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

ABSTRACT: 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.

SUBMITTER: Mason S

PROVIDER: S-EPMC6554270 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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

Mason Stephen S Young Sarah S Araga Mako M Butler Andrew A Lucas Robert R Milleman Jeffery L JL Milleman Kimberly R KR

BDJ open 20190606

<h4>Aims</h4>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.<h4>Materials and methods</h4>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 ...[more]

PMID: 31231545

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Project description:BackgroundDentin hypersensitivity (DH) is a condition characterized by short and sharp episodes of pain which will arise in response to tactile, chemical, thermal, evaporative or osmotic stimuli. The painful symptoms cause discomfort in patients and reduce their quality of life. Recently, the novel zinc-containing desensitizer CAREDYNE Shield has been developed as a new type of desensitizer that acts by inducing chemical occlusion of dentinal tubules, and releasing zinc ion for root caries prevention. However, the clinical effectiveness of CAREDYNE Shield on DH remains unclear. Therefore, the aim of this study is to evaluate the effectiveness of CAREDYNE Shield on DH by comparing with that of another desensitizer, Nanoseal, commonly used in Japan.Methods/designThis study protocol is a two-arm, parallel, pilot randomized controlled trial. Forty DH patients will be randomly allocated to two groups. Participants in the intervention group will be treated with CAREDYNE Shield, while those in the control group will be treated with Nanoseal. The primary outcome is the reduction of pain intensity in response to air stimuli measured with a 5-point verbal response scale from baseline to 4 weeks after the intervention, and Fisher's exact test will be used for analyses.DiscussionCAREDYNE Shield can be casually applied to subgingival areas and proximal surfaces because it reacts with only tooth substance. Furthermore, zinc has been reported to reduce the demineralization of enamel and dentin and inhibit biofilm formation, plaque growth and dentin-collagen degradation. Therefore, CAREDYNE Shield may be expected to be a useful novel desensitizer that acts not only as a desensitizer but also as a root caries inhibitor.Trial registrationUMIN Clinical Trials Registry (UMIN-CTR), ID: UMIN000038072. Registered on 21 September 2019.Trial statusThis study (protocol version number: version 1.4.0; approved on 22 October 2019) is ongoing. The recruitment of participants began in December 2019 and will be continued until November 2020 (Hanke, Am Dent Assoc 27:1379-1393, 1940).

Dataset Information

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

Publications

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

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