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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-16
SponsorShanghai Jiao Tong University School of Medicine

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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.

Presence of active arthritis as determined by the attending rheumatologist;

Planned initiation or adjustment of disease-modifying antirheumatic drugs (DMARDs) or biologic agents within 1 month after enrolment;

Disqualifiers

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.

Trial population

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.

Trial design

Design model

Other

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

200 Participants
are grouped into 2 trial groups
Group A: JIA group
Group B: Healthy Control Group

Trial outcomes

Primary outcomes

1

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.

Time frame
At baseline, during a single routine outpatient visit immediately after written informed consent is obtained.

Secondary outcomes

1

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.

Time frame
Baseline visit (fasting morning)
2

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.

Time frame
Baseline visit

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.