A randomized, parallel design study to evaluate the effects of a Sonicare and a manual toothbrush on plaque and gingivitis.

OBJECTIVE

This study was designed to determine the effects of twice daily tooth brushing with the Sonicare Elite (Elite) and the Oral-B P40 manual toothbrush (MTB) on plaque accumulation and plaque-induced gingival inflammation.

METHODS

One-hundred and eighty (180) subjects, with moderate gingival inflammation and a Silness and Löe Plaque Index (PI) of > or = 0.8 after refraining from oral hygiene for three to six hours, were randomly assigned to receive the Elite or MTB in this single-blinded, controlled clinical trial. At baseline and after two and four weeks of using the product at home twice daily for two minutes, efficacy was assessed with the PI and the Löe and Silness Gingival Index (GI) after brushing three to six hours prior to assessment The primary efficacy variable was reduction of baseline plaque scores over the four weeks for Elite compared to MTB. Secondary outcomes included a change in GI and number of bleeding sites. Safety was appraised using adverse event reports and soft tissue examinations.

RESULTS

One-hundred and sixty-eight subjects (81 Elite, 87 MTB) completed the study. The four-week study period resulted in significant reductions of PI and GI from baseline at weeks two and four for both brushes. Reduction in mean PI from baseline to week four for Elite was 0.84 (95% CI: 0.80, 0.88), and 0.72 (0.68, 0.76) for MTB, p < 0.0001. Reduction in mean GI from baseline to four weeks for Elite was 0.56 (0.53, 0.59), and 0.47 (0.45, 0.50) for MTB, p = 0.0001. Both treatment groups demonstrated a significant reduction in number of bleeding sites relative to baseline (p < 0.0001); however, a significant difference in percent reduction in favor of Elite relative to MTB was found at week four: 82.5% vs. 75.8% (p = 0.026). Both toothbrushes were safe on oral tissues.

CONCLUSION

Elite was significantly more effective than MTB in the reduction of plaque after two and four weeks of product use, and significantly more effective in the reduction of gingivitis and bleeding sites than MTB after four weeks.