The Challenges of Validating Diagnostic Methods Relative to a Conventional Two-year Caries Clinical Trial

This paper is directed to the question, “What are the appropriate validation criteria for the use of a new clinical trial methodology as a replacement for a conventional two- to three-year caries study?” It is important to recognize that the objective of a two- to three-year randomized, controlled caries trial is to test a precisely framed hypothesis, regarding an experimental product's efficacy relative to a control product. The external validity of conventional two- to three-year caries clinical studies in determining the efficacy and safety of anti-caries products is well-accepted. However, caries clinical trials are not without limitations and have increasingly been viewed as inefficient with respect to measuring the disease process in a holistic manner. The endpoint of a caries lesion with loss of enamel integrity (cavitation) focuses on one end of the caries progression continuum at the expense of early caries initiation and progression. Several early caries detection methods have been developed tha...