Finding and confirming saliva biomarkers for early periodontitis
Discovery and Validation of Periodontitis Biomarkers
This project tests whether saliva-based biomarkers combined with an AI app can detect early periodontitis in adults aged 18–40.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 228 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Sponsor | Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT07293481 on ClinicalTrials.gov |
What this trial studies
This observational diagnostic study will enroll adults with gingivitis or stage I periodontitis and collect saliva samples and clinical data at Shanghai Ninth People's Hospital. Researchers will use molecular and/or biomarker analysis of saliva alongside a patented AI-based self-detection app to identify candidate markers linked to early disease. The study aims to validate which saliva signals reliably indicate early periodontitis and compare AI predictions with clinical periodontal exams. Findings will inform whether the saliva test and app could be used for population-level screening or risk identification.
Who should consider this trial
Good fit: Adults aged 18–40 with gingivitis or stage I periodontitis who can provide informed consent and comply with study procedures are ideal candidates.
Not a fit: People who are pregnant or breastfeeding, recently treated with antibiotics or periodontal therapy, have salivary gland or mucosal diseases, severe systemic illness, or advanced periodontitis are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the work could enable easier, noninvasive, earlier detection of periodontitis via a saliva test and AI app, helping to prevent disease progression.
How similar studies have performed: Previous research has shown promise for saliva biomarkers and AI-based detection of periodontal disease, but large-scale validation for population screening remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Adults between 18 and 40 years of age; 2. Diagnosed with varying degrees of periodontal disease, including gingivitis and stage I periodontitis; 3. Voluntarily agree to participate in the study, have signed the informed consent form, and are able to comply with the study protocol. Exclusion Criteria: 1. Pregnant or breastfeeding women; 2. Individuals who have received antibiotic treatment within the past 3 months; 3. Individuals who have received periodontal treatment (including supragingival scaling) within the past 6 months; 4. Individuals with mucosal or salivary gland diseases (e.g., Sjögren's syndrome); 5. Individuals with severe systemic diseases, immune dysfunction, or health conditions that contraindicate surgery; 6. Individuals who are unwilling to cooperate with the study.
Where this trial is running
Shanghai, Shanghai Municipality
- Shanghai 9th people's hospital — Shanghai, Shanghai Municipality, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.