Plaque and gingivitis reduction efficacy of an advanced pulsonic toothbrush: a 4-week randomized and controlled clinical trial.

摘要

PURPOSE: To compare the safety and efficacy of a novel sonic power toothbrush and a manual toothbrush in the reduction of gingivitis and plaque over a 4-week period. METHODS: This study employed a randomized two treatment, examiner-blinded, parallel group design. Subjects with evidence of gingivitis were randomly assigned to 4 weeks' twice daily home use of either the Oral-B Pulsonic sonic toothbrush or an ADA reference manual toothbrush. At baseline (Visit 1) and again after product use at Week 4, subjects received gingivitis evaluations with the Modified Gingival Index (MGI) and Gingival Bleeding Index (GBI) examinations, followed by plaque assessment using the Rustogi Modified Navy Plaque Index (RMNPI). For 12 hours before both visits, subjects abstained from all oral hygiene, and ceased eating, drinking and smoking 4 hours prior. RESULTS: Both brushes significantly reduced gingivitis, gingival bleeding and plaque compared with baseline, and were well-tolerated by the 129 subjects completing the study. The sonic toothbrush was statistically significantly (P < 0.0001) more effective than the manual brush, with greater relative mean reductions in MGI, GBI and RMNPI of 11.9%, 62.3% and 46.5%, respectively.