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Philips Sonicare FlexCare - Sonicare.com - Sonicare

Philips Sonicare FlexCare - Sonicare.com - Sonicare

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A Randomized, Parallel-design<br />

Study to Compare the Effects of<br />

the <strong>Sonicare</strong> <strong>FlexCare</strong> and the<br />

Oral-B P40 Manual Toothbrush<br />

on Plaque and Gingivitis<br />

Abstract<br />

Effects on plaque removal and plaque-induced gingival inflammation of a new sonic toothbrush, <strong>Sonicare</strong> <strong>FlexCare</strong><br />

(<strong>FlexCare</strong>), and a manual toothbrush were evaluated in a randomized, single-masked, controlled clinical trial. One<br />

hundred seventy-nine subjects with gingival index (GI) scores ≥2.0 at ≥20 sites and plaque index (PI) scores ≥0.8<br />

were randomly assigned to receive the <strong>FlexCare</strong> power toothbrush or the Oral-B P40 control manual toothbrush.<br />

After 2 and 4 weeks of using the product at home twice daily for 2 minutes, efficacy was assessed with the Löe and<br />

Silness GI and the Silness and Löe PI. Percent change in GI score between baseline and 4-week visit was the primary<br />

efficacy variable. Secondary out<strong>com</strong>es included change in PI scores and number of bleeding sites. Safety was<br />

appraised using adverse event reports and soft tissue examinations. Statistical analyses were performed using a linear<br />

mixed effects model and treatments were <strong>com</strong>pared using appropriate F tests. One hundred seventy-five subjects (87<br />

<strong>FlexCare</strong> users, 88 manual toothbrush users) <strong>com</strong>pleted the study. Mean (± standard deviation) GI scores at baseline<br />

were 1.45 ± 0.14 and 1.42 ± 0.15 for the <strong>FlexCare</strong> and manual toothbrushes, respectively. The 4-week study period<br />

resulted in significant reductions of GI and PI scores from baseline (P

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