Outcomes of Surgical Management of Temporomandibular Joint Anterior Disc Displacement Without Reduction

Sponsor
Sohag University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05478915
Collaborator
(none)
40
1
1
35.6
1.1

Study Details

Study Description

Brief Summary

this study will be done to detect the best management of temporo-mandibular joint anterior disc displacement without reduction, for diagnosis, we use MRI on the TMJ to detect status of the disc and joint space, for management, we try to select best operation as discopexy, discectomy with or without replacement, and we follow up the patients and detect side effects and effect for each operation

Condition or Disease Intervention/Treatment Phase
  • Procedure: discectomy of the TMJ disc
  • Procedure: TMJ discopexy
N/A

Detailed Description

Discopexy is a procedure in which the displaced disk is freed by the surgeon and lysing adhesions first. The success of the disc repositioning depends on the degree of deformity and the extent of degenerative changes at the time of the arthroplasty. Repositioning the disc restores the condylar movement that was previously blocked by the displaced disc, stabilizes the joint, and improves nutrition and lubrication of articular cartilage. In addition, the workload of the masticatory muscles is reduced when the obstructing disc is repositioned. TMJ disc repositioning surgery seems to improve pain, mouth opening, and patient quality of life

Temporomandibular Joint (TMJ) arthroscopy is one of the most advanced and a minimally invasive technique involving optical instrumentation and prescribed surgical armamentarium, used for the treatment of the TMJ disorders. It is one of the most popular and effective methods of diagnosing and treating TMJ disorders since TMJ disorders have become an increasingly widespread problem in our society. Also, it enables the surgeon to visualize the joint and, therefore, contributes to the diagnosis of the internal pathological condition of the joint and allows inspection of a surgically undisturbed joint both at rest and in function

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Outcomes of Surgical Management of Temporomandibular Joint Anterior Disc Displacement Without Reduction
Anticipated Study Start Date :
Aug 13, 2022
Anticipated Primary Completion Date :
Aug 1, 2025
Anticipated Study Completion Date :
Aug 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: patients with TMJ anterior disc displacement

patients had clinically limited mouth opening and by MRI we found anterior disc displacement

Procedure: discectomy of the TMJ disc
removal of the TMJ disc

Procedure: TMJ discopexy
fixation of the TMJ disc

Outcome Measures

Primary Outcome Measures

  1. pain of the TMJ [6 months]

    degree of pain related to TMJ measured by Visual Analogue Scoring System from 0 to 10 where 0 means no pain and 10 means severe unbearable pain

Secondary Outcome Measures

  1. mouth openning [3 months]

    degree of mouth opening measured in centimeters measured by ruler

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • This study will include patients diagnosed as anterior disc displacement without reduction based on clinical manifestations and MRI.
Exclusion Criteria:
  • o Patients with severe osteoarthritic changes of the condyle and glenoid fossa.

  • Patients with bony ankylosis.

  • Patients with infection or tumors around joint area.

  • Patients with previous TMJ surgery.

  • Any patient with systemic inflammatory disease or myopathic disease affecting TMJ such as Rheumatoid Arthritis And Systemic Lupus Erythromatosis.

  • Patients unfit for intervention.

  • Patients who refused to share in the study.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sohag University Hospital Sohag Egypt

Sponsors and Collaborators

  • Sohag University

Investigators

  • Study Director: Kamal M El- sharkawy, proffessor, sohag univesity hospitals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mohamed Abdelaal Ali, assistant lecturer of maxillofacial surgery, Sohag University
ClinicalTrials.gov Identifier:
NCT05478915
Other Study ID Numbers:
  • Soh-Med-22-6-12
First Posted:
Jul 28, 2022
Last Update Posted:
Jul 28, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jul 28, 2022