NCT05478915

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 28, 2022

Completed
1 year until next milestone

Study Start

First participant enrolled

August 13, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

April 12, 2023

Status Verified

April 1, 2023

Enrollment Period

2 years

First QC Date

June 22, 2022

Last Update Submit

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

EXPERIMENTAL

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

Procedure: discectomy of the TMJ discProcedure: TMJ discopexy

Interventions

removal of the TMJ disc

patients with TMJ anterior disc displacement
TMJ discopexyPROCEDURE

fixation of the TMJ disc

patients with TMJ anterior disc displacement

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

Study Sites (1)

Sohag University Hospital

Sohag, Egypt

Location

Study Officials

  • Kamal M El- sharkawy, proffessor

    sohag univesity hospitals

    STUDY DIRECTOR

Central Study Contacts

Mohamed A ALI, lecturer

CONTACT

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)

Locations