Mazza Lorenzo, Gatto Maria Rosaria, Monaco Giuseppe, Pelliccioni Gian Andrea
Department of Biomedical and Neuromotor Sciences, Alma Mater Studiorum-University of Bologna School of Dentistry, Via San Vitale 59, 40125 Bologna, Italy.
ScientificWorldJournal. 2014;2014:763968. doi: 10.1155/2014/763968. Epub 2014 Nov 18.
To demonstrate the noninferiority of a new toothbrush head with retractile bristles compared to traditional toothbrush heads on dental models.
The new toothbrush head, mounted on manual and electrical handles, presents retractile bristle groups that can singularly retract over its entire length and offer calibrated resistance. Fourteen gypsum models of dental arches, twelve with and two without anatomical impairments, were spread with a "plaque simulator." Each arch was brushed twice with each of the four toothbrushes, one minute by the same operator, blinded to the study. The plaque index (PI) was recorded at the end of each brushing session. GLM for repeated measures analysed the data.
On all the casts, the manual prototype and the electric prototype, removed 11% and 14% more "plaque simulator" compared to the standard toothbrush. In presence of dental anomalies, the prototypes removed 13% and 16% more plaque, respectively, compared to standard toothbrushes (P = 0.04). In both situations, the 95% confidence intervals of PI did not include -10% (the minimal margin of clinical relevance).
The prototype is more effective in removing plaque from the casts with anomalies. The noninferiority of the prototype with respect to the standard toothbrushes was demonstrated.
在牙科模型上证明一种带有可收缩刷毛的新型牙刷头相较于传统牙刷头的非劣效性。
安装在手动和电动手柄上的新型牙刷头具有可收缩刷毛组，这些刷毛组可在其整个长度上单独收缩并提供校准阻力。14个牙弓石膏模型，其中12个有解剖学损伤，2个没有，均涂抹了“菌斑模拟器”。每个牙弓用四把牙刷中的每一把各刷两次，由同一名操作者操作一分钟，操作者对研究情况不知情。每次刷牙结束时记录菌斑指数（PI）。重复测量的广义线性模型分析数据。
在所有模型上，手动原型和电动原型与标准牙刷相比，清除的“菌斑模拟器”分别多11%和14%。在存在牙齿异常的情况下，与标准牙刷相比，原型分别多清除13%和16%的菌斑（P = 0.04）。在两种情况下，PI的95%置信区间均未包含-10%（临床相关性的最小界限）。
该原型在从有异常的模型上清除菌斑方面更有效。证明了该原型相对于标准牙刷的非劣效性。
