title: A Thirty-Day Safety and Efficacy Evaluation of the Rowenta, Braun and Sonicare Powered Toothbrushes and a Manual Toothbrush.
abstract: A 30-day study was conducted to compare a new powered toothbrush (Rowenta Plaque Dentacontrol Plus) with a standard manual ADA-approved toothbrush (Oral-B P35) and two marketed powered toothbrushes (Braun Oral-B Ultra and Sonicare) for safety, plaque area before and after toothbrushing with dentifrice, gingivitis and bleeding on probing. The three powered toothbrushes had label directions giving somewhat different times for brushing. It was presumed that these stated times were justified on the basis of some observations or measurements of thorough cleaning. One brush, the Rowenta, had labelled time requirements involving both a flat-surface brush and an interproximal brush head. The manual toothbrush came with no recommended time reference for brushing. It was thought to assess the relative efficacy of the four toothbrushes for plaque removal and soft tissue changes, if subjects were to follow label directions. The subjects used only their randomly assigned toothbrush during the study. Assessments at baseline and on days 15 and 30 were performed with the subjects having not brushed for 10-16 hours prior to the examination (overnight plaque formation). There were no side effects reported by the subjects or observed by the examiners attributed to toothbrush use at any time in the study. All groups had similar plaque levels at the beginning of the study and all toothbrushes removed statistically significant amounts of plaque after brushing. On gingivitis measurements at baseline, there were no significant statistical differences among the toothbrushes tested; however, by day 15 the Rowenta was significantly lower than the Braun group. By day 30, the Rowenta was statistically significantly lower than all the groups in gingivitis scores. For bleeding on probing assessments, there were no significant statistical differences among the toothbrush means at baseline or day 15. By day 30, the Rowenta was statistically significantly lower than the Oral-B P35 on this measurement. The Rowenta toothbrush significantly lowered the bleeding on probing scores from baseline to day 15 and from day 15 to day 30. The Braun, Sonicare and Oral-B P35 significantly lowered scores from baseline to day 30, but not from day 15 to day 30. The Rowenta toothbrush was found to be an effective device for the removal of plaque, and for significantly lowering gingivitis compared to the Braun, Sonicare and Oral-B P35 toothbrushes by the conclusion of the study. The Rowenta was significantly better than the Oral-B P35 manual toothbrush for reducing bleeding on probing over the 30 days of this study.
authors.affiliation: School of Dental Medicine, University of Pennsylvania, Philadelphia, PA, USA.
authors.forename: S L
authors.initials: SL
authors.lastname: Yankell
authors.forename: R C
authors.initials: RC
authors.lastname: Emling
mesh_terms: D000293:Adolescent; D000328:Adult; D003773:Dental Plaque / Q000628:therapy; D003774:Dental Plaque Index; D003802:Dentifrices / Q000627:therapeutic use; D055615:Electrical Equipment and Supplies; D004867:Equipment Design; D004869:Equipment Safety; D005260:Female; D005500:Follow-Up Studies; D005884:Gingival Hemorrhage / Q000517:prevention & control; D005891:Gingivitis / Q000517:prevention & control; D006801:Humans; D008297:Male; D008875:Middle Aged; D010512:Periodontal Index; D016037:Single-Blind Method; D013997:Time Factors; D014099:Toothbrushing / Q000295:instrumentation*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D003802:Dentifrices