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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
Sponsor:
Collaborators:
University of Bergen
University of Oslo
Information provided by (Responsible Party):
Bodil Lund, 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.

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

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.

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.





Primary Outcome Measures :
  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 Outcome Measures :
  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


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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

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


Locations
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Sweden
Karolinska Institutet, Department of Dental Medicine
Huddinge, Sweden, 14104
Sponsors and Collaborators
Karolinska Institutet
University of Bergen
University of Oslo
Investigators
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Principal Investigator: Bodil Lund, Professor Karolinska Institutet, University of Bergen
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Responsible Party: Bodil Lund, Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT04251455    
Other Study ID Numbers: 2014/622-31/1
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Joint Diseases
Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Musculoskeletal Diseases
Craniomandibular Disorders
Mandibular Diseases
Jaw Diseases
Muscular Diseases
Stomatognathic Diseases
Myofascial Pain Syndromes