The clinical effect of a stabilized stannous fluoride dentifrice on plaque formation, gingivitis and gingival bleeding: a six-month study.

The effects of a stabilized 0.454% stannous fluoride dentifrice, currently marketed as Crest Gum Care, on supragingival plaque, gingivitis, gingival bleeding and oral soft tissue condition were studied in 328 adult male and female subjects who completed a six-month, double blind clinical study. Following initial examinations, subjects presenting with a minimum of five gingival bleeding sites received a thorough dental prophylaxis and were instructed to brush at least twice a day for three months with a commercially available fluoride dentifrice, packaged in such a way as to blind its identity to the study subjects. This constituted the three-month pre-test period. At the end of this period, subjects were again examined, given a second oral prophylaxis, and randomly assigned to brush with one of the following dentifrices: 1) stabilized 0.454% stannous fluoride, 2) 0.243% sodium fluoride control, or 3) one of three experimental dentifrices. Subjects were instructed to brush their teeth as they normally would, at least twice a day for one minute per brushing. Follow-up examinations after three and six months of dentifrice use evaluated supragingival plaque, gingivitis, gingival bleeding, extrinsic tooth stain and oral soft tissue status. After six months, the stabilized stannous fluoride dentifrice significantly reduced gingivitis and gingival bleeding by 20.5% and 33.4% compared to the sodium fluoride control group. However, the stabilized stannous fluoride dentifrice group was not significantly different from the control dentifrice group with respect to supragingival plaque scores. As expected, accumulation of extrinsic tooth stain was greater in the stabilized stannous fluoride group than the control group. No unexpected nor clinically significant oral soft tissue health effects were associated with the use of the test dentifrices. The results from this clinical study demonstrate that over a six-month period, twice-daily use of a dentifrice containing 0.454% stabilized stannous fluoride significantly reduced gingivitis and gingival bleeding, relative to a 0.243% sodium fluoride control dentifrice.

Microbiological assessment of an improved stannous fluoride dentifrice.

Recently, a new stabilized stannous fluoride (SnF2) dentifrice (SSF) has been developed. The aim of the present work was to examine the antimicrobial activity of SnF2, and to assess the long-term microbial safety of this dentifrice in a series of in vitro and clinical evaluations. Results of in vitro time-kill experiments with representative oral bacteria demonstrated that SnF2 exerts broad antimicrobial activity against both Gram-positives and Gram-negatives and, in particular, has potent activity against Streptococcus mutans. Sixty-eight subjects participated in a nine-day plaque regrowth clinical study to assess the short-term antiplaque effect of SSF. The results revealed no significant differences from the negative control, suggesting that SnF2 does not detectably or directly alter plaque microbial viability or composition. Separately, evaluation of microbial safety in a subgroup of 120 subjects participating in a six-month clinical efficacy and safety trial found no significant ecological shifts between SSF and the negative (NaF dentifrice) control among 11 supragingival microbial populations examined. The potential for development of bacterial resistance to SnF2 was assessed under both in vitro and clinical conditions. In a rigorous assessment of the ability of bacterial populations to develop either phenotypic or genotypic resistance to SnF2, representative bacteria were exposed to continuous sub-lethal concentrations of SnF2 in a laboratory chemostat for at least 9 days. Results of time-kill experiments on exposed populations revealed no significant changes in susceptibility despite exposure of over 10(12) bacteria. Based on typical spontaneous mutation rates of 10(-6) to 10(-8), these results suggested that the potential for bacteria to develop resistance to SnF2 is low. Evaluation of susceptibility to SnF2 to over 800 bacterial isolates obtained over the course of the six-month clinical trial corroborate the in vitro findings, revealing no changes in susceptibility suggestive of development of resistance to SnF2 is a microbiologically safe agent for oral use and support separate clinical observations demonstrating the safety and efficacy of this stabilized SnF2 dentifrice.

Candida in pancreatic infection: a clinical experience.

Pancreatic infection remains a significant clinical problem, with substantial morbidity and mortality. Published case reports of Candida species identified in these infections prompted a review of 17 consecutive patients recently treated for peripancreatic infection by scheduled relaparotomy. Six patients were transferred from other hospitals, all having undergone prior operative intervention (median stay elsewhere: 58 days). The 11 other patients underwent initial operation an average of 14 days after admission. Candida species were identified in the initial operative cultures of 5 patients (29%), three of whom had undergone previous drainage at other hospitals. Two patients (11.7%) had Candida identified at subsequent operation. Six patients were treated with Amphotericin B for a median of 12 days (range 6-32) and a median dosage of 420 mg (range 225-830 mg). All patients were cleared of their Candida infection, but three subsequently died, for an overall mortality of 17.6%. Candida infected patients suffered a 42 per cent mortality. Our series supports the suspicion that Candida is much more frequent (41% of patients) than previously recognized in peripancreatic sepsis, and is commonly acquired after the initial operation. Amphotericin B therapy is effective in clearing Candida infection, but affected patients have a high associated mortality.