Yankell Samuel L, Shi Xiuren, Emling Robert C
University of Pennsylvania School of Dental Medicine, Philadelphia, PA, USA.
J Clin Dent. 2002;13(3):125-9.
The objective of this double-blind, four-week clinical study was to evaluate the efficacy of BrushPicks, a new cleaning aid, and Glide floss on the reduction of plaque area, gingivitis and bleeding on probing, and to monitor safety when these products were used in addition to toothbrushing with an ADA-Accepted toothbrush (Oral-B P35) and an ADA-Accepted fluoride-containing dentifrice (Crest Regular). No special instructions on or supervision of product use was conducted, other than requesting twice-a-day (morning and evening) use of the assigned products. Following a baseline examination, 63 qualifying adult male and female subjects from the Philadelphia, Pennsylvania area were randomized into two groups. Subjects were also told to use their assigned dental aid after each toothbrushing. Examinations for efficacy and safety were repeated after two and four weeks' use of the products. Sixty-two subjects completed all aspects of the study. There were no untoward side effects attributed to product use, reported or observed, at the two- or four-week examination times. At baseline, there were no significant differences in plaque, gingivitis or bleeding on probing mean scores between the BrushPicks and Glide floss groups. At the two- and four-week evaluation times, both the BrushPicks and Glide floss had numerically lower plaque scores compared to baseline levels. The only statistically significant reduction (p < 0.01) was in the BrushPicks group, comparing the week two mean with the baseline value. Gingivitis (GI) at four weeks was statistically (p < 0.05) lower in the BrushPicks group as compared to the Glide floss mean value. When the changes in scores from baseline to two weeks and to four weeks were assessed, the mean GI score for the Glide floss group was significantly lower at two weeks (p < 0.01) compared to baseline, and also from two weeks to four weeks (p < 0.001). The change in mean GI score for the Glide floss group from baseline to four weeks was also significant statistically (p < 0.001). When the changes in mean GI scores for the BrushPicks group were assessed, there was a significant decrease from baseline to two weeks (p < 0.001), from two weeks to four weeks (p < 0.001), and from baseline to four weeks (p < 0.001). For bleeding on probing, when the baseline to two- and four-week mean values were compared, only the BrushPicks produced significant (p < 0.001) decreases. At two and four weeks, the BrushPicks group mean bleeding on probing scores were significantly (p < 0.05-0.01) lower than the Glide floss group scores. At the end of this four-week study, the BrushPicks product was significantly more effective than Glide floss in the reduction of gingivitis and bleeding on probing, important attributes of soft-tissue health.
这项双盲、为期四周的临床研究的目的是评估一种新型清洁辅助工具BrushPicks和牙线Glide在减少菌斑面积、牙龈炎和探诊出血方面的效果,并监测在使用ADA认可的牙刷(欧乐B P35)和ADA认可的含氟牙膏(佳洁士常规款)刷牙的基础上使用这些产品时的安全性。除了要求每天早晚使用指定产品外,未对产品使用进行特殊指导或监督。在进行基线检查后,来自宾夕法尼亚州费城地区的63名符合条件的成年男性和女性受试者被随机分为两组。受试者还被告知在每次刷牙后使用指定的牙齿清洁辅助工具。在使用产品两周和四周后,重复进行疗效和安全性检查。62名受试者完成了研究的所有方面。在两周或四周的检查时,未报告或观察到因使用产品而产生的不良副作用。在基线时,BrushPicks组和牙线Glide组在菌斑、牙龈炎或探诊出血的平均得分上没有显著差异。在两周和四周的评估时,与基线水平相比,BrushPicks和牙线Glide的菌斑得分在数值上都较低。唯一具有统计学显著降低(p<0.01)的是BrushPicks组,将第二周的平均值与基线值进行比较。与牙线Glide的平均值相比,四周时BrushPicks组的牙龈炎(GI)在统计学上(p<0.05)更低。当评估从基线到两周和四周的得分变化时,牙线Glide组的平均GI得分在两周时(p<0.01)与基线相比显著降低,并且从两周到四周也显著降低(p<0.001)。牙线Glide组从基线到四周的平均GI得分变化在统计学上也显著(p<0.001)。当评估BrushPicks组的平均GI得分变化时,从基线到两周(p<0.001)、从两周到四周(p<0.001)以及从基线到四周(p<0.001)都有显著下降。对于探诊出血,当比较基线到两周和四周的平均值时,只有BrushPicks产生了显著(p<