Computer-guided Versus Conventional Eminectomy

NCT ID: NCT06791265

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-10

Study Completion Date

2025-12-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

TMJ dislocation occurs in different forms, acute dislocation as a result of trauma or excessive opening, chronic dislocation as a result of capsule laxity due to prolonged disarticulation, and finally recurrent dislocation. Recurrent dislocation is a repeated sporadic acute TMJ dislocation. Unlike chronic dislocation, the mandibular condyle is located in its normal position between dislocation episodes. Recurrent TMJ dislocation treatment modalities can be organized according to the stability factor into ligaments alteration, musculature alteration, and bony anatomy alteration. Nonsurgical/minimally invasive and surgical/invasive therapies have been used. Conservative modalities are usually used before invasive modalities, yet surgical modalities are still superior to non surgical modalities due to its higher success rate. Eminectomy is one of the widely used surgical procedures to manage recurrent dislocation. It is considered as a "rescue procedure" by many surgeons

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

TMJ - Dislocation of Temporomandibular Joint

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Guided Eminectomy

computer-guided osteotomy

Group Type ACTIVE_COMPARATOR

Guided Eminectomy

Intervention Type DEVICE

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

Free hand Eminectomy

conventional osteotomy

Group Type ACTIVE_COMPARATOR

Free hand Eminectomy

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Guided Eminectomy

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

Intervention Type DEVICE

Free hand Eminectomy

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

medically compromised patients
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Beni-Suef University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Amr Gibaly

Associate Professor of Oral and Maxillofacial Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Amr Gibaly

Cairo, , Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

16

Identifier Type: -

Identifier Source: org_study_id