Temporomandibular Disorders (TMDs)NCT07914465
Clinical Outcomes of First-Line Temporomandibular Joint Arthrocentesis Versus Arthrocentesis Following Anti-Inflammatory Treatment
A study testing Temporomandibular Joint Arthrocentesis in people with Temporomandibular Disorders (TMDs) and Temporomandibular Joint Disc Displacement, Without Reduction, run by Bahçeşehir University at 1 site in Turkey (Türkiye).
Trial summary
This prospective comparative clinical study evaluates the clinical outcomes of temporomandibular joint arthrocentesis in patients diagnosed with disc displacement without reduction. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Temporomandibular Disorders (TMDs), Temporomandibular Joint Disc Displacement, Without Reduction
- What is being tested?
- Temporomandibular Joint Arthrocentesis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Sep 2019to 19 Apr 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 diagnosed with temporomandibular joint disc displacement without reduction (DDwoR), confirmed by magnetic resonance imaging (MRI).
- Patients with temporomandibular joint pain (VAS >3) and/or restricted maximum mouth opening (MMO <35 mm).
- Patients undergoing arthrocentesis as first-line treatment or following insufficient pain control with anti-inflammatory medication.
- Patients who provided informed consent to participate in the study.
Who cannot join
- Previous temporomandibular joint surgery.
- Temporomandibular joint ankylosis or other structural joint pathology.
- Systemic inflammatory or rheumatologic diseases affecting the temporomandibular joint.
- History of maxillofacial trauma affecting temporomandibular joint function.
- Active infection in the temporomandibular joint region.
- Incomplete clinical follow-up data.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Clinical Success of Arthrocentesis as a First-Line Treatment for Temporomandibular Joint Disc Displacement Without Reduction: A Prospective Clinical Study
This prospective comparative clinical study evaluates the clinical outcomes of temporomandibular joint arthrocentesis in patients diagnosed with disc displacement without reduction. Patients undergoing arthrocentesis as a first-line treatment are compared with patients undergoing arthrocentesis following an insufficient response to anti-inflammatory treatment. Pain intensity, assessed using a 0-10 Visual Analog Scale (VAS), and maximum mouth opening (MMO), measured in millimeters, are evaluated at baseline, immediately before arthrocentesis, and at 1 week, 1 month, and 3 months after the procedure.
Read the detailed description
Temporomandibular joint disc displacement without reduction (DDwoR) is associated with pain and restricted mandibular movement. Arthrocentesis is a minimally invasive treatment option for patients with this condition. However, the clinical outcomes of arthrocentesis performed as an initial treatment compared with arthrocentesis following anti-inflammatory therapy remain an area of clinical interest.
This prospective comparative clinical study includes 28 patients diagnosed with temporomandibular joint disc displacement without reduction.
Patients are evaluated in two groups:
Group A (n=13): Patients who undergo arthrocentesis as a first-line treatment without prior anti-inflammatory therapy.
Group B (n=15): Patients who initially receive 14 days of anti-inflammatory treatment and subsequently undergo arthrocentesis due to insufficient pain control.
All patients undergo temporomandibular joint arthrocentesis and receive a stabilization splint.
The clinical outcome measures are pain intensity, assessed using a 0-10 Visual Analog Scale (VAS), and maximum mouth opening (MMO), measured in millimeters.
For Group A, baseline and preoperative measurements represent the same assessment. For Group B, baseline measurements are obtained before anti-inflammatory treatment, while preoperative measurements are obtained after the medication period and immediately before arthrocentesis.
Postoperative evaluations are performed at 1 week, 1 month, and 3 months after arthrocentesis.
The study aims to compare changes in pain intensity and maximum mouth opening between the two treatment approaches, evaluating both postoperative improvement and overall clinical improvement from the initial assessment through the 3-month follow-up.
- Conditions
- Temporomandibular Disorders (TMDs), Temporomandibular Joint Disc Displacement, Without Reduction
- Being tested
- Temporomandibular Joint Arthrocentesis
- Keywords
- arthrocentesis, Temporomandibular Joint, Disc Displacement Without Reduction
- 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.
Temporomandibular Joint ArthrocentesisProcedure or surgery
Temporomandibular joint arthrocentesis is a minimally invasive procedure involving irrigation of the upper joint space to remove inflammatory mediators and improve joint mobility. The procedure is performed in both treatment groups.
| Study group | Role | What they receive |
|---|---|---|
| First-Line Arthrocentesis | Experimental | Patients with temporomandibular joint disc displacement without reduction who undergo arthrocentesis as the initial treatment without prior anti-inflammatory medication. A stabilization splint is provided following arthrocentesis. Receives: Procedure: Temporomandibular Joint Arthrocentesis |
| Arthrocentesis Following Anti-Inflammatory Treatment | Experimental | Patients who initially receive 14 days of anti-inflammatory medication and subsequently undergo arthrocentesis due to insufficient pain control. A stabilization splint is provided following arthrocentesis. Receives: Procedure: Temporomandibular Joint Arthrocentesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Maximum Mouth Opening (MMO)
Maximum mouth opening is measured in millimeters (mm) as the maximum interincisal distance. Changes in MMO are evaluated following temporomandibular joint arthrocentesis.
Measured: Immediately before arthrocentesis and at 1 week, 1 month, and 3 months after arthrocentesis.
Change in Pain Intensity (VAS)
Pain intensity is assessed using a 0-10 visual analog scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Changes in pain intensity are evaluated following arthrocentesis.
Measured: Immediately before arthrocentesis and at 1 week, 1 month, and 3 months after arthrocentesis.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start11 Sep 2019
- Primary completion1 Jan 2023
- Study completion19 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Disorders (TMDs)Studies 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
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bahçeşehir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilara KAZAN, Bahçeşehir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07914465
- Sponsor's protocol ID
- OMÜ KAEK 2019/258
- Status last verified
- Oct 2026
- First submitted
- 28 Oct 2026
- Last updated
- 3 Nov 2026
- 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 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Clinical Success of Arthrocentesis as a First-Line Treatment for Temporomandibular Joint Disc Displacement Without Reduction: A Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT07914465
- Acronym / sponsor ID
- OMÜ KAEK 2019/258
- Conditions
- Temporomandibular Disorders (TMDs), Temporomandibular Joint Disc Displacement, Without Reduction
- Keywords
- arthrocentesis, Temporomandibular Joint, Disc Displacement Without Reduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Bahçeşehir UniversityUniversity, hospital or other
- Study start
- 11 Sep 2019 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 19 Apr 2023 (actual)
- First posted
- 3 Nov 2026 (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 prospective comparative clinical study evaluates the clinical outcomes of temporomandibular joint arthrocentesis in patients diagnosed with disc displacement without reduction. Patients undergoing arthrocentesis as a first-line treatment are compared with patients undergoing arthrocentesis following an insufficient response to anti-inflammatory treatment. Pain intensity, assessed using a 0-10 Visual Analog Scale (VAS), and maximum mouth opening (MMO), measured in millimeters, are evaluated at baseline, immediately before arthrocentesis, and at 1 week, 1 month, and 3 months after the procedure.
Detailed description
Temporomandibular joint disc displacement without reduction (DDwoR) is associated with pain and restricted mandibular movement. Arthrocentesis is a minimally invasive treatment option for patients with this condition. However, the clinical outcomes of arthrocentesis performed as an initial treatment compared with arthrocentesis following anti-inflammatory therapy remain an area of clinical interest.
This prospective comparative clinical study includes 28 patients diagnosed with temporomandibular joint disc displacement without reduction.
Patients are evaluated in two groups:
Group A (n=13): Patients who undergo arthrocentesis as a first-line treatment without prior anti-inflammatory therapy.
Group B (n=15): Patients who initially receive 14 days of anti-inflammatory treatment and subsequently undergo arthrocentesis due to insufficient pain control.
All patients undergo temporomandibular joint arthrocentesis and receive a stabilization splint.
The clinical outcome measures are pain intensity, assessed using a 0-10 Visual Analog Scale (VAS), and maximum mouth opening (MMO), measured in millimeters.
For Group A, baseline and preoperative measurements represent the same assessment. For Group B, baseline measurements are obtained before anti-inflammatory treatment, while preoperative measurements are obtained after the medication period and immediately before arthrocentesis.
Postoperative evaluations are performed at 1 week, 1 month, and 3 months after arthrocentesis.
The study aims to compare changes in pain intensity and maximum mouth opening between the two treatment approaches, evaluating both postoperative improvement and overall clinical improvement from the initial assessment through the 3-month follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First-Line Arthrocentesis | Experimental | Procedure: Temporomandibular Joint ArthrocentesisPatients with temporomandibular joint disc displacement without reduction who undergo arthrocentesis as the initial treatment without prior anti-inflammatory medication. A stabilization splint is provided following arthrocentesis. |
| Arthrocentesis Following Anti-Inflammatory Treatment | Experimental | Procedure: Temporomandibular Joint ArthrocentesisPatients who initially receive 14 days of anti-inflammatory medication and subsequently undergo arthrocentesis due to insufficient pain control. A stabilization splint is provided following arthrocentesis. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients diagnosed with temporomandibular joint disc displacement without reduction (DDwoR), confirmed by magnetic resonance imaging (MRI).
- Patients with temporomandibular joint pain (VAS >3) and/or restricted maximum mouth opening (MMO <35 mm).
- Patients undergoing arthrocentesis as first-line treatment or following insufficient pain control with anti-inflammatory medication.
- Patients who provided informed consent to participate in the study.
Key exclusion criteria (6 listed)
- Previous temporomandibular joint surgery.
- Temporomandibular joint ankylosis or other structural joint pathology.
- Systemic inflammatory or rheumatologic diseases affecting the temporomandibular joint.
- History of maxillofacial trauma affecting temporomandibular joint function.
- Active infection in the temporomandibular joint region.
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 |
|---|---|---|
| Temporomandibular Joint ArthrocentesisTemporomandibular joint arthrocentesis is a minimally invasive procedure involving irrigation of the upper joint space to remove inflammatory mediators and improve joint mobility. The procedure is performed in both treatment groups. | Procedure or surgery | Arthrocentesis Following Anti-Inflammatory Treatment, First-Line Arthrocentesis |
Primary outcome
Change in Maximum Mouth Opening (MMO)
Time frame: Immediately before arthrocentesis and at 1 week, 1 month, and 3 months after arthrocentesis.
Maximum mouth opening is measured in millimeters (mm) as the maximum interincisal distance. Changes in MMO are evaluated following temporomandibular joint arthrocentesis.
Change in Pain Intensity (VAS)
Time frame: Immediately before arthrocentesis and at 1 week, 1 month, and 3 months after arthrocentesis.
Pain intensity is assessed using a 0-10 visual analog scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Changes in pain intensity are evaluated following arthrocentesis.
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 3 Nov 2026.
- 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.
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 Temporomandibular Joint Arthrocentesis in people with Temporomandibular Disorders (TMDs) and Temporomandibular Joint Disc Displacement, Without Reduction, run by Bahçeşehir University at 1 site in Turkey (Türkiye).
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 4 inclusion and 6 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 3 Nov 2026. 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 Turkey (Türkiye). 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?
Change in Maximum Mouth Opening (MMO) (time frame: Immediately before arthrocentesis and at 1 week, 1 month, and 3 months after arthrocentesis.). The study lists 2 primary outcomes in all. 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 3 Nov 2026.