West Nicola, He Tao, Hellin Nikki, Claydon Nicholas, Seong Joon, Macdonald Emma, Eusebio Rachelle
Restorative Dentistry (Periodontology), Clinical Trials Unit, University of Bristol Dental School and Hospital, Bristol, UK.
The Procter & Gamble Company, Mason, OH, USA.
Am J Dent. 2018 Apr;31(2):63-66.
To assess the anti-erosion effects of a 0.454% stannous fluoride dentifrice versus a marketed dentifrice in an in situ clinical study.
This was a double-blind, randomized and controlled, two-treatment, four-period crossover clinical study involving healthy adults. Each study period was 10 days. Subjects were randomized to one of two dentifrice products each period: an experimental 0.454% stannous fluoride dentifrice (1,100 ppm fluoride) or a marketed 1.5% arginine-containing dentifrice (Colgate Maximum Cavity Protection, 1,450 ppm fluoride). Subjects wore an intra-oral appliance fitted with two polished human enamel samples for 6 hours per day, swishing with the assigned dentifrice slurry twice a day in addition to sipping and swishing with 250 ml of orange juice for 10 minutes (in increments of 25 ml each minute) four times each day. Contact profilometry was used to measure surface loss of tooth enamel over the course of the study. Two measurements for each sample were taken at baseline and Day 10.
35 subjects were randomized to treatment and 31 completed the study (mean age = 40 years). At Day 10, enamel loss means were 0.128 µm for the stannous fluoride dentifrice and 1.377 µm for the arginine-containing dentifrice, respectively (P< 0.001). This represents 90.7% less enamel loss for the stannous fluoride dentifrice. Both products were well tolerated.
The 0.454% stannous fluoride dentifrice demonstrated significantly greater protection to human enamel against erosive acid challenges relative to the marketed 1.5% arginine-containing dentifrice in this in situ clinical study.
在一项原位临床研究中，评估含0.454%氟化亚锡的牙膏与市售牙膏的抗侵蚀效果。
这是一项双盲、随机对照、双治疗、四阶段交叉临床研究，涉及健康成年人。每个研究阶段为10天。受试者在每个阶段被随机分为两种牙膏产品之一：实验性的含0.454%氟化亚锡的牙膏（氟含量1100 ppm）或市售的含1.5%精氨酸的牙膏（高露洁极致防蛀牙膏，氟含量1450 ppm）。受试者每天佩戴装有两块抛光人牙釉质样本的口腔矫治器6小时，除了每天四次饮用并含漱250毫升橙汁（每分钟增量25毫升，每次10分钟）外，还每天用指定的牙膏糊剂含漱两次。在研究过程中，使用接触式轮廓仪测量牙釉质的表面损失。在基线和第10天对每个样本进行两次测量。
35名受试者被随机分配接受治疗，31名完成了研究（平均年龄 = 40岁）。在第10天，氟化亚锡牙膏的牙釉质损失均值为0.128 µm，含精氨酸牙膏的牙釉质损失均值为1.377 µm（P < 0.001）。这表明氟化亚锡牙膏的牙釉质损失减少了90.7%。两种产品耐受性均良好。
在这项原位临床研究中，相对于市售的含1.5%精氨酸的牙膏，含0.454%氟化亚锡的牙膏对人牙釉质免受侵蚀性酸挑战的保护作用显著更强。
