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

2026년 8월 28일 업데이트: Biyu Shen, Shanghai Jiao Tong University School of Medicine

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.

연구 개요

상태

모병

상세 설명

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.

연구 유형

관찰

등록 (추정된)

200

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

  • 이름: Biyu Shen, PhD
  • 전화번호: 86+13862937317
  • 이메일: shenbiyu@126.com

연구 연락처 백업

  • 이름: Yuan Yuan Xiang, Graduate Student
  • 전화번호: 86+15995792738
  • 이메일: 2115746605@qq.com

연구 장소

    • Pudongxinqu
      • Shanghai, Pudongxinqu, 중국, 200135
        • 모병
        • Shanghai Children's Medical Center, Lujiazui Campus, affiliated to Shanghai Jiao Tong University School of Medicine
        • 연락하다:
          • Biyu Biyu Shen, PhD
          • 전화번호: 86+13862937317
          • 이메일: shenbiyu@126.com

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 어린이

건강한 자원 봉사자를 받아들입니다

예

샘플링 방법

비확률 샘플

연구 인구

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.

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Oral Health Status
기간: At baseline, during a single routine outpatient visit immediately after written informed consent is obtained.
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.

2차 결과 측정

결과 측정
측정값 설명
기간
Salivary Microbiota
기간: Baseline visit (fasting morning)
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.
Baseline visit (fasting morning)
Disease Activity Assessment
기간: Baseline visit
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.
Baseline visit

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

  • [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.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 7월 1일

기본 완료 (추정된)

2027년 7월 1일

연구 완료 (추정된)

2027년 7월 1일

연구 등록 날짜

최초 제출

2026년 8월 28일

QC 기준을 충족하는 최초 제출

2026년 8월 28일

처음 게시됨 (실제)

2026년 9월 2일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 2일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 28일

마지막으로 확인됨

2026년 8월 1일

추가 정보

이 연구와 관련된 용어

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

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.

약물 및 장치 정보, 연구 문서

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아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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