About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Not listed
Trial groups
Sponsors and collaborators
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Lead sponsor
University of Chieti
Collaborator
King's College London
Collaborator
University of Roma La Sapienza
Collaborator
University of Turin, Italy
Collaborator