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

NCT06782191 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2025-06-29

No results posted yet for this study

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.

Conditions

  • Temporomandibular Joint Disc Displacement, With Reduction
  • Temporomandibular Disorders (TMD)

Interventions

PROCEDURE

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.

PROCEDURE

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.

Sponsors & Collaborators

  • Karolinska Institutet

    lead OTHER

  • Karolinska University Hospital

    collaborator OTHER

  • Eastmaninstitutet

    collaborator OTHER

Principal Investigators

  • Mattias Ulmner, DDS, PhD · Karolinska Institutet, Department of Dental Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-01
Primary Completion
2029-02-28
Completion
2031-02-28

Countries

  • Sweden

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06782191 on ClinicalTrials.gov