NCT06791265

Brief Summary

Dislocation of temporomandibular joint (TMJ) is a pathologic condition in which the patient suffers non-self limiting hypermobility in the joint due to the displacement of mandibular condyle outside its position within the glenoid fossa. Although lateral and posterior dislocation is mentioned in literature, Anteromedial position is the most common. In this condition, the condyle is stuck beyond the articular eminence anteriorly in a non-functional position.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 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

First Submitted

Initial submission to the registry

January 10, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 24, 2025

Completed
17 days until next milestone

Study Start

First participant enrolled

February 10, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2025

Completed
Last Updated

December 19, 2025

Status Verified

December 1, 2025

Enrollment Period

10 months

First QC Date

January 10, 2025

Last Update Submit

December 12, 2025

Conditions

TMJ - Dislocation of Temporomandibular Joint

Outcome Measures

Primary Outcomes (1)

  • Dislocation recurrence

    The recurrence will be investigated for ocuurence in the followups

    6 months

Secondary Outcomes (2)

  • Maximum interincisal opening (MIO)

    6 months

  • Accuracy of the digital workflow

    One week postoperative

Study Arms (2)

Guided Eminectomy

ACTIVE COMPARATOR

computer-guided osteotomy

Device: Guided Eminectomy

Free hand Eminectomy

ACTIVE COMPARATOR

conventional osteotomy

Procedure: Free hand Eminectomy

Interventions

Guided EminectomyDEVICE

The patients will be subjected to computer-guided osteotomy utilizing a virtually preplanned cutting guide

Guided Eminectomy
Free hand EminectomyPROCEDURE

The patients will be subjected to a free-hand Eminectomy utilizing the routine surgical technique

Free hand Eminectomy

Eligibility Criteria

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

You may qualify if:

  • Patients with an age range of 18-60 years, males and females, with bilateral dislocation o
  • Medically free

You may not qualify if:

  • medically compromised patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amr Gibaly

Cairo, 62764, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Oral and Maxillofacial Surgery

Study Record Dates

First Submitted

January 10, 2025

First Posted

January 24, 2025

Study Start

February 10, 2025

Primary Completion

December 12, 2025

Study Completion

December 12, 2025

Last Updated

December 19, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)