RESUMO
PURPOSE: To demonstrate the robustness of the Featherstone pH cycling model when tested in three independent laboratories and to evaluate the use of "non-inferiority" testing at those laboratories. METHODS: The fundamental principles for the Featherstone laboratory pH cycling model to be an appropriate alternative to animal testing is that it must demonstrate equivalent accuracy to the "Gold Standard" (rat caries model) by: (1) providing a meaningful representation of the caries process; (2) demonstrating a proportionate response to fluoride dose (or concentration); (3) being able to show that clinically proven formulations perform similarly relative to the controls; and (4) differentiating products that have attenuated fluoride activity. RESULTS: This cross-validation study confirmed the ability of the three independent laboratories to discriminate between various concentrations of fluoride-containing dentifrice formulations, demonstrated that clinically proven formulas perform as expected and identified an attenuated fluoride formulation (NaF/CaCO3 dentifrice - 1100 ppm NaF) as inferior compared to the 1100 ppm F (NaF/silica) positive control.