Tissue and Clinical Characterisation of Temporomandibular Joint Diseases
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|ClinicalTrials.gov Identifier: NCT04251455|
Recruitment Status : Completed
First Posted : February 5, 2020
Last Update Posted : February 5, 2020
|Condition or disease||Intervention/treatment|
|Temporomandibular Joint Disorders Temporomandibular Arthritis Temporomandibular Joint Disc Displacement Temporomandibular Joint Osteoarthritis||Procedure: Arthroscopy or discectomy with sampling of synovial fluid and synovial tissue|
|Study Type :||Observational|
|Actual Enrollment :||100 participants|
|Official Title:||Tissue and Clinical Characterisation of Temporomandibular Joint Diseases|
|Actual Study Start Date :||January 14, 2014|
|Actual Primary Completion Date :||June 5, 2018|
|Actual Study Completion Date :||June 5, 2018|
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
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.
- Characterisation of synovial tissue [ Time Frame: 1-5 years after study completion ]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.
- Characterisation of synovial fluid [ Time Frame: 1-5 years after study completion ]Synovial fluid, harvested during surgery, will be assessed through: immunoassays, masspectrometry.
- Comparison of protein content [ Time Frame: 1-5 years after study completion ]Extracted synovial fluid and synovial tissue will be compared with each other according to protein content.
- Outcome of surgery, change in four different variables [ Time Frame: Pre-surgery,6 months after surgery ]Outcome of surgery is based on four different variables: objective measurement of MIO (≥35mm), TMJ pain (≤3 on a 0-10 scale), TMJ disability (≤3 on a 0-10 scale), and TMJ psychosocial impact (≤3 on a 0-10 scale). The variables are measured berfore surgery and 6 months after surgery.
- Factors predicting surgery [ Time Frame: Pre-surgery, during surgery ]Clinical parameters (anamnestic variables,medical variables, TMJ diagnoses and subdiagnoses, objective and subjective measurements) will be related to surgical outcome. Synovial tissue and synovial fluid characteristics (as analysed per above described) related to outcome of surgery.
- General joint hypermobility [ Time Frame: Pre-surgery. ]Joint mobility measured by the Beighton score, 0-3=normal joint mobility, 4-9 general joint mobility. Joint mobility (general and normal) related to surgical outcome
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04251455
|Karolinska Institutet, Department of Dental Medicine|
|Huddinge, Sweden, 14104|
|Principal Investigator:||Bodil Lund, Professor||Karolinska Institutet, University of Bergen|