A study of the ability of an in situ remineralization model to differentiate between the effects of two fluoride dentifrices that produced significantly different clinical caries results.

The purpose of this study was to determine whether an in situ remineralization model was able to show a difference in the effects of two dentifrices of different fluoride concentrations and significantly different clinical efficacies. Three dentifrices were tested in a double-blind, cross-over study design. The products contained 0 ppm F, 250 ppm F, or 1000 ppm F from sodium fluoride and were formulated with a silica base according to the formulations used in a human caries trial (Koch et al., 1990). Nineteen subjects each carried three or four thin sections of enamel in their partial dentures. The thin sections, containing artificial caries lesions, were covered with a steel mesh to provide space for plaque formation and then brushed in situ three times daily with the dentifrices. Following the two-week treatment periods, the specimens were removed from the dentures and analyzed for changes in mineral content. The findings showed that the placebo dentifrice (0 ppm F) resulted in 56.8 +/- 74.3% demineralization, the 250-ppm-F dentifrice produced 12.9 +/- 41.3% demineralization, thereby showing partial caries protection, and the 1000-ppm-F dentifrice produced 17.3 +/- 32.1% remineralization. Linear regression analysis showed that the percent remineralization was significantly related to the fluoride concentration in the dentifrice (p less than 0.001). The 250-ppm-F dentifrice was also significantly less effective than the 100-ppm-F dentifrice (p = 0.04, one-tailed Fisher Protected LSD test). These findings are in accord with the human caries trial and support the use of the present in situ remineralization model for prediction of the anticaries efficacy of fluoride dentifrice products.