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Juvenile Idiopathic ArthritisJIANCT07799831

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

An observational study of Juvenile Idiopathic Arthritis, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.

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Looking for participants now. Contact the study team or a site below to ask about taking part.

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Trial 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… Read more about this study

Who is it for?
Ages 6 to 16 yearsHealthy volunteers can take part
Conditions the study is for
Juvenile Idiopathic Arthritis
How many people
200 participants
Where
1 siteChina
Study dates
1 Jul 2026to Jul 2027
Phase
Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 16 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Study 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.

Who may be able to join

  • 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:
  • 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;
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Biyu Shen, PhD contact

86+13862937317

shenbiyu@126.com

Yuan Yuan Xiang, Graduate Student contact

86+15995792738

2115746605@qq.com

China1 site, 1 recruiting
  • Shanghai Children's Medical Center, Lujiazui Campus, affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, Pudongxinqu, 200135

    Biyu Biyu Shen, PhD, 86+13862937317, shenbiyu@126.com

    Recruiting

Other trials in China

About this study

Official title: Association of Oral Health Status and Salivary Microbiota With Disease Activity in Children With Juvenile Idiopathic Arthritis: A Cross-Sectional Study.

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.

Read the detailed description

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.

This 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.

Study 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.

Grouping 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.

Statistical 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.

Clinical 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.

Medical subject headings
Arthritis, Juvenile

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07799831
Study groupRoleWhat they receive
JIA groupChildren 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.
Healthy Control GroupHealthy 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (2)
  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.

    Measured: 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.

    Measured: Baseline visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Sep 2026
  2. Study start1 Jul 2026
  3. Primary completionJul 2027 (estimated)
  4. Study completionJul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07799831
Sponsor's protocol ID
SCMCIRB-K2026053-1
Acronym
JIA
Status last verified
Aug 2026
First submitted
28 Aug 2026
Last updated
2 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: This study does not involve a clinical trial or interventional design. The data collected include sensitive oral health and biological information from children, and participant consent obtained does not cover data sharing with external researchers. Should circumstances change in the future, we will update this plan accordingly.

Publications

  • [1]Klingberg G.,Hallberg U.Oral health-Not a priority issue A Grounded Theory analysis of barriers for young patients with disabilities to receive oral health care on the same premise as others.Eur.J.Oral Sci.2012;120:232-238. [2]Szabo Y Z,Slavish D C,Graham-Engeland J E.The effect of acute stress on salivary markers of inflamma-tion:a systematic review and meta-analysis[J].Brain Behav Immun,2020,88:887-900. [3]Walton AG,Welbury RR,Thomason JM,Foster HE.Oral health and juvenile idiopathic arthritis:a review.Rheumatology(Oxford).2000 May;39(5):550-5. [4]LANGE L,THIELE G M,MCCRACKEN C,et al.Symptoms of periodontitis and antibody responses to Porphyromonas gingivalis in juvenile idiopathic arthritis.Pediatr Rheumatol Online J,2016,14(1):8. [5]Romero-Sanchez C,Malagon C,Vargas C,et al.Porphyromonas gingivalis and IgG1 and IgG2 subclass antibodies in patients with juvenile idiopathic arthritis[J].J Dent Child(Chic),2017,84(2):72-79. [6]Titusson C,Jansson L,Modin C,Lundmark A,Eriksson K,Adler L,Yucel-Lindberg T.Salivary Inflammatory Mediator Profiles in Periodontal and Peri-Implant Health and Disease:A Cross-Sectional Study.Clin Implant Dent Relat Res.2025 Feb;27(1):e70002. [7]Halbig JM,Jönsson B,Gil EG,Åstrøm AN,Rypdal V,Frid P,Augdal TA,Fischer J,Cetrelli L,Rygg M,Lundestad A,Tylleskär K,Nordal E;Norwegian JIA Study-Temporo-mandibular Involvement,Oral Health,Uveitis,Bone Health,Quality of Life in Children with Juvenile Idiopathic Arthritis.Oral health-related quality of life,impaired physical health and orofacial pain in children and adolescents with juvenile idiopathic arthritis-a prospective multicenter cohort study.BMC Oral Health.2023 Nov 20;23(1):895. [8]Savioli C,Silva CA,Ching LH,Campos LM,Prado EF,Siqueira JT.Dental and facial characteristics of patients with juvenile idiopathic arthritis.Rev Hosp Clin Fac Med Sao Paulo.2004 Jun;59(3):93-8.

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