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 , (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 . Study conducted by Alice’s team formally found that poor oral hygiene in Jia children is related to saliva changes . 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 , 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 .