Tissue and Clinical Characterisation of Temporomandibular Joint Diseases

Completed

• Conditions: Temporomandibular Joint Disc Displacement; Temporomandibular Joint Disorders; Temporomandibular Joint Osteoarthritis; Temporomandibular Arthritis
• Interventions: Procedure: Arthroscopy or discectomy with sampling of synovial fluid and synovial tissue

• Registration Number: NCT04251455
• Lead Sponsor: Karolinska Institutet

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.

Detailed Description

TMJ disc displacement is common, affecting 20-30% of the population. Some of these patients will eventually need health-care attention. Patients with TMJ osteoarthritis (OA) or chronic inflammatory arthritis (CIA) are not that common, prevalence numbers are lacking. These TMJ diseases or dysfunctions can severely affect the patients' well-being because of local pain, chewing problems, psychosocial impact, amongst others. Treatment is primarily non-invasive to its character where orthotic splint, physiotherapy, medication, or other treatments can be evaluated. Patients who do not respond to these efforts might have surgery. Arthroscopy is a minimal invasive intervention with a described success rate from 50-90%. From the patients', the society and the surgeons' point of view, better individual pre-operative prognostication is valuable. TMJ disc displacement, OA and CIA is not fully characterised in terms of aetiopathogenesis. There are studies investigating components of extra cellular matrix and cytokines TMJ. The multitude of proteins still not studied may contribute in an unknown fashion to new insights in aetiology and to new treatment opportunities. The aim of the study is to characterise synovial tissue, synovial fluid, and clinical parameters and relate them to the specific TMJ diagnosis but also to each others. A secondary aim is to relate the outcome of surgery to both clinical and tissue variables in order to determine if there are factors that might function as predictors of outcome. A tertiary aim is to investigate if patients who suddenly develops disc displacement without reduction (DDwoR) without any prior signs or symptoms from the TMJ differs in their tissue or clinical characteristics compared to patients who develops DDwoR after having prior signs or symptoms from the TMJ.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-01-14
• Primary Completion: 2018-06-05
• Study Completion: 2018-06-05
• Status Verified: 2020-01
• Study First Submitted: 2020-01-28
• Study First Submitted QC: 2020-01-30
• Last Update Submitted: 2020-01-30
• Study First Posted: 2020-02-05
• Last Update Posted: 2020-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TMJ disease/disorder characterisation	Arthroscopy or discectomy with sampling of synovial fluid and synovial tissue	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.

Primary Outcome Measures

Name	Time	Method
Characterisation of synovial tissue	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	1-5 years after study completion	Synovial fluid, harvested during surgery, will be assessed through: immunoassays, masspectrometry.

Secondary Outcome Measures

Name	Time	Method
Comparison of protein content	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	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	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	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

Trial Locations

Locations (1)

Karolinska Institutet, Department of Dental Medicine; 🇸🇪 Huddinge, Sweden