NCT07799831 Oral Health, Saliva Bacteria, and Disease Activity in Children With JIA: A Cross-Sectional Study.
| NCT ID | NCT07799831 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shanghai Jiao Tong University School of Medicine |
| Condition | Juvenile Idiopathic Arthritis |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2026-07-01 |
| Primary Completion | 2027-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2026-07-01 with a primary completion date of 2027-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07799831 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 16 Years, studying Juvenile Idiopathic Arthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07799831 currently recruiting?
Yes, NCT07799831 is actively recruiting participants. Contact the research team at shenbiyu@126.com for enrollment information.
Where is the NCT07799831 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07799831 clinical trial?
NCT07799831 is sponsored by Shanghai Jiao Tong University School of Medicine. The trial plans to enroll 200 participants.