Thirty-day evaluation of the action toothbrush for clinical safety and efficacy.
A 30-day clinical investigation was undertaken in accordance with American Dental Association guidelines for evaluating toothbrush efficacy and safety. The test toothbrush was a unique design incorporating bristles mounted in base quadrants that have independent movements under brushing pressure. This toothbrush (Action) was tested against the Oral-B 35, an accepted ADA toothbrush, to evaluate safety, gingivitis reduction, bleeding on probing and plaque removal. Twenty-nine randomly assigned subjects in the Action group and 27 subjects in the Oral-B group completed the study under single-blind conditions. At baseline, day 15 and day 30 the subjects reported for the assessments after not having brushed for 12-14 hours. When the data were analyzed at the conclusion of the study, it was found that the Action brush significantly removed plaque from both buccal and lingual surfaces, whereas the Oral-B brush had significant plaque removal on buccal surfaces alone, at baseline and day 15. By the end of the study the two brushes were at parity and both demonstrated significant total plaque removal. On gingivitis, the Action group demonstrated a significant reduction on both buccal and lingual surfaces by the end of the study. The Oral-B group had a significant buccal surface reduction, however no reduction occurred on lingual surfaces. Both brushes demonstrated a significant reduction in bleeding on probing from baseline to day 30. No oral irritation was found throughout the study. The Action toothbrush was judged to be safe for regular use and to be effective in removing both buccal and lingual plaque, for reducing gingivitis and bleeding on probing.
Emling
R C
RC
University of Pennsylvania School of Dental Medicine, Philadelphia.
Yankell
S L
SL
D000293:Adolescent; D000328:Adult; D000704:Analysis of Variance; D003773:Dental Plaque / Q000628:therapy*; D003774:Dental Plaque Index; D005069:Evaluation Studies as Topic; D005260:Female; D005891:Gingivitis / Q000517:prevention & control; D006801:Humans; D008297:Male; D008875:Middle Aged; D010512:Periodontal Index; D014099:Toothbrushing / Q000295:instrumentation*