Animal Coronal Caries Model

Animal Coronal Caries Model
for Evaluating Fluoride Dentifrices

Field of Application: Therapeutic Dental Products

Marketplace: During the last half-century, the increased use of fluoride for caries prevention has resulted in a growing number of manufacturers developing fluoride systems. In order to predict the efficacy of their fluoride dentifrices, manufacturers have utilized pre-clinical animal caries models. These models have played a significant role in the development and evaluation of clinical prevention of dental caries and are of major importance to review agencies such as the American Dental Association's Council on Dental Therapeutics. The major challenge is to utilize a model that is representative of clinical reality and is capable of reliably predicting clinical efficacy. Animal caries models used in this manner should offer the following capabilities: 

  • to reflect clinical reality by producing responses which are generally similar to those observed in humans;
  • to predict the clinical cariostatic efficacy of fluoride-containing dentifrices reliability;
  • to develop caries generally structurally and etiologically characteristic of the lesions which develop in humans on smooth surfaces and fissures;
  • to be responsive to changing concentrations of fluorides; and
  • to be reproducible, with the ability to replicate efficacy assessments.

Technology Research and Development Description: For the past 40 years, IU's Oral Health Research Institute has developed, significantly modified and utilized a rat caries model that successfully evaluates the effects of fluoride dentifrice formulations on coronal caries.

Market Advantage: This model was developed at the IU Oral Health Research Institute, one of the worlds best known product testing sites and has produced published study data demonstrating its value for predicting clinical efficacy. Advantages serving to validate this animal caries model include the following: 

  • significant relevance to observations in humans;
  • clear responsiveness to fluoride;
  • a fluoride dose response as has been observed in human clinical trials;
  • increased efficacy in relation to increasing fluoride content; and
  • IU Oral Health Research Institute's compliance with FDA Good Laboratory Practices.