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

NCT07406867 | Recruiting

• 2 other identifiers: SH9H-2025-T363-2Post-NCT07164573
• Study Type: observational
• Target: 2,000
• Locations: 3 countries
• Sites: 3

Brief 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.

Conditions

Periodontal Disease; Gingivitis; Periodontitis

Keywords

Diagnosis; ArtiLcial Intelligence; Periodontal Diseases; Radiography; Machine Learning; Photography

Outcome Measures

Primary Outcomes (1)

• 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)

  Cross-sectional (assessed at the day 1 of participant enrollment)

Study Arms (1)

All Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: lead
• University of Chieti: collaborator
• King's College London: collaborator
• University of Roma La Sapienza: collaborator
• University of Turin, Italy: collaborator

Study Sites (3)

Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Department of Oral and Maxillofacial Sciences, Policlinico Umberto I, affiliated to Sapienza University

Roma, Roma, 06100, Italy

NOT YET RECRUITING

Department of Periodontology, Guy's Hospital affiliated to King's College London

London, United Kingdom

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Unstimulated saliva (5 mL), oral rinse, and subgingival plaque samples collected from first molars. Samples will be collected at the Shanghai center only for biomarker analysis including protein and microbial signatures.

MeSH Terms

Conditions

Periodontal Diseases; Gingivitis; Periodontitis; Disease

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Maurizio S. Tonetti

CONTACT

15000102368; tonetti@hku.hk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 5, 2026
• First Posted: February 12, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2029
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1); GB (1); CN (1)