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Clinical Trials in China / NCT07799831
Recruiting Observational

Oral Health, Saliva Bacteria, and Disease Activity in Children With JIA: A Cross-Sectional Study.

NCT07799831 · tracked via the Priya Life Science China tracker
Sponsor
Shanghai Jiao Tong University School of Medicine
Phase
Observational
Started
2026-07-01
Last updated
2026-09-02

Condition(s) studied

Juvenile Idiopathic Arthritis

Study summary

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:

Is 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.

This 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.

Eligibility

Sex
ALL
Min age
6 Years
Max age
16 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Children aged 6 to 16 years. * Diagnosed with juvenile idiopathic arthritis according to the International League of Associations for Rheumatology (ILAR) classification criteria, excluding the systemic-onset subtype. * For the active disease subgroup, all of the following must be met: 1. Presence of active arthritis as determined by the attending rheumatologist; 2. Planned initiation or adjustment of disease-modifying antirheumatic drugs (DMARDs) or biologic agents within 1 month after enrolment; 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. * Able to cooperate with oral examination and saliva sample collection. * Written informed consent provided by a legal guardian, with assent obtained from the child. Exclusion Criteria: * 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. * 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. * 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). * Significant cognitive or behavioural impairment that prevents cooperation with study procedures. * Ongoing or planned orthodontic treatment within the next 6 months.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Shanghai Children's Medical Center, Lujiazui Campus, affiliated to Shanghai Jiao Tong University School of Medicine Shanghai Pudongxinqu Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07799831 on ClinicalTrials.gov ↗ ← All trials in China