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

NCT07799831 | Recruiting

• 1 other identifier: SCMCIRB-K2026053-1
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Juvenile Idiopathic Arthritis

Outcome Measures

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.

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

Secondary Outcomes (2)

• Salivary Microbiota

  Baseline visit (fasting morning)

• Disease Activity Assessment

  Baseline visit

Study Arms (2)

JIA group

Children 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 Group

Healthy 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.

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

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

Shanghai, Pudongxinqu, 200135, China

RECRUITING

Related Publications (1)

• [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.

  BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

This study collects unstimulated whole saliva samples from children with JIA in the morning under fasting conditions. Participants provide naturally secreted saliva into sterile collection tubes using the passive drooling method. Samples are transported to the laboratory on ice, aliquoted, and stored at -80°C. All samples are identified by unique numeric codes with no personally identifiable information. Residual samples will be destroyed or used for future research approved by the ethics committee according to institutional regulations.

MeSH Terms

Conditions

Arthritis, Juvenile

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Biyu Shen, PhD

CONTACT

86＋13862937317; shenbiyu@126.com

Yuan Yuan Xiang, Graduate Student

CONTACT

86＋15995792738; 2115746605@qq.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Superintendent Nurse, Doctoral Supervisor

Study Record Dates

• First Submitted: August 28, 2026
• First Posted: September 2, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: September 2, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)