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Clinical Trials in Sweden / NCT06782191
Recruiting Not applicable

TMJ Arthroscopic Lysis and Lavage Compared to Operative Arthroscopy in Disc Displacement With Reduction.

NCT06782191 · tracked via the Priya Life Science Sweden tracker
Sponsor
Karolinska Institutet
Phase
Not applicable
Started
2025-04-01
Last updated
2026-08-06

Condition(s) studied

Temporomandibular Joint Disc Displacement, With ReductionTemporomandibular Disorders (TMD)

Investigational drug(s) / intervention(s)

Arthroscopic lysis and lavageOperative arthroscopy

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.

Operative arthroscopy: Operative arthroscopy refers to an arthroscopic procedure where the temporomandibular joint is accessed via two ports of entry. The joint is rinsed with saline solution and the anterior disc attachment is released with cold ablation where after the posterior attachment is sclerosed with the coagulation mode on the coblator.

Study summary

The goal of this clinical trial is to compare the intervention arthroscopic lysis and lavage to the intervention operative arthroscopy in treating disabling and painful temporomandibular joint disc displacement with 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 operative arthroscopy to see if operative arthroscopy 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 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

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 (yes/no). 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

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Other trials for the same condition

TMJ Arthroscopy Compared to Arthrocentesis in Disc Displacement Without Reduction Recruiting
Virtual Planning of Total Temporomandibular Joint Replacement Recruiting
Long-term Follow up of TMJ Surgery and Evaluation of the 6-month Control as a Prognostic Marker. 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 NCT06782191 on ClinicalTrials.gov ↗ ← All trials in Sweden