Arthroscopic lysis and lavage versus operative arthroscopy for TMJ disc displacement with reduction
Temporomandibular Joint Arthroscopic Lysis and Lavage Compared to Operative Arthroscopy in Disc Displacement With Reduction: a Randomised, Double-blind, Controlled Trial
NA · Karolinska Institutet · NCT06782191
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 96 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Karolinska Institutet (other) |
| Locations | 1 site (Huddinge) |
| Trial ID | NCT06782191 on ClinicalTrials.gov |
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.
Who should consider this trial
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).
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Huddinge
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Temporomandibular Joint Disc Displacement, With Reduction, Temporomandibular Disorders