Interventions

  • ProcedureTMJ discopexy

    Arthroscopic versus open TMJ discopexy

06

What researchers measure

Primary outcomes

  1. TMJ pain

    change of pain on a visual analogue scale from 0 to 10 with decreased number means less pain

    Time frame: one year

07

Study locations

1 of 1 sites recruiting
  • Assiut university hospital
    Assiut, Government 71111, Egypt
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 10, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05938257
Lead sponsor
Mohamed Gamal Thabet
Responsible party
Mohamed Gamal Thabet (Assiut university, Assiut University) — Sponsor-investigator
First posted
Jul 10, 2023
Start date
Aug 2023 (estimated)
Primary completion
Jul 2025 (estimated)
Completion
Aug 2025 (estimated)
Last update
Jul 10, 2023

Study contacts

Mohamed G Thabet, physician
Contact
mohamed.g.t772@gmail.com
01026674177

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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