Mirza Farah, Argosino Krista, Ward Marilyn, Ou San-San, Milleman Kimberly R, Milleman Jefferey L
Philips Oral Healthcare, Bothell, WA, USA.
Salus Research, Fort Wayne, IN, USA.
J Clin Dent. 2019 Mar;30(Spec No A):A9-15.
To compare the effect of the Philips Sonicare DiamondClean Smart and Oral-B Genius 8000 powered toothbrushes on gingivitis, gingival bleeding, and supragingival plaque reduction following 42 days of home use.
This was a randomized, parallel, examiner-blinded, prospective clinical trial with two treatment groups. Eligible participants were generally healthy volunteers who were manual toothbrush users, non-flossers, 18-65 years of age. The subject panel included non-smokers with = 50 sites of gingival bleeding according to the Gingival Bleeding Index (GBI), and a supragingival plaque score of = 1.8 per Modified Plaque Index (MPI) at 3-6 hours following last tooth brushing encounter. Eligible subjects were randomized to use either a Philips Sonicare DiamondClean Smart with Premium Plaque Control brush head (DCS) or an Oral-B Genius 8000 with FlossAction brush head (OBG) for home use. Each toothbrush was used twice daily for two minutes. All subjects used a standardized fluoride-containing dentifrice. All other oral hygiene measures were prohibited. Subjects returned at Day 14 for an interim compliance and safety assessment, and at Day 42 for the final safety and efficacy assessments.
Of 222 enrolled and eligible subjects, 219 completed (112 in the SDC group, 107 in the OBG group) the study. The least squares (LS) mean and 95% confidence interval (CI) estimates for gingivitis reduction and percent reduction per Modified Gingival Index (MGI) following 42 days of product home use were 1.38 (1.30, 1.46) and 51.32% (48.45%, 54.19%) for DCS, and 0.53 (0.45, 0.61) and 20.07% (17.14%, 23.00%) for OBG. The differences, expressed as either reduction or percent reduction, were statistically significant between the two groups, p < 0.001. Statistically significant differences were also observed between products at Day 42 for the gingival bleeding and supragingival plaque reduction endpoints, p < 0.001. There were two reported adverse events.
The Philips Sonicare DiamondClean Smart powered toothbrush reduced gingival inflammation, gingival bleeding, and supragingival plaque significantly more than the Oral-B Genius 8000 powered toothbrush following a 42-day home-use period. Both products were safe for use.
比较在家使用42天后，飞利浦钻石亮白智能型声波震动牙刷和欧乐B智臻8000电动牙刷对牙龈炎、牙龈出血和龈上菌斑减少的效果。
这是一项随机、平行、检查者盲法的前瞻性临床试验，分为两个治疗组。符合条件的参与者为一般健康的志愿者，他们是手动牙刷使用者，不使用牙线，年龄在18 - 65岁之间。受试者群体包括根据牙龈出血指数（GBI）有≥50个牙龈出血部位，且在最后一次刷牙后3 - 6小时，改良菌斑指数（MPI）≥1.8的非吸烟者。符合条件的受试者被随机分配在家使用飞利浦钻石亮白智能型声波震动牙刷搭配高级洁齿刷头（DCS）或欧乐B智臻8000搭配牙线引导型刷头（OBG）。每支牙刷每天使用两次，每次两分钟。所有受试者使用标准化含氟牙膏。禁止采取所有其他口腔卫生措施。受试者在第14天返回进行中期依从性和安全性评估，在第42天返回进行最终安全性和疗效评估。
在222名登记并符合条件的受试者中，219名完成了研究（SDC组112名，OBG组107名）。在家使用产品42天后，DCS组牙龈炎减少的最小二乘（LS）均值及95%置信区间（CI）估计值和改良牙龈指数（MGI）的减少百分比分别为1.38（1.30，1.46）和51.32%（48.45%，54.19%），OBG组分别为0.53（0.45，0.61）和20.07%（17.14%，23.00%）。两组之间以减少量或减少百分比表示的差异具有统计学意义，p < 0.001。在第42天，产品在牙龈出血和龈上菌斑减少终点方面也观察到具有统计学意义的差异，p < 0.001。报告了两起不良事件。
在家使用42天后，飞利浦钻石亮白智能型声波震动牙刷在减少牙龈炎症、牙龈出血和龈上菌斑方面比欧乐B智臻8000电动牙刷显著更有效。两种产品使用均安全。
