Clinical trial · Observational
Discovery and Validation of Biomarkers for Periodontitis, Dental Caries and Oral Squamous Cell Carcinoma
Discovery and Validation of Biomarkers for Periodontitis, Dental Caries and Oral Squamous Cell Carcinoma: A Multi-Disease Cohort Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Dental Caries | — | UNRESOLVED | — |
| Oral Squamous Cell Carcinoma (OSCC) | Oral Cavity Squamous Cell Carcinoma | ALIAS | 0.85 |
| Periodontal Disease | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dental filling with or without root canal treatment | Procedure | — | UNRESOLVED |
| Oral cancer surgical resection including extension, dissection and reconstruction with adjunctive radiation, chemotherapy and/or biological treatments per international guidelines, | Procedure | — | UNRESOLVED |
| Step 1 and 2 periodontal therapy according to the EFP clinical practice guidelines | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Periodontitis group
- description
- Subjects with a diagnosis of stage II-IV periodontitis. Subjects will be referred to the relevant hospital department for guideline-conformant clinical care.
- interventionNames
- Procedure: Step 1 and 2 periodontal therapy according to the EFP clinical practice guidelines
- label
- Caries group
- description
- Subjects with a diagnosis of caries. Subjects will be referred to the relevant hospital department or to primary care facilities for guideline-conforming care.
- interventionNames
- Procedure: Dental filling with or without root canal treatment
- label
- Oral cancer group
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Participants must meet all of the following criteria: 1. Adults aged 18 years or older. 2. Able to understand the study information and provide written informed consent. 3. 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: 1. Edentulous individuals. 2. History of radiotherapy to the head and neck region. 3. Presence of immunodeficiency conditions (for example, human immunodeficiency virus infection). 4. Pregnancy.
References
Publications (0)
Data not yet available