Comparative plaque removal efficacy of a new children's powered toothbrush and a manual toothbrush: Randomized, single use clinical study.

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.

The effects of two baking-soda toothpastes in enhancing mechanical plaque removal and improving gingival health: A 6-month randomized clinical study.

PURPOSE: To compare the effectiveness in reducing plaque and gingivitis of two fluoride toothpastes containing baking soda (35% and 20%) with a fluoride toothpaste control. METHODS: 319 subjects, who met entry criteria, participated in this single-center, three-cell, double-blind, randomized, parallel-group clinical study. Gingival Index (MGI), Gingival Bleeding Index (GBI), and Plaque Index (PI) were assessed at baseline, and after 6 weeks, 3 and 6 months. RESULTS: All three toothpastes significantly (P< 0.0001) reduced MGI, GBI, and PI versus baseline, and the two baking soda toothpastes significantly (P< 0.0001) reduced MGI, GBI, and PI compared to the fluoride control, at all three time points. After 6 months use, the 35% and 20% baking soda toothpastes had reduced MGI, GBI and PI by 15.0%, 46.9%, and 18.3%, and 9.4%, 25.9%, and 12.4%, respectively, compared to the control. In addition, the 35% baking soda toothpaste had reduced (P≤ 0.0005) MGI, GBI, and PI by 6.2%, 28.4%, and 6.8%, respectively, compared to the 20% baking soda toothpaste. This clinical study showed that brushing with fluoride toothpastes containing baking soda at 35% and 20% reduces plaque, gingival inflammation and bleeding more effectively than regular fluoride toothpaste. Further, it showed that 35% baking soda toothpaste was more effective in reducing these parameters than 20% baking soda toothpaste. CLINICAL SIGNIFICANCE: Fluoride toothpastes containing 20% or more baking soda can provide significant and meaningful gingival health benefits when used regularly as an adjunct to tooth brushing.