PURPOSE: To evaluate the efficacy of a novel multi-directional power toothbrush in reducing plaque and gingivitis relative to a standard manual toothbrush control. METHODS: This 4-week, randomized and controlled, single-center, parallel group, examiner-blinded clinical study enrolled adults with mild-to-moderate gingivitis. At baseline, pre-treatment gingivitis and plaque levels were assessed via the Lobene Modified Gingival Index (MGI), the Gingival Bleeding Index (GBI), and the Rustogi Modified Navy Plaque Index (RMNPI). Subjects qualifying were assigned randomly to one of two toothbrush groups: a novel multi-directional power toothbrush (Oral-B Professional Deep Sweep TRICLEAN 1000, also marketed as Oral-B TriZone) or a standard soft manual control toothbrush. Aside from a supervised brushing at baseline on-site, subjects brushed at home twice daily with their assigned test brush. After 1 week, subjects returned for RMNPI plaque evaluations. At Week 4, subjects were again recalled to evaluate toothbrush efficacy, and received MGI and GBI gingivitis and RMNPI plaque evaluations. RESULTS:119 evaluable subjects completed the study. Both the novel power and manual control toothbrushes yielded statistically significant (P < 0.001) mean plaque reductions compared to baseline at Weeks 1 and 4 (except Week 1 manual brush gingival margin) and significant mean MGI and GBI gingivitis reductions (P < 0.001). Comparing the relative effectiveness of the test brushes, the novel multi-directional power brush produced significantly superior anti-gingivitis and anti-plaque reductions compared to pre-treatment relative to the manual control brush in every analysis at both time points. The Week 4 adjusted mean relative reductions favoring the multi-directional power brush were 3 and 1.49 times greater for whole mouth MGI and GBI, respectively (P < 0.001); and were 2.1, 4.7 and 2 times greater for the RMNPI whole mouth, gingival margin and interproximal regions, respectively (P < 0.001). Both toothbrushes were well-tolerated.
RCT Entities:
PURPOSE: To evaluate the efficacy of a novel multi-directional power toothbrush in reducing plaque and gingivitis relative to a standard manual toothbrush control. METHODS: This 4-week, randomized and controlled, single-center, parallel group, examiner-blinded clinical study enrolled adults with mild-to-moderate gingivitis. At baseline, pre-treatment gingivitis and plaque levels were assessed via the Lobene Modified Gingival Index (MGI), the Gingival Bleeding Index (GBI), and the Rustogi Modified Navy Plaque Index (RMNPI). Subjects qualifying were assigned randomly to one of two toothbrush groups: a novel multi-directional power toothbrush (Oral-B Professional Deep Sweep TRICLEAN 1000, also marketed as Oral-B TriZone) or a standard soft manual control toothbrush. Aside from a supervised brushing at baseline on-site, subjects brushed at home twice daily with their assigned test brush. After 1 week, subjects returned for RMNPI plaque evaluations. At Week 4, subjects were again recalled to evaluate toothbrush efficacy, and received MGI and GBI gingivitis and RMNPI plaque evaluations. RESULTS: 119 evaluable subjects completed the study. Both the novel power and manual control toothbrushes yielded statistically significant (P < 0.001) mean plaque reductions compared to baseline at Weeks 1 and 4 (except Week 1 manual brush gingival margin) and significant mean MGI and GBI gingivitis reductions (P < 0.001). Comparing the relative effectiveness of the test brushes, the novel multi-directional power brush produced significantly superior anti-gingivitis and anti-plaque reductions compared to pre-treatment relative to the manual control brush in every analysis at both time points. The Week 4 adjusted mean relative reductions favoring the multi-directional power brush were 3 and 1.49 times greater for whole mouth MGI and GBI, respectively (P < 0.001); and were 2.1, 4.7 and 2 times greater for the RMNPI whole mouth, gingival margin and interproximal regions, respectively (P < 0.001). Both toothbrushes were well-tolerated.
Authors: Munirah Yaacob; Helen V Worthington; Scott A Deacon; Chris Deery; A Damien Walmsley; Peter G Robinson; Anne-Marie Glenny Journal: Cochrane Database Syst Rev Date: 2014-06-17