A multicenter study investigating the oral health status and influencing factors in children with rheumatism: a protocol for cross-sectional survey

doi:10.21203/rs.3.rs-1433401/v1

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A multicenter study investigating the oral health status and influencing factors in children with rheumatism: a protocol for cross-sectional survey

https://doi.org/10.21203/rs.3.rs-1433401/v1

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Background: Rheumatic disease in children is a chronic systemic disease with unclear etiology and pathogenesis. A growing number of evidence shows that there is an important relationship between chronic systemic diseases and oral cavity. However, there is still a lack of research on children's rheumatic diseases and oral health in Eastern countries.

Methods: This study is a multicenter cross-sectional study. The oral health status and habits of children with rheumatic diseases in China were analyzed by investigating the oral health status of children with rheumatic diseases newly diagnosed in four hospitals in Shanghai.

Discussion: This study will fill the gap in oral health status and habits of children with rheumatic diseases in Eastern countries. To analyze the influencing factors of oral health of children with rheumatic diseases in Eastern countries. So as to better provide plans and guidance programs for oral health of children with rheumatic diseases in Eastern countries.

Oral health

protocol

Rheumatic diseases

Rheumatism is a kind of disease with connective tissue lesions as the main symptoms caused by systemic immune system abnormalities. It mainly affects bone, joints and surrounding soft tissues, such as muscle, bursa or tendon sheath, and is often accompanied by pain.

The etiology and pathogenesis of pediatric rheumatic diseases were still unclear. It was a group of diseases with complex clinical manifestations, multiple system or organ involved which incurable and recurrent and with high mortality and disability rate.

Children with rheumatism may have fever, joint swelling and pain during disease activity. Long term use of anti-inflammatory drugs or corticosteroids and other drugs may lead to growth retardation and dysfunction which then limit the children's activities and affecting the quality of life of children.

Oral cavity is one of the most bacteria accumulating parts in human body. Compared with healthy people, oral bacteria are overload in rheumatic patients and more likely to cause oral and intestinal flora imbalance [1, 2]. Children with rheumatism, especially patients with rheumatoid arthritis, ineffectively remove dental plaque due to upper limb function limitation, which affects effective brushing. In addition, because of ineffective mouth clean such as gargling after oral sugary or acidic drugs in time, eating soft and liquid food, which leads to poor oral hygiene [3]. Children with temporomandibular disorder syndrome (TMD) caused by rheumatism have difficulty in opening mouth and pain affect oral cleaning [4]. When the disease further progresses and leads to mandibular joint deformity and growth disorder, it brings difficulties to effective oral care [5].

In recent years, studies have found that there is a certain relationship between chronic systemic diseases and oral health [6, 7]. The relationship between rheumatoid arthritis and periodontitis has been confirmed [8]. The results of oral health survey in patients with juvenile idiopathic arthritis (JIA) show that compared with healthy children, the oral health of JIA patients is poor [9]. Further research confirmed that the incidence of periodontitis in Jia patients with anticyclic citrullinated peptide antibody (CCP) positive is higher than that in patients with CCP negative [10].

The oral health survey of teenagers aged 10–18 years with idiopathic arthritis found that the dental plaque index and gingival detection bleeding of patients with JIA were higher than those of children of the same age [11]. Different studies also confirmed the causal relationship between periodontitis and JIA, and rheumatoid arthritis could be controlled to a certain extent through treatment of periodontitis [12]. Although this view has been recognized by many pediatric rheumatologists, there have been no Oriental reports on oral health of children with rheumatic diseases. The comprehensive literature research, combined with the consideration of the number of research samples and the cost and benefit of the implementation of the research, provides a theoretical and practical basis for the implementation of this multi-center cross-sectional survey.

The primary aims of this study are to fill critical gaps between the oral health status and oral care habits of children with rheumatism in China. The secondary aims are to analyze the main influencing factors of children's oral health. So as to better provide plans for oral health of children with rheumatic diseases in Eastern countries. We hypothesized that the oral health status of children with rheumatism in China is related to whether the disease stage is in the active stage and joint dysfunction, and by changing the oral care habits of children with rheumatism (such as mouthwash times, solution, temperature, regular visit to the dentist, etc.), can improve the oral health of rheumatic children and improve the progress of the disease.

3.1 Protocol and registration

This study has received ethical approval from the Shanghai Children Medical center (approval number: SCMCIRB-YN2021002). The study methodology was documented in a protocol and registered before recruitment. (ID: ChiCTR2100050480). This protocol report is conducted according to the guidelines defined in the cross-sectional study protocol.

3.2 Design and setting

This study is a multicenter, cross-sectional investigation. The study population is newly diagnosed pediatric rheumatism at the Shanghai children medical center, Shanghai Xinhua hospital, Children's Hospital of Shanghai and Nantong maternal and Child Health Hospital. All four hospitals are located in China's densely populated coastal cities, with patients from urban and rural areas. The study design works well at all four hospitals. The personnel have a good routine of how to ask the children and caregivers to consent to the study and to give their time to fulfill the questionnaires after oral examination. Blood samples are taken at the same time of routine sampling, and patients and staff do not need additional work.

3.3 Eligibility criteria for participants

Eligible participants are children aged between 4 and 18 years who meet the inclusion criteria of (1) newly diagnosed as children's rheumatic disease by rheumatism experts according to 2016 rheumatism diagnostic criteria [13], (2) agree to accept oral periodontal examination and complete the questionnaire, (3) cooperate with investigation and sign informed consent. Exclusion (1) congenital maldevelopment of the teeth and jaw (2) incomplete medical report or refusal to oral examination (3) combined with other systemic inflammatory diseases and using anti-inflammatory treatment within 3 months (4) combined with diabetes or cardiovascular diseases.

3.4 Time plan

2021–2023: enrollment of patients: At the time of diagnosis of children's rheumatism, the patient's disease-related information would be collected, Patient-reported outcomes measurement information system (PROMIS) was filled in, receive the dental examination at the same time, and social and economic variables were collected.

2022–2024: One year follow-up data collection: in addition to the blood sample examination, patients will receive the same assessment information collection as above.

3.5 Data collection

(1) Oral health evaluation

All oral examinations will be performed by a trained dentist who was properly calibrated. According to the method of Chinese national oral epidemiological survey, the community periodic index (CPI) probe would be used to examine the oral and periodontal conditions according to the oral quadrant order. All patients were examined 6 index teeth: 16, 26, 36, 46, 11, 31. If the index teeth were missing, the adjacent teeth would be examined instead. Six loci would be detected for each tooth. The number of missing teeth, probing pocket depth (PPD), clinical attachment loss (CAL), bleeding on probing (BOP), plaque index (PLI) and periodontal disease index (PDI) would be recorded.

(2) Rheumatism related symptoms and indicators

Duration of morning stiffness, cumulative number of joints, erythrocyte sedimentation rate(ESR), C-reactive protein༈CRP༉, anti-cyclic citrullinated peptide antibody.

(3) Salivary parameters

Saliva plays an important role in maintaining oral health, including lubrication, regeneration of mucous membrane, buffering, antibacterial, helping digestion and so on [14]. Study conducted by Alice’s team formally found that poor oral hygiene in Jia children is related to saliva changes [15]. Saliva samples from fasting and 2 hours after meal were collected for microbiological examination. The samples were rinsed with water before collection and sent for examination immediately after collection.

(4) Demographic and clinical information

Demographic information of patients, including time of illness, diet and oral care habits, was obtained and recorded from hospital medical information system and caregivers.

(5) Caregiver burden

Caregiver burden has become a hot topic in the study of patients with chronic diseases, and it is an important part of the people-centered concept in modern medicine. CBI was formulated through the study of 106 elderly caregivers by Novak and Guese [16], It can effectively and comprehensively assess the burden of caregivers and is now widely used in the world. We used the Chinese version of Caregiver Burden Inventory to investigate the care burden of primary caregivers of children with rheumatism [17].

SPSS 23.0 software will used to statistic describe and analyze the data. Descriptive statistics like the mean and standard deviation, median and interquartile range, and confidence intervals will be used to report the sample demographics (age, gender, and condition of the oral health etc,) and to report outcome measures, as appropriate. Using appropriate methods to analyze the relationship between oral health status and the variables, and then logistic analysis of the variables related to oral health. In all of the above analyses, confounding factors such as age, disease stage, Arthralgia, and the type of treatment modalities, etc. will be considered. Statistical significance will be set at p < 0.05.

The project proposes a hypothesis testing protocol that integrates the oral health of children with rheumatic disease with disease progression and quality of life in a multi-center, large-sample cross-sectional survey project.

The study will fill the gap in oral health status and living habits of children with rheumatic diseases in Eastern countries, and analyze the influencing factors of oral health of children with rheumatic diseases. By analyzing the influencing factors of oral health, it will better provide a plan for the oral health of children with rheumatic diseases in Eastern countries.

This study highlights the importance and necessity of oral health education for children with rheumatic disease. From the clinical point of view, the most important thing is to identify the factors that are detrimental to the oral health of children with rheumatic disease, and improve oral health by changing health behaviors, so as to improve the quality of life of children.

The molecular biometrics of blood and saliva samples collected to determine whether they are associated with the progression of rheumatic disease could open a new avenue for the study of quality of life in children with rheumatic disease.

The basic hypothesis here is that oral hygiene in children with rheumatic disease can be ameliorated through lifestyle changes or interventions that improve the quality of life associated with the child and reduce caregiver care burden.

TMD

temporomandibular disorder syndrome

JIA

juvenile idiopathic arthritis

CCP

cyclic citrullinated peptide

PROMIS

Patient-reported outcomes measurement information system

CPI

community periodic index

PPD

probing pocket depth

CAL

clinical attachment loss

BOP

bleeding on probing

PLI

plaque index

PDI

periodontal disease index

ESR

erythrocyte sedimentation rate

CRP

C-reactive protein.

Acknowledgment

None

Author Contributions

Yunyun Li contributed to the study concept, data analysis, and drafting of the manuscript. Songsong Shi, Hengmei Cui and Haoyang Chen contributed to data analysis and study supervision. Biyu Shen contributed to the study concept, design, drafting of the manuscript, and study supervision. All authors approved the final version of the manuscript.

Funding

None

Availability of data and materials

Data sharing is not applicable to this article as no new data were created or analyzed in this study.

Ethics approval and consent to participate

This study has received ethical approval from the Shanghai Children Medical center (approval number: SCMCIRB-YN2021002). The study methodology was documented in a protocol and registered before recruitment. (ID: ChiCTR2100050480). Parents/legal guardians and patients aged between 4 and 18 years who meet the inclusion criteria signed the informed consent form before any study-related procedures occurred.

Consent for publication

Consent has been given by the patients and parents, via the written informed consent.

Competing interests

The authors declare that they have no conflicts of interest.

Author details

^aNursing Administration of Shanghai Children Medical Center, Shanghai, China;

^bDepartment of Rheumatology, Shanghai Children Medical Center, Shanghai, China;

^cNursing Administration of Nantong Second People's Hospital, Jiangsu, China.

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Version 1

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A multicenter study investigating the oral health status and influencing factors in children with rheumatism: a protocol for cross-sectional survey

Status:

Version 1

Abstract

1. Introduction

2. Objectives

3. Methods

3.1 Protocol and registration

3.2 Design and setting

3.3 Eligibility criteria for participants

3.4 Time plan

3.5 Data collection

4. Statistical Methods

5. Discussion

6. Abbreviations

Declarations

References

Status:

Version 1