Actively Recruiting

Age: 18Years - 40Years
All Genders
Healthy Volunteers
ID07293481

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

Age: 18Years - 40Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for eligibility assessment and consent

Diagnostic Evaluation

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

Long-term Monitoring

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

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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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