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Diagnostic Accuracy of Oral Images, Orthopantomographs (OPGs), Biomarkers and Self-Reported Questionnaires vs. Clinical Assessment for Detecting Periodontal Health and Disease: a Multi-center Diagnostic Study

Status: Recruiting
Location: See all (3) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
China
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
RECRUITING
Shanghai
Italy
Department of Oral and Maxillofacial Sciences, Policlinico Umberto I, affiliated to Sapienza University
NOT_YET_RECRUITING
Roma
United Kingdom
Department of Periodontology, Guy's Hospital affiliated to King's College London
NOT_YET_RECRUITING
London
Contact Information
Primary
Maurizio S. Tonetti
tonetti@hku.hk
15000102368
Time Frame
Start Date: 2026-03-01
Estimated Completion Date: 2029-03-01
Participants
Target number of participants: 2000
Treatments
All Participants
Related Therapeutic Areas
Sponsors
Leads: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Collaborators: University of Turin, Italy, University of Chieti, University of Roma La Sapienza, King's College London

This content was sourced from clinicaltrials.gov