About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Patients participating in the studies with ethical approval numbers EPN 2014/764-31/2 and 2014/622-31/1.
Initial diagnosis DDwR or DDwoR.
Disqualifiers
Patient unable to verify informed consent.
Trial population
The cohort has already been operated (arthroscopy or discectomy) due to temporomandibular joint disc displacement during the years 2014-2017, then participating in a prospective cohort study mainly focusing on surgical outcome predictors (ethical approval: 2014/622-31/1 and 2014/764-31/2). These patients will now be offered a clinical and radiological examination approximately 10 years postoperative.
Trial design
Cohort
Prospective
Treatments tested in this trial
Arthroscopy & saline irrigation alone
Procedure/SurgeryArthroscopic 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
Procedure/SurgeryDiscectomy refers to open temporomandibular joint surgery where the joint disc is completely removed without being replaced.
Treatment groups
Trial outcomes
Primary outcomes
Treatment success.
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
Secondary outcomes
Joint degeneration
At the timepoint of long-term examination, a radiological evaluation of the TMJ status will be made with a cone beam computed tomography (CBCT). The patients were evaluated preoperatively with a CBCT scan, which makes it possible to evaluate eventual time dependent deterioration of the joints.
Other outcomes
Maximum interincisal opening
Measured in millimeters. The distance between teeth 11 and 41 is measured as the patient opens their mouth as wide as possible. If this is not feasible due to malocclusion, tooth loss, etc., an alternative representative pair of front teeth is chosen for measurement. This should be noted in the patient's record to ensure consistent measurements in the future.
Pain in the temporomandibular joint (TMJ) during function
The patient is asked to estimate how much pain TMJ function (opening, biting, chewing, speaking, etc.) has caused on average over the past 2-week period. This estimation should exclude the worst imaginable pain. Each TMJ is assessed individually, meaning the patient should provide a numerical value between 0 (no pain) and 10 (worst imaginable pain) for each joint.
Pain in the temporomandibular joint at rest
The patient is asked to estimate pain in each TMJ at rest. The value should reflect an average representative of the past 2-week period.meaning the patient should provide a numerical value between 0 (no pain) and 10 (worst imaginable pain) for each joint.
Functional impairment of the temporomandibular joint
The patient is asked to estimate the degree of functional impairment caused by current TMJ issues. This variable includes both joint mobility and the ability to consume food. The scale is graded from 0 to 10. A score of 0 indicates no impairment, meaning unrestricted jaw opening and the ability to eat all types of food without difficulty. A score of 10 represents complete functional impairment, such as zero millimeters of opening or being able to consume only liquids due to the inability to chew solid food.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Karolinska Institutet
Lead sponsor
Karolinska University Hospital
Collaborator