In vivo Fluoride Release From Nuvora-F-Lozenges into Saliva

Long-term low-level salivary fluoride concentrations are extremely effective in caries prevention and enhance the rate of enamel remineralization. “Objectives:”, Assess ability of Nuvora-F-Lozenges (Xylitol-aCP/Baking-Soda Ethyl-Cellulose-matrix-polymers) to significantly raise the available fluoride in saliva over and above the fluoride level achieved by the use of a standard 1,100ppm fluoride toothpaste in comparison to placebo lozenges in a double blind three-leg cross-over clinical pilot study. “Methods:”, 12 caries free, healthy subjects (average age 31±11 years) with at least 7 permanent teeth were recruited. In each study leg a two-week washout phase (1100ppmF as NaF dentifrice) was followed by a one-week treatment phase. Subjects were directed to brush twice daily, and use 3 lozenges per day each for one hour after breakfast, lunch and dinner, respectively. 2ml of stimulated saliva were collected once A) during the lozenge use and B) 5, C) 15, D) 30, and E) 60 minutes after lozenge use on multiple scheduled occasions. Lozenge formulations were: 1) 0.5mg F as NaF, 2) 1.5mg F as NaF, 3) 0mg F as negative control. Fluoride in saliva was analyzed by the diffusion method that measures concentrations ≥0.005ppm F. “Results:”, Fluoride levels (ppm F, mean±SD) in saliva for 1A) 0.896±0.738; 1B) 0.147±0.117; 1C) 0.076±0.067; 1D) 0.029±0.024; 1E) 0.030±0.020; and for 2A) 1.271±0.741; 2B) 0.124±0.082; 2C) 0.115±0.060; 2D) 0.065±0.037; 2E) 0.038±0.019; and for 3A) 0.020±0.010; 3B) 0.015±0.005; 3C) 0.017±0.007; 3D) 0.018±0.006; 3E) 0.016±0.008; baseline at 0.017±0.012. Both F-containing lozenges resulted in significantly higher salivary-F-levels than placebo at every sampling time (p<0.05 ANOVA/Newman-Keuls). “Conclusion:”, Nuvora-F-lozenges raise salivary-fluoride-levels significantly for up to 60 minutes after use in comparison to placebo and baseline. Financially supported by Nuvora, Inc., USA.