Effects of Two Therapeutic Dentifrices on Plaque Regrowth

Objectives: This research evaluated the plaque regrowth efficacy of a stannous-containing sodium fluoride dentifrice relative to a marketed positive control in a 4-day plaque model.
Methods: This was a controlled, double-blind, randomized, 2-treatment, 4-period, cross-over 4-day partial brushing design. Thirty-two subjects completed an acclimation period and were randomized to a treatment sequence consisting of the following two products: 1) Test Product – stannous-containing 0.32% Sodium Fluoride dentifrice, Crest/Oral-B Pro-Salud Advanced and 2) a Positive Control - triclosan-containing 0.32% Sodium Fluoride dentifrice, Colgate Total 12. Subjects received a dental prophylaxis prior to study initiation. Treatment periods were separated by wash-out periods of 7 days. Subjects used a regular cavity protection toothpaste during wash-out and acclimation. In each treatment period, overnight plaque was assessed by a qualified dental examiner at Baseline and Day 4 by Turesky-modified Quigley Hein index (TMQH), and teeth were polished following the Baseline TMQH exam. Subjects brushed their lingual surfaces for 30 seconds with the assigned product and then swished with the slurry for 60 seconds. Plaque scores were analyzed using a general linear mixed model; baseline was used as a covariate. Statistical comparisons were two-sided with a significance level of 0.05.
Results: Mean age was 48.3 ranging from 24 to 62, and 53% of subjects were male. There were no significant differences in the mean whole mouth Baseline TMQH scores between treatments (p > 0.08). At Day 4, the Test Dentifrice demonstrated significantly (p < 0.0001) lower overnight TMQH scores relative to the Positive Control with the corresponding TMQH values of 1.232 and 1.391, respectively. Most Adverse Events were mild in nature, and no subject discontinued treatment due to an Adverse Event.
Conclusions: Use of stannous-containing sodium fluoride dentifrice resulted in greater overnight plaque control when compared to a triclosan-containing sodium fluoride dentifrice in this 4-Day plaque model.