Moore Joel, White Donald J, Schneiderman Eva, Chen Haijing, Strand Ross, Grender Julie M
The Procter & Gamble Company in Mason, Ohio, USA.
The Procter & Gamble Company in Mason, OH, USA,
Am J Dent. 2020 Jun;33(3):161-164.
To assess the hard tissue safety of a variety of low pH oral care rinses to dental enamel in a newly developed screening method.
Bovine enamel specimens were subjected to a cycling model that consisted of commercial mouthrinse product exposures and artificial saliva soaks based on a previously published screening method. The effect of test products on the surface of treated specimens was measured using surface microhardness (SMH). Results are presented as the change in SMH (between sound enamel baseline and cycling final). An assortment of rinse products were assessed relative to distilled water (positive control) and 1% citric acid (negative control). A priori, a product was considered safe if the change in measured SMH values over the course of six treatment cycles was both significantly greater than the negative control and was not significantly different from the positive control. A non-inferiority statistical test was applied to create a quantitative rule defining product safety.
Products tested included two rinses with a pH in excess of 5.5, and eight with a pH less than 5.5. Four of the rinses included fluoride, while six did not. Analyses showed that all of the rinse products tested passed the non-inferiority acceptance criteria. One of the 10 marketed oral care rinses failed to meet the a priori criteria needed to be considered safe as the product was significantly better than the negative control but also significantly lower than the positive control treatment. This product had the lowest pH of all products tested and did not contain fluoride. Application of the non-inferiority statistical test showed the questionable product passing safety criteria. As a proposed method for a screening tool, further testing would be recommended based on these results.
An in vitro enamel safety screening method was applied as an assessment of the enamel demineralization safety to a number of oral care rinse products. Surface microhardness, coupled with a non-inferiority statistical evaluation, provided a reasonable approach for detecting potential product issues. Products failing this screening laboratory method may require additional testing to verify their safety on hard tissues.
采用一种新开发的筛选方法，评估多种低pH值口腔护理漱口水对牙釉质的硬组织安全性。
根据先前发表的筛选方法，牛牙釉质标本采用一种循环模型，该模型包括商业漱口水产品暴露和人工唾液浸泡。使用表面显微硬度（SMH）测量测试产品对处理后标本表面的影响。结果以SMH的变化（在完好牙釉质基线和循环结束之间）表示。相对于蒸馏水（阳性对照）和1%柠檬酸（阴性对照），评估了一系列漱口水产品。预先设定，如果在六个处理周期内测量的SMH值变化既显著大于阴性对照，又与阳性对照无显著差异，则该产品被认为是安全的。应用非劣效性统计检验来制定定义产品安全性的定量规则。
测试的产品包括两种pH值超过5.5的漱口水和八种pH值低于5.5的漱口水。其中四种漱口水含有氟化物，六种不含。分析表明，所有测试的漱口水产品均通过非劣效性验收标准。10种市售口腔护理漱口中有一种未能达到被认为安全所需的预先设定标准，因为该产品显著优于阴性对照，但也显著低于阳性对照处理。该产品在所有测试产品中pH值最低，且不含氟化物。非劣效性统计检验的应用表明该有问题的产品通过了安全标准。作为一种筛选工具的提议方法，基于这些结果建议进一步测试。
一种体外牙釉质安全筛选方法被用于评估多种口腔护理漱口水产品对牙釉质脱矿的安全性。表面显微硬度与非劣效性统计评估相结合，为检测潜在的产品问题提供了一种合理的方法。未通过这种筛选实验室方法的产品可能需要额外测试以验证其对硬组织的安全性。
