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

NCT07164573 | Not Yet Recruiting

• 1 other identifier: SH9H-2025-T363-1
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multi-center, cross-sectional diagnostic study aimed at evaluating the accuracy of various non-invasive methods-including self-reported questionnaires, intra-oral photographs, smartphone images, intraoral scans (IOS), and orthopantomographs (OPGs)-in detecting periodontal health and disease, compared to clinical periodontal examination as the gold standard. The study will enroll 2,000 subjects across five centers, representing the full spectrum of periodontal conditions (health, gingivitis, and periodontitis stages I-IV). Participants will undergo a standardized clinical examination, radiographic imaging, and complete validated questionnaires. Machine learning models (e.g., HC-Net+ for OPGs and DLM for oral image) will be used to analyze images and integrate data domains. The primary outcome is the diagnostic accuracy (sensitivity, specificity, AUROC) of each method alone and in combination for classifying periodontal status. The study aims to validate and refine AI-based tools for scalable, efficient periodontal screening in clinical and community settings.

Conditions

Periodontal Diseases; Gingivitis; Periodontitis

Keywords

Diagnosis; Artificial 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)

  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 five 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
• Department of Medical Sciences, University of Torino: collaborator
• King's College London: collaborator
• University of Roma La Sapienza: collaborator

Study Sites (1)

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

Shanghai, Shanghai Municipality, China

Location

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: September 2, 2025
• First Posted: September 10, 2025
• Study Start: November 13, 2025
• Primary Completion (Estimated): November 13, 2028
• Study Completion (Estimated): November 13, 2028
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)