Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Phase
Observational
Started
2026-03-01
Last updated
2026-04-30
Condition(s) studied
Periodontal DiseaseGingivitisPeriodontitis
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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.
Primary outcome measure(s)
Diagnostic accuracy for detecting periodontitis (Stage II-IV) as determined by the Area Under the Receiver Operating Characteristic Curve (AUROC) of each index test against the clinical reference standard — Cross-sectional (assessed at the day 1 of participant enrollment) 1. Diagnostic accuracy of the AI-based analysis of OPGs (HC-Net+) for detecting periodontitis (Stage II-IV)
2. Diagnostic accuracy of the AI-based analysis of intra-oral photographs for detecting periodontitis (Stage II-IV)
3. Diagnostic accuracy of the self-reported questionnaire (modified CDC-AAP) for detecting periodontitis (Stage II-IV)
4. Diagnostic accuracy of salivary biomarker-based classifiers (specific proteins obtained from unstimulated saliva and oral rinse) for detecting periodontitis (Stage II-IV)
5. Diagnostic accuracy of microbial biomarker-based classifiers (microbial signatures obtained from subgingival plaque) for detecting periodontitis (Stage II-IV)
6. Diagnostic accuracy of combined multi-modal algorithm integrating questionnaires, oral images, OPGs, and biomarkers for detecting periodontitis (Stage II-IV)
Trial sites (3)
Facility
City
Region
Status
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai
Shanghai Municipality
Recruiting
Department of Oral and Maxillofacial Sciences, Policlinico Umberto I, affiliated to Sapienza University
Roma
Roma
Not Yet Recruiting
Department of Periodontology, Guy's Hospital affiliated to King's College London
London
United Kingdom
Not Yet Recruiting
More Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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