PURPOSE: To compare the safety and efficacy of a new power toothbrush (Braun Oral-B D17) with an ADA reference manual toothbrush. MATERIALS AND METHODS: 110 healthy subjects, 18-65 yrs of age, with a mean plaque index of > or = 1.80 and a gingival index of > or = 1.00, were enrolled in this 3-month, randomized, parallel-group, examiner-blind 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 the baseline visit and randomization, subjects were instructed to brush twice daily for 2 mins with their assigned brush. RESULTS:101 subjects completed the study with evaluable data for all time periods, 52 in the D17 group and 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 reported. There was no clinically significant soft or hard tissue abrasion observed at any time point in either group. After 1 and 3 months, significant reductions from baseline in whole mouth and interproximal plaque, gingivitis and bleeding were observed in both groups. A comparison of the two groups revealed 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. The whole mouth gingival index was also reduced to a greater extent in the D17 group at 1 and 3 months, but a difference in the approximal gingival index was only apparent after 3 months. With respect to the bleeding index, there 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 approximal 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.
RCT Entities:
PURPOSE: To compare the safety and efficacy of a new power toothbrush (Braun Oral-B D17) with an ADA reference manual toothbrush. MATERIALS AND METHODS: 110 healthy subjects, 18-65 yrs of age, with a mean plaque index of > or = 1.80 and a gingival index of > or = 1.00, were enrolled in this 3-month, randomized, parallel-group, examiner-blind 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 the baseline visit and randomization, subjects were instructed to brush twice daily for 2 mins with their assigned brush. RESULTS: 101 subjects completed the study with evaluable data for all time periods, 52 in the D17 group and 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 reported. There was no clinically significant soft or hard tissue abrasion observed at any time point in either group. After 1 and 3 months, significant reductions from baseline in whole mouth and interproximal plaque, gingivitis and bleeding were observed in both groups. A comparison of the two groups revealed 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. The whole mouth gingival index was also reduced to a greater extent in the D17 group at 1 and 3 months, but a difference in the approximal gingival index was only apparent after 3 months. With respect to the bleeding index, there 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 approximal 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.
Authors: Munirah Yaacob; Helen V Worthington; Scott A Deacon; Chris Deery; A Damien Walmsley; Peter G Robinson; Anne-Marie Glenny Journal: Cochrane Database Syst Rev Date: 2014-06-17