He Tao, Eusebio Rachelle, Goyal C R, Qaqish Jimmy G
Procter & Gamble, Mason, OH, USA.
All Sum Research, Mississauga, Ontario, Canada.
J Clin Dent. 2017 Dec;28(4 Spec No B):B12-16.
The aim of this study was to compare the antibleeding/antigingivitis effectiveness of a newly formulated 0.454% stabilized stannous fluoride dentifrice and a marketed positive control triclosan-containing dentifrice in adults with mild-to-moderate gingivitis.
This single-center, two-month, randomized and controlled, double-blind, parallel group clinical trial involved adults with preexisting mild-to-moderate gingivitis. Baseline bleeding and gingivitis levels were assessed with the Gingival Bleeding Index (GBI) and Lobene Modified Gingival Index (MGI). Subjects were randomly assigned to either a new smooth formula 0.454% stabilized stannous fluoride test dentifrice (Crest® Pro-Health™) or a commercially available positive control 0.30% triclosan dentifrice (Colgate® Total®). Subjects brushed with their assigned dentifrice at home according to the manufacturer's instructions. At Month 2, subjects were re-evaluated for bleeding and gingivitis as at Baseline, with MGI and GBI evaluations.
Of the 200 subjects randomized to treatment, 197 completed the study and had fully evaluable data. At Month 2, both the stannous fluoride and triclosan control dentifrices produced statistically significant reductions (p < 0.0001) in the mean number of bleeding sites, MGI, and GBI compared to Baseline. Use of this 0.454% stannous fluoride dentifrice resulted in 22% fewer bleeding sites versus the positive control triclosan dentifrice (p < 0.0001). Similarly, after two months of brushing, the stannous fluoride dentifrice group showed statistically significant lower mean MGI and GBI scores than subjects using the triclosan positive control dentifrice (p < 0.0001). Both dentifrices were well-tolerated.
Subjects brushing with a newly formulated stannous fluoride dentifrice had statistically significantly fewer bleeding sites and less gingivitis than those using a positive control triclosan dentifrice after two months.
本研究旨在比较一种新配方的0.454%稳定化氟化亚锡牙膏与市售含三氯生阳性对照牙膏对患有轻至中度牙龈炎成年人的止血/抗牙龈炎效果。
这项单中心、为期两个月的随机对照双盲平行组临床试验纳入了已有轻至中度牙龈炎的成年人。采用牙龈出血指数（GBI）和洛贝内改良牙龈指数（MGI）评估基线出血和牙龈炎水平。受试者被随机分配至新的0.454%稳定化氟化亚锡测试牙膏（佳洁士®专业健康™）或市售含0.30%三氯生阳性对照牙膏（高露洁®全效®）。受试者在家按照制造商说明使用分配的牙膏刷牙。在第2个月时，按照基线时的方法，通过MGI和GBI评估对受试者的出血和牙龈炎情况进行重新评估。
随机接受治疗的200名受试者中，197名完成了研究并拥有完全可评估的数据。在第2个月时，与基线相比，氟化亚锡牙膏和三氯生对照牙膏在平均出血部位数量、MGI和GBI方面均产生了具有统计学意义的降低（p < 0.0001）。使用这种0.454%氟化亚锡牙膏导致出血部位比阳性对照三氯生牙膏少22%（p < 0.0001）。同样，刷牙两个月后，氟化亚锡牙膏组的平均MGI和GBI得分在统计学上显著低于使用三氯生阳性对照牙膏的受试者（p < 0.0001）。两种牙膏耐受性均良好。
两个月后，使用新配方氟化亚锡牙膏刷牙的受试者在统计学上的出血部位显著少于使用阳性对照三氯生牙膏的受试者，牙龈炎也更少。
