Exploratory Randomized Clinical Trial of an Experimental Gel-to-Foam Fluoride Dentifrice Formulation Using an In Situ Caries Model.

ABSTRACT

OBJECTIVE: To evaluate the in situ caries performance and safety of two experimental fluoride dentifrice formulations (1450 ppm fluoride) with and without 2% isopentane as an excipient, in comparison to a positive control, currently marketed dentifrice (1450 ppm fluoride) and a negative control dentifrice (0 ppm fluoride). METHODS: This was a single-center, examiner-blind, randomized, controlled, four-treatment cross-over study. During each treatment period, the subject wore a modified mandibular partial denture fitted with two gauze-covered, partially demineralized human enamel specimens, and brushed at home for one timed minute, twice daily, for two weeks. At the end of each treatment period, the enamel specimens were removed from the dentures for analysis. During the week between treatment periods, subjects returned to their usual dental hygiene practices for four to five days, received a dental prophylaxis, and used a study-designated non-fluoride dentifrice for two to three days before starting the next treatment. Treatment effect on enamel specimen remineralization was assessed by surface microhardness (SMH). Enamel fluoride uptake was assessed using microdrill enamel biopsy. RESULTS: All fluoride-containing dentifrices demonstrated significant, superior SMH recovery and levels of fluoride uptake compared to the negative control dentifrice. No significant differences were observed for either efficacy variable between the experimental dentifrice formulations and the positive control dentifrice. No significant difference was observed between the 2% isopentane dentifrice and the 0% isopentane dentifrice for SMH recovery. CONCLUSION: The addition of 2% isopentane did not positively or negatively affect fluoride efficacy in this model.