Multi-center Study to Evaluate the Accuracy of Oral Photos, X-rays, Biomarkers, and Questionnaires in Detecting Gum Health and Disease

What this Trial Is About

Researchers are conducting a multi-center, cross-sectional diagnostic study to evaluate the accuracy of various non-invasive tools for detecting periodontal health and diseases, including gingivitis and different stages of periodontitis. This study extends previous research by adding salivary and microbial biomarker analysis to the evaluation of self-reported questionnaires, oral images, orthopantomographs OPGs, and intraoral scans IOS. The goal is to compare these different methods against a comprehensive full-mouth clinical examination, which serves as the reference standard. Participants will undergo several non-invasive tests such as completing questionnaires, having intra-oral photographs taken with professional cameras and smartphones, performing self-taken intra-oral photos, and receiving digital OPGs and intraoral scans. Biomarker samples will also be collected from saliva, oral rinse, and subgingival plaque at one center. The collected data will be analyzed using logistic regression and machine learning models to assess each methods diagnostic performance and to develop an optimized multi-modal screening algorithm. During the study, participants will receive a full-mouth clinical periodontal examination by trained examiners to establish their periodontal status. Researchers will collect and analyze data from the various screening tools and biomarkers. The main outcome measured is the diagnostic accuracy of detecting periodontitis stages II to IV, evaluated by the area under the receiver operating characteristic curve AUROC. The study follows ethical guidelines and includes up to 2,000 participants across five international centers.

Diagnostic Accuracy of Oral Images, OPGs, Biomarkers and Questionnaires vs. Clinical Assessment for Periodontal Disease (PostNCT07164573)