TMJ Disc DisorderNCT06013059
A Comparative Study Between the Different Levels of TMJ Arthroscopy in the Management of TMJ Internal Derangement
A study testing three levels of TMJ arthroscopy in people with TMJ Disc Disorder, run by Alexandria University at 1 site in Egypt.
Trial summary
The temporomandibular joint (TMJ) arthroscopy has emerging role nowadays in the treatment of TMJ internal derangement with its three levels of intervention. A comparative study between the 3 levels is essential to develop a standardized selection criteria and management algorithm. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- TMJ Disc Disorder
- What is being tested?
- three levels of TMJ arthroscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2021to 30 Jul 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with TMJ internal derangement Wilkes III
Who cannot join
- Medically unfit patients.
- Patients with TMDs secondary to malocclusion.
- Psychological instability.
- Patients operated before for other TMJ problems.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Study Between the Different Levels of TMJ Arthroscopy in the Management of TMJ Internal Derangement (A Randomized Clinical Trial)
The temporomandibular joint (TMJ) arthroscopy has emerging role nowadays in the treatment of TMJ internal derangement with its three levels of intervention. A comparative study between the 3 levels is essential to develop a standardized selection criteria and management algorithm.
- Conditions
- TMJ Disc Disorder
- Being tested
- three levels of TMJ arthroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
three levels of TMJ arthroscopyProcedure or surgery
Group I: 10 patients will be treated with Lysis and lavage
three levels of TMJ arthroscopyProcedure or surgery
Group II: 10 patients will be treated with operative arthroscopy
three levels of TMJ arthroscopyProcedure or surgery
Group III: 10 patients will be treated with operative arthroscopy + discopexy
| Study group | Role | What they receive |
|---|---|---|
| level (I) arthroscopy (Lysis and lavage) | Active comparator | Not described Receives: Procedure: three levels of TMJ arthroscopy |
| level (II) arthroscopy (operative arthroscopy) | Active comparator | Not described Receives: Procedure: three levels of TMJ arthroscopy |
| level (III) arthroscopy (operative arthroscopy + disc repositioning and fixation) | Active comparator | Not described Receives: Procedure: three levels of TMJ arthroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mouth opening measurement
measuring the maximal interincisal opening (MIO)
Measured: 1, 3 and 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2023
- Study start1 Jun 2021
- Primary completion1 Dec 2022
- Study completion30 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TMJ Disc DisorderStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Hamza Fayad, Alexandria University
- Investigators
- Mohamed Fayad, MD, Principal investigator, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06013059
- Sponsor's protocol ID
- 001056 - IORG 0008839
- Status last verified
- Oct 2023
- First submitted
- 22 Aug 2023
- Last updated
- 10 Oct 2023
- Results posted
- 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 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study Between the Different Levels of TMJ Arthroscopy in the Management of TMJ Internal Derangement (A Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT06013059
- Acronym / sponsor ID
- 001056 - IORG 0008839
- Conditions
- TMJ Disc Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 28 Aug 2023 (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.
The temporomandibular joint (TMJ) arthroscopy has emerging role nowadays in the treatment of TMJ internal derangement with its three levels of intervention. A comparative study between the 3 levels is essential to develop a standardized selection criteria and management algorithm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| level (I) arthroscopy (Lysis and lavage) | Active comparator | Procedure: three levels of TMJ arthroscopy |
| level (II) arthroscopy (operative arthroscopy) | Active comparator | Procedure: three levels of TMJ arthroscopy |
| level (III) arthroscopy (operative arthroscopy + disc repositioning and fixation) | Active comparator | Procedure: three levels of TMJ arthroscopy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with TMJ internal derangement Wilkes III
Key exclusion criteria (4 listed)
- Medically unfit patients.
- Patients with TMDs secondary to malocclusion.
- Psychological instability.
- Patients operated before for other TMJ problems.
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 |
|---|---|---|
| three levels of TMJ arthroscopyGroup I: 10 patients will be treated with Lysis and lavage | Procedure or surgery | level (I) arthroscopy (Lysis and lavage) |
| three levels of TMJ arthroscopyGroup II: 10 patients will be treated with operative arthroscopy | Procedure or surgery | level (II) arthroscopy (operative arthroscopy) |
| three levels of TMJ arthroscopyGroup III: 10 patients will be treated with operative arthroscopy + discopexy | Procedure or surgery | level (III) arthroscopy (operative arthroscopy + disc repositioning and fixation) |
Primary outcome
Mouth opening measurement
Time frame: 1, 3 and 6 months postoperatively
measuring the maximal interincisal opening (MIO)
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 10 Oct 2023.
- Individual participant dataSharing planned: No
Related trials for TMJ Disc Disorder
Recruiting
Calcium Gluconate Activated in Anterior Disc Displacement With Reduction of the Temporomandibular Joint
Temporomandibular Joint Disorders
Not yet recruiting
Effects of Orofacial Myofunctional Therapy and Cervical Stabilization Exercises in Patients With Axis-i Group Iia Temporomandibular Dysfunction
Temporo-mandibular Dysfunction, Disc Displacement
Enrolling by invitation
Physiotherapy and Osteopathic Treatment for Pain in the Cervical and Lumbar Spine and Temporomandibular Joints
Disc Degenerative Disease, Spine Degeneration
Not yet recruiting
Effects of Orofascial Myofunctional Therapy and Cervical Stabilization Exercises on Temporomandibular Dysfunction
Temporomandibular Disorders (TMDs), Temporo-mandibular Dysfunction
Recruiting
Liquid Phase Concentrated Growth Factor Versus Conventional Arthrocentesis in Temporomandibular Disc Displacement
Temporomandibular Disorders (TMD), Internal Derangement of the Tempromandibular Joint
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.
Mohamed Fayad, MD principal investigator
Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing three levels of TMJ arthroscopy in people with TMJ Disc Disorder, run by Alexandria 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 4 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 10 Oct 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?
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?
Mouth opening measurement (time frame: 1, 3 and 6 months postoperatively). 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 10 Oct 2023.