Klukowska Malgorzata, Grender Julie M, Goyal C Ram, Qaqish J, Biesbrock Aaron R
Procter & Gamble Health Care Research Center, 8700 Mason-Montgomery Road, Mason, OH 45040, USA.
Am J Dent. 2012 Sep;25 Spec No A(A):27A-32A.
To assess the ability of a novel multi-directional power toothbrush to control plaque and gingivitis when compared to a marketed sonic power toothbrush control.
This was a randomized and controlled, examiner-blinded, parallel group, 8-week study at a single center, in adult subjects with mild-to-moderate gingivitis. Pre-treatment gingivitis levels and plaque coverage were evaluated at baseline using the Lobene Modified Gingival Index (MGI), the Gingival Bleeding Index (GBI), and the Rustogi Modified Navy Plaque Index (RMNPI). Qualified subjects were randomly assigned to either a novel multi-directional power toothbrush with a wireless display (Oral-B Professional Deep Sweep + SmartGuide TRICLEAN 5000, also marketed as Oral-B TriZone) or the marketed control sonic toothbrush (Philips Sonicare FlexCare). After a supervised brushing at the clinical site at baseline, subjects brushed unsupervised at home twice daily according to manufacturer instructions with the assigned test brush and standard sodium fluoride dentifrice. After 8 weeks, subjects were recalled to assess toothbrush efficacy via the MGI and GBI gingivitis and RMNPI plaque evaluations.
A total of 128 evaluable subjects completed the study. After 8 weeks of brushing, both test toothbrushes provided statistically significant reductions compared to baseline in mean whole mouth MGI and GBI, and in RMNPI whole mouth and interproximal (approximal) sites (P < 0.001). The novel multi-directional power brush consistently produced significantly superior anti-gingivitis and anti-plaque reductions relative to pre-treatment versus the sonic control brush: the Week 8 adjusted mean relative reductions were 30% and 29% greater for whole mouth MGI and GBI, respectively (P < 0.001); and were 44% and 77% greater for the RMNPI whole mouth and interproximal regions, respectively (P < or = 0.003). Both toothbrushes were well-tolerated.
与市售声波电动牙刷对照,评估一款新型多向电动牙刷控制牙菌斑和牙龈炎的能力。
这是一项在单一中心进行的随机对照、检查者盲法、平行组、为期8周的研究,研究对象为患有轻至中度牙龈炎的成年受试者。在基线时使用洛贝内改良牙龈指数(MGI)、牙龈出血指数(GBI)和鲁斯托吉改良海军牙菌斑指数(RMNPI)评估治疗前的牙龈炎水平和牙菌斑覆盖情况。符合条件的受试者被随机分配到一款带有无线显示屏的新型多向电动牙刷(欧乐-B专业深度清洁 + 智能指导TRICLEAN 5000,也作为欧乐-B三区清洁牙刷销售)或市售对照声波牙刷(飞利浦 Sonicare FlexCare)。在基线时在临床场所进行监督刷牙后,受试者按照制造商说明使用指定的测试牙刷和标准含氟牙膏在家中每天无监督刷牙两次。8周后,召回受试者通过MGI和GBI评估牙龈炎以及RMNPI评估牙菌斑来评估牙刷功效。
共有128名可评估受试者完成了研究。刷牙8周后,与基线相比,两款测试牙刷在全口平均MGI和GBI以及RMNPI全口和邻面(近中面)部位均有统计学上的显著降低(P < 0.001)。与声波对照牙刷相比,新型多向电动牙刷在治疗后始终产生显著更优的抗牙龈炎和抗牙菌斑效果:第8周全口MGI和GBI的调整后平均相对降低分别比声波对照牙刷高30%和29%(P < 0.001);RMNPI全口和邻面区域分别比声波对照牙刷高44%和77%(P ≤ 0.003)。两款牙刷耐受性均良好。