TMJ - Dislocation of Temporomandibular JointComputer-guideNCT06791265
Computer-guided Versus Conventional Eminectomy
A study testing Guided Eminectomy and Free hand Eminectomy in people with TMJ - Dislocation of Temporomandibular Joint, run by Beni-Suef University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- TMJ - Dislocation of Temporomandibular Joint
- What is being tested?
- Guided Eminectomy and Free hand Eminectomy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Feb 2025to 12 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with an age range of 18-60 years, males and females, with bilateral dislocation o
- Medically free
Who cannot join
- medically compromised patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Guided Eminectomy, Free hand Eminectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided EminectomyDevice
The patients will be subjected to computer-guided osteotomy utilizing a virtually preplanned cutting guide
Free hand EminectomyProcedure or surgery
The patients will be subjected to a free-hand Eminectomy utilizing the routine surgical technique
| Study group | Role | What they receive |
|---|---|---|
| Guided Eminectomy | Active comparator | computer-guided osteotomy Receives: Device: Guided Eminectomy |
| Free hand Eminectomy | Active comparator | conventional osteotomy Receives: Procedure: Free hand Eminectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dislocation recurrence
The recurrence will be investigated for ocuurence in the followups
Measured: 6 months
Secondary outcomes (2)
Maximum interincisal opening (MIO)
maximum mouth opening will be measured in followups
Measured: 6 months
Accuracy of the digital workflow
The accuracy of the work flow will be assessed by superimposing the CBCT scans
Measured: One week postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start10 Feb 2025
- Primary completion12 Dec 2025
- Study completion12 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TMJ - Dislocation of Temporomandibular JointStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Gibaly, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06791265
- Sponsor's protocol ID
- 16
- Acronym
- Computer-guide
- Status last verified
- Dec 2025
- First submitted
- 10 Jan 2025
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer-guided Versus Conventional Eminectomy for Treatment of Recurrent Temporomandibular Joint Dislocation
- ClinicalTrials.gov ID
- NCT06791265
- Acronym / sponsor ID
- Computer-guide / 16
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 10 Feb 2025 (actual)
- Primary completion
- 12 Dec 2025 (actual)
- Study completion
- 12 Dec 2025 (actual)
- First posted
- 24 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Guided Eminectomy | Active comparator | Device: Guided Eminectomycomputer-guided osteotomy |
| Free hand Eminectomy | Active comparator | Procedure: Free hand Eminectomyconventional osteotomy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients with an age range of 18-60 years, males and females, with bilateral dislocation o
- Medically free
Key exclusion criteria (1 listed)
- medically compromised patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guided EminectomyThe patients will be subjected to computer-guided osteotomy utilizing a virtually preplanned cutting guide | Device | Guided Eminectomy |
| Free hand EminectomyThe patients will be subjected to a free-hand Eminectomy utilizing the routine surgical technique | Procedure or surgery | Free hand Eminectomy |
Primary outcome
Dislocation recurrence
Time frame: 6 months
The recurrence will be investigated for ocuurence in the followups
2 secondary outcomes
Maximum interincisal opening (MIO)
Time frame: 6 months
Accuracy of the digital workflow
Time frame: One week postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided Eminectomy and Free hand Eminectomy in people with TMJ - Dislocation of Temporomandibular Joint, run by Beni-Suef University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dislocation recurrence (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.