Arthritis, JuvenileNorJIANCT03904459
Jaw, Mouth and Bone Health, and Quality of Life in Children With Juvenile Idiopathic Arthritis (JIA)
An observational study of Arthritis, Juvenile, run by Haukeland University Hospital at 5 sites in Norway.
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. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Arthritis, Juvenile
- How many people
- 452 participants
- Where
- 5 sitesNorway
- Study dates
- 25 Mar 2015to 20 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- fulfilling the ILAR criteria for juvenile idiopathic arthritis
Who cannot join
- no consent
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Norway5 sites
Oral Health Centre of Expertise West Norway
Bergen
Oral Health Centre of Expertise North Norway
Tromsø
University Hospital in North Norway
Tromsø
Oral heath Centre of Expertise Mid Norway
Trondheim
St Olavs Hospital
Trondheim
About this study
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
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.
- Conditions
- Arthritis, Juvenile
- Being tested
- no intervention
- Keywords
- Temporomandibular Joint, Oral Health, Bone & Bones, Bone Density, Quality of Life
- Medical subject headings
- Arthritis, Juvenile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
| Study group | Role | What they receive |
|---|---|---|
| cases | Children with juvenile idiopathic arthritis Receives: Other: no intervention | |
| controls | healthy children Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Joint inflammation and damage
defined according to predefined standard protocol for 3-Tesla MRI of the temporomandibular joints
Measured: 2 years
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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2019
- Study start25 Mar 2015
- Primary completion17 Aug 2018
- Study completion20 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Arthritis, JuvenileStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 452 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital, University Hospital of North Norway, Oral Health Centre of Expertise Mid, North and West Norway, Norwegian University of Science and Technology, University of Tromso, University of Bergen
- Responsible party
- Sponsor
- Investigators
- Ansgar Berg, Study director, Department of Pediatrics, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03904459
- Sponsor's protocol ID
- NorJIA
- Acronym
- NorJIA
- Status last verified
- Apr 2019
- First submitted
- 3 Apr 2019
- Last updated
- 5 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Halbig JM, Stoustrup P, Kristensen KD, Frid P, Rypdal V, Songstad NT, Augdal TA, Fischer J, Gil EG, Cetrelli L, Lundestad A, Angenete O, Aukland SM, Tylleskar K, Rosen A, Skeie MS, Rygg M, Rosendahl K, Jonsson B, Nordal E. Temporomandibular disorder in children with juvenile idiopathic arthritis with and without temporomandibular joint involvement compared to controls - a two-year prospective multicenter cohort study. BMC Oral Health. 2026 Jan 24;26(1):334. doi: 10.1186/s12903-026-07738-4.
PubMed 41580689Lundestad A, Cetrelli L, Angenete OW, Augdal TA, Tylleskar K, Nordal EB, Rosendahl K, Hoftun GB, Hoff M, Romundstad PR, Rygg M. Bone health in juvenile idiopathic arthritis compared with controls based on a Norwegian observational study. RMD Open. 2025 Jun 19;11(2):e005605. doi: 10.1136/rmdopen-2025-005605.
PubMed 40537274Arneng SM, Jenssen IP, Lundestad A, Cetrelli L, Angenete O, Nordal E, Tylleskar KB, Romundstad PR, Rygg M. The patient's voice: a cross-sectional study of physical health and disability in juvenile idiopathic arthritis. Pediatr Rheumatol Online J. 2024 Nov 18;22(1):100. doi: 10.1186/s12969-024-01034-7.
PubMed 39558411Halbig JM, Jonsson B, Gil EG, Astrom AN, Rypdal V, Frid P, Augdal TA, Fischer J, Cetrelli L, Rygg M, Lundestad A, Tylleskar K, Nordal E; Norwegian JIA Study - Temporo-mandibular Involvement, Oral Health, Uveitis, Bone Health, Quality of Life in Children with Juvenile Idiopathic Arthritis. Oral health-related quality of life, impaired physical health and orofacial pain in children and adolescents with juvenile idiopathic arthritis - a prospective multicenter cohort study. BMC Oral Health. 2023 Nov 20;23(1):895. doi: 10.1186/s12903-023-03510-0.
PubMed 37986155Augdal TA, Angenete OW, Shi XQ, Sall M, Fischer JM, Nordal E, Rosendahl K. Cone beam computed tomography in the assessment of TMJ deformity in children with JIA: repeatability of a novel scoring system. BMC Oral Health. 2023 Jan 10;23(1):12. doi: 10.1186/s12903-022-02701-5.
PubMed 36627622Fischer 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.
PubMed 33050890
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03904459
- Acronym / sponsor ID
- NorJIA / NorJIA
- Conditions
- Arthritis, Juvenile
- Keywords
- Temporomandibular Joint, Oral Health, Bone & Bones, Bone Density, Quality of Life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 452 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Collaborators
- St. Olavs Hospital, University Hospital of North Norway, Oral Health Centre of Expertise Mid, North and West Norway, Norwegian University of Science and Technology, University of Tromso, University of Bergen
- Study start
- 25 Mar 2015 (actual)
- Primary completion
- 17 Aug 2018 (actual)
- Study completion
- 20 Jun 2020 (estimated)
- First posted
- 5 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cases | – | Other: no interventionChildren with juvenile idiopathic arthritis |
| controls | – | Other: no interventionhealthy children |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (1 listed)
- fulfilling the ILAR criteria for juvenile idiopathic arthritis
Key exclusion criteria (1 listed)
- no consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no intervention | Other | cases, controls |
Primary outcome
Bone mineral density
Time frame: 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
Time frame: 2 years
defined according to predefined standard protocol for 3-Tesla MRI of the temporomandibular joints
caries experience DMFTS/dmfts
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2019.
- Derived from this study: PubMed 41580689Halbig JM, Stoustrup P, Kristensen KD, Frid P, Rypdal V, Songstad NT, Augdal TA, Fischer J, Gil EG, Cetrelli L, Lundestad A, Angenete O, Aukland SM, Tylleskar K, Rosen A, Skeie MS, Rygg M, Rosendahl K, Jonsson B, Nordal E. Temporomandibular disorder in children with juvenile idiopathic arthritis with and without temporomandibular joint involvement compared to controls - a two-year prospective multicenter cohort study. BMC Oral Health. 2026 Jan 24;26(1):334. doi: 10.1186/s12903-026-07738-4.
- Derived from this study: PubMed 40537274Lundestad A, Cetrelli L, Angenete OW, Augdal TA, Tylleskar K, Nordal EB, Rosendahl K, Hoftun GB, Hoff M, Romundstad PR, Rygg M. Bone health in juvenile idiopathic arthritis compared with controls based on a Norwegian observational study. RMD Open. 2025 Jun 19;11(2):e005605. doi: 10.1136/rmdopen-2025-005605.
- Derived from this study: PubMed 39558411Arneng SM, Jenssen IP, Lundestad A, Cetrelli L, Angenete O, Nordal E, Tylleskar KB, Romundstad PR, Rygg M. The patient's voice: a cross-sectional study of physical health and disability in juvenile idiopathic arthritis. Pediatr Rheumatol Online J. 2024 Nov 18;22(1):100. doi: 10.1186/s12969-024-01034-7.
- Derived from this study: PubMed 37986155Halbig JM, Jonsson B, Gil EG, Astrom AN, Rypdal V, Frid P, Augdal TA, Fischer J, Cetrelli L, Rygg M, Lundestad A, Tylleskar K, Nordal E; Norwegian JIA Study - Temporo-mandibular Involvement, Oral Health, Uveitis, Bone Health, Quality of Life in Children with Juvenile Idiopathic Arthritis. Oral health-related quality of life, impaired physical health and orofacial pain in children and adolescents with juvenile idiopathic arthritis - a prospective multicenter cohort study. BMC Oral Health. 2023 Nov 20;23(1):895. doi: 10.1186/s12903-023-03510-0.
- Derived from this study: PubMed 36627622Augdal TA, Angenete OW, Shi XQ, Sall M, Fischer JM, Nordal E, Rosendahl K. Cone beam computed tomography in the assessment of TMJ deformity in children with JIA: repeatability of a novel scoring system. BMC Oral Health. 2023 Jan 10;23(1):12. doi: 10.1186/s12903-022-02701-5.
- Derived from this study: PubMed 33050890Fischer 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ansgar Berg study director
Department of Pediatrics, Haukeland University Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthritis, Juvenile, run by Haukeland University Hospital at 5 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone mineral density (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03904459, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2019.