Long-term Follow up of TMJ Surgery and Evaluation of the 6-month Control as a Prognostic Marker.

NCT06782165 | Recruiting

• 1 other identifier: 2024-06070-01
• Study Type: observational
• Target: 91
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate the long-term outcome of surgical intervention (arthroscopy or discectomy) due to the diagnoses temporomandibular joint disc displacement with or without displacement. The main questions it aims to answer are:

• Does the surgical outcome recorded at the earlier 6-month follow up persist at the long-term follow up approximately 10 years postoperatively?
• How does the radiologically determined degree of joint degeneration change with time in patients that have had joint surgery? Researchers will compare the six-month surgical outcome to the ten-year outcome to see if temporomandibular joint surgery results are stable over time. Participants with an earlier performed joint surgery will:
• Have a clinical examination approximately ten years postoperatively.
• Have a temporomandibular joint x-ray scan performed (cone-beam computed tomography).

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Treatment success.

  Treatment outcome (successful, good, intermediate, deteriorated). This is ordinal data and a compiled judgement will be made after evaluating four different parameters: 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. 4. Patient-reported TMJ psychosocial impact. VAS ≤ 3, or a 40 % reduction. * Successful outcome: criteria 1-4 fulfilled * Good: criteria 1 and one or two of criteria 2-4 fulfilled * Intermediate: no criterias fulfilled * Deteriorated: criterias 1-4 worsened

  From intervention to the 10 year follow up.

Secondary Outcomes (1)

• Joint degeneration

  From intervention to the 10 year follow up.

Other Outcomes (10)

• Maximum interincisal opening

  From intervention to the 10 year follow up.

• Pain in the temporomandibular joint (TMJ) during function

  From intervention to the 10 year follow up.

• Pain in the temporomandibular joint at rest

  From intervention to the 10 year follow up.

Study Arms (1)

Surgically treated patients due to temporomandibular joint disc displacment

The cohort has already been operated (arthroscopy or discectomy) due to temporomandibular joint disc displacement during the years 2014-2017, then participating in a prospective cohort study mainly focusing on surgical outcome predictors (ethical approval: 2014/622-31/1 and 2014/764-31/2). These patients will now be offered a clinical and radiological examination approximately 10 years postoperative.

Procedure: Arthroscopy & saline irrigation alone; Procedure: Discectomy

Interventions

Arthroscopy & saline irrigation alone 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

Surgically treated patients due to temporomandibular joint disc displacment

Discectomy PROCEDURE

Discectomy refers to open temporomandibular joint surgery where the joint disc is completely removed without being replaced.

Surgically treated patients due to temporomandibular joint disc displacment

Eligibility Criteria

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

Study Population

The cohort has already been operated (arthroscopy or discectomy) due to temporomandibular joint disc displacement during the years 2014-2017, then participating in a prospective cohort study mainly focusing on surgical outcome predictors (ethical approval: 2014/622-31/1 and 2014/764-31/2). These patients will now be offered a clinical and radiological examination approximately 10 years postoperative.

You may qualify if:

• Patients participating in the studies with ethical approval numbers EPN 2014/764-31/2 and 2014/622-31/1.
• Initial diagnosis DDwR or DDwoR.

You may not qualify if:

• Patient unable to verify informed consent.

Sponsors & Collaborators

• Karolinska Institutet: lead
• Karolinska University Hospital: collaborator

Study Sites (1)

Karolinska Institutet

Huddinge, 14104, Sweden

RECRUITING

Related Publications (20)

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• Ulmner M, Sugars R, Naimi-Akbar A, Tudzarovski N, Kruger-Weiner C, Lund B. Synovial Tissue Proteins and Patient-Specific Variables as Predictive Factors for Temporomandibular Joint Surgery. Diagnostics (Basel). 2020 Dec 30;11(1):46. doi: 10.3390/diagnostics11010046.

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• Ulmner M, Bjornland T, Rosen A, Berge TI, Olsen-Bergem H, Lund B. Evidence for minimally invasive treatment-A systematic review on surgical management of disc displacement. J Oral Rehabil. 2024 Jun;51(6):1061-1080. doi: 10.1111/joor.13661. Epub 2024 Feb 23.

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• Schiffman E, Ohrbach R, Truelove E, Look J, Anderson G, Goulet JP, List T, Svensson P, Gonzalez Y, Lobbezoo F, Michelotti A, Brooks SL, Ceusters W, Drangsholt M, Ettlin D, Gaul C, Goldberg LJ, Haythornthwaite JA, Hollender L, Jensen R, John MT, De Laat A, de Leeuw R, Maixner W, van der Meulen M, Murray GM, Nixdorf DR, Palla S, Petersson A, Pionchon P, Smith B, Visscher CM, Zakrzewska J, Dworkin SF; International RDC/TMD Consortium Network, International association for Dental Research; Orofacial Pain Special Interest Group, International Association for the Study of Pain. Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) for Clinical and Research Applications: recommendations of the International RDC/TMD Consortium Network* and Orofacial Pain Special Interest Groupdagger. J Oral Facial Pain Headache. 2014 Winter;28(1):6-27. doi: 10.11607/jop.1151.

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  PMID: 11467389 BACKGROUND

• Lund B, Ulmner M, Bjornland T, Berge T, Olsen-Bergem H, Rosen A. A disease-focused view on the temporomandibular joint using a Delphi-guided process. J Oral Sci. 2020;62(1):1-8. doi: 10.2334/josnusd.19-0128.

  PMID: 31996510 BACKGROUND

• Leibur E, Jagur O, Muursepp P, Veede L, Voog-Oras U. Long-term evaluation of arthroscopic surgery with lysis and lavage of temporomandibular joint disorders. J Craniomaxillofac Surg. 2010 Dec;38(8):615-20. doi: 10.1016/j.jcms.2010.02.003. Epub 2010 Mar 23.

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• Kircos LT, Ortendahl DA, Mark AS, Arakawa M. Magnetic resonance imaging of the TMJ disc in asymptomatic volunteers. J Oral Maxillofac Surg. 1987 Oct;45(10):852-4. doi: 10.1016/0278-2391(87)90235-7.

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• Eriksson L, Westesson PL. Diskectomy in the treatment of anterior disk displacement of the temporomandibular joint. A clinical and radiologic one-year follow-up study. J Prosthet Dent. 1986 Jan;55(1):106-16. doi: 10.1016/0022-3913(86)90085-5. No abstract available.

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• Bjornland T, Larheim TA. Discectomy of the temporomandibular joint: 3-year follow-up as a predictor of the 10-year outcome. J Oral Maxillofac Surg. 2003 Jan;61(1):55-60. doi: 10.1053/joms.2003.50010.

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MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Arthroscopy; Diskectomy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Orthopedic Procedures; Therapeutics; Decompression, Surgical

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: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• 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: February 1, 2026
• Study Completion: May 1, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

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

Locations

SE (1)