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

Sponsor

Mohamed Gamal Thabet (Other)

Overall Status

Recruiting

CT.gov ID

NCT05938257

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Efficacy of TMJ Arthroscopy	Procedure: TMJ discopexy	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

randomized controlled clinical trialrandomized controlled clinical trial

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Jul 1, 2025

Anticipated Study Completion Date :

Aug 1, 2025

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: TMJ dysfunction

TMJ discopexy

Procedure: TMJ discopexy

Arthroscopic versus open TMJ discopexy

Outcome Measures

Primary Outcome Measures

TMJ pain [one year]
change of pain on a visual analogue scale from 0 to 10 with decreased number means less pain

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assiut university hospital	Assiut	Government	Egypt	71111

Sponsors and Collaborators

Mohamed Gamal Thabet

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mohamed Gamal Thabet, Assiut university, Assiut University

ClinicalTrials.gov Identifier:

NCT05938257

Other Study ID Numbers:

Mohamed G Thabet

First Posted:

Jul 10, 2023

Last Update Posted:

Jul 10, 2023

Last Verified:

Jul 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jul 10, 2023