Parkinson C R, Siddiqi M, Mason S, Lippert F, Hara A T, Zero D T
GSK Consumer Healthcare, Weybridge, UK.
Oral Health Research Institute, Indiana University School of Dentistry, Indianapolis, IN, USA.
J Clin Dent. 2017 Jun;28(2):27-31.
A randomized, investigator-blind, five-treatment, crossover, non-inferiority study was conducted to investigate the effect of the addition of calcium sodium phosphosilicate (CSPS), an agent known to relieve dentin hypersensitivity, to a sodium monofluorophosphate (SMFP)-containing dentifrice on the enamel remineralization potential of fluoride (F), as assessed by percentage surface microhardness recovery (%SMHR) and enamel fluoride uptake (EFU) using a standard in situ caries model.
Seventy-seven subjects wearing bilateral mandibular partial dentures holding partially demineralized bovine enamel specimens 24 hours/day brushed their teeth with their assigned randomized dentifrice containing either 1500 or 0 ppm F with 5% CSPS or 1500, 500, or 0 ppm F with 0% CSPS twice daily for 21 days. The success criterion was to observe a difference in % SMHR between dentifrices containing 1500 ppm F of six units or less in the upper bound of the two-sided 95% confidence interval (CI).
Following 21 days of treatment, the upper bound CI of the %SMHR difference between the dentifrices containing 1500 ppm F was 1.66, thus within the non-inferiority limit. No statistically significant differences for %SMHR (p = 0.2601) and EFU (p = 0.2984) were noted between these two dentifrices.
The present in situ caries study provides evidence demonstrating that the addition of the calcium-containing compound CSPS to a 1500 ppm F dentifrice does not interfere with the ability of fluoride to remineralize surface-softened enamel; i.e., CSPS neither impairs nor improves the potential cariostatic value of SMFP dentifrice.
开展一项随机、研究者盲法、五治疗组、交叉、非劣效性研究，以使用标准原位龋模型通过表面显微硬度恢复百分比（%SMHR）和釉质氟摄取量（EFU）评估添加已知可缓解牙本质过敏的磷酸硅钙钠（CSPS）至含单氟磷酸钠（SMFP）的牙膏中对氟化物（F）的釉质再矿化潜力的影响。
77名佩戴双侧下颌局部义齿且每天24小时持有部分脱矿牛牙釉质标本的受试者，使用分配给他们的随机牙膏刷牙，这些牙膏含有1500或0 ppm F以及5% CSPS，或者含有1500、500或0 ppm F以及0% CSPS，每天刷牙两次，共21天。成功标准是观察含1500 ppm F的牙膏之间在双侧95%置信区间（CI）上限中%SMHR的差异为6个单位或更小。
治疗21天后，含1500 ppm F的牙膏之间%SMHR差异的CI上限为1.66，因此在非劣效性限度内。这两种牙膏之间在%SMHR（p = 0.2601）和EFU（p = 0.2984）方面未观察到统计学上的显著差异。
本原位龋研究提供的证据表明，向含1500 ppm F的牙膏中添加含钙化合物CSPS不会干扰氟化物再矿化表面软化釉质的能力；即，CSPS既不损害也不提高含SMFP牙膏的潜在防龋价值。
