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临床试验/NCT03904459
NCT03904459Unknown不适用

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

Haukeland University Hospital5 个研究点 分布在 1 个国家目标入组 452 人开始时间: 2015年3月25日最近更新:
适应症

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

研究者

发起方
Haukeland University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (5)

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