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临床试验/NCT04251455
NCT04251455已完成不适用

Tissue and Clinical Characterisation of Temporomandibular Joint Diseases

Karolinska Institutet1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2014年1月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Characterisation of synovial tissue

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Characterisation of synovial tissue

时间窗: 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.

Characterisation of synovial fluid

时间窗: 1-5 years after study completion

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

次要结局

  • Factors predicting surgery(Pre-surgery, during surgery)
  • Comparison of protein content(1-5 years after study completion)
  • Outcome of surgery, change in four different variables(Pre-surgery,6 months after surgery)
  • General joint hypermobility(Pre-surgery.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bodil Lund

Professor

Karolinska Institutet

研究点 (1)

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