An observational study in Periodontal Disease, Gingivitis and Periodontitis, sponsored by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University. Recruiting at 3 sites in 3 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-30.
Sponsored by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · Observational
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.
This study is an extension of NCT07164573, with the addition of salivary and microbial biomarker analysis as index tests. While NCT07164573 focuses on questionnaires, oral images, and OPGs, this study incorporates biomarker-based classifiers to evaluate a comprehensive multi-modal diagnostic approach for periodontal disease detection.This is a multi-center, cross-sectional diagnostic accuracy study. The study aims to validate and compare the performance of multiple index tests against a clinical reference standard for the detection of periodontal health and disease. The reference standard for periodontal diagnosis will be a comprehensive full-mouth periodontal examination conducted by trained and calibrated examiners at five international clinical centers. Diagnoses (periodontal health, gingivitis, periodontitis Stages I-IV) will be assigned based on the integration of clinical, radiographic, and demographic data according to the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. The decision-making algorithms proposed by Tonetti and Sanz (2019) will be applied. The index tests under investigation include: 1. A set of self-reported questionnaires, including a modified CDC-AAP questionnaire, OHIP-14, and a dietary survey. 2. Intra-oral clinical photographs captured with a professional camera and a smartphone. 3. A self-performed intra-oral photograph ("selfie"), with and without cheek retractors. 4. Digital orthopantomographs (OPGs). 5. Intraoral scans (IOS). 6. Biomarker analysis of specific proteins and microbial signatures obtained from unstimulated saliva, oral rinse, and subgingival plaque (collected at the Shanghai center only). Data from the index tests will be analyzed using previously developed and validated machine learning models (e.g., HC-Net+ for OPG analysis, a deep learning model for single frontal-view images, and biomarker-based classifiers for periodontal disease detection). The data collected in this study will also be used to further refine these models, particularly to improve the differentiation between gingivitis/Stage I periodontitis and health/Stage II-IV periodontitis.
The primary analytical method will involve assessing the diagnostic accuracy of each index test, both individually and in combination, by calculating sensitivity, specificity, and the area under the receiver operating characteristic curve (AUROC) against the clinical reference standard. Logistic regression and machine learning algorithms will be employed to identify the most predictive variables and optimal diagnostic sequences. A total of 2,000 participants will be recruited across the five centers. The study will be conducted in compliance with the Declaration of Helsinki, ICH-GCP guidelines, and relevant STARD and AI-specific reporting guidelines.
867 studies on the registry are indexed under Periodontal Diseases; 189 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 99 across 302 observational studies indexed under Periodontal Diseases.
Browse Periodontal Diseases studies →Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University is the lead sponsor of 164 studies on the registry; 73 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population will consist of a convenience sample of consecutive adult patients seeking routine dental care across Lve participating dental centers. We aim to enroll a total of 2000 participants, representing the full spectrum of periodontal conditions (i.e., periodontal health, gingivitis, and periodontitis stages I through IV) based on the reference clinical examination.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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)
Time frame: Cross-sectional (assessed at the day 1 of participant enrollment)
Plan to share: No — The individual participant data collected in this study contains highly sensitive personal health information. The informed consent obtained from participants did not include provisions for public sharing of their individual-level data. Making this data publicly available could compromise participant privacy and confidentiality, which are our primary ethical obligations. Furthermore, the data is part of an ongoing research program focused on the development and validation of artificial intelligence models. The complete datasets are complex and require specialized knowledge for appropriate analysis and interpretation. Aggregated, de-identified results will be made available in published manuscripts and supplementary materials.
No publications or documents are linked to this record.
Started Mar 2026 (actual). Primary completion is estimated for Mar 2029, 36 months after the start.
Of 79 non-industry observational studies under Periodontal Diseases, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 30. This study's planned 36 months is above that.
Counting every sponsor, half of 83 studies reached it within 13 months; a quarter within 7 and three quarters within 32.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University →