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

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.

Study Overview

• Status: Recruiting
• Conditions: Efficacy of TMJ Arthroscopy
• Intervention / Treatment: Procedure: TMJ discopexy

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohamed G Thabet, physician; Phone Number: 01026674177; Email: mohamed.g.t772@gmail.com

Study Locations

• Egypt
  • Government
    • Assiut, Government, Egypt, 71111
      • Recruiting
      • Assiut University Hospital
      • Contact: Mohamed G Thabet, physician; Phone Number: 01026674177; Email: mohamed.g.t772@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TMJ dysfunction; TMJ discopexy	Procedure: TMJ discopexy; Arthroscopic versus open TMJ discopexy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TMJ pain	change of pain on a visual analogue scale from 0 to 10 with decreased number means less pain	one year

Collaborators and Investigators

• Sponsor: Mohamed Gamal Thabet

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2023
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: June 20, 2023
• First Submitted That Met QC Criteria: July 3, 2023
• First Posted (Actual): July 10, 2023

Study Record Updates

• Last Update Posted (Actual): July 10, 2023
• Last Update Submitted That Met QC Criteria: July 3, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: Mohamed G Thabet

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No