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Philips Sonicare FlexCare - Sonicare.com - Sonicare

Philips Sonicare FlexCare - Sonicare.com - Sonicare

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A Randomized, Single-use Study to<br />

Compare Plaque Removal Ability<br />

of <strong>Sonicare</strong> <strong>FlexCare</strong> and Oral-B<br />

Triumph Professional Care 9000<br />

Abstract<br />

The plaque removal ability of a new sonic toothbrush, the <strong>Sonicare</strong> <strong>FlexCare</strong>, was <strong>com</strong>pared with the Oral-B<br />

Triumph Professional Care 9000 rotating–oscillating power toothbrush, in a single-use, examiner-blinded, crossover<br />

clinical trial. The Turesky Modified Quigley-Hein (TMQH) plaque index was used for efficacy measurements. A<br />

TMQH score ≥1.8 at screening after 24 hours of oral hygiene abstinence was required for inclusion in the study. At<br />

Visit 1, qualifying subjects received their assigned toothbrush and toothpaste and were instructed to use them twice<br />

daily for 2 minutes during the 7 ± 1-day familiarization phase. Subjects refrained from oral hygiene for 24 hours<br />

before Visit 2. At Visit 2, TMQH scores were appraised before and after a 2-minute supervised brushing episode and<br />

the second test product was issued. Familiarization, plaque accumulation, and clinical examinations were the same<br />

for both study periods. Percent reduction in overall plaque score was the primary efficacy measure. The statistical<br />

data analysis used a linear mixed effects model approach. Comparisons between treatment groups were performed<br />

using F tests. The safety analysis was based on reported adverse events and oral examinations performed at Visits 2<br />

and 3. The study was <strong>com</strong>pleted by 91 subjects. The sample’s mean (standard deviation) TMQH score at Visit 1 was<br />

3.45 (0.58). Full-mouth TMQH prebrushing scores were 2.55 (0.76) for <strong>FlexCare</strong> and 2.81 (0.69) for Triumph.<br />

Brushing reduced the scores by 66.5% (13.0) and 60.1% (13.8) for <strong>FlexCare</strong> and Triumph, respectively. The mean<br />

percentages were significantly different (P

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