. Withintreatment comparisons of Month 2 to baseline were also performed using a paired-difference t-test. All comparisons utilized two-sided testing with a significance level of 0.05. Up to 150 subjects were planned to be enrolled in the trial, with 75 subjects per group providing at least 85% power to detect a mean difference between groups for gingival bleeding and inflammation. This estimate assumed an effect size (mean test group difference divided by the standard deviation) of approximately 0.51 or higher using two-sided testing with a 5% significance level, and further allowing for an approximate 5% dropout rate.