Oral Squamous Cell Carcinoma (OSCC)NCT07745803
Discovery and Validation of Biomarkers for Periodontitis, Dental Caries and Oral Squamous Cell Carcinoma
An observational study of Oral Squamous Cell Carcinoma (OSCC) and Periodontal Disease, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oral Squamous Cell Carcinoma (OSCC), Periodontal Disease, Dental Caries
- What is being tested?
- Step 1 and 2 periodontal therapy according to the EFP clinical practice guidelines, Dental filling with or without root canal treatment and Oral cancer surgical resection including extension, dissection and reconstruction with adjunctive radiation, chemotherapy and/or biological treatments per international guidelines,
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- How many people
- 4,000 participants
- Where
- 1 siteChina
- Study dates
- 25 Aug 2026to 30 Dec 2031
- How long will I take part?
- 4 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- Participants must meet all of the following 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:
- Oral squamous cell carcinoma (OSCC); Periodontal disease; Dental caries; Oral health without the corresponding diseases (healthy controls).
Who cannot join
- Participants will be excluded if they meet any of the following criteria:
- Edentulous individuals.
- History of radiotherapy to the head and neck region.
- Presence of immunodeficiency conditions (for example, human immunodeficiency virus infection).
- Pregnancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200000
Yuan Li, 13916337473, ly9919@hotmail.com
About this study
Official title: Discovery and Validation of Biomarkers for Periodontitis, Dental Caries and Oral Squamous Cell Carcinoma: A Multi-Disease Cohort Study
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.
Read the detailed description
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.
- Being tested
- Step 1 and 2 periodontal therapy according to the EFP clinical practice guidelines, Dental filling with or without root canal treatment, Oral cancer surgical resection including extension, dissection and reconstruction with adjunctive radiation, chemotherapy and/or biological treatments per international guidelines,
- Keywords
- Oral disease, Oral squamous cell carcinoma, Periodontal disease, Dental caries, Biomarkers, Early detection, Prognostic prediction
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Periodontal Diseases, Dental Caries, Mouth Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Step 1 and 2 periodontal therapy according to the EFP clinical practice guidelinesProcedure or surgery
Standard of care treatment
Dental filling with or without root canal treatmentProcedure or surgery
Standard of care treatment with a composite filling material
Oral cancer surgical resection including extension, dissection and reconstruction with adjunctive radiation, chemotherapy and/or biological treatments per international guidelines,Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Periodontitis group | Subjects with a diagnosis of stage II-IV periodontitis. Subjects will be referred to the relevant hospital department for guideline-conformant clinical care. Receives: Procedure: Step 1 and 2 periodontal therapy according to the EFP clinical practice guidelines | |
| Caries group | Subjects with a diagnosis of caries. Subjects will be referred to the relevant hospital department or to primary care facilities for guideline-conforming care. Receives: Procedure: Dental filling with or without root canal treatment | |
| Oral cancer group | 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. Receives: Procedure: Oral cancer surgical resection including extension, dissection and reconstruction with adjunctive radiation, chemotherapy and/or biological treatments per international guidelines, |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline assessment
Secondary outcomes (4)
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: up to 48 months of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start25 Aug 2026 (estimated)
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Squamous Cell Carcinoma (OSCC)Studies of the same condition, open and under way.
- More trials run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,000 participants (estimated)
- Target duration
- 4 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maurizio Tonetti, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07745803
- Sponsor's protocol ID
- SH9H-2026-T152-2
- Status last verified
- Jul 2026
- First submitted
- 13 Jul 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discovery and Validation of Biomarkers for Periodontitis, Dental Caries and Oral Squamous Cell Carcinoma: A Multi-Disease Cohort Study
- ClinicalTrials.gov ID
- NCT07745803
- Acronym / sponsor ID
- SH9H-2026-T152-2
- Keywords
- Oral disease, Oral squamous cell carcinoma, Periodontal disease, Dental caries, Biomarkers, Early detection, Prognostic prediction
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- 25 Aug 2026 (estimated)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2031 (estimated)
- First posted
- 4 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Periodontitis group | – | Procedure: Step 1 and 2 periodontal therapy according to the EFP clinical practice guidelinesSubjects with a diagnosis of stage II-IV periodontitis. Subjects will be referred to the relevant hospital department for guideline-conformant clinical care. |
| Caries group | – | Procedure: Dental filling with or without root canal treatmentSubjects with a diagnosis of caries. Subjects will be referred to the relevant hospital department or to primary care facilities for guideline-conforming care. |
| Oral cancer group | – | Procedure: Oral cancer surgical resection including extension, dissection and reconstruction with adjunctive radiation, chemotherapy and/or biological treatments per international guidelines,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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- 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:
- Oral squamous cell carcinoma (OSCC); Periodontal disease; Dental caries; Oral health without the corresponding diseases (healthy controls).
Key exclusion criteria (5 listed)
- Edentulous individuals.
- History of radiotherapy to the head and neck region.
- Presence of immunodeficiency conditions (for example, human immunodeficiency virus infection).
- Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Step 1 and 2 periodontal therapy according to the EFP clinical practice guidelinesStandard of care treatment | Procedure or surgery | Periodontitis group |
| Dental filling with or without root canal treatmentStandard of care treatment with a composite filling material | Procedure or surgery | Caries group |
| Oral cancer surgical resection including extension, dissection and reconstruction with adjunctive radiation, chemotherapy and/or biological treatments per international guidelines,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. | Procedure or surgery | Oral cancer group |
Primary outcome
Diagnostic accuracy to detect oral diseases
Time frame: At baseline assessment
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.
4 secondary outcomes
Sensitivity to detect oral diseases
Time frame: At baseline assessment
Specificity to detect oral diseases
Time frame: At baseline assessment
Hazard ratio of oral disease progression
Time frame: up to 48 months of follow-up
Hazard ratio of oral squamous cell carcinoma metastasis
Time frame: up to 48 months of follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Squamous Cell Carcinoma (OSCC) and Periodontal Disease, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maurizio S. Tonetti (15000102368, tonetti@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy to detect oral diseases (time frame: At baseline assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.