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随机数字菌斑成像试验:评估一种新型稳定化氟化亚锡牙膏与胺氟化物/氟化亚锡牙膏相比的菌斑抑制效果。

Randomized digital plaque imaging trial evaluating plaque inhibition efficacy of a novel stabilized stannous fluoride dentifrice compared with an amine fluoride/stannous fluoride dentifrice.

作者信息

Bellamy P G, Boulding A, Farmer S, Day T N, Mussett A J, Barker M L

机构信息

Procter & Gamble London Innovation Centre, Egham, Surrey, UK.

出版信息

J Clin Dent. 2012;23(3):71-5.

PMID:23210416
Abstract

OBJECTIVE

To assess the plaque inhibition efficacy ofa novel 0.454% stabilized stannous fluoride test dentifrice (SnF2) to an amine fluoride/stannous fluoride marketed control dentifrice (AmF/SnF2) using digital plaque imaging analysis (DPIA).

METHODS

The 10-week study was a randomized, two-treatment, three-period, double-blind crossover design. Subjects brushed twice daily with their assigned dentifrice (SnF2 or AmF/SnF2) using a standard manual toothbrush during three treatment periods each lasting 17 days, separated by four-day washout periods. DPIA was used to analyze plaque coverage on facial surfaces of the 12 anterior teeth (canine to canine) by three assessments on Days 15, 16, and 17 at the end of each treatment period. Assessments were conducted the morning following no overnight brushing of facial surfaces (A.M. pre-brush), after 40 seconds of full mouth brushing with the assigned dentifrice (A.M. post-brush), and during the afternoon (P.M.).

RESULTS

Twenty-seven subjects were randomized and completed the study. At each assessment time point, plaque levels for the SnF2 dentifrice were statistically significantly lower compared to those for the AmF/SnF2 dentifrice (21.4%, 22.6%, 24.3%, respectively; p < 0.0001 for all).

CONCLUSION

Plaque coverage, as assessed by DPIA, was significantly lower with a novel SnF2 dentifrice than with the AmF/SnF2 dentifrice. The plaque control benefits of the SnF2 dentifrice seen at the morning and afternoon time points indicated significantly better inhibition of plaque re-growth.

摘要

目的

使用数字菌斑成像分析(DPIA)评估一种新型0.454%稳定氟化亚锡试验牙膏(SnF2)相对于市售含胺氟化物/氟化亚锡对照牙膏(AmF/SnF2)的菌斑抑制效果。

方法

这项为期10周的研究采用随机、双处理、三阶段、双盲交叉设计。在三个为期17天的治疗阶段,受试者每天使用标准手动牙刷按照指定牙膏(SnF2或AmF/SnF2)刷牙两次,各阶段之间有4天的洗脱期。在每个治疗阶段结束时的第15、16和17天,通过三次评估,使用DPIA分析12颗前牙(犬齿至犬齿)面部表面的菌斑覆盖率。评估在面部表面未进行夜间刷牙后的早晨(上午刷牙前)、使用指定牙膏进行40秒全口刷牙后(上午刷牙后)以及下午进行。

结果

27名受试者被随机分组并完成了研究。在每个评估时间点,SnF2牙膏的菌斑水平与AmF/SnF2牙膏相比在统计学上显著更低(分别为21.4%、22.6%、24.3%;所有p值均<0.0001)。

结论

通过DPIA评估,新型SnF2牙膏的菌斑覆盖率显著低于AmF/SnF2牙膏。在上午和下午时间点观察到的SnF2牙膏的菌斑控制益处表明其对菌斑再生长的抑制效果明显更好。

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