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

This multi-center, cross-sectional diagnostic trial evaluates the accuracy of multiple non-invasive screening tools-including self-reported questionnaires, intra-oral photographs, orthopantomographs (OPGs), intraoral scans (IOS), and salivary/microbial biomarkers-for detecting periodontal health and diseases (gingivitis and periodontitis Stages I-IV), using full-mouth clinical periodontal examination as the reference standard. A total of 2,000 participants will be recruited across five international centers. Diagnostic performance (sensitivity, specificity, AUROC) of individual and combined methods will be assessed using logistic regression and machine learning algorithms to establish an optimized multi-modal screening algorithm.

NCT Number	NCT07406867
Lead Sponsor	Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University Collaborators: University of Chieti, King's College London, University of Roma La Sapienza, University of Turin, Italy
Conditions	Periodontal Disease, Gingivitis, Periodontitis
Enrollment	2,000 participants
Start Date	2026-03-01
Primary Completion	2029-03-01 (estimated)
Study Completion	2029-03-01 (estimated)
Updated on ClinicalTrials.gov	2026-04-30