Safety, efficacy and acceptability of a new power toothbrush: A 3-month comparative clinical investigation

Purpose: To compare the safety and efficacy of a new power toothbrush (Brau n Oral-B D17) with an ADA reference manual toothbrush. Materials and Method s: 110 healthy subjects, 18-65 yrs of age, with a mean plaque index of grea ter than or equal to 1.80 and a gingival index of greater than or equal to 1.00, were enrolled in this 3-month, randomized, parallel-group, examiner-b lind study. Oral soft and hard tissues were examined for safety, and plaque , gingivitis and bleeding were measured to evaluate efficacy. Measurements were made at baseline and after 1 and 3 months of product use. Following th e baseline visit and randomization, subjects were instructed to brush twice daily for 2 mins with their assigned brush. Results: 101 subjects complete d the study with evaluable data for all time periods, 52 in the D17 group a nd 49 in the manual group. None of the nine withdrawals from the study were related to product use and no product-related adverse effects were reporte d. There was no clinically significant soft or hard tissue abrasion observe d at any time point in either group. After 1 and 3 months, significant redu ctions from baseline in whole mouth and interproximal plaque, gingivitis an d bleeding were observed in both groups. A comparison of the two groups rev ealed that the whole mouth and approximal plaque indices were reduced to a significantly greater extent in the D17 group after both 1 and 3 months. Th e whole mouth gingival index was also reduced to a greater extent in the D1 7 group at 1 and 3 months, but a difference in the approximal gingival inde x was only apparent after 3 months. With respect to the bleeding index, the re was a significant difference between the two groups for the whole mouth at both 1 and 3 months, but the differences in favor of the D17 for approxi mal values did not achieve statistical significance. In conclusion, the D17 was found to be safe and had increased efficacy with respect to reduction of plaque and gingivitis, compared with a manual toothbrush.