Discovery and Validation of Biomarkers for Periodontitis, Dental Caries and Oral Squamous Cell Carcinoma

Condition(s) studied

Investigational drug(s) / intervention(s)

Step 1 and 2 periodontal therapy according to the EFP clinical practice guidelines: Standard of care treatment

Dental filling with or without root canal treatment: Standard 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,: All 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.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Diagnostic accuracy to detect oral diseases — At baseline assessment
  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.

Trial sites (1)

More Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University trials in China

Other trials for the same condition