Warren P R, Cugini M, Marks P, King D W
Oral-B Laboratories, Boston, MA 02127, USA.
Am J Dent. 2001 Feb;14(1):3-7.
To compare the safety and efficacy of a new power toothbrush (Braun Oral-B D17) with an ADA reference manual toothbrush.
110 healthy subjects, 18-65 yrs of age, with a mean plaque index of > or = 1.80 and a gingival index of > or = 1.00, were enrolled in this 3-month, randomized, parallel-group, examiner-blind study. Oral soft and hard tissues were examined for safety, and plaque, gingivitis and bleeding were measured to evaluate efficacy. Measurements were made at baseline and after 1 and 3 months of product use. Following the baseline visit and randomization, subjects were instructed to brush twice daily for 2 mins with their assigned brush.
101 subjects completed the study with evaluable data for all time periods, 52 in the D17 group and 49 in the manual group. None of the nine withdrawals from the study were related to product use and no product-related adverse effects were reported. There was no clinically significant soft or hard tissue abrasion observed at any time point in either group. After 1 and 3 months, significant reductions from baseline in whole mouth and interproximal plaque, gingivitis and bleeding were observed in both groups. A comparison of the two groups revealed that the whole mouth and approximal plaque indices were reduced to a significantly greater extent in the D17 group after both 1 and 3 months. The whole mouth gingival index was also reduced to a greater extent in the D17 group at 1 and 3 months, but a difference in the approximal gingival index was only apparent after 3 months. With respect to the bleeding index, there was a significant difference between the two groups for the whole mouth at both 1 and 3 months, but the differences in favor of the D17 for approximal values did not achieve statistical significance. In conclusion, the D17 was found to be safe and had increased efficacy with respect to reduction of plaque and gingivitis, compared with a manual toothbrush.
比较一款新型电动牙刷（博朗欧乐 - B D17）与美国牙医学会（ADA）推荐的手动牙刷的安全性和有效性。
110名年龄在18至65岁之间、平均菌斑指数≥1.80且牙龈指数≥1.00的健康受试者参与了这项为期3个月的随机、平行组、检查者盲法研究。对口腔软硬组织进行安全性检查，并测量菌斑、牙龈炎和出血情况以评估有效性。在基线以及产品使用1个月和3个月后进行测量。在基线访视和随机分组后，指导受试者使用分配的牙刷每天刷牙两次，每次2分钟。
101名受试者完成了整个研究且所有时间段均有可评估数据，其中D17组52人，手动组49人。9名退出研究的受试者均与产品使用无关，且未报告与产品相关的不良反应。两组在任何时间点均未观察到具有临床意义的软硬组织磨损。1个月和3个月后，两组全口及邻面菌斑、牙龈炎和出血情况均较基线显著降低。两组比较显示，1个月和3个月后，D17组全口及邻面菌斑指数降低幅度更大。1个月和3个月时，D17组全口牙龈指数降低幅度也更大，但邻面牙龈指数仅在3个月后才有明显差异。关于出血指数，1个月和3个月时两组全口均有显著差异，但邻面值中D17组更优的差异未达到统计学意义。总之，与手动牙刷相比，D17被发现是安全的，并且在减少菌斑和牙龈炎方面有效性更高。
