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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05938257
Enrollment
40
Registered
2023-07-10
Start date
2023-08-31
Completion date
2025-08-31
Last updated
2023-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Efficacy of TMJ Arthroscopy

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.

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.

Interventions

PROCEDURETMJ discopexy

Arthroscopic versus open TMJ discopexy

Sponsors

Mohamed Gamal Thabet
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

randomized controlled clinical trial

Eligibility

Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
TMJ painone yearchange of pain on a visual analogue scale from 0 to 10 with decreased number means less pain

Countries

Egypt

Contacts

Primary ContactMohamed G Thabet, physician
mohamed.g.t772@gmail.com01026674177

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026