Harpenau Lisa, Grill Gary, Storz Marlene, Zingale Joseph, Lundergan William, Chambers David
J Clin Dent. 2015;26(4):86-90.
The purpose of this single-blind, crossover study was to compare plaque removal associated with a new manual toothbrush, the O'Nano and a best-selling, commercially available manual toothbrush, the Oral-B Indicator 40. The O'Nano toothbrush has a patented "one-piece molded design" made of Thermal Plastic Urethane, a plastic that has been used in medical devices.
Over a six-week period, 40 subjects participated. Following random assignment, 22 subjects started with the O'Nano brush and the remaining started with the Oral-B Indicator 40 brush. Crossover occurred after two-weeks' use of each brush (two-week washout in between). Plaque was scored before and after brushing using the Turesky modification of the Quigley-Hein Index (T/Q-H). Plaque accumulation was 12 to 18 hours prior to examination and brushing.
Thirty-nine subjects completed the study; one subject was dropped for non-compliance. Groups were virtually identical at the onset in plaque level scores by study design. In comparison to baseline, both brushes achieved significant (p < 0.001) plaque reductions (gains) with a matched-paired comparison t-test. The O'Nano brush gain was 0.445 (18%) per subject and the Oral-B Indicator 40 brush was 0.504 (20%) per subject. The difference in plaque removal capability between brushes averaged 0.60 in favor of the Oral-B Indicator 40 brush, a non-significant (p = 0.20) finding determined by a matched-paired comparison t-test, which is identical to the repeated measures ANOVA when there are two groups and two time periods. Standard deviation (SD) was smaller for the O'Nano brush in plaque reduction scores (0.183 < 0.235). This difference was tested and found to be non-significant with this particular group size.
Statistical analysis of T/Q-H scores demonstrated that the O'Nano brush is comparable to the Oral-B Indicator 40 brush under the conditions of this study protocol. With this small study group the slight differences in plaque removal efficiency between both brushes was not significant. The unique "one-piece molded" design of the O'Nano brush was not evaluated for durability in comparison to a more conventional brush, the Oral-B 40.
本单盲交叉研究旨在比较一种新型手动牙刷O'Nano与畅销的市售手动牙刷Oral-B Indicator 40在清除牙菌斑方面的效果。O'Nano牙刷采用了获得专利的“一体成型设计”，由热塑性聚氨酯制成，这种塑料已用于医疗设备。
在六周的时间里，有40名受试者参与。随机分组后，22名受试者从使用O'Nano牙刷开始，其余受试者从使用Oral-B Indicator 40牙刷开始。在每支牙刷使用两周后进行交叉（中间有两周的洗脱期）。使用Quigley-Hein指数（T/Q-H）的Turesky修正版在刷牙前后对牙菌斑进行评分。在检查和刷牙前，牙菌斑已积累了12至18小时。
39名受试者完成了研究；一名受试者因不依从被剔除。根据研究设计，两组在牙菌斑水平评分开始时几乎相同。与基线相比，通过配对比较t检验，两种牙刷都实现了显著的（p < 0.001）牙菌斑减少（改善）。O'Nano牙刷每位受试者的改善值为0.445（18%），Oral-B Indicator 40牙刷每位受试者的改善值为0.504（20%）。两种牙刷在清除牙菌斑能力上的差异平均为0.60，有利于Oral-B Indicator 40牙刷，通过配对比较t检验确定这一差异不显著（p = 0.20），当有两组和两个时间段时，这与重复测量方差分析结果相同。O'Nano牙刷在牙菌斑减少评分方面的标准差（SD）较小（0.183 < 0.235）。对这一差异进行检验，发现对于这个特定的样本量，差异不显著。
对T/Q-H评分的统计分析表明，在本研究方案的条件下，O'Nano牙刷与Oral-B Indicator 40牙刷相当。在这个小研究组中，两种牙刷在清除牙菌斑效率上的细微差异不显著。与更传统的Oral-B 40牙刷相比，未对O'Nano牙刷独特的“一体成型”设计的耐用性进行评估。
