Temporomandibular Joint Disc Displacement, Without ReductionNCT05478915
Outcomes of Surgical Management of Temporomandibular Joint Anterior Disc Displacement Without Reduction
A study testing discectomy of the TMJ disc and TMJ discopexy in people with Temporomandibular Joint Disc Displacement, Without Reduction, run by Sohag University at 1 site in Egypt.
Trial summary
this study will be done to detect the best management of temporo-mandibular joint anterior disc displacement without reduction, for diagnosis, we use MRI on the TMJ to detect status of the disc and joint space, for management, we try to select best operation as discopexy, discectomy with or without replacement, and we… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Temporomandibular Joint Disc Displacement, Without Reduction
- What is being tested?
- discectomy of the TMJ disc and TMJ discopexy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 13 Aug 2023to 1 Aug 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
- This study will include patients diagnosed as anterior disc displacement without reduction based on clinical manifestations and MRI.
Who cannot join
- o Patients with severe osteoarthritic changes of the condyle and glenoid fossa.
- Patients with bony ankylosis.
- Patients with infection or tumors around joint area.
- Patients with previous TMJ surgery.
- Any patient with systemic inflammatory disease or myopathic disease affecting TMJ such as Rheumatoid Arthritis And Systemic Lupus Erythromatosis.
- Patients unfit for intervention.
- Patients who refused to share in the study.
Trial locations and contacts
1 site in 1 country.
Kamal M Hassanein, professor contact
About this study
this study will be done to detect the best management of temporo-mandibular joint anterior disc displacement without reduction, for diagnosis, we use MRI on the TMJ to detect status of the disc and joint space, for management, we try to select best operation as discopexy, discectomy with or without replacement, and we follow up the patients and detect side effects and effect for each operation
Read the detailed description
Discopexy is a procedure in which the displaced disk is freed by the surgeon and lysing adhesions first. The success of the disc repositioning depends on the degree of deformity and the extent of degenerative changes at the time of the arthroplasty. Repositioning the disc restores the condylar movement that was previously blocked by the displaced disc, stabilizes the joint, and improves nutrition and lubrication of articular cartilage. In addition, the workload of the masticatory muscles is reduced when the obstructing disc is repositioned. TMJ disc repositioning surgery seems to improve pain, mouth opening, and patient quality of life
Temporomandibular Joint (TMJ) arthroscopy is one of the most advanced and a minimally invasive technique involving optical instrumentation and prescribed surgical armamentarium, used for the treatment of the TMJ disorders. It is one of the most popular and effective methods of diagnosing and treating TMJ disorders since TMJ disorders have become an increasingly widespread problem in our society. Also, it enables the surgeon to visualize the joint and, therefore, contributes to the diagnosis of the internal pathological condition of the joint and allows inspection of a surgically undisturbed joint both at rest and in function
- Being tested
- discectomy of the TMJ disc, TMJ discopexy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
discectomy of the TMJ discProcedure or surgery
removal of the TMJ disc
TMJ discopexyProcedure or surgery
fixation of the TMJ disc
| Study group | Role | What they receive |
|---|---|---|
| patients with TMJ anterior disc displacement | Experimental | patients had clinically limited mouth opening and by MRI we found anterior disc displacement Receives: Procedure: discectomy of the TMJ disc; Procedure: TMJ discopexy |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain of the TMJ
degree of pain related to TMJ measured by Visual Analogue Scoring System from 0 to 10 where 0 means no pain and 10 means severe unbearable pain
Measured: 6 months
Secondary outcomes (1)
mouth openning
degree of mouth opening measured in centimeters measured by ruler
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2022
- Study start13 Aug 2023 (estimated)
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Joint Disc Displacement, Without ReductionStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Abdelaal Ali, Sohag University
- Investigators
- Kamal M El- sharkawy, proffessor, Study director, sohag univesity hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05478915
- Sponsor's protocol ID
- Soh-Med-22-6-12
- Status last verified
- Apr 2023
- First submitted
- 22 Jun 2022
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be shared with other researchers through NIH(national institute of health)
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Surgical Management of Temporomandibular Joint Anterior Disc Displacement Without Reduction
- ClinicalTrials.gov ID
- NCT05478915
- Acronym / sponsor ID
- Soh-Med-22-6-12
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 13 Aug 2023 (estimated)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 28 Jul 2022 (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.
this study will be done to detect the best management of temporo-mandibular joint anterior disc displacement without reduction, for diagnosis, we use MRI on the TMJ to detect status of the disc and joint space, for management, we try to select best operation as discopexy, discectomy with or without replacement, and we follow up the patients and detect side effects and effect for each operation
Detailed description
Discopexy is a procedure in which the displaced disk is freed by the surgeon and lysing adhesions first. The success of the disc repositioning depends on the degree of deformity and the extent of degenerative changes at the time of the arthroplasty. Repositioning the disc restores the condylar movement that was previously blocked by the displaced disc, stabilizes the joint, and improves nutrition and lubrication of articular cartilage. In addition, the workload of the masticatory muscles is reduced when the obstructing disc is repositioned. TMJ disc repositioning surgery seems to improve pain, mouth opening, and patient quality of life
Temporomandibular Joint (TMJ) arthroscopy is one of the most advanced and a minimally invasive technique involving optical instrumentation and prescribed surgical armamentarium, used for the treatment of the TMJ disorders. It is one of the most popular and effective methods of diagnosing and treating TMJ disorders since TMJ disorders have become an increasingly widespread problem in our society. Also, it enables the surgeon to visualize the joint and, therefore, contributes to the diagnosis of the internal pathological condition of the joint and allows inspection of a surgically undisturbed joint both at rest and in function
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with TMJ anterior disc displacement | Experimental | Procedure: discectomy of the TMJ disc, Procedure: TMJ discopexypatients had clinically limited mouth opening and by MRI we found anterior disc displacement |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- This study will include patients diagnosed as anterior disc displacement without reduction based on clinical manifestations and MRI.
Key exclusion criteria (7 listed)
- o Patients with severe osteoarthritic changes of the condyle and glenoid fossa.
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 |
|---|---|---|
| discectomy of the TMJ discremoval of the TMJ disc | Procedure or surgery | patients with TMJ anterior disc displacement |
| TMJ discopexyfixation of the TMJ disc | Procedure or surgery | patients with TMJ anterior disc displacement |
Primary outcome
pain of the TMJ
Time frame: 6 months
degree of pain related to TMJ measured by Visual Analogue Scoring System from 0 to 10 where 0 means no pain and 10 means severe unbearable pain
1 secondary outcome
mouth openning
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Individual participant dataSharing planned: No. IPD will be shared with other researchers through NIH(national institute of health)
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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.
Kamal M Hassanein, professor contact
Kamal M El- sharkawy, proffessor study director
sohag univesity hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing discectomy of the TMJ disc and TMJ discopexy in people with Temporomandibular Joint Disc Displacement, Without Reduction, run by Sohag 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 1 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 12 Apr 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed A ALI, lecturer (01093459925, mohamed.abdelaal@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain of the TMJ (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 12 Apr 2023.