RESUMO
PURPOSE: To compare the plaque removal efficacy of a new children's powered toothbrush to a children's manual toothbrush. METHODS: 55 subjects aged 5-8 years old, who met entry criteria, participated in this single-center, two-cell, examiner-blind, randomized, crossover, single use clinical study. Subjects brushed at home with their first assigned toothbrush and fluoride toothpaste, under supervision of a parent or legal guardian, at least once daily for 2 minutes during a 1-week acclimation period. After refraining from oral hygiene for 12-16 hours, and from eating and drinking for 4 hours, subjects returned to the clinical site where they were assessed for plaque using the Rustogi Modified Navy Plaque Index (RMNPI). Subjects then brushed their teeth with their assigned toothbrush and toothpaste for 2 minutes and plaque levels were reassessed. Subjects were then given their second assigned toothbrush and the acclimation period and clinical site visit were repeated. Safety-in-use was also assessed during each clinic visit. Differences between pre-and post-brushing scores were analyzed for each toothbrush and between toothbrush groups for whole mouth plaque and 12 subset sites using baseline adjusted ANCOVA. RESULTS: Both toothbrushes significantly (P< 0.0001) reduced whole mouth and 12 subset site plaque scores from the pre-brushing baseline. Between treatment comparisons showed that use of the powered toothbrush resulted in statistically significant reductions in whole mouth plaque (55%, P< 0.0001) and in 12 subset site scores (40-208%) compared to the manual brush. This clinical study showed that brushing with a new children's powered toothbrush was safe and significantly more effective than brushing with a manual toothbrush in reducing whole mouth plaque scores, as well as plaque scores at a range of subset sites in the mouth. CLINICAL SIGNIFICANCE: This new powered toothbrush may enable children to safely achieve significant and meaningful improvements in oral hygiene compared to brushing with a manual toothbrush.
