Outcomes of Surgical Management of Temporomandibular Joint Anterior Disc Displacement Without Reduction
1 other identifier
interventional
40
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 22, 2022
CompletedFirst Posted
Study publicly available on registry
July 28, 2022
CompletedStudy Start
First participant enrolled
August 13, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2025
CompletedApril 12, 2023
April 1, 2023
2 years
June 22, 2022
April 10, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
pain of the TMJ
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
6 months
Secondary Outcomes (1)
mouth openning
3 months
Study Arms (1)
patients with TMJ anterior disc displacement
EXPERIMENTALpatients had clinically limited mouth opening and by MRI we found anterior disc displacement
Interventions
removal of the TMJ disc
Eligibility Criteria
You may qualify if:
- This study will include patients diagnosed as anterior disc displacement without reduction based on clinical manifestations and MRI.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sohag Universitylead
Study Sites (1)
Sohag University Hospital
Sohag, Egypt
Study Officials
- STUDY DIRECTOR
Kamal M El- sharkawy, proffessor
sohag univesity hospitals
Central Study Contacts
Kamal M Hassanein, professor
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- assistant lecturer of maxillofacial surgery
Study Record Dates
First Submitted
June 22, 2022
First Posted
July 28, 2022
Study Start
August 13, 2023
Primary Completion
August 1, 2025
Study Completion
August 1, 2025
Last Updated
April 12, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share
IPD will be shared with other researchers through NIH(national institute of health)