TMJ DisorderNCT06856811
Condylar Position Changes in Anterior Disc Displacement with Reduction
A study testing tmj lavage with ringer lactate solution in people with TMJ Disorder, run by Sana'a University at 1 site in Yemen.
Trial summary
the goal of this clinical trial is to know if TMJ lavage does change the condyle position in patients diagnosed with unilateral anterior disc displacement with reduction. The main questions it aims to answer are: Is the condyle position in anterior disc displacement with reduction joints are the same in normal joints?… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- TMJ Disorder
- What is being tested?
- tmj lavage with ringer lactate solution
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteYemen
- Study dates
- 1 Aug 2023to 30 Oct 2024
- 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
- • Unilateral anterior disc displacement with reduction according to Helkimo's clinical dysfunction index including (Covert et al., 2021a).:
- Impaired range of movement.
- Impaired TMJ dysfunction.
- Muscles pain.
- TMJ pain.
Who cannot join
- • Bilateral anterior disc displacement with reduction.
- Previous fracture in TMJ.
- Any pathological lesion in TMJ.
- Congenital craniofacial anomalies.
- Any previous surgical procedure in TMJ.
- Any medically compromised patient (mental deficiency, osteoporosis…)
Show all 9Show fewer
- Previous arthrocentesis in TMJ.
- Partial or complete edentulous patients.
- Any psychological patient.
Trial locations and contacts
1 site in 1 country.
About this study
the goal of this clinical trial is to know if TMJ lavage does change the condyle position in patients diagnosed with unilateral anterior disc displacement with reduction. The main questions it aims to answer are:
- Is the condyle position in anterior disc displacement with reduction joints are the same in normal joints?
- Does TMJ lavage will affect the condyle position, or affects the contralateral condyle position? Researchers will compare condyle position in unilateral anterior disc displacement with reduction to the normal joint using CBCT before and after lavage to see if any changes in position will occur in even side.
Read more
Participants will:
Make CBCT for both condyles before lavage and after three months post lavage. Visit clinic after two weeks, one month, and three months to evaluate the clinical data.
- Conditions
- TMJ Disorder
- Being tested
- tmj lavage with ringer lactate solution
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tmj lavage with ringer lactate solutionProcedure or surgery
tmj lavage using 150ml ringer lactate in symptomatic side of unilateral anterior disc displacement with reduction
| Study group | Role | What they receive |
|---|---|---|
| unilateral anterior disc displacement with reduction | Experimental | Not described Receives: Procedure: tmj lavage with ringer lactate solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
measuring joint spaces in coronal, sagittal and axial views in mm as follows: sagittal view: measuring superior, posterior and anterior space, coronal measuring medial and lateral joint spaces, axial measuring the intercondylar distance and angle
Measured: three months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start1 Aug 2023
- Primary completion30 Oct 2024
- Study completion30 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TMJ 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sana'a University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suha Hussein Mohammed Almoqayad, Sana'a University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06856811
- Sponsor's protocol ID
- tmj lavage
- Status last verified
- Mar 2025
- First submitted
- 24 Feb 2025
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Condylar Position Changes in Anterior Disc Displacement with Reduction
- ClinicalTrials.gov ID
- NCT06856811
- Acronym / sponsor ID
- tmj lavage
- Conditions
- TMJ Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Sana'a UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 4 Mar 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.
the goal of this clinical trial is to know if TMJ lavage does change the condyle position in patients diagnosed with unilateral anterior disc displacement with reduction. The main questions it aims to answer are:
- Is the condyle position in anterior disc displacement with reduction joints are the same in normal joints?
- Does TMJ lavage will affect the condyle position, or affects the contralateral condyle position? Researchers will compare condyle position in unilateral anterior disc displacement with reduction to the normal joint using CBCT before and after lavage to see if any changes in position will occur in even side.
Participants will:
Make CBCT for both condyles before lavage and after three months post lavage. Visit clinic after two weeks, one month, and three months to evaluate the clinical data.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| unilateral anterior disc displacement with reduction | Experimental | Procedure: tmj lavage with ringer lactate solution |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- • Unilateral anterior disc displacement with reduction according to Helkimo's clinical dysfunction index including (Covert et al., 2021a).:
Key exclusion criteria (9 listed)
- • Bilateral anterior disc displacement with reduction.
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 lavage with ringer lactate solutiontmj lavage using 150ml ringer lactate in symptomatic side of unilateral anterior disc displacement with reduction | Procedure or surgery | unilateral anterior disc displacement with reduction |
Primary outcome
measuring joint spaces in coronal, sagittal and axial views in mm as follows: sagittal view: measuring superior, posterior and anterior space, coronal measuring medial and lateral joint spaces, axial measuring the intercondylar distance and angle
Time frame: three months follow up
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 4 Mar 2025.
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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.
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 tmj lavage with ringer lactate solution in people with TMJ Disorder, run by Sana'a University at 1 site in Yemen.
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 5 inclusion and 9 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 4 Mar 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 Yemen. 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?
measuring joint spaces in coronal, sagittal and axial views in mm as follows: sagittal view: measuring superior, posterior and anterior space, coronal measuring medial and lateral joint spaces, axial measuring the intercondylar distance and angle (time frame: three months follow up). 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 4 Mar 2025.