Arthroscopy versus arthrocentesis for TMJ disc displacement without reduction
Official title: Temporomandibular Joint Arthroscopic Lysis and Lavage Compared to Arthrocentesis in Disc Displacement Without Reduction: a Randomised, Double-blind, Controlled Trial
Run by Karolinska Institutet · NCT06782178 · Data updated 2026-11-12
This trial will try two surgical procedures — arthroscopic lysis and lavage versus arthrocentesis — to see which better helps adults with painful TMJ disc displacement that limits mouth opening.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Karolinska Institutet Academic / other |
| Locations | 1 site (Huddinge) |
| Status | Recruiting |
| Started | April 1, 2025 |
| Main results expected | February 2028 |
| Study ends | February 2030 |
| Registry record updated | August 6, 2026 |
| Trial ID | NCT06782178 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) with MRI-confirmed uni- or bilateral disc displacement without reduction causing mouth opening ≤35 mm and significant TMJ pain and disability (NRS ≥3) are the intended participants.
✕Probably not a fit
Patients with prior open TMJ surgery, diagnosed rheumatologic joint disease, ASA score >3, or who cannot provide informed consent are not likely to be eligible or to benefit from this trial.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults with MRI-confirmed temporomandibular joint (TMJ) disc displacement without reduction and reduced mouth opening are randomly assigned to receive either arthroscopic lysis and lavage or arthrocentesis under general anesthesia, with patients blinded to which procedure they receive. Outcomes include mouth opening capacity, TMJ pain, and TMJ-related disability measured before surgery and at 1, 3, 6, 12, and 24 months after the procedure, plus three quality-of-life questionnaires at follow-up visits. The trial also looks for pre- or peri-operative factors that predict better or worse surgical outcomes. Data will be compared between the two procedure groups to determine which method provides greater and more durable symptom relief.
Why it matters
Potential benefit: If successful, one procedure could provide better and longer-lasting improvement in mouth opening, reduce TMJ pain and disability, and improve eating and social functioning for affected patients.
How similar studies have gone: Previous studies have reported symptomatic improvement after both arthroscopy and arthrocentesis, but direct high-quality head-to-head comparisons are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Uni- or bilateral DDwoR affecting the patients mouth opening capacity to a range of ≤ 35 mm, verified with clinical and magnetic resonance imaging (MRI) findings. * TMJ pain ≥ 3 (NRS) * TMJ disability ≥ 3 (NRS) * Age ≥ 18 years Exclusion Criteria: * Prior open TMJ surgery * Patient diagnosed with rheumatologic joint disease. * ASA (American Society of Anaesthesiologists) \> 3 * Patient unable to verify informed consent.
Where it's running
-
Karolinska Institutet
Huddinge, Sweden Recruiting
Study contacts
- Principal investigator: Mattias Ulmner, DDS, PhD — Karolinska Institutet, Department of Dental Medicine
- Study coordinator: Mattias Ulmner, DDS, PhD
- Email: mattias.ulmner@ki.se
- Phone: +46 707648141
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.