Safety and antibacterial properties of controlled release SnF2.
Two clinical studies were performed to evaluate the safety and efficacy of an intracoronal device for the controlled release of SnF2. SnF2-polycarboxylate cement, containing approximately 72 mg F-, was placed in subjects' molars requiring two-surface restorations. In the trial for safety, eight subjects had the restoration in place for 34 days. The salivary fluoride levels were elevated to a mean of 0.3/10(6) over the experimental period. Urinary fluoride levels were only above baseline levels during the first few days. The restoration's physical properties were adequate; however, subjects experienced gingival irritation in areas where the restoration was contacted with gingiva. In the trial for efficacy, fourteen subjects had either a SnF2-polycarboxylate or a placebo restoration placed in a molar tooth during a 2 week period of no oral hygiene. During the experimental period, the control subjects had higher levels of salivary total CFU, Streptococcus sanguis and Streptococcus mutans: while the subjects with the SnF2 restoration had increased S. sanguis and decreased S. mutans levels. No differences in G.I. or PL 1 scores were noted between groups. Further development of this controlled release system should include using the SnF2-polycarboxylate restoration in more than one tooth per subject to increase the fluoride reservoir, and not allowing the restoration to contact gingival tissues.
D000328:Adult; D002986:Clinical Trials as Topic; D003692:Delayed-Action Preparations; D003793:Dental Restoration, Permanent; D005459:Fluorides / Q000008:administration & dosage*; D005881:Gingiva / Q000187:drug effects; D006801:Humans; D010919:Placebos; D011076:Polycarboxylate Cement; D011897:Random Allocation; D012463:Saliva / Q000032:analysis; D013291:Streptococcus / Q000187:drug effects*; D013295:Streptococcus mutans / Q000187:drug effects; D013298:Streptococcus sanguis / Q000187:drug effects; D014002:Tin Fluorides / Q000008:administration & dosage* / Q000032:analysis / Q000494:pharmacology / Q000652:urine
D003692:Delayed-Action Preparations; D010919:Placebos; D011076:Polycarboxylate Cement; D014002:Tin Fluorides; D005459:Fluorides