Abstrait

A Novel Surrogate Parameter Measuring the Outcome in Dental Clinical Trials

Just BA, Quaas S, Rudolph H, Walter M, Foest EM and Luthardt RG

Outcome assessment of dental clinical trials in general is either focused on survival and longevity or on highly specific parameters such as the clinical attachment level or the probing depth. However, when only a few primary objectives with limited clinical relevance are evaluated, the potential of high-quality clinical trials might not be fully exploited in terms of outcome assessment. By combining and weighting several specific parameters, a Clinical Success Parameter (CSP) was developed as a global innovative parameter for measuring treatment success in dental clinical trials. Also biological, technical and quality of life properties in dental therapy studies can be assessed. By merging these three aspects in a combined, ideal, virtual and risk-oriented surrogate parameter, the outcome of dental clinical trials can be compared quickly, with few patients and cost-efficiently. For clinical performance evaluation, the developed CSP rating system also allows for differentiation between a large number of clinical parameters and can be focused and adapted for a wide range of specific outcome measures.