Prediction of Temporomandibular Involvement in Juvenile Idiopathic Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Clinical findings in children with JIA
研究概览
简要总结
Purpose and aims The general aim of this project is to improve the diagnostic methods for disease activity and identify predictive factors (clinical and radiographic factors, pro- and anti-inflammatory mediators in saliva and plasma) for temporomandibular joint (TMJ) involvement in juvenile idiopathic arthritis (JIA).
The hypothesis is that self-reported pain and impaired jaw function together with clinical findings correlates well with radiological signs of jaw involvement.
Null hypothesis: Self-reported pain, impaired jaw function and clinical findings do not correlate with radiological signs of jaw involvement.
Study 1 The aim of this study is to investigate which findings from the patient history and from clinical examination that is of significance for diagnostics of TMJ involvement in patients with JIA both in a short- and long-term perspective. The patients will be followed-up during two years. They will undergo a clinical examination according to Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD; Dworkin and LeResche 1992) once a year and a telephone follow-up sixth months after the clinical examination. Further, the clinical findings from the orofacial regions will be compared to their general disease activity.
Study 2 The aim of the second study is to correlate radiological findings and clinical findings in order to investigate any early radiological signs of disease activity and progression but also to compare the radiographic examination using conventional panoramic technique with computer tomography (CT).
详细描述
One-hundred consecutive patients with active JIA, as diagnosed by the Department of Pediatric Rheumatology, Astrid Lindgrens Barnsjukhus, Karolinska University Hospital will be included.
Inclusion criteria are:
- age between 7 and 14 years
- a diagnosis of JIA according to the International League of Associations for rheumatology
Exclusion criteria are:
- current malignancies
- TMJ surgery or trauma within two years
- recent intra-articular glucocorticoid injection in TMJ (within 1 month)
- other conditions or diseases than JIA that may cause orofacial pain. The parents of the patients and/or the patients will give their verbal and written informed consent to participate in the study according to the permission from the regional ethical committee 2011/2:1.
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
- 7 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 7 and 14 years
- •a diagnosis of JIA according to the International League of Associations for rheumatology (ILAR) The parents of the patients and/or the patients will give their verbal and written informed consent to participate in the study according to the permission from the regional ethical committee 2011/2:1.
排除标准
- •current malignancies
- •TMJ surgery or trauma within two years
- •recent intra-articular glucocorticoid injection in TMJ (within 1 month)
- •other conditions or diseases than JIA that may cause orofacial pain.
结局指标
主要结局
Clinical findings in children with JIA
时间窗: 2 years
To find similarities in patients with JIA according to RDC-TMD (a clinical protocol validated for children)
Patient history
时间窗: Two years
Repeated interview on function and pain in the jaw area
Radiographic findings in children with JIA
时间窗: Two years
Repeated radiographic examination
次要结局
未报告次要终点
研究者
Malin Collin
DDS, PhD-student
Folktandvården Stockholms län AB