Stain control with two experimental dentin hypersensitivity toothpastes containing spherical silica: a randomised, early-phase development study,BDJ Open

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Stain control with two experimental dentin hypersensitivity toothpastes containing spherical silica: a randomised, early-phase development study
BDJ Open ( IF 2.5 ) Pub Date : 2019-06-06 , DOI: 10.1038/s41405-019-0016-x
Stephen Mason ₁ , Sarah Young ₁ , Mako Araga ₂ , Andrew Butler ₁ , Robert Lucas ₁ , Jeffery L Milleman ₃ , Kimberly R Milleman ₃

Affiliation

Aims

To determine in human participants whether toothpastes containing small quantities of a novel spherical silica, added to provide enhanced cleaning properties, could achieve similar or greater extrinsic dental stain removal compared to toothpastes containing standard dental abrasive silica concentrations.

Materials and methods

One hundred and twenty-three adults with extrinsic dental stain were randomised to one of four parallel groups for 8 weeks’ twice-daily brushing with an experimental toothpaste containing either 0.5% or 1% spherical silica (with relative dentin abrasivity [RDA] of ~38 and ~58, respectively), or marketed toothpastes containing either 6% (RDA ~ 36) or 16% (RDA ~ 166) standard abrasive silica. The objective was to evaluate the ranking order in extrinsic dental stain removal at Week 8, as measured by MacPherson modification of Lobene stain index Area × Intensity.

Results

Small treatment differences were observed between toothpaste formulations. The ranking order in extrinsic dental stain removal was: experimental 1% spherical silica toothpaste >16% standard abrasive silica toothpaste >6% standard abrasive silica toothpaste >experimental 0.5% spherical silica toothpaste. Toothpastes were generally well tolerated.

Conclusion

This early-phase development study suggests that toothpaste formulations with low concentrations of a novel spherical silica abrasive with high-cleaning capability are generally well tolerated and appropriate for further development.

中文翻译：

用两种含有球形二氧化硅的实验性牙本质过敏牙膏控制染色：一项随机的早期开发研究

目标

为了在人类参与者中确定与含有标准牙科磨料二氧化硅浓度的牙膏相比，含有少量新型球形二氧化硅（添加以提供增强的清洁性能）的牙膏是否可以实现相似或更大的外在牙齿污渍去除。

材料和方法

123 名患有外源性牙渍的成年人被随机分配到四个平行组之一，为期 8 周，每天两次使用含有 0.5% 或 1% 球形二氧化硅的实验性牙膏（相对牙本质磨蚀性 [RDA] 为 ~分别为 38 和 ~58)，或含有 6% (RDA ~ 36) 或 16% (RDA ~ 166) 标准研磨二氧化硅的市售牙膏。目的是评估第 8 周外在牙渍去除的排名顺序，通过 MacPherson 修正的 Lobene 染色指数面积 × 强度测量。