1. Efficacy and Safety of a Novel Stabilized Stannous Fluoride and Dentifrice for Dentinal Hypersensitivity

Efficacy and Safety of a Novel Stabilized Stannous Fluoride and Dentifrice for Dentinal Hypersensitivity

Reference: Schiff T, He T, Sagel L, et al. J Contemp Dent Pract. 2006;7(2):1-8.

CONCLUSION

Crest® PRO-HEALTH provided statistically significant reductions in dentinal hypersensitivity at 4 and 8 weeks compared to the sodium fluoride control dentifrice.

OBJECTIVE

To compare the efficacy of Crest® PRO-HEALTH vs a negative control dentifrice in the reduction of dentinal hypersensitivity over an 8-week period.

MATERIALS AND METHODS

  • Crest® PRO-HEALTH™ (a novel 0.454% stabilized stannous fluoride dentifrice with sodium hexametaphosphate for cosmetic benefits) was compared to a negative control dentifrice containing 0.243% sodium fluoride (Crest® Cavity Protection).
  • Study subjects were 90 generally healthy adults with moderate dentinal hypersensitivity: minimum of 2 bicuspid or cuspid teeth with sensitivity criteria of Yeaple Probe Index score = 10 g and Schiff Air Sensitivity Scale score of >1.
  • Experimental 0.454% stabilized SnF2 dentifrice (Crest® PRO-HEALTH Clean Mint [Smooth Formula], Procter & Gamble)
  • Tooth sensitivity was measured by tactile examination using the Yeaple probe (only teeth responding positively to 10 g and rechallenge at 10 g were evaluated) and cold air using the Schiff Air Index (teeth responding to air stimulus were evaluated).
  • Oral soft tissue examinations were performed.
  • Subjects were randomized to either the stabilized stannous fluoride dentifrice or the control dentifrice.
  • Subjects brushed twice daily with their assigned dentifrice using a manual soft toothbrush for 8 weeks.
  • Subjects were assessed again for sensitivity and safety at weeks 4 and 8.

RESULTS

  • Data were analyzed for all 90 subjects (45 in each treatment group).
  • Schiff Air Index scores were statistically significantly lower for the stabilized stannous fluoride group than the sodium fluoride control group at both weeks 4 and 8 (P<0.0001).
  • Compared to the sodium fluoride control group, the stannous fluoride group showed a 33% lower Schiff Air Index score (adjusted mean) than the sodium fluoride control group at week 4 and a 44% lower score at week 8.
  • Yeaple Probe Index scores were statistically significantly higher for the stabilized stannous fluoride group than the sodium fluoride control group at both weeks 4 and 8 (P<0.0001).
  • Compared to the sodium fluoride control group, the stabilized stannous fluoride group had a mean Yeaple Probe Index score 14 units higher (representing a mean desensitizing improvement of 114% greater) than that of the sodium fluoride control group at week 4, and 11 units higher (representing a mean desensitizing improvement of 71% greater) at week 8.
  • No adverse events were reported or observed.
Lower Schiff Air Index scores indicate less tooth sensitivity

Lower Schiff Air Index scores indicate less tooth sensitivity

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