Oral health, saliva bacteria, and disease activity in children with JIA

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center, cross-sectional observational study will assess disease activity alongside an oral health examination and saliva analysis in children with juvenile idiopathic arthritis. Participants will be categorized into active disease or remission groups based on rheumatologist assessment and JADAS-27 scores. The aim is to see whether active disease associates with poorer oral health and to explore saliva-related factors that might relate to disease activity. No intervention is given; data are collected during a routine outpatient visit at one time point. Eligible children are aged 6 to 16 and must meet ILAR criteria for non-systemic JIA, with several exclusions to avoid confounding oral health from other conditions or recent antibiotics.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Study coordinator: Biyu Shen, PhD
• Email: shenbiyu@126.com
• Phone: 86＋13862937317

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.