Plaque removal and oral health promotion potential for the elmex interX medium toothbrush: clinical efficacy and safety evaluation.

OBJECTIVE This study was designed to assess a newly developed toothbrush for efficacy in plaque removal, reduction of gingivitis and soft tissue bleeding, and retardation of stain formation over 30 days. METHODOLOGY Healthy adult subjects (N = 112) were admitted to the study, and randomly given a test toothbrush, (the elmex interX medium) or the control toothbrush, an ADA-Accepted flat-bristle profile toothbrush. Additionally, the subjects were randomly assigned to be given oral hygiene instruction, or no formal oral hygiene instruction. Examinations and assessments were performed at baseline, 15 and 30 days, and included gingivitis levels, stain levels, bleeding on probing, and plaque levels before and after brushing. RESULTS No significant statistical differences were found between the two toothbrushes on gingivitis, nor on the stain index; however, over the course of the study the gingivitis decreased significantly (p = 0.012) for the test toothbrush group. For the bleeding index, a significant statistical difference (p = 0.027) was found at 30 days favoring the test toothbrush. There was also a significant decrease for the test toothbrush on bleeding over time (p = 0.004). Following overnight plaque formation, the before-brushing plaque levels were significantly different in favor of the test toothbrush at 15 days (p = 0.002), and again at 30 days (p = 0.001). Immediately after brushing, there was a significant statistical difference (p = 0.015) favoring the test toothbrush at 30 days. CONCLUSION These results clearly indicate improved plaque removal and reduction of bleeding and gingivitis for the new elmex interX medium toothbrush compared to the ADA-Accepted control toothbrush.