Statistical considerations related to intra-oral studies

Intra-oral studies use caries models from which conclusions are drawn concerning the caries process in the clinical environment. Recently, attention has been drawn to the issue of proper analysis and interpretation of the data from such studies, with particular emphasis placed on a consideration of the role such studies can and should play as a component of product claim submissions to the American Dental Association (ADA). This presentation discusses a number of issues relevant to this consideration, including the validity and reliability of the intra-oral modeling process, the relationship between these concepts and the requirements imposed by the ADA Guidelines for superiority and equivalence claims, and a brief enumeration of several other statistical issues which ought to be considered in the handling of data from such studies.