Clinical Effect of a Novel Therapeutic Dentifrice on Endotoxin Reduction

Objectives: Control of bacterial toxin in dental biofilm is important in the treatment and prevention of periodontal diseases. This research evaluated the endotoxin reduction efficacy of a stannous-containing sodium fluoride dentifrice relative to a negative control in a gingivitis treatment model.
Methods: The systemic analysis comprises two independent clinical trials with similar study design and subject entrance criteria. The studies were controlled, double-blind, randomized, 2-treatment, one month gingivitis treatment study. Subjects enrolled were randomized to one of the two dentifrices: 1) Test Dentifrice – a novel Stannous-containing 0.32% Sodium Fluoride dentifrice, and 2) a negative Control 0.32% Sodium Fluoride dentifrice. Dentifrices were used twice daily, 90sec each time. Gingivitis was assessed using standard gingival index and dental plaque was collected from gingival sulcus for lipopolysaccharides (LPS) measures. Treatment was compared using analysis of covariance models with average baseline as the covariate, study as a random effect. Statistical comparisons were two-sided with a significance level of 0.05.
Results: Two hundred and twenty-two adult subjects had evaluable data and were included in the analysis. Mean age was 46 ranging from 21 to 63. Baseline LPS values were balanced between the treatments (p=0.55). After 1-month product use, the Stannous containing test dentifrice provided statistically significant reduction in LPS relative to the negative control dentifrice (P=0.04). The Stannous containing test dentifrice also exhibited significantly better anti-gingivitis efficacy versus the negative control. The dentifrices were well tolerated in the studies.
Conclusions: Use of stannous-containing sodium fluoride dentifrice led to LPS reduction, decreased bacterial toxicity to hosts, and improved gingival health.