Statistical Considerations Related to the Use of Caries Model Systems for the Determination of Clinical Effectiveness of Therapeutic Agents

Abstract

Caries model systems bear great promise for the eventual determination of clinical benefits of therapeutic agents without the time and expense involved in the conduct of a full-fledged clinical trial. However, before such models can routinely be applied for such purposes, there are several issues which must first be resolved, including the consideration of a number of statistical matters. These include the assessment of the validity and reliability of the models to be so used. A procedure presented by Proskin, Chilton, and Kingman provides a quantitative means by which a conclusion concerning clinical effectiveness can be derived on the basis of data obtained through the use of a model system, given that certain fairly general underlying conditions prevail. The present paper provides some discussion and recommendations of the author related to statistical matters concerning the use of models, and discusses the derivation and logic of the Proskin, Chilton, and Kingman procedure.

Keywords

Statistics caries models therapeutics evaluation.

Get full access to this article

View all access options for this article.

References

Chilton NW (1992). Consensus conference on intra-oral models: experimental design and analysis. J Dent Res 71(Spec Iss):953.

Council on Dental Therapeutics (1985). Guidelines for the acceptance of fluoride-containing dentifrices. J Am Dent Assoc 110:545-547.

Council on Dental Therapeutics (1988). Report of workshop aimed at defining guidelines for caries clinical trials: superiority and equivalence claims for anticaries dentifrices. J Am Dent Assoc 117:663-665.

Koch G. , Bergmann-Amadottir I. , Bjarnason S. , Finnbogason S. , Hoskuldsson O. , Karlsson R. (1990). Caries-preventive effect of fluoride dentifrices with and without anticalculus agents: a 3-year controlled clinical trial. Caries Res 24:72-79.

Mitropoulos C. , Holloway P. , Davies R. , Worthington H. (1984). Relative efficacy of dentifrices containing 250 or 1000 ppm F- in preventing dental caries. Report of a 32-month clinical trial. Community Dent Health 1:193-200.

Proskin HM (1992). Statistical considerations related to intra-oral studies. J Dent Res 71(Spec Iss):901-904.

Proskin HM , Chilton NW , Kingman A. (1992). Interim report of the ad hoc committee for the consideration of statistical concerns related to the use of intra-oral models in submissions for product claims approval to the American Dental Association . J Dent Res 71(Spec Iss):949-952.

Raubertas R. (1995). Statistical considerations in caries models: Reaction paper. Adv Dent Res 9: 285-289.