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Objective: The objective of this single-use, examiner-blind, two-treatment crossover clinical study was to evaluate the efficacy of a new battery-powered toothbrush (Colgate MicroSonic) relative to that of a currently marketed manual toothbrush (Oral-B Indicator) for the removal of supragingival plaque. This study included the assessment of plaque removal in the whole mouth, at the gumline, and at interproximal sites via the comparison of pre- and post-brushing plaque levels measured using the Rustogi Modification of the Modified Navy Plaque Index.

Methodology: Qualifying adult male and female subjects from the Newark, New Jersey area were provided with a commercially available toothbrush (Colgate Plus Toothbrush) and dentifrice (Colgate Cavity Protection Great Regular Flavor Fluoride Toothpaste) to use at home for three days before beginning the first phase of the crossover study. Subjects returned to the study site after refraining from any oral hygiene procedures for twenty-four hours, and from eating, drinking, or smoking for four hours. Following an examination for supragingival plaque (pre-brushing), they were stratified, based on their plaque scores, into two balanced groups, each of which used the two study toothbrushes in the order specified by a pre-determined randomization plan. Subjects were instructed to brush their teeth for one minute under supervision with their first assigned toothbrush and the commercially available toothpaste provided, after which they were again evaluated for supragingival plaque (post-brushing). Subjects were then dismissed from the study site, and instructed to use the home-use toothbrush and dentifrice. After three days, subjects returned to the study site for the second phase of the crossover study. Pre- and post-brushing evaluations were again performed following the same procedure, with each of the two subject groups now using the second toothbrush in the assigned treatment order.

Results: Of the forty-two (42) subjects entered into the study, thirty-nine (39) complied with the protocol and completed the clinical study. The results of the study indicate that the Colgate MicroSonic battery-powered toothbrush provided a statistically significant reduction in pre- to post-brushing plaque index scores of up to 52.9%. Relative to the manual toothbrush, the Colgate MicroSonic battery-powered toothbrush provided a statistically significant greater reduction in supragingival plaque scores of up to 200%.

Conclusion: The results of this study support the conclusion that the new Colgate MicroSonic battery-powered toothbrush provides a clinically acceptable level of efficacy for the removal of supragingival plaque. Further, the Colgate MicroSonic battery-powered toothbrush exhibited significantly greater levels of efficacy for the removal of supragingival plaque when compared to the Oral-B Indicator Toothbrush.

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