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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorKarolinska Institutet

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Arthroscopy & saline irrigation alone

    Procedure/Surgery

    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

    Procedure/Surgery

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

Treatment groups

91 Participants
are divided into 1 treatment group
Group A: Surgically treated patients due to temporomandibular joint disc displacment2 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
From intervention to the 10 year follow up.

Secondary outcomes

1

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.

Time frame
From intervention to the 10 year follow up.

Other outcomes

1

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.

Time frame
From intervention to the 10 year follow up.
2

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.

Time frame
From intervention to the 10 year follow up.
3

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.

Time frame
From intervention to the 10 year follow up.
4

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.

Time frame
From intervention to the 10 year follow up.

Sponsors and contacts

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Karolinska Institutet

Lead sponsor

Karolinska University Hospital

Collaborator