He Tao, Barker Matthew L, Biesbock A R, Sharma N C, Qaqish J, Goyal C R
Procter & Gamble Company, Mason, OH, USA.
J Clin Dent. 2012;23(3):80-5.
The purpose of this study was to evaluate the anti-gingivitis effectiveness of a 0.454% stannous fluoride test dentifrice relative to a marketed positive-control triclosan-containing dentifrice in adults with gingivitis.
This was a two-month, randomized and controlled, double-blind, parallel group, single-center investigation involving 150 adults with existing mild to moderate gingivitis. Pre-treatment gingivitis levels were assessed at baseline using the Lobene Modified Gingival Index (MGI) and the Gingival Bleeding Index (GBI). Qualified subjects were randomly assigned to either a 0.454% stannous fluoride test dentifrice or a marketed, positive-control 0.30% triclosan/copolymer dentifrice. Subjects then brushed for two months unsupervised in the home setting with their assigned dentifrice per manufacturer's instructions. At Month 2, subjects were re-evaluated for gingivitis via MGI and GBI examinations.
All 150 enrolled subjects completed the trial and were evaluable. Both the stannous fluoride test and triclosan/copolymer control dentifrices provided statistically significant reductions in average MGI, GBI, and number of bleeding sites relative to pre-treatment (p < 0.0001) at Month 2. The adjusted mean improvement from baseline at Month 2 for the stannous fluoride test dentifrice group was 65% greater for number of bleeding sites, 62% greater for GBI, and 45% greater for MGI compared to the triclosan/copolymer positive-control group, with groups differing significantly (p < 0.0001) via each of the three gingivitis measures. Both dentifrices were well-tolerated.
An advanced stannous fluoride test dentifrice provided superior reductions in gingival inflammation and gingival bleeding compared to a commercially available triclosan/copolymer positive-control dentifrice after two months of tooth brushing.
本研究旨在评估含0.454%氟化亚锡的试验牙膏相对于市售含三氯生阳性对照牙膏对患有牙龈炎的成年人的抗牙龈炎效果。
这是一项为期两个月的随机对照双盲平行组单中心研究，涉及150名患有轻至中度牙龈炎的成年人。在基线时使用洛贝内改良牙龈指数（MGI）和牙龈出血指数（GBI）评估治疗前的牙龈炎水平。符合条件的受试者被随机分配到含0.454%氟化亚锡的试验牙膏组或市售的含0.30%三氯生/共聚物的阳性对照牙膏组。然后，受试者按照制造商的说明，在家中无人监督的情况下使用分配的牙膏刷牙两个月。在第2个月时，通过MGI和GBI检查对受试者的牙龈炎进行重新评估。
所有150名入组受试者均完成试验且可进行评估。在第2个月时，相对于治疗前，氟化亚锡试验牙膏和三氯生/共聚物对照牙膏在平均MGI、GBI和出血部位数量方面均有统计学上的显著降低（p < 0.0001）。与三氯生/共聚物阳性对照组相比，第2个月时氟化亚锡试验牙膏组从基线的调整后平均改善情况为：出血部位数量多65%，GBI多62%，MGI多45%，通过这三种牙龈炎测量方法，两组差异均有统计学意义（p < 0.0001）。两种牙膏耐受性均良好。
在刷牙两个月后，一种先进的含氟化亚锡试验牙膏与市售的含三氯生/共聚物阳性对照牙膏相比，在减轻牙龈炎症和牙龈出血方面效果更佳。
