A Study to Investigate the Stain and Plaque Removal Capability of Two Experimental Potassium Nitrate Dentifrices

Summary

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.

Timeline

Start

2017-09-25

Primary completion

2017-12-02

Completion

2017-12-02

Outcome

Missed primary endpoint

registry analysis (other test); Test Product 1 vs Reference Product 1; p = 0.6499; Difference of Least Mean Square 0.06 (95% CI -0.19 to 0.31); ANCOVA NCT03267511 ↗

registry analysis (other test); Test Product 2 vs Reference Product 2; p = 0.5680; Difference of Least Square mean -0.07 (95% CI -0.33 to 0.18); ANCOVA NCT03267511 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	5% KNO3 / 0.2542% NaF dentifrice with 0.5% spherical silica	Unknown	—	Topical
Subject	5% KNO3 / 0.2542% NaF dentifrice with 1% spherical silica and 5% STP	Unknown	—	Topical
Comparator	5% KNO3 / 0.2542% NaF dentifrice with 6% abrasive silica	Unknown	—	Topical
Comparator	5% KNO3 / 0.2543% NaF dentifrice with 16% abrasive silica and 5% STP	Unknown	—	Topical

Indications

No indication recorded.