[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654478":3},{"organization":4,"outcomesModule":7,"designInfo":23,"detailedDescription":25,"studyPopulation":26,"armGroups":27,"interventions":22,"overallOfficials":22,"centralContacts":34,"locations":44,"responsibleParty":62,"collaborators":22,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":74,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":22,"studyType":81,"phases":22,"briefSummary":82,"conditions":83,"keywords":22,"overallStatus":47,"whyStopped":22,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Shanghai Jiao Tong University School of Medicine","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":22},[9],{"measure":10,"description":11,"timeFrame":12},"Oral Health Status","A comprehensive oral health examination is conducted by trained dentists in accordance with the World Health Organization Oral Health Surveys: Basic Methods. The examination covers dental hard tissue status, periodontal soft tissue status, oral hygiene status, oral mucosal assessment, and oral health-related behaviours. For dental caries assessment, each tooth is visually and tactilely examined under standardised lighting, and indices are calculated for permanent and primary dentition as appropriate. Periodontal status is evaluated using standardised probes to assess gingival bleeding and pocket depth. Oral hygiene is assessed following WHO recommendations; prior to evaluation, a disclosing agent is applied to tooth surfaces to visualise plaque, enabling standardised scoring of debris and calculus on representative surfaces. The oral mucosa is inspected for any soft tissue abnormalities. Oral health behaviours, including toothbrushing habits, dietary practices, and dental attendance.","At baseline, during a single routine outpatient visit immediately after written informed consent is obtained.",[14,18],{"measure":15,"description":16,"timeFrame":17},"Salivary Microbiota","The samples are analysed for microbial composition using 16S rRNA gene sequencing, assessing microbial diversity, relative abundance of major taxa, and compositional differences between study groups. In addition, levels of soluble inflammatory proteins are measured to evaluate local inflammatory status.","Baseline visit (fasting morning)",{"measure":19,"description":20,"timeFrame":21},"Disease Activity Assessment","Disease activity is assessed by experienced rheumatologists using standardised clinical evaluation at the baseline visit. The assessment includes joint examination (swollen and tender joint count), physician global assessment of disease activity on a visual analogue scale, and routine laboratory inflammatory markers (erythrocyte sedimentation rate and C-reactive protein level). Based on the combined findings, participants are classified as having active disease or being in clinical remission.","Baseline visit",null,{"allocation":22,"interventionModel":22,"interventionModelDescription":22,"primaryPurpose":22,"observationalModel":6,"timePerspective":24,"maskingInfo":22},"CROSS_SECTIONAL","Juvenile idiopathic arthritis (JIA) is the most common chronic rheumatic disease in children, characterised by alternating periods of active disease and remission. Despite therapeutic advances, joint involvement in the hands, wrists, or temporomandibular joints can hinder daily oral hygiene practices, and long-term medication use may affect the oral microenvironment, increasing the risk of dental caries and gingivitis. In current routine rheumatology follow-up in China, oral health status is not systematically assessed; it is usually addressed only when the child complains of symptoms, leading to delayed recognition and intervention.\n\nThis single-centre, cross-sectional observational study aims to compare oral health status between JIA children with different levels of disease activity and to preliminarily explore the association of salivary local biological characteristics with disease activity. No intervention is applied. All data are collected at a single time point during a regular outpatient visit.\n\nStudy Population Children aged 6 to 16 years who meet the ILAR classification criteria for JIA are eligible. Exclusion criteria include use of systemic antibiotics within the past 3 months, ongoing fixed orthodontic treatment, presence of other systemic conditions known to affect oral health (e.g., diabetes, Sjögren's syndrome), or inability to cooperate with the examination.\n\nGrouping and Assessments At enrolment, two experienced rheumatologists independently classify each participant as having \"active disease\" or \"clinical remission\" based on standardised clinical assessment (joint examination, physician global assessment, and routine laboratory inflammatory markers). During the same visit, the following are completed: (1) collection of demographic and disease-related data; (2) a comprehensive oral clinical examination conducted by trained dentists, covering dental hard tissues, periodontal soft tissues, and oral hygiene status; and (3) collection of unstimulated whole saliva for subsequent analysis of local inflammatory markers and microbial community profiles. All data are recorded using coded identifiers to protect participant privacy.\n\nStatistical Analysis Oral health parameters will be compared between the two groups, with multivariable methods used to control for potential confounders such as age, sex, and disease duration. The correlation between continuous disease activity scores and composite oral health indices will be evaluated. Saliva data will be explored for associations with disease activity and oral health parameters.\n\nClinical Significance This study addresses a long-neglected but clinically relevant question: whether disease activity in JIA is associated with oral health status. If children with active disease show poorer oral conditions, this would support the need for rheumatologists to actively inquire about oral hygiene habits and dental history during follow-up, and to consider incorporating basic oral health screening (e.g., questions on brushing, gum bleeding, toothache) into routine visits. Through this work, we aim to promote clinical awareness of oral health issues in children with chronic diseases and advocate for the inclusion of oral health assessment as a fundamental component of JIA chronic disease management, fostering collaboration between paediatric rheumatology and dentistry, and ultimately improving patients' quality of life.","Children aged 6 to 16 years diagnosed with juvenile idiopathic arthritis according to the ILAR classification criteria (excluding systemic-onset subtype), recruited from both inpatient and outpatient rheumatology services at the study site. Healthy controls aged 6 to 16 years with no history of chronic inflammatory or autoimmune diseases are recruited from the same city. All participants must be able to cooperate with oral examination and saliva collection. Written informed consent is obtained from parents or legal guardians, and assent from children.",[28,31],{"label":29,"type":22,"description":30,"interventionNames":22},"JIA group","Children aged 6 to 16 years diagnosed with juvenile idiopathic arthritis according to the ILAR classification criteria, receiving routine rheumatology care at the study site. Participants are classified into active disease or clinical remission subgroups based on standardised clinical assessment at enrolment. No intervention is applied.",{"label":32,"type":22,"description":33,"interventionNames":22},"Healthy Control Group","Healthy children aged 6 to 16 years with no history of chronic inflammatory or autoimmune diseases, recruited from the same city or community as the JIA group. No intervention is applied.",[35,40],{"name":36,"role":37,"phone":38,"phoneExt":22,"email":39},"Biyu Shen, PhD","CONTACT","86＋13862937317","shenbiyu@126.com",{"name":41,"role":37,"phone":42,"phoneExt":22,"email":43},"Yuan Yuan Xiang, Graduate Student","86＋15995792738","2115746605@qq.com",[45],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Shanghai Children's Medical Center, Lujiazui Campus, affiliated to Shanghai Jiao Tong University School of Medicine","RECRUITING","Shanghai","Pudongxinqu","200135","China","CN",{"type":54,"coordinates":55},"Point",[56,57],121.45806,31.22222,{"lat":57,"lon":56},[60],{"name":61,"role":37,"phone":38,"phoneExt":22,"email":39},"Biyu Biyu Shen, PhD",{"type":63,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":22,"oldOrganization":22},"PRINCIPAL_INVESTIGATOR","Biyu Shen","Chief Superintendent Nurse, Doctoral Supervisor","100654478","oral-health-saliva-bacteria-and-disease-activity-in-children-with-jia-a-cross-sectional-study-100654478",false,"NCT07799831","Oral Health, Saliva Bacteria, and Disease Activity in Children With JIA: A Cross-Sectional Study.","Association of Oral Health Status and Salivary Microbiota With Disease Activity in Children With Juvenile Idiopathic Arthritis: A Cross-Sectional Study.","JIA","Inclusion Criteria:\n\n* Children aged 6 to 16 years.\n* Diagnosed with juvenile idiopathic arthritis according to the International League of Associations for Rheumatology (ILAR) classification criteria, excluding the systemic-onset subtype.\n* For the active disease subgroup, all of the following must be met:\n\n  1. Presence of active arthritis as determined by the attending rheumatologist;\n  2. Planned initiation or adjustment of disease-modifying antirheumatic drugs (DMARDs) or biologic agents within 1 month after enrolment;\n  3. Meeting the following disease activity criterion: JADAS-27 score \\> 1. For the remission subgroup, the following must be met: JADAS-27 score ≤ 1 and clinically stable disease.\n* Able to cooperate with oral examination and saliva sample collection.\n* Written informed consent provided by a legal guardian, with assent obtained from the child.\n\nExclusion Criteria:\n\n* Use of systemic antibiotics within 3 months prior to enrolment, or use of mouthwash containing antibiotics, corticosteroids, or chlorhexidine within 1 month prior to enrolment.\n* Diagnosis of other autoimmune diseases (e.g., systemic lupus erythematosus, Sjögren's syndrome), chronic inflammatory diseases (e.g., inflammatory bowel disease), diabetes mellitus, congenital heart disease, or other systemic conditions that may affect the study outcomes.\n* Presence of acute infection at the time of sampling or examination (e.g., body temperature \\> 37.5°C, upper respiratory tract infection, acute oral infection).\n* Significant cognitive or behavioural impairment that prevents cooperation with study procedures.\n* Ongoing or planned orthodontic treatment within the next 6 months.",true,"ALL","6 Years","16 Years",{"count":79,"type":80},200,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to learn about the relationship between disease activity and oral health status in children with juvenile idiopathic arthritis (JIA). The main question it aims to answer is:\n\nIs disease activity associated with oral health in children with JIA? Do children with active disease have poorer oral health compared to those in clinical remission? Participants already receiving routine rheumatology care for JIA will undergo a single study visit. At that visit, disease activity will be assessed, an oral health examination will be performed, and saliva samples will be collected. Based on the disease activity assessment, participants will be classified into two groups: those with active disease and those in remission. Oral health measures and saliva-related parameters will be compared between the two groups.\n\nThis study is expected to provide preliminary evidence to help identify JIA children at higher risk of oral health problems and to support the integration of oral health evaluation into comprehensive JIA management.",[84],"Juvenile Idiopathic Arthritis","2026-08-28",{"date":87,"type":88},"2026-09-02","ACTUAL",{"date":90,"type":88},"2026-07-01",{"date":92,"type":80},"2027-07",{"name":5,"class":6},1]