Long-term Follow up of TMJ Surgery and Evaluation of the 6-month Control as a Prognostic Marker.
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| Karolinska Institutet | Huddinge | Sweden | Recruiting |
More Karolinska Institutet trials in Sweden
Other trials for the same condition
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