Ghassemi A, Hooper W, Vorwerk L, Domke T, DeSciscio P, Nathoo S
Church & Dwight Co., Inc. Princeton, NJ, USA.
J Clin Dent. 2012;23(3):86-91.
The primary purpose of this randomized, controlled, six-week clinical trial was to determine the effectiveness and safety of a new whitening dentifrice in removing extrinsic tooth stain and whitening teeth. An additional two-week exploratory study was conducted to determine whether the whitening or stain-prevention activity of the dentifrice would persist following cessation of use.
In the first study (Phase I), one-hundred and forty-six qualifying subjects were randomly assigned to either a sodium bicarbonate whitening dentifrice group (Arm & Hammer Advance White Extreme Whitening Baking Soda and Peroxide Toothpaste) or a silica-based negative control dentifrice group, and brushed twice daily with their assigned dentifrice for six weeks. Tooth shade on the labial surfaces of the eight incisors was assessed using a Vita Classic shade guide, and extrinsic tooth stain was scored using a Modified Lobene Stain Index (MLSI) at baseline, week 4, and week 6. In Phase II (after the week 6 examination), volunteers from the Arm & Hammer whitening dentifrice group were randomly assigned to continue using the whitening dentifrice or to use the negative control dentifrice twice daily for two weeks. The six-week shade and stain index scores served as the baseline for this exploratory phase and were rescored after two weeks.
The whitening dentifrice group had statistically significant (p < 0.0001) mean shade score reductions of 1.82 and 2.57 from baseline to weeks 4 and 6, respectively. For the same periods, the negative control dentifrice group was virtually unchanged from baseline. For tooth stain, the MLSI total mean scores for the whitening dentifrice group showed statistically significant (p < 0.0001) decreases from baseline of 1.42 (41.6%) and 2.11 (61.6%) at weeks 4 and 6, respectively. In contrast, the negative control dentifrice group had a MLSI reduction of 0.07 at week 4 and a 0.06 increase at week 6. Between-group analyses using baseline-adjusted ANCOVA showed the whitening dentifrice to be statistically significantly more effective (p < 0.0001) than the negative control for shade and tooth stain reductions for all index comparisons. Compared to the six-week (baseline) scores, subjects who continued to use the whitening dentifrice for the additional two weeks experienced statistically significant (p < 0.0001) further mean reductions of 0.88 in shade score and 0.46 in MLSI score, while subjects who switched to the negative control dentifrice experienced smaller, statistically significant (p < 0.05) reductions of 0.34 in shade score and 0.13 in total MLSI score.
The Arm & Hammer whitening dentifrice tested in this study is effective for removing extrinsic tooth stain and whitening teeth. While the results also suggest that this dentifrice may have stain-prevention activity that persists following cessation of product use, such activity would need to be confirmed with further studies.
这项随机对照六周临床试验的主要目的是确定一种新型美白牙膏在去除外源性牙渍和美白牙齿方面的有效性和安全性。还进行了一项为期两周的探索性研究,以确定该牙膏在停止使用后美白或防渍活性是否会持续。
在第一项研究(第一阶段)中,146名符合条件的受试者被随机分配到碳酸氢钠美白牙膏组(艾禾美高级亮白极致小苏打加过氧化氢牙膏)或二氧化硅基阴性对照牙膏组,每天用分配的牙膏刷牙两次,持续六周。使用Vita经典比色板评估八颗前牙唇面的牙齿色度,并在基线、第4周和第6周使用改良的洛贝内污渍指数(MLSI)对牙齿外源性污渍进行评分。在第二阶段(第6周检查后),艾禾美美白牙膏组的志愿者被随机分配继续使用美白牙膏或每天两次使用阴性对照牙膏,为期两周。六周的色度和污渍指数评分作为该探索阶段的基线,并在两周后重新评分。
美白牙膏组从基线到第4周和第6周的平均色度评分分别有统计学显著降低(P<0.0001),分别为1.82和2.57。在同一时期,阴性对照牙膏组与基线相比几乎没有变化。对于牙渍,美白牙膏组的MLSI总平均分在第4周和第6周分别比基线有统计学显著降低(P<0.0001),分别为1.42(41.6%)和2.11(61.6%)。相比之下,阴性对照牙膏组在第4周MLSI降低了0.07,在第6周增加了0.06。使用基线调整的协方差分析进行组间分析表明,在所有指数比较中,美白牙膏在降低色度和牙渍方面比阴性对照在统计学上显著更有效(P<0.0001)。与六周(基线)评分相比,继续使用美白牙膏额外两周的受试者在色度评分上平均进一步有统计学显著降低(P<0.0001),降低了0.88,在MLSI评分上降低了0.46,而改用阴性对照牙膏的受试者在色度评分上有较小的统计学显著降低(P<0.05),降低了0.34,在总MLSI评分上降低了0.13。
本研究中测试的艾禾美美白牙膏在去除外源性牙渍和美白牙齿方面是有效的。虽然结果还表明该牙膏可能具有在停止使用产品后持续的防渍活性,但这种活性需要进一步研究来证实。