Arthroscopic lysis and lavage versus operative arthroscopy for TMJ disc displacement with reduction
Official title: Temporomandibular Joint Arthroscopic Lysis and Lavage Compared to Operative Arthroscopy in Disc Displacement With Reduction: a Randomised, Double-blind, Controlled Trial
Run by Karolinska Institutet · NCT06782191 · Data updated 2026-11-12
This study tests two types of TMJ arthroscopy to see which one better improves mouth opening, reduces pain, and helps daily function in adults with painful disc displacement that reduces.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 96 (estimated) |
| Sponsor | Karolinska Institutet Academic / other |
| Locations | 1 site (Huddinge) |
| Status | Recruiting |
| Started | April 1, 2025 |
| Main results expected | February 2029 |
| Study ends | February 2031 |
| Registry record updated | August 6, 2026 |
| Trial ID | NCT06782191 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (age ≥18) with uni- or bilateral MRI‑verified TMJ disc displacement with reduction who report TMJ pain and/or disability of at least 3 on a numeric rating scale, have not had prior open TMJ surgery, do not have rheumatologic joint disease, can give informed consent, and are medically fit for anesthesia (ASA ≤3).
✕Probably not a fit
People under 18, those with prior open TMJ surgery, rheumatologic joint disease, ASA >3, inability to give informed consent, or very mild symptoms (pain/disability <3) are unlikely to be eligible or to benefit from the procedures tested.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The trial compares arthroscopic lysis and lavage to operative arthroscopy as surgical options for adults with MRI‑verified temporomandibular joint disc displacement with reduction. Participants receive one of the two procedures under general anesthesia without knowing which procedure they receive. Clinical outcomes including mouth opening, TMJ pain, TMJ-related disability, and three quality-of-life questionnaires are collected at 1, 3, 6, 12, and 24 months after surgery. Researchers will also examine pre- and peri-operative variables to identify possible predictors of surgical outcome.
Why it matters
Potential benefit: If successful, the findings could help surgeons choose the surgical method that gives better mouth opening and less pain and disability for people with TMJ disc displacement with reduction.
How similar studies have gone: Arthroscopic techniques for TMJ disorders have been used before with some positive reports, but direct comparative evidence between lysis/lavage and more extensive operative arthroscopy is limited and mixed.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Uni- or bilateral DDwR verified with clinical and magnetic resonance imaging (MRI) findings * TMJ pain ≥ 3 (NRS) and/or 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.