A 3-MONTH CLINICAL INVESTIGATION COMPARING THE SAFETY AND EFFICACY OFA NOVEL ELECTRIC TOOTHBRUSH [BRAUN ORAL-B 3D PLAQUE REMOVER] WITH A MANUAL TOOTHBRUSH

Purpose: To compare the efficacy and safety of a novel electric toothb rush (Braun Oral-B 3D Plaque Remover) with a standard reference ADA ma nual toothbrush. Materials and Methods: 114 subjects were included in a 3-month randomized, parallel group, examiner-blind study and divided into two groups: 3D users and manual toothbrush users. Subjects were instructed to brush twice daily for 2 minutes. Evaluation of oral soft and hard tissue for safety, plaque, gingivitis and bleeding was condu cted prior to the start of product use (at baseline), at days 14 and 3 5, and at 3 months. Results: 105 subjects (55 3D users and 50 manual t oothbrush users) completed the study. At days 14, 35 and at 3 months b oth groups showed reductions from baseline in whole mouth plaque, ging ivitis and bleeding that were statistically significant (P < 0.005), e xcept in the case of plaque at day 35 in manual toothbrush users. At 3 months, reductions for whole mouth plaque, gingivitis and bleeding we re 15%, 16% and 65%, for 3D users and 8%, 12% and 56%, for manual toot hbrush users, respectively. Group differences were significant (P< 0.0 5) in favor of the 3D with respect to plaque reduction for the whole m outh and for interproximal and anterior lingual sites at all three tim e periods. With respect to gingivitis, reductions for the whole mouth and interproximal and posterior lingual sites at 3 months were signifi cantly greater in the 3D group. There was no clinically significant so ft or hard tissue abrasion in either group. In conclusion, the 3D elec tric toothbrush was found to be safe and had increased efficacy with r espect to reduction of plaque and gingivitis compared to a manual toot hbrush.