Discovery and Validation of Biomarkers for Periodontitis, Dental Caries and Oral Squamous Cell Ca… (NCT07745803) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Discovery and Validation of Biomarkers for Periodontitis, Dental Caries and Oral Squamous Cell Carcinoma
China4,000 participantsStarted 2026-08-25
Plain-language summary
The goal of this observational study is to develop better ways to detect and predict major oral diseases, including oral cancer, gum disease, and tooth decay. This study will collect detailed oral health information and biological samples from adults with different oral health conditions and healthy participants to identify markers that may help doctors detect diseases earlier and predict how diseases may change over time. The main questions this study aims to answer are whether biological markers from saliva, mouth rinse samples, blood, or oral tissue samples can help identify people with oral diseases, whether these markers can predict future disease changes such as worsening gum disease, new or progressing tooth decay, or recurrence and spread of oral cancer, and whether combining clinical information with biological markers can improve disease detection and risk prediction. Participants will receive a standard oral health examination, provide information about their health history and oral health behaviors, provide biological samples when appropriate, and be followed over time through clinical visits, questionnaires, and health information collection. Researchers will compare findings among people with different oral health conditions and healthy participants to better understand disease-related changes and develop tools for earlier detection and prediction of oral disease outcomes.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Adults aged 18 years or older.
. Able to understand the study information and provide written informed consent.
. Meet the criteria for one of the study groups based on clinical evaluation and disease assessment, including:
Exclusion criteria
. Edentulous individuals.
. History of radiotherapy to the head and neck region.
. Presence of immunodeficiency conditions (for example, human immunodeficiency virus infection).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is focused on finding biomarkers to detect oral diseases like oral squamous cell carcinoma, periodontitis, and dental caries — does my current diagnosis or oral health situation make me a potentially suitable candidate to discuss with the research team once recruitment opens?
2Since this trial is listed as 'not yet recruiting,' how long might it be before it actually starts enrolling participants, and should I be pursuing standard diagnostic or treatment options in the meantime rather than waiting?
3Because this study appears to be primarily about discovering and validating diagnostic tools rather than treating any condition, does participating mean I would receive any treatment, or would I mainly be contributing samples or data to help build better tests for future patients?
4Given that oral squamous cell carcinoma is one of the conditions being studied, if I have concerns about that diagnosis, would you recommend I pursue currently available diagnostic workups and treatment right away, rather than waiting to see if this biomarker study could play a role in my care?
5What would my involvement in this kind of biomarker discovery study actually look like in practical terms — for example, what samples might be collected, how many visits might be required, and are there any risks I should understand before deciding whether to ask about enrolling?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Diagnostic accuracy to detect oral diseases
Timeframe: At baseline assessment
Trial details
NCT IDNCT07745803
SponsorShanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University