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NCT Number: NCT04251455

Tissue and Clinical Characterisation of Temporomandibular Joint Diseases

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.

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Key information

Conditions

Temporomandibular Joint Disorders Craniomandibular Disorders Jaw Diseases Joint Diseases Mandibular Diseases Muscular Diseases Musculoskeletal Diseases Stomatognathic Diseases Temporomandibular Arthritis Temporomandibular Joint Disc Displacement Temporomandibular Joint Osteoarthritis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Karolinska Institutet, Department of Dental Medicine

Huddinge, 14104, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. Characterisation of synovial fluid

    Time frame: 1-5 years after study completion

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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • University of Bergen
  • University of Oslo

Registry information

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Feb 5, 2020
Registry last updated
Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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