title: Efficacy and safety of a new power toothbrush in a population with mild to moderate gingivitis.
abstract: OBJECTIVE
  To evaluate the efficacy and safety of a novel ultrasound power toothbrush over a 30-day period in a population with mild to moderate gingivitis.
  
  
  METHODS
  A 30-day, randomized, examiner-blind, parallel-arm study was conducted to evaluate the safety and efficacy of a ultrasound novel power toothbrush (Ultreo - ULT) as compared to a control manual toothbrush (Oral-B 35-MTB). Fifty-three subjects (n = 26 ULT, n = 27 MTB) with a minimum of 18 natural teeth and a Löe and Silness Gingival Index of > or = 1.5 were enrolled. An intraoral examination (oral soft and hard tissues, restorations) was performed, and Löe and Silness Gingival Index scores were recorded at baseline and 30 days. Subjects were instructed to brush at home twice per day with their assigned toothbrush and study toothpaste. A product evaluation questionnaire was also completed at the 30-day study visit.
  
  
  RESULTS
  Oral examinations indicated normal findings at all time points for both groups, and no adverse events were reported during the study. There were no significant differences in gingivitis scores at baseline between the toothbrush groups (p > 0.05). From baseline, each treatment group demonstrated a significant reduction in gingivitis over the 30-day period (p < 0.001). However, subjects in the ULT group demonstrated a significantly greater reduction in gingivitis compared to those using the manual toothbrush (p = 0.010). Results from the questionnaire, on average, indicated subjects in the ULT group scored their device higher with respect to the clean feeling after brushing and perceived improvements in gingival health.
  
  
  CONCLUSIONS
  The novel Ultreo ultrasound power toothbrush significantly reduced gingivitis over the 30-day study, and resulted in a significantly greater reduction in gingivitis than a manual toothbrush. No adverse events or safety concerns were identified with either the power or manual toothbrush.
authors.affiliation: BioSci Research Canada, Ltd. Mississauga, ON, Canada.
authors.forename: C Ram
authors.initials: CR
authors.lastname: Goyal
authors.forename: Jimmy G
authors.initials: JG
authors.lastname: Qaqish
authors.forename: Jack
authors.initials: J
authors.lastname: Galustians
authors.forename: Katherine
authors.initials: K
authors.lastname: Ortbald
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D004560:Electricity; D004812:Epidemiologic Methods; D005260:Female; D005891:Gingivitis / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D014099:Toothbrushing / Q000295:instrumentation*; D014464:Ultrasonic Therapy / Q000295:instrumentation*