An observational study in Oral Squamous Cell Carcinoma (OSCC), Periodontal Disease and Dental Caries, sponsored by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-04.
Sponsored by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · Observational
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.
Oral diseases, including oral squamous cell carcinoma (OSCC), periodontal disease, and dental caries, are common conditions that can significantly affect oral health and quality of life. Early identification of individuals at risk and accurate prediction of disease progression are important for improving prevention, treatment planning, and long-term outcomes. However, current approaches mainly rely on clinical signs and symptoms, and there is still a need for reliable biological markers that can support earlier detection and better prediction of disease changes over time.
This observational cohort study aims to establish a comprehensive clinical and biological resource for the discovery and evaluation of markers associated with major oral diseases. The study will combine standardized oral examinations, health information collection, biological sample collection, and long-term follow-up to investigate factors associated with disease presence, severity, progression, and treatment outcomes.
Participants will undergo standardized oral health examinations and provide information related to their general health, oral health behaviors, and medical history. Biological samples, including saliva and mouth rinse samples, will be collected from participants to study changes associated with oral diseases. Additional samples, including blood samples, may be collected when appropriate. Oral lesion-related samples will only be collected from participants with oral squamous cell carcinoma (OSCC) when clinically indicated as part of their routine diagnostic or treatment procedures. Participants without OSCC, including those with periodontal disease, dental caries, or healthy oral conditions, will not undergo oral tissue biopsy for this study.
Participants will be followed over time to collect information on changes in oral health status and clinically relevant outcomes. Follow-up assessments may include repeated clinical examinations, questionnaires, and biological sample collection according to the study plan. The collected clinical information and biological samples will be analyzed to identify markers that may help improve early detection, disease risk assessment, and prediction of future disease progression.
The long-term goal of this study is to support the development of improved approaches for early detection and personalized risk assessment of major oral diseases. The clinical data and biological sample resources generated from this cohort may also support future research into the mechanisms underlying oral disease development and response to treatment.
2,018 studies on the registry are indexed under Squamous Cell Carcinoma of Head and Neck; 573 are open to participants now.
This study's planned enrollment of 4,000 is above the median of 100 across 236 observational studies indexed under Squamous Cell Carcinoma of Head and Neck.
Browse Squamous Cell Carcinoma of Head and Neck studies →Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University is the lead sponsor of 164 studies on the registry; 73 are open to participants now.
Counted across the registry records on this site, refreshed daily.
This study will enroll adults from the outpatient clinics of Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine. The study population will include individuals with major oral diseases, including oral squamous cell carcinoma (OSCC), periodontal disease, and dental caries, as well as participants without these conditions who will serve as healthy controls. Participants will be recruited through relevant dental and oral disease clinics using a continuous recruitment approach. Standardized clinical assessments will be performed to characterize oral health status, and biological samples will be collected to investigate markers associated with disease detection, progression, and prognosis. Participants will be followed longitudinally to evaluate changes in oral health status and clinically relevant outcomes over time.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants must meet all of the following criteria:
Oral squamous cell carcinoma (OSCC); Periodontal disease; Dental caries; Oral health without the corresponding diseases (healthy controls).
Exclusion Criteria:
Participants will be excluded if they meet any of the following criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects with a diagnosis of stage II-IV periodontitis. Subjects will be referred to the relevant hospital department for guideline-conformant clinical care.
Procedure: Step 1 and 2 periodontal therapy according to the EFP clinical practice guidelines
Subjects with a diagnosis of caries. Subjects will be referred to the relevant hospital department or to primary care facilities for guideline-conforming care.
Procedure: Dental filling with or without root canal treatment
Subjects with histologically confirmed oral squamous cell carcinoma or precancerous lesions. Subjects will be identified among those attending the Hospital's Oral Oncology Department. They will receive standard-of-care case workup and treatment.
Procedure: Oral cancer surgical resection including extension, dissection and reconstruction with adjunctive radiation, chemotherapy and/or biological treatments per international guidelines,
Standard of care treatment
Standard of care treatment with a composite filling material
All the necessary surgical procedures to remove the primary oral cancer tumour from the oral cavity, including the necessary dissection and plastic reconstructive surgery. All necessary adjunctive treatments, including radiation, chemotherapy and/or biological therapies.
Diagnostic accuracy to detect oral diseases
The diagnostic accuracy will be measured as the area under the receiver operating characteristic curve (AUC). Clinical diagnosis will be the reference standard and will be performed by calibrated examiners in accordance with international case-definition standards.
Time frame: At baseline assessment
Sensitivity to detect oral diseases
Sensitivity will be calculated using clinical diagnosis as the reference standard as defined by calibrated examiners in accordance with international case-definition standards
Time frame: At baseline assessment
Specificity to detect oral diseases
Specificity will be reported as the proportion of participants without oral diseases correctly classified by the test. The reference standard will be clinical diagnosis performed by calibrated examiners in accordance with international case definition standards.
Time frame: At baseline assessment
Hazard ratio of oral disease progression
The hazard ratio (HR) for oral disease progression will be estimated using survival analysis methods. The progression of oral disease will be assessed using longitudinal changes in standardized clinical parameters and tooth loss. The reference standard will be clinical diagnosis performed by calibrated examiners in accordance with international case definition standards.
Time frame: up to 48 months of follow-up
Hazard ratio of oral squamous cell carcinoma metastasis
The hazard ratio (HR) for oral squamous cell carcinoma (OSCC) metastasis will be estimated using survival analysis methods. Metastasis will be assessed based on clinical and imaging evaluations during follow-up by calibrated examiners and following international standards.
Time frame: up to 48 months of follow-up
Plan to share: No — Individual participant data (IPD) will not be shared publicly because the study includes sensitive clinical information and biological sample-related data. Although data will be de-identified, sharing individual-level data may present risks related to participant privacy and confidentiality. Access to study data may be considered for qualified researchers upon reasonable request and appropriate approval, including ethical review and data use agreements, in accordance with institutional policies and applicable regulations.
No publications or documents are linked to this record.
Start is estimated for Aug 2026; primary completion for Dec 2027, 16 months later.
Of 108 non-industry observational studies under Squamous Cell Carcinoma of Head and Neck, half reached primary completion within 81 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 132. This study's planned 16 months is below that.
Counting every sponsor, half of 118 studies reached it within 81 months; a quarter within 29 and three quarters within 132.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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