ClinicalTrials.gg
CompletedNCT07914465Updated Nov 3, 2026

Clinical Outcomes of First-Line Temporomandibular Joint Arthrocentesis Versus Arthrocentesis Following Anti-Inflammatory Treatment

An interventional study of Temporomandibular Joint Arthrocentesis in Temporomandibular Disorders (TMDs) and Temporomandibular Joint Disc Displacement, Without Reduction, sponsored by Bahçeşehir University. Completed at 1 site in Turkey (Türkiye). Per ClinicalTrials.gov, last updated 2026-11-03.

Sponsored by Bahçeşehir University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 7 years 1 month after the study started (first participant enrolled Sep 2019, registered Oct 2026).
Updated Nov 3, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
28
Allocation
Randomized
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 150 studies in Temporomandibular Joint Disorders with a site in Turkey — 27 open to participants now, 28 under way, none of them phase 3. Temporomandibular Joint Disorders · Turkey.

Enrollment
69th of 80
28 · median 45
Started
2019
with 12 others
No phase
76 of 150
13 open now
Registered
150th of 150
by date
Lead sponsor
5 of 150
Bahçeşehir University

Among the 150 studies in Temporomandibular Joint Disorders with a site in Turkey, this one is the 69th largest by enrollment of the 80 interventional ones, is one of 13 that started in 2019, is one of 76 with no phase, and was the 150th registered.

By phase

150 studies; the count open now beside each. This study's row is marked.

No phasethis study76 · 13 open
Observational70 · 14 open
Phase 43 · 0 open
Phase 1/21 · 0 open

By the year they started

First in 2011; this study’s year is marked. 13 started in 2019.

Size and results

Median enrollment 45 across the 80 interventional studies, 78 across the 70 observational. Of the 114 that completed or were terminated, 4 (4%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 150 studies in Temporomandibular Joint Disorders with a site in Turkey, or all of them as a file.
02

Study summary

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.

03

Conditions studied

  • Temporomandibular Disorders (TMDs)
  • Temporomandibular Joint Disc Displacement, Without Reduction

Keywords

  • arthrocentesis
  • Temporomandibular Joint
  • Disc Displacement Without Reduction
04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 treatment or following insufficient pain control with anti-inflammatory medication.
  • Patients who provided to participate in the study.

Exclusion criteria

Exclusion Criteria:

  • 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
28 participants (actual)

Study arms

  • Experimental
    First-Line Arthrocentesis

    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.

    Procedure: Temporomandibular Joint Arthrocentesis

  • Experimental
    Arthrocentesis Following Anti-Inflammatory Treatment

    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.

    Procedure: Temporomandibular Joint Arthrocentesis

Interventions

  • ProcedureTemporomandibular Joint Arthrocentesis

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Immediately before arthrocentesis and at 1 week, 1 month, and 3 months after arthrocentesis.

  2. 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.

    Time frame: Immediately before arthrocentesis and at 1 week, 1 month, and 3 months after arthrocentesis.

07

Study locations

1 site
  • Ondokuz Mayıs Üniversitesi
    Samsun, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2019 to primary completion in Jan 2023, 39 months.

Of 242 non-industry interventional studies with no phase under Temporomandibular Joint Disorders, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 21. This study's 39 months is above that.

Counting every sponsor, half of 246 studies reached it within 10 months; a quarter within 5 and three quarters within 21.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 28, 2026
First posted
Nov 3, 2026
StartActual
Sep 11, 2019
Primary completionActual
Jan 1, 2023
CompletionActual
Apr 19, 2023
Last update
Nov 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 3, 2026
Show all 1 update
  1. Nov 3, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07914465
Responsible party
Dilara KAZAN (assistant prof, Bahçeşehir University) — Principal investigator
First posted
Nov 3, 2026
Start date
Sep 11, 2019
Primary completion
Jan 1, 2023
Completion
Apr 19, 2023
Last update
Nov 3, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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