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

Official title

Discovery and Validation of Biomarkers for Periodontitis, Dental Caries and Oral Squamous Cell Carcinoma: A Multi-Disease Cohort Study

Overview

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.

Interventions

• Procedure Step 1 and 2 periodontal therapy according to the EFP clinical practice guidelines
  Standard of care treatment
• Procedure Dental filling with or without root canal treatment
  Standard of care treatment with a composite filling material
• Procedure 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.

Primary outcome measures

• Diagnostic accuracy to detect oral diseases [Time frame: At baseline assessment]

Secondary outcome measures (4)

• 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]

Eligibility criteria

Inclusion criteria

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).

Exclusion criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model

Cohort

Study locations

China · 1 center

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

Identifiers

NCT: NCT07745803 · SH9H-2026-T152-2

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗