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Philips Sonicare FlexCare - Sonicare.com - Sonicare

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Table 4—Change in number of bleeding sites after 2 and 4 weeks<br />

Parameter<br />

P value is from ANCOVA.<br />

SD = standard deviation; ANCOVA = analysis of covariance.<br />

N<br />

Baseline<br />

Sites<br />

2 Weeks<br />

Change in sites<br />

4 Weeks<br />

Change in sites<br />

<strong>FlexCare</strong> 87 44.72 ± 12.35 -24.07 ± 9.15 -31.59 ± 9.33<br />

Oral-B P40 88 41.85 ± 11.91 -21.80 ± 7.57 -27.89 ± 9.06<br />

P value .324 .029<br />

tions at each visit and review of subject-reported<br />

adverse events demonstrated the safety of the tested<br />

products with respect to hard and soft tissues.<br />

Discussion<br />

The results from this 4-week clinical trial<br />

demonstrate a strong effect of the <strong>FlexCare</strong> on reducing<br />

plaque-induced gingival inflammation. This<br />

was reflected in a highly significant reduction of GI<br />

scores after 2 and 4 weeks of use. The positive out<strong>com</strong>e<br />

corroborates results obtained in similar studies<br />

conducted with other sonic toothbrushes. 16-18 It was<br />

further substantiated by significantly reduced PI<br />

scores and a drop in the number of bleeding sites by<br />

70.6% over the 4-week period. Reductions in GI and<br />

PI scores were 28.4% and 43.9%, respectively, and<br />

associated score reductions between baseline and<br />

visit 3 were statistically significant. The results<br />

achieved with <strong>FlexCare</strong> clearly exceeded the efficacy<br />

thresholds of 15% for GI and statistical significance<br />

for PI established by the American Dental Association<br />

Acceptance Program 19 for power toothbrushes.<br />

This study also demonstrates that <strong>FlexCare</strong><br />

offers statistically significantly greater plaque<br />

removal ability than a manual toothbrush. The<br />

observed treatment effect of 3.9% probably underestimated<br />

the true advantage that could be expected<br />

from using the <strong>FlexCare</strong> in a nontrial situation. For<br />

instance, all manual toothbrush users reported<br />

excellent <strong>com</strong>pliance with instructions for brushing<br />

Figure 2—Number of gingival sites with GI score ≥2.0 at baseline (bleeding sites) by treatment group<br />

45<br />

40<br />

<strong>FlexCare</strong><br />

MTB<br />

35<br />

30<br />

Number<br />

of bleeding<br />

sites<br />

25<br />

20<br />

P = .324<br />

P = .029<br />

15<br />

10<br />

5<br />

0<br />

Baseline Week 2 Week 4<br />

Weeks of product use<br />

P values were calculated from ANCOVA adjusted for baseline differences.<br />

GI = gingival index; MTB = manual toothbrush; ANCOVA = analysis of covariance.<br />

Vol. 28, No. 9 (Suppl 1) Compendium / September 2007<br />

39

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