Tissue and Clinical Characterisation of Temporomandibular Joint Diseases

NCT04251455 | Completed

• 1 other identifier: 2014/622-31/1
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Temporomandibular joint (TMJ) diseases or dysfunctions affects many patients. Surgical treatment is planned when non-invasive interventions have failed. Still, much is not known regarding aetiology of TMJ diseases and how and why the disease develops over time. The study aims to investigate synovial tissue, synovial fluid and clinical characteristics for patients with TMJ diseases or dysfunctions designated for surgery. Patient samples and clinical variables will be analysed in relation to TMJ diagnosis and related to surgical outcome. The study is a cohort observational study.

Conditions

Temporomandibular Joint Disorders; Temporomandibular Arthritis; Temporomandibular Joint Disc Displacement; Temporomandibular Joint Osteoarthritis

Outcome Measures

Primary Outcomes (2)

• Characterisation of synovial tissue

  Synovial tissue, harvested during surgery, will be assessed through: common histo-pathology analysis, immunohistochemistry, protein analysis in immunoassays, cell characterisation with flow cytometry, and gene expression profiles with PCR.

  1-5 years after study completion

• Characterisation of synovial fluid

  Synovial fluid, harvested during surgery, will be assessed through: immunoassays, masspectrometry.

  1-5 years after study completion

Secondary Outcomes (4)

• Comparison of protein content

  1-5 years after study completion

• Outcome of surgery, change in four different variables

  Pre-surgery,6 months after surgery

• Factors predicting surgery

  Pre-surgery, during surgery

• General joint hypermobility

  Pre-surgery.

Study Arms (1)

TMJ disease/disorder characterisation

Patients with the diagnosis disc displacement without reduction (DDwoR), or disc displacement with reduction (DDwR), or osteoarthritis (OA), or chronic inflammatory arthritis (CIA) were designated to TMJ surgery. According to the Swedish national guidelines on TMJ surgery DDwoR, OA, and CIA patients had arthroscopy and DDwR had discectomy.

Procedure: Arthroscopy or discectomy with sampling of synovial fluid and synovial tissue

Interventions

Arthroscopy or discectomy with sampling of synovial fluid and synovial tissue PROCEDURE

Arthroscopic lysis and lavage: performed under general anaesthesia. Before initiation of arthroscopy synovial fluid was sampled with a push-and-pull method. The TMJ was investigated with an arthroscope during irrigation with sterile saline solution. Adhesions were addressed with a coblator. Synovial tissue biopsies were taken from the posterior attachment of the disc. Discectomy without replacement: performed under general anaesthesia. Before initiation of surgery, synovial fluid was sampled as above described. During surgery synovial tissue biopsies were taken as described above.

TMJ disease/disorder characterisation

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

Patients referred to the department of Craniofacial Diseases, Karolinska University Hospital, Stockholm, Sweden, because of disc displacement with reduction (DDwR), disc displacement without reduction (DDwoR), osteoarthritis, and chronic inflammatory arthritis (CIA) were eligible for inclusion. Written informed consent were mandatory. Diagnoses were set according to the Diagnostic Criteria for Temporomandibular Disorders accept CIA, where a rheumatologist had to set the diagnosis. Apart from above mentioned diagnoses criteria for surgery were: visual analogue scale (VAS) value of ≥ 4 for TMJ pain or TMJ disability, and DDwoR patients had to have a maximal interincisal opening (MIO) of ≤ 35 mm.

You may qualify if:

• Age 18 or older
• diagnosis DDwoR, DDwR, OA, or CIA
• conservative treatment (i.e. orthotic split, physiotherapy, medication) tried for at least 3-6 months without success

You may not qualify if:

• earlier TMJ surgery
• age under 18 years
• patients not able to give informed consent

Sponsors & Collaborators

• Karolinska Institutet: lead
• University of Bergen: collaborator
• University of Oslo: collaborator

Study Sites (1)

Karolinska Institutet, Department of Dental Medicine

Huddinge, 14104, Sweden

Location

Biospecimen

Retention: SAMPLES WITH DNA

Synovial tissue: biopsies taken from the superior aspect of the posterior band of the TMJ disc attachment. Synovial fluid: synovial fluid samples will be taken with the push-and-pull method.

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

• Bodil Lund, Professor

  Karolinska Institutet, University of Bergen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 28, 2020
• First Posted: February 5, 2020
• Study Start: January 14, 2014
• Primary Completion: June 5, 2018
• Study Completion: June 5, 2018
• Last Updated: February 5, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)