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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Sweden
Karolinska Institutet
RECRUITING
Huddinge
Contact Information
Primary
Mattias Ulmner, DDS, PhD
mattias.ulmner@ki.se
+46 707648141
Time Frame
Start Date: 2025-04-01
Estimated Completion Date: 2031-02
Participants
Target number of participants: 96
Treatments
Active_comparator: Arthroscopic 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. This is mananged through one port of entry into the joint.
Experimental: Operative 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.
Related Therapeutic Areas
Sponsors
Collaborators: Eastmaninstitutet, Karolinska University Hospital
Leads: Karolinska Institutet

This content was sourced from clinicaltrials.gov