Tissue and Clinical Characterisation of Temporomandibular Joint Diseases

Temporomandibular Joint Disorders Clinical Trial

Official title:

Tissue and Clinical Characterisation of Temporomandibular Joint Diseases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04251455
• Other study ID #: 2014/622-31/1
• Status: Completed
• Start date: January 14, 2014
• Est. completion date: June 5, 2018

Study information

• Verified date: January 2020
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 5, 2018
• Est. primary completion date: June 5, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Joint Diseases
• Temporomandibular Arthritis
• Temporomandibular Joint Disc Displacement
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome
• Temporomandibular Joint Osteoarthritis

Intervention

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.

Locations

Country	Name	City	State
Sweden	Karolinska Institutet, Department of Dental Medicine	Huddinge

Sponsors (3)

Lead Sponsor	Collaborator
Karolinska Institutet	University of Bergen, University of Oslo

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Characterisation of synovial tissue	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.	1-5 years after study completion
Primary	Characterisation of synovial fluid	Synovial fluid, harvested during surgery, will be assessed through: immunoassays, masspectrometry.	1-5 years after study completion
Secondary	Comparison of protein content	Extracted synovial fluid and synovial tissue will be compared with each other according to protein content.	1-5 years after study completion
Secondary	Outcome of surgery, change in four different variables	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.	Pre-surgery,6 months after surgery
Secondary	Factors predicting 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.	Pre-surgery, during surgery
Secondary	General joint hypermobility	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	Pre-surgery.