Clinical trial NCT04251455: Tissue and Clinical Characterisation of Temporomandibular Joint Diseases
Official title: Tissue and Clinical Characterisation of Temporomandibular Joint Diseases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Temporomandibular Joint Disorders
Temporomandibular Arthritis
Temporomandibular Joint Disc Displacement
Temporomandibular Joint Osteoarthritis
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: University of Bergen
name: University of Oslo
First posted: 2020-02-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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

Primary outcomes:
measure: Characterisation of synovial tissue
timeFrame: 1-5 years after study completion
measure: Characterisation of synovial fluid
timeFrame: 1-5 years after study completion
Secondary outcomes:
measure: Comparison of protein content
timeFrame: 1-5 years after study completion
measure: Outcome of surgery, change in four different variables
timeFrame: Pre-surgery,6 months after surgery
measure: Factors predicting surgery
timeFrame: Pre-surgery, during surgery
measure: General joint hypermobility
timeFrame: Pre-surgery.
Other outcomes:
Locations:
city: Huddinge
country: Sweden
facility: Karolinska Institutet, Department of Dental Medicine
Study officials:
affiliation: Karolinska Institutet, University of Bergen
name: Bodil Lund, Professor
role: PRINCIPAL_INVESTIGATOR
References: