Clinical Evaluation of Gingivitis Using the Ultrasonex Ultima Toothbrush With and Without the Ultrasonic Transducer Enabled

Objective: To evaluate an Ultrasonex Ultima toothbrush with and without its ultrasonic transducer enabled to investigate the influence of the ultrasonic component in reduction of plaque, bleeding, and gingivitis. Methods: Fifty-one adult patients participated in this double-blind, randomized, parallel design study. The Löe & Silness Gingival Index was used to record inflammation scores and the Turesky Modification of the Quigley Hein Plaque Index was used to record pre- and post-brushing plaque scores. Subjects with a pre-brushing average plaque index of ³1.8 and 20 sites ³ 2 on the gingival index at screening were enrolled into the study and were instructed to brush with their assigned device for 3 minutes 2X per day. Clinical evaluations were conducted at baseline, 4 and 12 weeks. Each clinical evaluation included a 12 –18 hour period of plaque accumulation, intraoral photographs, oral soft tissue evaluation, gingival index, and pre- and post- brushing plaque scores. At each clinical evaluation subjects brushed with their assigned device for 3 minutes. Results: There were no significant differences between the 2 groups in post-brushing P.I. scores except at the 12-week evaluation, where the mean score for the disabled group was 2.81 and the mean score for the enabled group was 3.02, which was statistically significant (p=0.03). There were no significant differences between the two groups at any of the evaluations in gingival index scores or bleeding index scores, although both groups had significantly lower bleeding indices at the 12-week evaluation compared to baseline. Conclusion: The test toothbrush did not produce significantly better results with its transducer enabled compared to disabled in any of the 3 indices tested. At the 12-week evaluation the mean plaque scores for the enabled group were statistically significantly higher than those of the disabled group. This research was supported in part by Philips Oral Healthcare, Inc.