Richter R, Jogun S, Won B, Zhang Y P, Miller S
J Clin Dent. 2015;26(4):91-5.
To assess the efficacy of an experimental 1450 ppm fluoride as sodium monofluorophosphate (SMFP)/zinc-based dentifrice (Test), a clinically proven 1450 ppm fluoride as SMFP/zinc-based dentifrice (Positive Control), and a 1000 ppm fluoride as SMFP and 450 ppm fluoride as sodium fluoride (NaF) dentifrice (Negative Control) in delivering 12-hour anti-tartar benefits as measured by calcium buildup after a single product brushing.
Fourteen (14) adult subjects completed this single-center, double-blind, randomized, cross-over clinical study conducted in Piscataway, New Jersey. An intra-oral appliance was custom-made for each subject as a surface on which the anti-calculus agents' inhibition of early calculus formation could be analyzed. After brushing with their assigned toothpaste, each subject wore their respective appliance for 12 hours overnight. When the appliance was removed, it was washed, suspended in 0.1 MHCL to release Ca2+ from deposits, and analyzed by Inductively Coupled Plasma (ICP) for deposited calcium. There was a one-week washout period between each product use. Statistical analyses were performed on the mean level of calcium (μg). Comparisons of the treatment groups with respect to 12-hour post-brushing (overnight) calcium levels were performed via a two-way analysis of variance (ANOVA), with subjects and products as factors in the ANOVA model. Post-ANOVA pair-wise comparisons of the study treatments were performed using the Tukey's test for multiple comparisons. All statistical tests of hypothesis were two-sided, and employed a level of significance of α = 0.05.
At the 12-hour post-brushing examination, the mean level of calcium buildup was 0.46 μg for subjects assigned to the experimental Test dentifrice, 0.41 μg for subjects assigned to the Positive Control dentifrice, and 2.47 μg for subjects assigned to the Negative Control dentifrice. After 12 hours post-brushing, subjects assigned to the experimental Test dentifrice and Positive Control dentifrice both exhibited statistically significantly (p = 0.005 and p = 0.004, respectively) lower levels of calcium buildup as compared to the subjects assigned to the Negative Control dentifrice. No statistically significant (p = 0.996) difference was observed between the experimental Test dentifrice and Positive Control dentifrice with respect to tartar control efficacy after 12 hours post-brushing. No adverse effects of the hard or soft oral tissue were observed by the clinical investigators or reported by the subjects.
Both the experimental Test dentifrice (1450 ppm fluoride as SMFP/zinc-based dentifrice) and the Positive Control dentifrice (1450 ppm fluoride as SMFP/zinc-based dentifrice) provided significantly greater 12-hour tartar control as measured by calcium buildup, as compared to the Negative Control dentifrice containing 1000 ppm fluoride as SMFP and 450 ppm fluoride as NaF.
评估一种含1450 ppm单氟磷酸钠（SMFP）/锌基牙膏（试验组）、一种临床验证有效的含1450 ppm SMFP/锌基牙膏（阳性对照组）以及一种含1000 ppm SMFP和450 ppm氟化钠（NaF）牙膏（阴性对照组）在单次刷牙后通过钙沉积测量提供12小时防牙石益处的效果。
14名成年受试者完成了在新泽西州皮斯卡塔韦进行的这项单中心、双盲、随机、交叉临床研究。为每位受试者定制了一个口腔内装置，作为分析防牙石剂对早期牙石形成抑制作用的表面。在用分配的牙膏刷牙后，每位受试者佩戴各自的装置过夜12小时。当装置取下后，进行清洗，悬浮于0.1 M盐酸中以从沉积物中释放Ca2+，并通过电感耦合等离子体（ICP）分析沉积的钙。每种产品使用之间有一周的洗脱期。对钙的平均水平（μg）进行统计分析。通过双向方差分析（ANOVA）对刷牙后12小时（过夜）钙水平的治疗组进行比较，将受试者和产品作为ANOVA模型中的因素。ANOVA后，使用Tukey多重比较检验对研究治疗进行两两比较。所有假设的统计检验均为双侧检验，显著性水平α = 0.05。
在刷牙后12小时的检查中，分配到试验组牙膏的受试者钙沉积平均水平为0.46 μg，分配到阳性对照组牙膏的受试者为0.41 μg，分配到阴性对照组牙膏的受试者为2.47 μg。刷牙后12小时，与分配到阴性对照组牙膏的受试者相比，分配到试验组牙膏和阳性对照组牙膏的受试者钙沉积水平均显著降低（分别为p = 0.005和p = 0.004）。刷牙后12小时，试验组牙膏和阳性对照组牙膏在牙石控制效果方面未观察到统计学显著差异（p = 0.996）。临床研究人员未观察到口腔软硬组织的不良反应，受试者也未报告。
与含1000 ppm SMFP和450 ppm NaF的阴性对照组牙膏相比，试验组牙膏（含1450 ppm SMFP/锌基牙膏）和阳性对照组牙膏（含1450 ppm SMFP/锌基牙膏）通过钙沉积测量在12小时牙石控制方面均有显著更好的效果。
