A randomized clinical trial to assess anti-plaque effects of an oral hygiene regimen with a stannous-containing sodium fluoride dentifrice, advanced manual toothbrush, and CPC rinse

摘要

Purpose: To assess the anti-plaque efficacy of an oral hygiene regimen comprised of a stannous-containing sodium fluoride dentifrice, advanced manual toothbrush, and a cetylpyridinium chloride (CPC) rinse compared to a negative control regimen. Methods: This was a 4-week randomized and controlled, parallel group, single-center, single-blind, clinical trial in generally healthy Chinese adults with existing dental plaque. Following a 1-week acclimation period and cessation of overnight oral hygiene prior to the baseline examination, overnight pre-brushing plaque levels were assessed via digital plaque imaging analysis (DPIA). Subjects were randomly assigned to either: (1) the test regimen of a stannous-containing sodium fluoride dentifrice (Crest Pro-Health Expert), an advanced manual toothbrush with CrissCross bristles (Crest Pro-Health manual toothbrush), and a 0.07% CPC rinse (Crest Pro-Health Multi-Protection); or (2) the negative control regimen group, a 0.243% sodium fluoride dentifrice (Crest Cavity Protection) and a soft flat trim manual toothbrush (Crest MeiLiLiangJie). Subjects returned at Week 2 and Week 4 following twice daily use of their assigned products, again following pre-visit cessation of overnight oral hygiene, for DPIA evaluation of overnight plaque levels. Results: 35 fully evaluable subjects completed the trial. At Week 2, the pre-brushing overnight average DPIA plaque scores for the advanced products regimen group were 72.4% statistically significantly lower relative to the control group (P < 0.0001). At Week 4, the mean plaque inhibition benefit provided by the regimen group was 76.8% greater than the control group (P < 0.0001). All products were well-tolerated.