Evaluation of oral hygiene products: science is true; don't be misled by the facts.

Most people in industrialized countries use oral hygiene products. When an oral health benefit is expected, it is important that sufficient scientific evidence exist to support such claims. Ideally, data should be cumulative derived from studies in vitro and in vivo. The data should be available to the profession for evaluation by publication in refereed scientific journals. Terms and phrases require clarification, and claims made by implication or derived by inference must be avoided. Similarity in products is not necessarily proof per se of efficacy. Studies in vitro and in vivo should follow the basic principles of scientific research. Studies must be ethical, avoid bias and be suitably controlled. A choice of controls will vary depending on whether an agent or a whole product is evaluated and the development stage of a formulation. Where appropriate, new products should be compared with products already available and used by the general public. Conformity with the guidelines for good clinical practice appears to be a useful way of validating studies and a valuable guide to the profession. Studies should be designed with sufficient power to detect statistically significant differences if these exist. However, consideration must be given to the clinical significance of statistically significant differences between formulations since these are not necessarily the same. Studies in vitro provide supportive data but extrapolation to clinical effect is difficult and even misleading, and such data should not stand alone as proof of efficacy of a product. Short-term studies in vivo provide useful information, particularly at the development stage. Ideally, however, products should be proved effective when used in the circumstances for which they are developed. Nevertheless, a variety of variable influence the outcome of home-use studies, and the influence of the variable cannot usually be calculated. Although rarely considered, the cost-benefit ratio of some oral hygiene products needs to be considered.