The Norwegian JIA Study - Temporo-mandibular Involvement, Oral Health, Uveitis, Bone Health and Quality of Life in Children With Juvenile Idiopathic Arthritis (JIA). A Large Multicentre Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 452
- 试验地点
- 5
- 主要终点
- Bone mineral density
研究概览
简要总结
The Norwegian JIA Study (NorJIA) is a prospective, longitudinal, multicenter, observational study of 250 children with juvenile idiopathic arthritis (JIA) and 250 healthy controls, attending the three Norwegian university clinics in Bergen, Tromsø, or Trondheim. The study will run over 5 years, and include extensive clinical, laboratory, radiological and oral examinations at baseline and after 2 years follow-up. There will be a special focus on the jaw (temporomandibular joints) with extensive imaging and clinical examination, aiming at establishing scoring systems for active and chronic disease and growth disturbances. Another focus is to study mouth and teeth problems, such as caries and gingivitis, and look for predictors of poor oral health in children with JIA compared to health peers. As chronic inflammation, reduced physical activity and certain anti-inflammatory drugs can be detrimental for bone strength and development, the investigators also want to study the bone health of children with JIA, and look for predictors of poor bone mineral density. The results of the study may contribute to better diagnostics of inflammatory processes, earlier detection of poor oral or bone health, and thereby point to possible prevention strategies to increase quality of life for children with JIA in the future.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 4 Years 至 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •fulfilling the ILAR criteria for juvenile idiopathic arthritis
排除标准
- •no consent
结局指标
主要结局
Bone mineral density
时间窗: 2 years
measured by a Dual-energy X-ray absorptiometry (DXA) scan of the hip, lumbar spine and total body with body composition and expressed in Z scores, number of standard deviations (SD) from the expected mean according to sex and age
Joint inflammation and damage
时间窗: 2 years
defined according to predefined standard protocol for 3-Tesla MRI of the temporomandibular joints
caries experience DMFTS/dmfts
时间窗: 2 years
Measured by: DMFTS = Number of decayed/missed/filled permanent teeth in the age group 12-17 years, or dmfts = No. of decayed/missed/filled primary teeth in children up to 11 years
次要结局
未报告次要终点
