Jaw, Mouth and Bone Health, and Quality of Life in Children With Juvenile Idiopathic Arthritis (JIA)

Arthritis, Juvenile Clinical Trial

— NorJIA  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03904459
• Other study ID #: NorJIA
• Status: Active, not recruiting
• Start date: March 25, 2015
• Est. completion date: June 20, 2020

Study information

• Verified date: April 2019
• Source: Haukeland University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 452
• Est. completion date: June 20, 2020
• Est. primary completion date: August 17, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 18 Years

Eligibility

Inclusion Criteria:

• fulfilling the ILAR criteria for juvenile idiopathic arthritis

Exclusion Criteria:

• no consent

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Juvenile

Intervention

Other:
• no intervention

Locations

Country	Name	City	State
Norway	Oral Health Centre of Expertise West Norway	Bergen
Norway	Oral Health Centre of Expertise North Norway	Tromsø
Norway	University Hospital in North Norway	Tromsø
Norway	Oral heath Centre of Expertise Mid Norway	Trondheim
Norway	St Olavs Hospital	Trondheim

Sponsors (7)

Lead Sponsor	Collaborator
Haukeland University Hospital	Norwegian University of Science and Technology, Oral Health Centre of Expertise Mid, North and West Norway, St. Olavs Hospital, University Hospital of North Norway, University of Bergen, University of Tromso

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone mineral density	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	2 years
Primary	Joint inflammation and damage	defined according to predefined standard protocol for 3-Tesla MRI of the temporomandibular joints	2 years
Primary	caries experience DMFTS/dmfts	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	2 years

External Links

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