Anti-plaque Efficacy of an Oral Hygiene Regimen Using DPIA

Objectives: This clinical study was conducted to compare the anti-plaque efficacy of an oral hygiene regimen versus a negative control using Digital Plague Image Analysis (DPIA) over 4-week treatment duration.
Methods: This was a randomized, parallel group, examiner-blind, 4-week clinical trial. Thirty-six healthy adult subjects who met study entrance criteria were enrolled into the study. Following one week of acclimation period, subjects were randomized to one of two treatment groups: (1) regimen of antimicrobial dentifrice (stabilized stannous-containing sodium fluoride toothpaste – China Crest Pro-Health® 7 complete) plus antimicrobial rinse (0.747% CPC mouth rinse – Crest® Pro-Health rinse) and Cross-action toothbrush (Pro-Health toothbrush) or (2) negative control: regular manual brush (Crest Indicator P35) plus regular fluoridated toothpaste (0.243% sodium fluoride - Crest Cavity Protection). Subjects used the oral hygiene regimen following manufacturer’s usage instruction. Overnight plaque accumulation was disclosed with fluorescein, and digital image analysis was used to measure plaque area (% coverage) on the anterior facial tooth surfaces at Baseline, Weeks 2 and 4. Between-group comparisons were conducted using analysis of covariance with baseline plaque level as the covariate. All comparisons were two-sided with a significance level of 0.05.
Results: Thirty-five (35) subjects completed the study. The two groups were well balanced on age and gender (P>0.473). Baseline plaque levels were also balanced between the two groups (p=0.825). At Weeks 2 and 4, the regimen group exhibited statistically significant (p<0.0001) lower mean overnight pre-brushing plaque coverage versus the negative control group by 72.37% and 76.75%, respectively. All test products were well tolerated.
Conclusions: The research demonstrated superior anti-plaque efficacy of the regimen relative to the negative control.