Method: This was a 6-month, parallel group, examiner-blind, randomized clinical trial. 223 subjects received dental prophylaxis and then entered a 2 month run-in phase, during which they brushed unsupervised with a regular manual toothbrush (ADA) and standard fluoridated dentifrice (Crest® Cavity Protection). At the end of the 2 months, subjects received Volpe Manhold Index (V-MI) calculus examination. 180 qualified subjects who formed a minimum of 7mm of calculus were re-prophied and randomly assigned to one of the two treatments (based on their Screening/2-month run-in V-MI score, gender and age): oscillation-rotation (Oral-B®Professional Care 1000 with Precision Clean brush head - OR) or manual toothbrush (ADA). Subjects brushed unsupervised twice daily with their assigned product for 6 months. V-MI and safety exams were performed at Months 1, 2 and 6. Analysis of covariance (ANCOVA) with treatment as a factor and 2-month run-in V-MI score as the covariate was used to assess treatment differences separately at Months 1, 2 and 6.
Result: Of the 180 subjects who were randomized to treatment, 170 (83 in OR and 87 in ADA group) were evaluable for analyses. 2-month run-in mean V-MI scores were 10.61mm for OR and 11.35mm for the ADA group, and didn’t differ significantly from each other (p=0.244). Month 6 V-MI scores were 8.97mm for OR and 11.02mm for the ADA group and were statistically better for OR group (p=0.002). The mean calculus score for the OR group was also statistically significantly lower in comparison to the ADA group at Month 1 (p<0.001) and Month 2 (p=0.011). Both test products were well tolerated.
Conclusion: The research demonstrated superior anti-calculus efficacy of oscillation-rotation toothbrush relative to the regular manual toothbrush over a 6-month duration.