Diagnostic Accuracy of Oral Images, OPGs, Biomarkers and Questionnaires vs. Clinical Asses
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 (gingiviti
| Condition(s) | Periodontal Disease, Gingivitis, Periodontitis |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | 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. |
| Who can participate | Inclusion Criteria: * Adult patients aged 18 years or older. * Seeking dental care at one of the participating study centers. * Ability to understand and willingness to provide written informed consent. Exclusion Criteria: * Edentulous patients (complete tooth loss). * Pregnancy or lactation. * History of periodontal therapy (other than supragingival prophylaxis/cleaning) within the past 12 months. * Use of antibiotic medication within the 3 months prior to enrollment. |
| Ages | 18 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University |
| Locations | Shanghai, Shanghai Municipality, China; Roma, Roma, Italy; London, United Kingdom |
| Start date | 2026-03-01 |
| NCT ID | NCT07406867 |
| Official listing | https://clinicaltrials.gov/study/NCT07406867 |