Abstract

AimsTo 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 methodsOne 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.ResultsSmall 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.ConclusionThis 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.

Highlights

  • Stain-causing substances from, for example, dietary sources or tobacco, can bind to proteinaceous compounds in plaque or pellicle and lead to the appearance of tooth discolouration.[1,2,3,4] Toothbrushing can remove dental plaque if carried out properly,[5] but many people brush using an inadequate technique and for less than the 2 min recommended to achieve adequate tooth surface cleaning.[6]

  • The first participant was enroled in September 2017; the last completed the study in December 2017

  • CONCLUSIONS relatively small reductions of stain removal were observed, a trend was shown in this early-phase development study that a toothpaste with a combination of 1% novel, structured, high-cleaning spherical silica (SS) plus 5% sodium tripolyphosphate (STP) facilitates higher stain removal than a toothpaste with 16% abrasive silica (AS) plus 5% STP and non-STPcontaining toothpastes with 0.5% SS or 6% AS

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Summary

Introduction

Stain-causing substances from, for example, dietary sources or tobacco, can bind to proteinaceous compounds in plaque or pellicle and lead to the appearance of tooth discolouration.[1,2,3,4] Toothbrushing can remove dental plaque if carried out properly,[5] but many people brush using an inadequate technique and for less than the 2 min recommended to achieve adequate tooth surface cleaning.[6] Toothpastes formulated with chemical or physically abrasive agents can aid plaque biofilm disruption and reduce stain formation.[5,7,8,9,10,11] the ability of a toothpaste to control extrinsic dental stain needs to be balanced with its potential to deleteriously affect the tooth surface, for individuals with exposed dentin and subsequent dentin hypersensitivity.[12] This is especially important as tooth wear is increasing across an ageing adult population.[13]. The ability of an abrasive to affect stain removal is influenced by particle shape, hardness, concentration, distribution and size.[12,14] Such abrasives are relatively hard, water insoluble, inert compounds effective at mechanical cleaning that impart a relative dentin abrasivity (RDA)

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