NCT06013059

Brief Summary

The temporomandibular joint (TMJ) arthroscopy has emerging role nowadays in the treatment of TMJ internal derangement with its three levels of intervention. A comparative study between the 3 levels is essential to develop a standardized selection criteria and management algorithm.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

June 1, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2023

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

August 22, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 28, 2023

Completed
Last Updated

October 10, 2023

Status Verified

October 1, 2023

Enrollment Period

1.5 years

First QC Date

August 22, 2023

Last Update Submit

October 7, 2023

Conditions

TMJ Disc Disorder

Outcome Measures

Primary Outcomes (1)

  • Mouth opening measurement

    measuring the maximal interincisal opening (MIO)

    1, 3 and 6 months postoperatively

Study Arms (3)

level (I) arthroscopy (Lysis and lavage)

ACTIVE COMPARATOR
Procedure: three levels of TMJ arthroscopy

level (II) arthroscopy (operative arthroscopy)

ACTIVE COMPARATOR
Procedure: three levels of TMJ arthroscopy

level (III) arthroscopy (operative arthroscopy + disc repositioning and fixation)

ACTIVE COMPARATOR
Procedure: three levels of TMJ arthroscopy

Interventions

three levels of TMJ arthroscopyPROCEDURE

Group I: 10 patients will be treated with Lysis and lavage

level (I) arthroscopy (Lysis and lavage)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with TMJ internal derangement Wilkes III

You may not qualify if:

  • Medically unfit patients.
  • Patients with TMDs secondary to malocclusion.
  • Psychological instability.
  • Patients operated before for other TMJ problems.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alexandria University

Alexandria, Egypt

Location

Study Officials

  • Mohamed Fayad, MD

    Alexandria University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

August 22, 2023

First Posted

August 28, 2023

Study Start

June 1, 2021

Primary Completion

December 1, 2022

Study Completion

July 30, 2023

Last Updated

October 10, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)