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The purpose of this study is to determine whether spherical silica can achieve similar or greater extrinsic dental stain and plaque removal, in comparison to dentifrices containing higher concentrations of standard abrasive silica, and how the addition of 5% sodium tripolyphosphate (STP) enhances cleaning capability.
This proof of principal (PoP) single centre, randomised, examiner blind, four-treatment arm, parallel design study will be conducted in healthy participants with a propensity for extrinsic dental stain (based on the judgement of the examiner) on the facial surfaces of the anterior teeth. This study will be used to evaluate and compare the extrinsic dental stain and plaque removal of an experimental low abrasivity 0.5% spherical silica dentifrice and a marketed low abrasivity 6% standard silica abrasive dentifrice, and an experimental moderate abrasivity 1% spherical silica / 5% STP dentifrice and a marketed high abrasivity 16% standard abrasive silica / 5% STP dentifrice. Stain will be assessed using an established clinical measure of extrinsic dental stain - the MacPherson modification of the Lobene stain index (MLSI). Particpants will be stratified by baseline MLSI score (total MLSI (area [A] × intensity [I]) for the facial surfaces of the 4 anterior assessment teeth). Plaque will be assessed using an established clinical measure of plaque - the Turesky Modification of the Quigley Hein Index. Stain and plaque will be assessed at intervals over an 8 week treatment period. As stain is the primary focus in this study, in addition to the baseline and Week 8 assessments, MLSI assessments will also be conducted at Weeks 2 and 4. Plaque will be assessed at baseline and Week 8 only.
5% KNO3 / 0.2542% NaF dentifrice with 0.5% spherical silica, 5% KNO3 / 0.2542% NaF dentifrice with 1% spherical silica and 5% STP, 5% KNO3 / 0.2542% NaF dentifrice with 6% abrasive silica, 5% KNO3 / 0.2543% NaF dentifrice with 16% abrasive silica and 5% S
Not yet recruiting
Published on BioPortfolio: 2017-08-30T20:53:21-0400
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A non-crystalline form of silicon oxide that has absorptive properties. It is commonly used as a desiccating agent and as a stationary phase for CHROMATOGRAPHY. The fully hydrated form of silica gel has distinct properties and is referred to as SILICIC ACID.
A dentifrice in paste form; usually contains binder, humectant, an abrasive, a detergent, flavoring agent and often caries preventives, anti-infective agents or other medicaments.
A poly(dimethylsiloxane) which is a polymer of 200-350 units of dimethylsiloxane, along with added silica gel. It is used as an antiflatulent, surfactant, and ointment base.
The generic term for salts derived from silica or the silicic acids. They contain silicon, oxygen, and one or more metals, and may contain hydrogen. (From McGraw-Hill Dictionary of Scientific and Technical Terms, 4th Ed)
A form of pneumoconiosis resulting from inhalation of dust containing crystalline form of SILICON DIOXIDE, usually in the form of quartz. Amorphous silica is relatively nontoxic.
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