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一项随机临床试验,以评估含亚锡氟化钠牙膏、高级手动牙刷和洗必泰漱口水的口腔卫生方案的抗牙菌斑效果。

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.

作者信息

Feng Xiping, He Tao, Cao Michelle, He Yanyan, Ji Nelson

出版信息

Am J Dent. 2016 Apr;29(2):120-4.

PMID:27295871
Abstract

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. (Am J Dent 2016;29:120-124)

摘要

目的

评估一种口腔卫生方案(包括含亚锡的氟化钠牙膏、高级手动牙刷和氯化十六烷基吡啶[CPC]漱口水)相对于阴性对照方案的抗牙菌斑效果。

方法

这是一项为期4周的随机对照平行组单中心单盲临床试验,研究对象为患有牙菌斑的一般健康中国成年人。在基线检查前经过1周适应期并停止夜间口腔卫生护理后,通过数字菌斑成像分析(DPIA)评估夜间刷牙前的菌斑水平。受试者被随机分配到以下两组之一:(1)试验方案组,使用含亚锡的氟化钠牙膏(佳洁士健康专家牙膏)、带有交错刷毛的高级手动牙刷(佳洁士健康专家手动牙刷)和0.07% CPC漱口水(佳洁士多效防护漱口水);(2)阴性对照方案组,使用0.243%氟化钠牙膏(佳洁士防蛀牙膏)和软质平边手动牙刷(佳洁士美丽亮洁牙刷)。受试者在每天两次使用指定产品后,于第2周和第4周再次返回,同样在就诊前停止夜间口腔卫生护理后,进行DPIA评估夜间菌斑水平。

结果

35名完全可评估的受试者完成了试验。在第2周时,高级产品方案组刷牙前夜间平均DPIA菌斑评分相对于对照组在统计学上显著降低了72.4%(P<0.0001)。在第4周时,方案组提供的平均菌斑抑制效果比对照组高76.8%(P<0.0001)。所有产品耐受性良好。(《美国牙科杂志》2016年;29:120 - 124)

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