Gingival health effects with an oscillating-rotating electric toothbrush with micro-vibrations and a novel brush head designed for stain control: Results from a 12-week randomized controlled trial.

PURPOSE: To evaluate the reduction of plaque and gingivitis by an oscillating-rotating (O-R) smart-connected electric rechargeable toothbrush with micro-vibrations used with a novel brush head designed for stain control versus a manual toothbrush. METHODS: 100 adult subjects with evidence of gingivitis and plaque were enrolled in this single-center, examiner-blind, two-treatment, parallel-group, controlled trial. Subjects were randomized to either the O-R toothbrush used in whitening mode (Oral-B iO with Radiant White brush head) or the manual toothbrush (Oral-B Indicator). Subjects brushed twice daily with their assigned toothbrush and a standard sodium fluoride dentifrice. At baseline, week 1, and week 12, gingivitis was assessed with the Modified Gingival Index (MGI) and the Gingival Bleeding Index (GBI), and plaque was assessed with the Rustogi Modification of the Navy Plaque Index (RMNPI). Gingival case status was classified as " healthy" (< 10% bleeding sites) or "not healthy" (</= 10% bleeding sites) according to the standard of the American Academy of Periodontology and the European Federation of Periodontology. RESULTS: All 100 subjects who were randomized to treatment completed the study. At baseline, the gingival case status for all subjects was classified as "not healthy". By week 12, 86% of subjects in the O-R brush group had transitioned to a " healthy" case status, in contrast to 20% of subjects in the manual toothbrush group (P< 0.001). The reduction in the adjusted mean number of bleeding sites from baseline was greater for the O-R brush group than for the manual brush group [at week 12, by 24.5 (74.6%) vs. by 7.8 (23.7%), respectively; P< 0.001]. Reductions for adjusted mean MGI and GBI scores were likewise statistically significantly greater for the O-R brush group relative to those of the manual brush group (P< 0.001). The O-R brush also provided greater relative reductions in adjusted mean whole mouth, gingival margin and approximal RMNPI scores at week 12 (P< 0.001), and plaque was similarly reduced in the lingual and buccal subregions (P< 0.001). Significant between-group plaque reductions favoring the O-R brush were observed for all regions as early as first use (P< 0.001). CLINICAL SIGNIFICANCE: The results of this 12-week study support the recommendation of the O-R toothbrush with micro-vibrations, used in whitening mode with a novel brush head designed for stain control, so patients motivated by esthetic desires can personalize their brushing experience without compromising cleaning and gingival health efficacy.