Ignite Creation Date:
2025-12-24 @ 2:30 PM
Ignite Modification Date:
2026-02-22 @ 4:13 AM
Study NCT ID:
NCT03904459
Status:
UNKNOWN
Last Update Posted:
2019-04-05
First Post:
2019-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Jaw, Mouth and Bone Health, and Quality of Life in Children With Juvenile Idiopathic Arthritis (JIA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001171', 'term': 'Arthritis, Juvenile'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Whole blood, serum, stimulated and unstimulated saliva'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 452}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-03-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2020-06-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-04-03', 'studyFirstSubmitDate': '2019-04-03', 'studyFirstSubmitQcDate': '2019-04-03', 'lastUpdatePostDateStruct': {'date': '2019-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bone mineral density', 'timeFrame': '2 years', 'description': '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'}, {'measure': 'Joint inflammation and damage', 'timeFrame': '2 years', 'description': 'defined according to predefined standard protocol for 3-Tesla MRI of the temporomandibular joints'}, {'measure': 'caries experience DMFTS/dmfts', 'timeFrame': '2 years', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Temporomandibular Joint', 'Oral Health', 'Bone & Bones', 'Bone Density', 'Quality of Life'], 'conditions': ['Arthritis, Juvenile']}, 'referencesModule': {'references': [{'pmid': '40537274', 'type': 'DERIVED', 'citation': 'Lundestad 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.'}, {'pmid': '39558411', 'type': 'DERIVED', 'citation': "Arneng 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."}, {'pmid': '37986155', 'type': 'DERIVED', 'citation': 'Halbig 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.'}, {'pmid': '36627622', 'type': 'DERIVED', 'citation': 'Augdal 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.'}, {'pmid': '33050890', 'type': 'DERIVED', '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.'}], 'seeAlsoLinks': [{'url': 'http://www.norjia.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '4 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* fulfilling the ILAR criteria for juvenile idiopathic arthritis\n\nExclusion Criteria:\n\n* no consent'}, 'identificationModule': {'nctId': 'NCT03904459', 'acronym': 'NorJIA', 'briefTitle': 'Jaw, Mouth and Bone Health, and Quality of Life in Children With Juvenile Idiopathic Arthritis (JIA)', 'organization': {'class': 'OTHER', 'fullName': 'Haukeland University Hospital'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'NorJIA'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'cases', 'description': 'Children with juvenile idiopathic arthritis', 'interventionNames': ['Other: no intervention']}, {'label': 'controls', 'description': 'healthy children', 'interventionNames': ['Other: no intervention']}], 'interventions': [{'name': 'no intervention', 'type': 'OTHER', 'armGroupLabels': ['cases', 'controls']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bergen', 'country': 'Norway', 'facility': 'Oral Health Centre of Expertise West Norway', 'geoPoint': {'lat': 60.39299, 'lon': 5.32415}}, {'city': 'Tromsø', 'country': 'Norway', 'facility': 'Oral Health Centre of Expertise North Norway', 'geoPoint': {'lat': 69.6489, 'lon': 18.95508}}, {'city': 'Tromsø', 'country': 'Norway', 'facility': 'University Hospital in North Norway', 'geoPoint': {'lat': 69.6489, 'lon': 18.95508}}, {'city': 'Trondheim', 'country': 'Norway', 'facility': 'Oral heath Centre of Expertise Mid Norway', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}, {'city': 'Trondheim', 'country': 'Norway', 'facility': 'St Olavs Hospital', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}], 'overallOfficials': [{'name': 'Ansgar Berg', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Pediatrics, Haukeland University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Haukeland University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'St. Olavs Hospital', 'class': 'OTHER'}, {'name': 'University Hospital of North Norway', 'class': 'OTHER'}, {'name': 'Oral Health Centre of Expertise Mid, North and West Norway', 'class': 'UNKNOWN'}, {'name': 'Norwegian University of Science and Technology', 'class': 'OTHER'}, {'name': 'University of Tromso', 'class': 'OTHER'}, {'name': 'University of Bergen', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}