OBJECTIVE: The objective of this study was to compare the plaque removal efficacy of a prototype manual Deep Clean toothbrush versus an American Dental Association (ADA) manual toothbrush and the ADA manual toothbrush in conjunction with floss. METHODS: This study was a randomized, examiner-blind, six-period cross-over, single-center study conducted in 60 adult subjects that examined plaque removal with a prototype Deep Clean manual toothbrush, an ADA reference manual toothbrush, and an ADA reference manual toothbrush followed by floss. During the course of this study, subjects used each treatment two times. Plaque was scored before and after brushing using the Rustogi Modification of the Navy Plaque Index. A mixed model analysis of covariance (ANCOVA) for a crossover design with baseline plaque score as the covariate was applied to the baseline minus one-minute post-brushing differences in average whole-mouth plaque scores. Supplemental analyses were also performed using the ANCOVA model separately for average gingival margin scores and for average interproximal scores, using the appropriate baseline score as the covariate. All comparisons were two-sided at the 0.05 level of significance. RESULTS: The prototype Deep Clean manual toothbrush delivered an adjusted (via ANCOVA) mean difference between baseline and post-brushing plaque scores of 0.245, while the ADA manual toothbrush plus floss delivered an adjusted mean difference of 0.207 versus 0.196 for the ADA manual toothbrush alone. The prototype Deep Clean manual toothbrush demonstrated a statistically significantly greater reduction in plaque than the ADA manual toothbrush plus floss (p<0.001), which in turn had a statistically significantly greater reduction in plaque than the ADA manual toothbrush alone (p<0.001). The prototype Deep Clean manual toothbrush group had, on average, 25.2% and 18.3% greater plaque removal scores than the ADA manual toothbrush alone and the ADA manual toothbrush plus floss groups, respectively. Results for the interproximal and gingival margin regions also demonstrated statistically significantly (p<0.001) greater plaque removal for the prototype Deep Clean manual toothbrush group relative to the other groups. CONCLUSIONS: The prototype manual Deep Clean toothbrush was found to deliver greater plaque removal by 25.2% and 18.3% compared to the control manual toothbrush group (ADA reference manual toothbrush) and ADA manual toothbrush plus floss group.
RCT Entities:
OBJECTIVE: The objective of this study was to compare the plaque removal efficacy of a prototype manual Deep Clean toothbrush versus an American Dental Association (ADA) manual toothbrush and the ADA manual toothbrush in conjunction with floss. METHODS: This study was a randomized, examiner-blind, six-period cross-over, single-center study conducted in 60 adult subjects that examined plaque removal with a prototype Deep Clean manual toothbrush, an ADA reference manual toothbrush, and an ADA reference manual toothbrush followed by floss. During the course of this study, subjects used each treatment two times. Plaque was scored before and after brushing using the Rustogi Modification of the Navy Plaque Index. A mixed model analysis of covariance (ANCOVA) for a crossover design with baseline plaque score as the covariate was applied to the baseline minus one-minute post-brushing differences in average whole-mouth plaque scores. Supplemental analyses were also performed using the ANCOVA model separately for average gingival margin scores and for average interproximal scores, using the appropriate baseline score as the covariate. All comparisons were two-sided at the 0.05 level of significance. RESULTS: The prototype Deep Clean manual toothbrush delivered an adjusted (via ANCOVA) mean difference between baseline and post-brushing plaque scores of 0.245, while the ADA manual toothbrush plus floss delivered an adjusted mean difference of 0.207 versus 0.196 for the ADA manual toothbrush alone. The prototype Deep Clean manual toothbrush demonstrated a statistically significantly greater reduction in plaque than the ADA manual toothbrush plus floss (p<0.001), which in turn had a statistically significantly greater reduction in plaque than the ADA manual toothbrush alone (p<0.001). The prototype Deep Clean manual toothbrush group had, on average, 25.2% and 18.3% greater plaque removal scores than the ADA manual toothbrush alone and the ADA manual toothbrush plus floss groups, respectively. Results for the interproximal and gingival margin regions also demonstrated statistically significantly (p<0.001) greater plaque removal for the prototype Deep Clean manual toothbrush group relative to the other groups. CONCLUSIONS: The prototype manual Deep Clean toothbrush was found to deliver greater plaque removal by 25.2% and 18.3% compared to the control manual toothbrush group (ADA reference manual toothbrush) and ADA manual toothbrush plus floss group.