CLINICAL TRIAL
COMPARATIVE STUDY
JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL
RESEARCH SUPPORT, NON-U.S. GOV'T
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Comparison of the Hydrabrush powered toothbrush with two commercially-available powered toothbrushes.

INTRODUCTION: An examiner-blinded, randomized, parallel, three-cell, controlled clinical trial was conducted to compare the efficacy of a new powered toothbrush (Hydrabrush) to that of two presently marketed power brushes (Oral-B and Sonicare) in reducing stain, supragingival plaque, gingivitis and the signs of periodontitis while monitoring safety.

METHODS: One hundred ten subjects were randomly assigned to three groups (35--Oral-B group, 36--Sonicare group, and 39--Hydrabrush group). Subjects were instructed to use the assigned powered toothbrush according to the manufacturer's instructions for 2-minutes duration twice per day. Clinical examinations conducted at baseline and at weeks 4, 8, and 12 included the following parameters: (1) oral tissues; (2) staining; (3) plaque index; (4) gingivitis; (5) probing depth; (6) clinical attachment loss; and 7) bleeding on probing.

RESULTS: The results showed that the body intensity and extent of stain and the gingival intensity and extent of stain at 8 and 12 weeks, respectively, were significantly less in the Hydrabrush group compared with the Sonicare group. The modified gingival index (MGI) in all groups significantly decreased over the 12 weeks. However, the groups did not differ from each other statistically. At 4, 8 and 12 weeks, the Hydrabrush group had statistically significantly less plaque than the Sonicare group. At 4 weeks, the Hydrabrush group had statistically significantly lower mean probing depth than both the Oral-B and Sonicare groups. At 8 and 12 weeks, the Hydrabrush group had statistically significantly lower mean probing depths than the Sonicare group. With regard to mean percentage of sites with probing depth > or =4 mm, the Hydrabrush group had statistically significantly fewer sites > or =4 mm at 4, 8 and 12 weeks. Differences among the groups in clinical attachment loss at 4, 8 and 12 weeks were representative of small imbalances at baseline. No differences were seen among the treatment groups with regard to gingival recession and bleeding on probing.

CONCLUSIONS: With the exception of clinical attachment loss, all subject groups were balanced for all measured clinical parameters at baseline. Tooth stain became significantly less in the Hydrabrush group compared with the Sonicare group at 8 and 12 weeks. At all examinations, the Hydrabrush group had statistically significantly less plaque than the Sonicare group. At 4 weeks, the Hydrabrush group had statistically significantly lower mean probing depth than both the Oral-B and Sonicare groups, and at 8 and 12 weeks, the Hydrabrush group had statistically significantly lower mean probing depth than the Sonicare group. With regard to mean percentage of sites with probing depth > or =4 mm, the Hydrabrush group had statistically significantly fewer sites > or =4 mm when compared to the other two tested brushes at all examinations. No differences were seen among the treatment groups with regard to gingival recession and bleeding on probing and none of the tested brushes caused any adverse reactions.

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