TMJ Arthroscopy Compared to Arthrocentesis in Disc Displacement Without Reduction

NCT06782178 | Recruiting

• 1 other identifier: 2023-06294-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Temporomandibular Joint Disc Displacement; Temporomandibular Joint Disc Displacement, Without Reduction; Temporomandibular Disorders (TMD)

Outcome Measures

Primary Outcomes (1)

• 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.

  From intervention to the 6 month postoperative follow up.

Secondary Outcomes (1)

• Qulity of life surveys

  From intervention to the 6 month postoperative follow up.

Other Outcomes (10)

• Pain in the temporomandibular joint (TMJ) during function

  From intervention to the 6 month postoperative follow up.

• Pain in the temporomandibular joint at rest

  From intervention to the 6 month postoperative follow up.

• Functional impairment of the temporomandibular joint

  From intervention to the 6 month postoperative follow up.

Study Arms (2)

Arthroscopic lysis and lavage

EXPERIMENTAL

Procedure: Arthroscopic lysis and lavage

Arthrocentesis

ACTIVE COMPARATOR

Procedure: Arthrocentesis/Saline

Interventions

Arthroscopic lysis and lavage PROCEDURE

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.

Arthroscopic lysis and lavage

Arthrocentesis/Saline PROCEDURE

Arthrocentesis refers to a blind irrigation of the temproromandibular joint with saline solution

Arthrocentesis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Karolinska Institutet: lead
• Eastmaninstitutet: collaborator
• Karolinska University Hospital: collaborator

Study Sites (1)

Karolinska Institutet

Huddinge, 14104, Sweden

RECRUITING

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MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Therapeutic Irrigation; Arthrocentesis; Sodium Chloride

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Hydrotherapy; Physical Therapy Modalities; Therapeutics; Rehabilitation; Investigative Techniques; Paracentesis; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Mattias Ulmner, DDS, PhD

  Karolinska Institutet, Department of Dental Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mattias Ulmner, DDS, PhD

CONTACT

+46 707648141; mattias.ulmner@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: January 2, 2025
• First Posted: January 17, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2030
• Last Updated: June 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Study protocol and SAP is available through ClinicalTrials.

Locations

SE (1)