A COMPARATIVE CLINICAL-STUDY OF THE SAFETY AND EFFICACY OF 3 TOOTHBRUSHES

THIS SINGLE (EXAMINER) BLIND, RANDOMIZED, 4-week study compared the safety and efficacy of a new electric toothbrush (experimental) regarding plaque removal and reducing gingivitis with two other brushes, an electric brush (control electric) and a manual toothbrush (control hand). Ninety-six subjects with 1) a minimum of 15 suitable teeth in acceptable occlusion; 2) a minimum gingivitis score of 0.9; and 3) a minimum plaque score of 1.8 were entered into the study. The subjects were randomly assigned to one of 3 groups: a control hand group (31 subjects), an experimental group (32 subjects), and a control electric group (33 subjects). Device use instructions were given according to the manufacturer's recommendations. Two examiners separately determined either gingival scores or plaque scores at baseline and 4 weeks. In regard to gingivitis, use of all 3 brushes for the study period showed statistically significant improvements in gingivitis scores (P values <0.01) within each of the 3 groups. Between group analyses of covariance showed that of the 3 groups, the control hand group improvement was better than both the experimental and the control electric groups (P <0.05). When interproximal gingivitis scores were analyzed separately, similar improvements were noted. Regarding effectiveness of plaque removal during a single brushing event at the initial and final visits, each of the 3 brushes was effective in reducing plaque for every tooth surface scored (P values <0.01). However, between group analyses of covariances showed that the experimental group was better than the other two (P <0.01). When facial surfaces were analyzed separately, all 3 brushes were equally effective in plaque removal. But, when palatal/lingual surfaces were analyzed separately, the experimental group was better than both control groups (P <0.01). When interproximal surfaces were analyzed separately, again the experimental group was better than both control groups (P <0.01). The safety and efficacy of the experimental toothbrush with respect to plaque and gingivitis score improvements during the 4-week study interval were demonstrated.