RecruitingNot ApplicableNCT06782191

TMJ Arthroscopic Lysis and Lavage Compared to Operative Arthroscopy in Disc Displacement With Reduction.

Temporomandibular Joint Arthroscopic Lysis and Lavage Compared to Operative Arthroscopy in Disc Displacement With Reduction: a Randomised, Double-blind, Controlled Trial


Sponsor

Karolinska Institutet

Enrollment

96 participants

Start Date

Apr 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to compare the intervention arthroscopic lysis and lavage to the intervention operative arthroscopy in treating disabling and painful temporomandibular joint disc displacement with 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 operative arthroscopy to see if operative arthroscopy 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.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • Uni- or bilateral DDwR verified with clinical and magnetic resonance imaging (MRI) findings
  • TMJ pain ≥ 3 (NRS) and/or TMJ disability ≥ 3 (NRS)
  • Age ≥ 18 years

Exclusion Criteria4

  • Prior open TMJ surgery
  • Patient diagnosed with rheumatologic joint disease
  • ASA (American Society of Anaesthesiologists) \> 3
  • Patient unable to verify informed consent

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Interventions

PROCEDUREArthroscopic lysis and lavage

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.

PROCEDUREOperative arthroscopy

Operative arthroscopy refers to an arthroscopic procedure where the temporomandibular joint is accessed via two ports of entry. The joint is rinsed with saline solution and the anterior disc attachment is released with cold ablation where after the posterior attachment is sclerosed with the coagulation mode on the coblator.


Locations(1)

Karolinska Institutet

Huddinge, Sweden

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NCT06782191


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