Li YuCheng, He Tao, Sun Lili, Zhang Yuqing, Li Xin, Wang Yan, Zhao Shouliang, Tang RongYin
College of Stomatology, Fourth Military Medical University, Xi'an, China.
Am J Dent. 2007 Aug;20(4):227-30.
To evaluate the extrinsic stain removal benefit of a sodium hexametaphosphate containing dual-phase dentifrice (Crest Vivid White) relative to a marketed negative control (Colgate Cavity Protection).
This was a parallel groups, examiner-blind, randomized and controlled clinical trial. A total of 200 healthy adults with natural stain on their anterior teeth were enrolled into the study. Following baseline examination, subjects were randomly assigned to one of the two treatment groups based on baseline Lobene composite scores, smoking status (yes/no), tea/coffee consumption (yes/no), and gender. Subjects brushed twice daily, at least 1 minute every time over 6 weeks. Clinical examinations including extrinsic stain evaluation and oral soft tissue examination were conducted at BL, Weeks 3 and 6. Extrinsic stain removal was evaluated on the anterior teeth by a dental examiner using Lobene stain index.
Of the 200 subjects who were randomized to treatment, 195 were available for the 3-week examination and 193 subjects completed the study. The dual-phase dentifrice exhibited a statistically significant (P< 0.01) reduction in Lobene stain composite scores when compared to the negative control dentifrice at Week 6. Adjusted mean Lobene composite reduction for the dual-phase dentifrice group (0.32) was twice as big as the negative control group (0.16). Change in Lobene stain extent (area) contributed primarily to the overall composite score reduction. All test products were well tolerated over the 6-week treatment period.
评估含六偏磷酸钠的双相牙膏(佳洁士亮白炫彩牙膏)相对于市售阴性对照牙膏(高露洁防蛀牙膏)在外源性色斑清除方面的效果。
这是一项平行组、检查者盲法、随机对照临床试验。共有200名前牙有天然色斑的健康成年人纳入研究。在基线检查后,根据基线洛贝内复合评分、吸烟状况(是/否)、茶/咖啡饮用情况(是/否)和性别,将受试者随机分配到两个治疗组之一。受试者每天刷牙两次,每次至少1分钟,持续6周。在基线、第3周和第6周进行包括外源性色斑评估和口腔软组织检查在内的临床检查。由牙科检查者使用洛贝内色斑指数对前牙的外源性色斑清除情况进行评估。
在随机接受治疗的200名受试者中,195名可进行3周检查,193名受试者完成了研究。与阴性对照牙膏相比,双相牙膏在第6周时洛贝内色斑复合评分有统计学显著降低(P<0.01)。双相牙膏组洛贝内复合评分的调整后平均降低值(0.32)是阴性对照组(0.16)的两倍。洛贝内色斑范围(面积)的变化是总体复合评分降低的主要原因。在6周治疗期间,所有测试产品耐受性良好。