The goal of this clinical trial is to compare the intervention arthroscopic lysis and lavage to the intervention arthrocentesis in treating disabling and painful temporomandibular joint disc displacement without 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 arthrocentesis to see if arthroscopic lysis and lavage 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.
Uni- or bilateral DDwoR affecting the patients mouth opening capacity to a range of ≤ 35 mm, verified with clinical and magnetic resonance imaging (MRI) findings.
TMJ pain ≥ 3 (NRS)
TMJ disability ≥ 3 (NRS)
Age ≥ 18 years
Prior open TMJ surgery
Patient diagnosed with rheumatologic joint disease.
ASA (American Society of Anaesthesiologists) > 3
Patient unable to verify informed consent.
Parallel
Arthroscopic lysis and lavage
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.
Arthrocentesis/Saline
Procedure/SurgeryArthrocentesis refers to a blind irrigation of the temproromandibular joint with saline solution
Treatment outcome
The three criteria below have to be fulfilled to verify a good treatment outcome. 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.
Qulity of life surveys
to evaluate EQ-5D-5L, JFSL-8, and OHIP 14-S and what impact DDwoR has got on QoL and difference in QoL after intervention.
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 on a scale graded from 0 to 10. The value should reflect an average representative of the past 2-week period.
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.
Psychosocial impact
The patient is asked to estimate the psychosocial impact of their TMJ issues from 0 to 10. A score of 0 indicates no impact, while a score of 10 represents the worst imaginable impact. This may include how much and how often the patient thinks about their TMJ issues, how it affects their mood, and how it impacts their social life, such as withdrawing from social interactions.
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Karolinska Institutet
Lead sponsor
Eastmaninstitutet
Collaborator
Karolinska University Hospital
Collaborator
