Tissue and Clinical Characterisation of Temporomandibular Joint Diseases

NCT ID: NCT04251455

Last Updated: 2020-02-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-01-14
• Study Completion Date: 2018-06-05

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.

Conditions

Temporomandibular Joint Disorders; Temporomandibular Arthritis; Temporomandibular Joint Disc Displacement; Temporomandibular Joint Osteoarthritis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Arthroscopy or discectomy with sampling of synovial fluid and synovial tissue

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Bergen

OTHER

Sponsor Role: collaborator

University of Oslo

OTHER

Sponsor Role: collaborator

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Bodil Lund

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bodil Lund, Professor

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet, University of Bergen

Locations

Karolinska Institutet, Department of Dental Medicine

Huddinge, , Sweden

Countries

Sweden

Other Identifiers

2014/622-31/1

Identifier Type: -

Identifier Source: org_study_id