Non‑invasive tests using photos, X‑rays, questionnaires and saliva markers to detect gum disease
Official title: 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
Run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · NCT07406867 · Data updated 2026-11-12
This project will test whether photos, dental X‑rays, questionnaires, and saliva/microbial markers can accurately detect gum disease in adults seeking dental care.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 2000 (estimated) |
| Sponsor | Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University Academic / other |
| Locations | 3 sites (Shanghai, Shanghai Municipality and 2 other locations) |
| Status | Recruiting |
| Started | March 1, 2026 |
| Main results expected | March 1, 2029 |
| Study ends | March 1, 2029 |
| Registry record updated | April 30, 2026 |
| Trial ID | NCT07406867 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older who are seeking dental care at one of the participating centers, have teeth (not edentulous), can provide informed consent, and meet the exclusion criteria are eligible.
✕Probably not a fit
People without teeth (edentulous), those who are pregnant or breastfeeding, or those who recently received antibiotics or periodontal therapy are excluded and therefore unlikely to benefit from this screening approach in the study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multi‑center, cross‑sectional diagnostic accuracy study will compare several non‑invasive index tests against a full‑mouth clinical periodontal examination as the reference standard. About 2,000 adult participants will be enrolled across five international clinical centers and undergo questionnaires, intra‑oral and self‑taken photos, orthopantomographs (OPGs), intraoral scans, and salivary/microbial biomarker analysis. Diagnostic performance of individual and combined methods will be measured by sensitivity, specificity, and AUROC using logistic regression and machine learning classifiers to develop an optimized multi‑modal screening algorithm. The study builds on prior work with imaging and questionnaires by adding biomarker classifiers to evaluate whether a combined approach improves detection of gingivitis and periodontitis (Stages I–IV).
Why it matters
Potential benefit: If successful, this approach could offer a quick, non‑invasive way to screen for periodontal disease and help identify people who need a full periodontal exam and treatment.
How similar studies have gone: Previous work including the earlier NCT07164573 has shown promising signals for questionnaires and oral images, but combining imaging, OPGs and salivary/microbial biomarkers using machine learning is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China Recruiting -
Department of Oral and Maxillofacial Sciences, Policlinico Umberto I, affiliated to Sapienza University
Roma, Roma, Italy Not yet recruiting -
Department of Periodontology, Guy's Hospital affiliated to King's College London
London, United Kingdom Not yet recruiting
Study contacts
- Study coordinator: Maurizio S. Tonetti
- Email: tonetti@hku.hk
- Phone: 15000102368
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.