Clinical trial NCT03904459: Jaw, Mouth and Bone Health, and Quality of Life in Children With Juvenile Idiopathic Arthritis (JIA)
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Arthritis, Juvenile
Keywords: Temporomandibular Joint
Oral Health
Bone & Bones
Bone Density
Quality of Life
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: University Hospital of North Norway
name: Oral Health Centre of Expertise Mid, North and West Norway
name: Norwegian University of Science and Technology
name: University of Tromso
name: University of Bergen
First posted: 2019-04-05
Enrollment: 452
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with juvenile idiopathic arthritis followed at any of the three participating centers according to hospital files. Controls are recruited at The Oral Health Centre of Expertise (Tk) Mid-Norway (TkMN), TkWest or at Tk Northern Norway (TkNN) from their lists of children due for a free visit to the dentist according to the Norwegian public dental service policy.

Brief 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.


Eligibility criteria: Inclusion Criteria:

* fulfilling the ILAR criteria for juvenile idiopathic arthritis

Exclusion Criteria:

* no consent

Primary outcomes:
measure: Bone mineral density
timeFrame: 2 years
measure: Joint inflammation and damage
timeFrame: 2 years
measure: caries experience DMFTS/dmfts
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Oral Health Centre of Expertise West Norway
city: Tromsø
country: Norway
facility: Oral Health Centre of Expertise North Norway
city: Tromsø
country: Norway
facility: University Hospital in North Norway
city: Trondheim
country: Norway
facility: Oral heath Centre of Expertise Mid Norway
city: Trondheim
country: Norway
facility: St Olavs Hospital
Study officials:
affiliation: Department of Pediatrics, Haukeland University Hospital
name: Ansgar Berg
role: STUDY_DIRECTOR
References:
citation: Fischer J, Skeie MS, Rosendahl K, Tylleskar K, Lie S, Shi XQ, Gil EG, Cetrelli L, Halbig J, von Wangenheim Marti L, Rygg M, Frid P, Stoustrup P, Rosen A. Prevalence of temporomandibular disorder in children and adolescents with juvenile idiopathic arthritis - a Norwegian cross- sectional multicentre study. BMC Oral Health. 2020 Oct 13;20(1):282. doi: 10.1186/s12903-020-01234-z.