Discovery and Validation of Biomarkers for Periodontitis, Dental Caries and Oral Squamous Cell Carcinoma

NCT07745803 | Not Yet Recruiting

• 1 other identifier: SH9H-2026-T152-2
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Oral Squamous Cell Carcinoma (OSCC); Periodontal Disease; Dental Caries

Keywords

Oral disease; Oral squamous cell carcinoma; Periodontal disease; Dental caries; Biomarkers; Early detection; Prognostic prediction

Outcome Measures

Primary Outcomes (1)

• 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.

  At baseline assessment

Secondary Outcomes (4)

• Sensitivity to detect oral diseases

  At baseline assessment

• Specificity to detect oral diseases

  At baseline assessment

• Hazard ratio of oral disease progression

  up to 48 months of follow-up

• Hazard ratio of oral squamous cell carcinoma metastasis

  up to 48 months of follow-up

Study Arms (3)

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.

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.

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.

Procedure: Oral cancer surgical resection including extension, dissection and reconstruction with adjunctive radiation, chemotherapy and/or biological treatments per international guidelines,

Interventions

Step 1 and 2 periodontal therapy according to the EFP clinical practice guidelines PROCEDURE

Standard of care treatment

Periodontitis group

Dental filling with or without root canal treatment PROCEDURE

Standard of care treatment with a composite filling material

Caries group

Oral cancer surgical resection including extension, dissection and reconstruction with adjunctive radiation, chemotherapy and/or biological treatments per international guidelines, PROCEDURE

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.

Oral cancer group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: lead

Study Sites (1)

Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200000, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Biological samples retained in this study will include saliva, mouth rinse samples, blood samples, and oral lesion-related samples when applicable. Saliva and mouth rinse samples will be collected from participants for biomarker and molecular analyses. Blood samples, including plasma and whole blood, may be collected from participants when appropriate, particularly among participants with oral squamous cell carcinoma (OSCC). Oral lesion-related samples will be collected only from participants with OSCC according to clinical procedures and may be used for biomarker research. All retained biospecimens will be labeled with coded study identifiers, processed according to standardized procedures, and stored under appropriate conditions for future analyses related to oral disease detection, progression, and prognosis.

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Periodontal Diseases; Dental Caries; Mouth Diseases

Interventions

Dissection; Plastic Surgery Procedures

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Maurizio S. Tonetti

CONTACT

15000102368; tonetti@hku.hk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: August 4, 2026
• Study Start (Estimated): August 25, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2031
• Last Updated: August 4, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)