Temporomandibular Joint Dysfunction SyndromeNCT06661096
Comparative Study Between Level I and Level II Temporomandibular Joint Arthroscopy in Wilkes Stage III Patients
A study testing TMJ arthroscopy in people with Temporomandibular Joint Dysfunction Syndrome, run by Mohamed Gamal Thabet at 1 site in Egypt.
Trial summary
Temporomandibular joint dysfunction (TMJD) represents a common health problem. Its prevalence is nearly 31% in adults and 11% in adolescence, more common in females. Aetiologies of TMJD are multifactorial and can be attributed to both physical and psycho-social factors. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Temporomandibular Joint Dysfunction Syndrome
- What is being tested?
- TMJ arthroscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 13 Oct 2024to 15 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Wilkes stage III patients
Who cannot join
- previous TMJ surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Temporomandibular Joint Dysfunction (TMJD)
Temporomandibular joint dysfunction (TMJD) represents a common health problem. Its prevalence is nearly 31% in adults and 11% in adolescence, more common in females. Aetiologies of TMJD are multifactorial and can be attributed to both physical and psycho-social factors. Internal derangement of the temporomandibular joint (TMJ) is the most frequent disorder; with anterior disc displacement is the most common form. Wilkes has classified internal derangement into five stages; patients with stage III usually present with limited mouth opening, joint pain and deviation of jaw upon opening to the affected side. MRI is considered the gold standard for diagnosis. Treatment of TMJD include non-surgical and surgical methods. Non-surgical treatment includes instructions, pharmacotherapy, physiotherapy and occlusal splints; while surgical interventions include minimally invasive procedures (arthroscopy and arthrocentesis) and open joint surgery
Read the detailed description
Arthroscopy of TMJ was first introduced by Ohnishi in 1975. There are three different levels of TMJ arthroscopy. Level I, single puncture arthroscopy, it allows lysis of adhesions in the upper joint compartment and lavage of the joint space and the inflammatory products. Level II is done by double puncture and it enables to perform maneuvers such as lateral pterygoid myotomy and ablation of the retrodiscal tissue. Operative devices including arthroscopic instruments, Nd-YAG and Holmium laser, and the high-frequency wave system (Coblation) is very useful for tissue coagulation and cutting. Both levels enabled getting joint mobilization and significant pain reduction. Level III (arthroscopic discopexy), it needs customized special instruments.
- Being tested
- TMJ arthroscopy
- Medical subject headings
- Temporomandibular Joint Dysfunction Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMJ arthroscopyProcedure or surgery
level I and level II TMJ arthroscopy
| Study group | Role | What they receive |
|---|---|---|
| TMJ dysfunction | Experimental | TMJ arthroscopy Receives: Procedure: TMJ arthroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximum inter-incisal opening
change of maximum inter-incisal opening, in mm.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start13 Oct 2024
- Primary completion13 Oct 2025 (estimated)
- Study completion15 Oct 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 Dysfunction SyndromeStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mohamed Gamal Thabet
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohamed Gamal Thabet, Assiut University
- Investigators
- Mohamed Gamal Thabet, MD, Principal investigator, MGThabet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06661096
- Sponsor's protocol ID
- TMJ arthroscopy
- Status last verified
- Oct 2024
- First submitted
- 21 Oct 2024
- Last updated
- 28 Oct 2024
- 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 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temporomandibular Joint Dysfunction (TMJD)
- ClinicalTrials.gov ID
- NCT06661096
- Acronym / sponsor ID
- TMJ arthroscopy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Mohamed Gamal ThabetUniversity, hospital or other
- Study start
- 13 Oct 2024 (actual)
- Primary completion
- 13 Oct 2025 (estimated)
- Study completion
- 15 Oct 2025 (estimated)
- First posted
- 28 Oct 2024 (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.
Temporomandibular joint dysfunction (TMJD) represents a common health problem. Its prevalence is nearly 31% in adults and 11% in adolescence, more common in females. Aetiologies of TMJD are multifactorial and can be attributed to both physical and psycho-social factors. Internal derangement of the temporomandibular joint (TMJ) is the most frequent disorder; with anterior disc displacement is the most common form. Wilkes has classified internal derangement into five stages; patients with stage III usually present with limited mouth opening, joint pain and deviation of jaw upon opening to the affected side. MRI is considered the gold standard for diagnosis. Treatment of TMJD include non-surgical and surgical methods. Non-surgical treatment includes instructions, pharmacotherapy, physiotherapy and occlusal splints; while surgical interventions include minimally invasive procedures (arthroscopy and arthrocentesis) and open joint surgery
Detailed description
Arthroscopy of TMJ was first introduced by Ohnishi in 1975. There are three different levels of TMJ arthroscopy. Level I, single puncture arthroscopy, it allows lysis of adhesions in the upper joint compartment and lavage of the joint space and the inflammatory products. Level II is done by double puncture and it enables to perform maneuvers such as lateral pterygoid myotomy and ablation of the retrodiscal tissue. Operative devices including arthroscopic instruments, Nd-YAG and Holmium laser, and the high-frequency wave system (Coblation) is very useful for tissue coagulation and cutting. Both levels enabled getting joint mobilization and significant pain reduction. Level III (arthroscopic discopexy), it needs customized special instruments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TMJ dysfunction | Experimental | Procedure: TMJ arthroscopyTMJ arthroscopy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Wilkes stage III patients
Key exclusion criteria (1 listed)
- previous TMJ surgery
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 |
|---|---|---|
| TMJ arthroscopylevel I and level II TMJ arthroscopy | Procedure or surgery | TMJ dysfunction |
Primary outcome
maximum inter-incisal opening
Time frame: 6 months
change of maximum inter-incisal opening, in mm.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2024.
- Individual participant dataSharing planned: No
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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.
Mohamed Gamal Thabet, MD principal investigator
MGThabet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TMJ arthroscopy in people with Temporomandibular Joint Dysfunction Syndrome, run by Mohamed Gamal Thabet 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 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: under way, not looking for participants, as of the sponsor's last update on 28 Oct 2024. 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?
This study is still under way. Results are not available in the source record yet.
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?
maximum inter-incisal opening (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 28 Oct 2024.