Actively Recruiting
Discovery and Validation of Periodontitis Biomarkers
Led by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · Updated on 2026-04-20
228
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Periodontitis is a significant public health concern in China, affecting millions of adults and leading to serious oral health problems such as loss of chewing function. The disease is expected to rise sharply by 2050, highlighting the need for coordinated actions including health education, AI-based self-detection tools, effective treatments, and healthcare system reorganization. Current diagnostic methods struggle to distinguish between early gingivitis and stage I periodontitis, limiting early intervention efforts. This research aims to discover new biomarkers to better understand and predict periodontitis onset and progression using advanced multi-omics techniques. The study will use a multi-omics approach including laser scanning microdissection proteomics, salivary proteomics, tissue transcriptomics, and microbiome analysis to identify distinct clusters within a mixed group of patients with gingivitis and stage I periodontitis. Participants will undergo diagnostic procedures including clinical measurements by a trained examiner and collection of various biological samples such as saliva, oral rinse, gingival fluid, subgingival microbiome samples, and tissue biopsies. These samples will be analyzed using state-of-the-art methods to discover biomarkers that may predict disease progression. Participants will be adults aged 18 to 40 diagnosed with different stages of periodontal disease. The study involves detailed clinical examinations and collection of biological samples stored for comprehensive analysis. Researchers will evaluate the accuracy of biomarker-defined clusters in predicting periodontitis progression over 24 months. The study is observational and aims to improve early detection methods. Participants’ health and cooperation will be monitored throughout the study period, which runs until October 2027.
CONDITIONS
Brief Title
Discovery and Validation of Periodontitis Biomarkers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults between 18 and 40 years of age
- Diagnosed with varying degrees of periodontal disease, including gingivitis and stage I periodontitis
- Voluntarily agree to participate in the study, have signed the informed consent form, and are able to comply with the study protocol
You will not qualify if you...
- Pregnant or breastfeeding women
- Received antibiotic treatment within the past 3 months
- Received periodontal treatment (including supragingival scaling) within the past 6 months
- Have mucosal or salivary gland diseases such as Sjögren's syndrome
- Have severe systemic diseases, immune dysfunction, or conditions that contraindicate surgery
- Unwilling to cooperate with the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessment and consent
Duration - 1 day
Participants undergo clinical measurements and provide various biological samples including saliva, oral rinse, gingival fluid, microbiome samples, and gingival biopsies for biomarker analysis.
1 visit (in-person) for sample collection and clinical measurements
Duration - 24 months
Participants are monitored over 24 months to evaluate the accuracy of biomarker-defined clusters in predicting periodontitis progression.
Follow-up visits as scheduled for monitoring progression
Trial Site Locations
Total: 1 location
1
Shanghai 9th people's hospital
Shanghai, Shanghai Municipality, China, 200120
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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