Starke E Michelle, Mwatha Anthony, Ward Marilyn, Argosino Krista, Jenkins Wendy, Milleman Jeffery L, Milleman Kimberly R
Philips Oral Healthcare, Bothell, WA, USA.
Salus Research, Fort Wayne, IN, USA.
J Clin Dent. 2019 Mar;30(Spec No A):A24-29.
To compare the effect of a powered and a manual toothbrush on gingivitis and plaque following two and four weeks of home use.
This was a randomized, parallel-design, single-blind clinical trial. Eligible participants were generally healthy non-smoking manual toothbrush users aged 18-65 years, with a plaque score of = 1.8 per Lobene and Soparkar Modified Plaque Index (MPI) following a 3-6 hour plaque accumulation period, and mild to moderate gingivitis defined as a Gingival Bleeding Index (GBI) = 1 on at least 20 sites. Subjects with advanced periodontal disease, xerostomia, excessive gingival recession, uncontrolled diabetes, and heavy deposits of calculus or rampant decay were excluded. Enrolled participants were randomly dispensed either a Philips Sonicare powered toothbrush used with the InterCare brush head (PTB) or an American Dental Association (ADA) reference manual toothbrush (MTB). Efficacy and safety variables were assessed at Baseline, and at two and four weeks following twice-daily product home use. The primary endpoint of the study was reduction of gingivitis per the Modified Gingival Index (MGI) after four weeks of home use.
All 148 randomized subjects (74 per group) completed the study. A statistically significant difference in MGI reduction was observed between the two study groups (p < 0.001). The least square (LS) mean and standard error reduction from Baseline was 0.72 (0.04) for the PTB group compared to 0.09 (0.04) for the MTB group. Expressed as percent reduction from Baseline, the LS mean values were 35.77% (2.19%) and 4.22% (2.19%) for PTB and MTB, respectively. Statistically significant differences were also observed for MGI reduction at Week 2, as well as for MPI and GBI reduction at Weeks 2 and 4.
The powered toothbrush was statistically significantly superior to a manual toothbrush in reducing gingival inflammation, gingival bleeding, and plaque following two and four weeks of home use.
比较电动牙刷和手动牙刷在家庭使用两周和四周后对牙龈炎和牙菌斑的影响。
这是一项随机、平行设计、单盲的临床试验。符合条件的参与者为年龄在18 - 65岁之间、一般健康且不吸烟的手动牙刷使用者，在菌斑积聚3 - 6小时后，根据洛贝内和索帕卡尔改良菌斑指数（MPI），菌斑评分为≥1.8，且轻度至中度牙龈炎定义为牙龈出血指数（GBI）在至少20个部位≥1。排除患有晚期牙周病、口干症、牙龈过度退缩、未控制的糖尿病以及牙结石大量沉积或猖獗龋坏的受试者。入选的参与者被随机分配使用飞利浦声波震动牙刷搭配InterCare刷头（PTB组）或美国牙科协会（ADA）参考手动牙刷（MTB组）。在基线时以及每天两次家庭使用产品两周和四周后评估疗效和安全性变量。该研究的主要终点是家庭使用四周后根据改良牙龈指数（MGI）评估的牙龈炎减轻情况。
所有148名随机分组的受试者（每组74名）均完成了研究。在两个研究组之间观察到MGI降低存在统计学显著差异（p < 0.001）。与MTB组基线时相比，PTB组从基线降低的最小二乘（LS）均值和标准误差为0.72（0.04），而MTB组为0.09（0.04）。以相对于基线降低的百分比表示，PTB组和MTB组的LS均值分别为35.77%（2.19%）和4.22%（2.19%）。在第2周时MGI降低以及在第2周和第4周时MPI和GBI降低也观察到统计学显著差异。
在家庭使用两周和四周后，电动牙刷在减轻牙龈炎症、牙龈出血和牙菌斑方面在统计学上显著优于手动牙刷。
