Adequate cohort sizes for caries clinical trials

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Abstract
Methods of determining cohort sizes were examined to determine their appropriateness for use in multi‐group caries clinical trials. The appropriate method to use depends on the type of trial being planned. It is shown that multiple comparison methods using certain Bonferonni type t‐statistics ought to be used in trials in which different levels or frequencies of application of known caries inhibitors are being tested. It is also demonstrated that using the F‐test procedure in the determination of cohort sizes can result in unacceptable low sensitivity levels being realized for the comparisons of primary concern. Tables are presented which can be used to determine group sizes needed to achieve specified sensitivity levels for two‐group trials and multi‐group trials.