The goal of this observational study is to develop better ways to detect and predict major oral diseases, including oral cancer, gum disease, and tooth decay. This study will collect detailed oral health information and biological samples from adults with different oral health conditions and healthy participants to identify markers that may help doctors detect diseases earlier and predict how diseases may change over time. The main questions this study aims to answer are whether biological markers from saliva, mouth rinse samples, blood, or oral tissue samples can help identify people with oral diseases, whether these markers can predict future disease changes such as worsening gum disease, new or progressing tooth decay, or recurrence and spread of oral cancer, and whether combining clinical information with biological markers can improve disease detection and risk prediction. Participants will receive a standard oral health examination, provide information about their health history and oral health behaviors, provide biological samples when appropriate, and be followed over time through clinical visits, questionnaires, and health information collection. Researchers will compare findings among people with different oral health conditions and healthy participants to better understand disease-related changes and develop tools for earlier detection and prediction of oral disease outcomes.
Adults aged 18 years or older.
Able to understand the study information and provide written informed consent.
Edentulous individuals.
History of radiotherapy to the head and neck region.
Presence of immunodeficiency conditions (for example, human immunodeficiency virus infection).
Pregnancy.
This study will enroll adults from the outpatient clinics of Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine. The study population will include individuals with major oral diseases, including oral squamous cell carcinoma (OSCC), periodontal disease, and dental caries, as well as participants without these conditions who will serve as healthy controls. Participants will be recruited through relevant dental and oral disease clinics using a continuous recruitment approach. Standardized clinical assessments will be performed to characterize oral health status, and biological samples will be collected to investigate markers associated with disease detection, progression, and prognosis. Participants will be followed longitudinally to evaluate changes in oral health status and clinically relevant outcomes over time.
Cohort
Prospective
Step 1 and 2 periodontal therapy according to the EFP clinical practice guidelines
Procedure/SurgeryStandard of care treatment
Dental filling with or without root canal treatment
Procedure/SurgeryStandard of care treatment with a composite filling material
Oral cancer surgical resection including extension, dissection and reconstruction with adjunctive radiation, chemotherapy and/or biological treatments per international guidelines,
Procedure/SurgeryAll the necessary surgical procedures to remove the primary oral cancer tumour from the oral cavity, including the necessary dissection and plastic reconstructive surgery. All necessary adjunctive treatments, including radiation, chemotherapy and/or biological therapies.
Diagnostic accuracy to detect oral diseases
The diagnostic accuracy will be measured as the area under the receiver operating characteristic curve (AUC). Clinical diagnosis will be the reference standard and will be performed by calibrated examiners in accordance with international case-definition standards.
Sensitivity to detect oral diseases
Sensitivity will be calculated using clinical diagnosis as the reference standard as defined by calibrated examiners in accordance with international case-definition standards
Specificity to detect oral diseases
Specificity will be reported as the proportion of participants without oral diseases correctly classified by the test. The reference standard will be clinical diagnosis performed by calibrated examiners in accordance with international case definition standards.
Hazard ratio of oral disease progression
The hazard ratio (HR) for oral disease progression will be estimated using survival analysis methods. The progression of oral disease will be assessed using longitudinal changes in standardized clinical parameters and tooth loss. The reference standard will be clinical diagnosis performed by calibrated examiners in accordance with international case definition standards.
Hazard ratio of oral squamous cell carcinoma metastasis
The hazard ratio (HR) for oral squamous cell carcinoma (OSCC) metastasis will be estimated using survival analysis methods. Metastasis will be assessed based on clinical and imaging evaluations during follow-up by calibrated examiners and following international standards.
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