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Recruiting Not applicable

TMJ Arthroscopy Compared to Arthrocentesis in Disc Displacement Without Reduction

NCT06782178 · tracked via the Priya Life Science Sweden tracker
Phase
Not applicable
Started
2025-04-01
Last updated
2026-08-06

Condition(s) studied

Temporomandibular Joint Disc DisplacementTemporomandibular Joint Disc Displacement, Without ReductionTemporomandibular Disorders (TMD)

Investigational drug(s) / intervention(s)

Arthroscopic lysis and lavageArthrocentesis/Saline

Arthroscopic lysis and lavage: Arthroscopic lysis and lavage refers to an arthroscopic procedure where the temporomandibular joint is rinsed with saline solution and where the joint capsule is distended and where adhesions are lysated bluntly.

Arthrocentesis/Saline: Arthrocentesis refers to a blind irrigation of the temproromandibular joint with saline solution

Study summary

The goal of this clinical trial is to compare the intervention arthroscopic lysis and lavage to the intervention arthrocentesis in treating disabling and painful temporomandibular joint disc displacement without reduction. The main questions it aims to answer are:

* Which surgical method that best improves mouth opening capacity, TMJ pain, and TMJ disability?
* If any pre- or peri-operative variable/-s could be identified as a predictor for surgical outcome? Researchers will compare arthroscopic lysis and lavage to arthrocentesis to see if arthroscopic lysis and lavage works better to treat temporomandibular joint disc displacement.

Participants will:

* Have one of the two interventions under general anesthesia, not knowing which intervention.
* Visit an external clinic for regular checkups at 1, 3, 6, 12, and 24 months after surgery.
* Answer three different quality of life surveys at the checkups.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Treatment outcome — From intervention to the 6 month postoperative follow up.
    The three criteria below have to be fulfilled to verify a good treatment outcome. 1. Maximum interincisal opening (MIO) of ≥ 35 mm, or an increase of MIO of ≥ 40 %. 2. Patient-reported TMJ pain. Visual analogue scale (VAS) ≤ 3, or ≤ 40% reduction. 3. Patient-reported TMJ disability. VAS ≤ 3, or a 40 % reduction.

Trial sites (1)

FacilityCityRegionStatus
Karolinska Institutet Huddinge Sweden Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06782178 on ClinicalTrials.gov ↗ ← All trials in Sweden