Clinical evaluation of an intraoral device for the controlled release of fluoride.

An intraoral-releasing device designed to release 0.5 mg of fluoride per day was evaluated in a one-month trial. The results showed that the 11 men who wore the fluoride-releasing device on their maxillary first molars had significantly elevated levels of fluoride in their saliva and plaque compared with baseline levels. No significant changes were observed in mean serum or urine fluoride levels or in the gingival or plaque indexes during the study. The prevalence of S mutans in whole saliva did not change during the study and the relative proportion of S. mutans, S. sanguis, and A viscosus and A naeslundii in plaque also remained relatively stable. The elevated fluoride levels in saliva and plaque are presumptive evidence that the intraoral fluoride-releasing device could exert a cariostatic effect in humans. However, long-term clinical trials are needed to determine the cariostatic potential of this fluoride releasing system.