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Recruiting Observational

Long-term Follow up of TMJ Surgery and Evaluation of the 6-month Control as a Prognostic Marker.

NCT06782165 · tracked via the Priya Life Science Sweden tracker
Phase
Observational
Started
2025-04-01
Last updated
2026-08-07

Condition(s) studied

Temporomandibular Disorders (TMD)Temporomandibular Joint Disc Displacement, With ReductionTemporomandibular Joint Disc Displacement, Without Reduction

Investigational drug(s) / intervention(s)

Arthroscopy & saline irrigation aloneDiscectomy

Arthroscopy & saline irrigation alone: 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

Discectomy: Discectomy refers to open temporomandibular joint surgery where the joint disc is completely removed without being replaced.

Study summary

The goal of this clinical trial is to evaluate the long-term outcome of surgical intervention (arthroscopy or discectomy) due to the diagnoses temporomandibular joint disc displacement with or without displacement. The main questions it aims to answer are:

* Does the surgical outcome recorded at the earlier 6-month follow up persist at the long-term follow up approximately 10 years postoperatively?
* How does the radiologically determined degree of joint degeneration change with time in patients that have had joint surgery? Researchers will compare the six-month surgical outcome to the ten-year outcome to see if temporomandibular joint surgery results are stable over time.

Participants with an earlier performed joint surgery will:

* Have a clinical examination approximately ten years postoperatively.
* Have a temporomandibular joint x-ray scan performed (cone-beam computed tomography).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patients participating in the studies with ethical approval numbers EPN 2014/764-31/2 and 2014/622-31/1. * Initial diagnosis DDwR or DDwoR. Exclusion Criteria: * Patient unable to verify informed consent.

Primary outcome measure(s)

  • Treatment success. — From intervention to the 10 year follow up.
    Treatment outcome (successful, good, intermediate, deteriorated). This is ordinal data and a compiled judgement will be made after evaluating four different parameters: 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. 4. Patient-reported TMJ psychosocial impact. VAS ≤ 3, or a 40 % reduction. * Successful outcome: criteria 1-4 fulfilled * Good: criteria 1 and one or two of criteria 2-4 fulfilled * Intermediate: no criterias fulfilled * Deteriorated: criterias 1-4 worsened

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 NCT06782165 on ClinicalTrials.gov ↗ ← All trials in Sweden