- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06791265
Computer-guided Versus Conventional Eminectomy (Computer-guide)
December 12, 2025 updated by: Amr Gibaly, Beni-Suef University
Computer-guided Versus Conventional Eminectomy for Treatment of Recurrent Temporomandibular Joint Dislocation
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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
Study Type
Interventional
Enrollment (Actual)
7
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Cairo, Egypt, 62764
- Amr Gibaly
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients with an age range of 18-60 years, males and females, with bilateral dislocation o
- Medically free
Exclusion Criteria:
medically compromised patients
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Guided Eminectomy
computer-guided osteotomy
|
The patients will be subjected to computer-guided osteotomy utilizing a virtually preplanned cutting guide
|
|
Active Comparator: Free hand Eminectomy
conventional osteotomy
|
The patients will be subjected to a free-hand Eminectomy utilizing the routine surgical technique
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dislocation recurrence
Time Frame: 6 months
|
The recurrence will be investigated for ocuurence in the followups
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maximum interincisal opening (MIO)
Time Frame: 6 months
|
maximum mouth opening will be measured in followups
|
6 months
|
|
Accuracy of the digital workflow
Time Frame: One week postoperative
|
The accuracy of the work flow will be assessed by superimposing the CBCT scans
|
One week postoperative
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 10, 2025
Primary Completion (Actual)
December 12, 2025
Study Completion (Actual)
December 12, 2025
Study Registration Dates
First Submitted
January 10, 2025
First Submitted That Met QC Criteria
January 19, 2025
First Posted (Actual)
January 24, 2025
Study Record Updates
Last Update Posted (Actual)
December 19, 2025
Last Update Submitted That Met QC Criteria
December 12, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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