Clinical discovery and verification of predictive biomarkers for caries and periodontitis
- Björn Klinge
- Malmö university and the Knowledge foundation
- Ansvarig vid Mau:
- Björn Klinge
- Henrik Jansson. Folktandvården Skåne
- Stefan Rüdiger
- Specialisttandvården Region Skåne
- 01 september 2018 - 31 augusti 2023
The Foresight research group “Clinical discovery and verification of predictive biomarkers” will focus on analysing candidate biomarkers supplied by the “Experimental discovery group” in patients with caries and periodontitis. The novel idea behind this project is that phenotypes in biofilms or specific molecules associated with them, in combination with specific molecules involved in the host response to the same biofilms, can be used as biomarkers to predict onset of disease.
Verification will be undertaken on five-six of the most promising biomarkers for caries and periodontitis, respectively. The expected output of the verification phase will be a small number (1-2) of highly credible biomarker candidates suitable for sensor development and subsequent clinical validation studies. Later in the project sensors supplied by the “Sensor group” will be used to analyse the biomarkers in patients in real-time. The group covers a range of competences: periodontology and study design, clinical sampling and analyses, sample analysis, microbiology and oral ecology, orthodontics, pedodontics and oral health.
The project will focus on one main research questions:
- What is the efficacy of developed biomarkers?
The research questions will be addressed through a set of key actions:
1. Verification of candidate biomarkers
Verification will be performed on samples that closely represent individuals in which the clinical risk assessment will be deployed. Candidate biomarker specificity will be assessed in samples from groups of individuals with ‘high risk’ and ‘low risk’, respectively. Differentiation of these two groups is based on clinical assessments of established disease. The verification will be performed in separate studies for caries and periodontitis respectively and will include in total 50 patients in each study (25 with high and 25 with low risk). The candidate biomarkers will be analyzed using the same analytical methods as in the discovery phase in order to ensure consistency with previous findings.
2. Clinical validation of predictive biomarkers
The clinical validation of predictive biomarkers will be undertaken in longitudinal prospective clinical trials conducted in accordance with “Standards for Reporting of Diagnostic Accuracy” (STARD-statement). Patients from the Public Dental Health in Halland, Småland and Skåne and from MaU will be recruited. Samples from multiple sites in each individual will be collected every six months over 3 years. The predictability of the biomarkers will be assessed by calculating their sensitivity, specificity, predictive values, and likelihood ratios for several threshold values.