IADR Abstract Archives
Clinical Effects of Stannous-Fluoride Hexametaphosphate Dentifrice on Subgingival Plaque Virulence.
Objectives: Antimicrobial toothpastes and mouthrinses are known to provide benefits in reduction of gingivitis – usually ascribed to more-or-less generic antiplaque actions. This clinical study was conducted to assess the effect of antigingivitis SnF2 dentifrice on toxicity of plaque over a 4-week period in population cohorts with high/low incidence of BOP.
Methods: This was a parallel, randomized, controlled, examiner-blind, clinical trial. Two groups (n=20 each) of subjects were included at Screening: a “high bleeding susceptibility group” (HB) (20+ bleeding sites) and a “low bleeding susceptibility group” (LB) (< 3 bleeding sites) with no pockets greater than 2mm deep. Gingivitis was evaluated using (Gingival Bleeding Index) and Modified Gingival Index (MGI). Both groups received 0.454% stannous fluoride - Crest Pro-Health® Clinical Gum Protection dentifrice and a regular manual brush (Oral-B Indicator P35) for 4 weeks ad lib home use. At Baseline and 2/4 weeks, sub-gingival plaque from both bleeding and non-bleeding sites was collected and analyzed for toxicity using an ex-vivo toll-receptor TLR4 assay. Statistical analyses utilized analysis of covariance.
Results: At Week 4 both groups demonstrated statistically significant (p≤0.0017) reductions in GBI and MGI. Reductions in the # of bleeding sites at Week 4 were 46.5% for the HB group and 52.8% for the LB group. In addition, both groups demonstrated significant reductions in plaque toxicity (via TLR4 assay activation) at both Weeks 2 and 4 (p<0.0307). The LB group exhibited significantly lower (p≤0.0101) plaque toxicity at each of the timepoints relative to the HB group.
Conclusions: This is the first evidence we know of showing antimicrobial dentifrice producing toxicity changes in plaque in the sulcus directly associated with gingivitis progression. Assessments of therapeutic effects on plaque virulence may represent the future for guidance on development and proof of effectiveness of new antimicrobial therapies.
Methods: This was a parallel, randomized, controlled, examiner-blind, clinical trial. Two groups (n=20 each) of subjects were included at Screening: a “high bleeding susceptibility group” (HB) (20+ bleeding sites) and a “low bleeding susceptibility group” (LB) (< 3 bleeding sites) with no pockets greater than 2mm deep. Gingivitis was evaluated using (Gingival Bleeding Index) and Modified Gingival Index (MGI). Both groups received 0.454% stannous fluoride - Crest Pro-Health® Clinical Gum Protection dentifrice and a regular manual brush (Oral-B Indicator P35) for 4 weeks ad lib home use. At Baseline and 2/4 weeks, sub-gingival plaque from both bleeding and non-bleeding sites was collected and analyzed for toxicity using an ex-vivo toll-receptor TLR4 assay. Statistical analyses utilized analysis of covariance.
Results: At Week 4 both groups demonstrated statistically significant (p≤0.0017) reductions in GBI and MGI. Reductions in the # of bleeding sites at Week 4 were 46.5% for the HB group and 52.8% for the LB group. In addition, both groups demonstrated significant reductions in plaque toxicity (via TLR4 assay activation) at both Weeks 2 and 4 (p<0.0307). The LB group exhibited significantly lower (p≤0.0101) plaque toxicity at each of the timepoints relative to the HB group.
Conclusions: This is the first evidence we know of showing antimicrobial dentifrice producing toxicity changes in plaque in the sulcus directly associated with gingivitis progression. Assessments of therapeutic effects on plaque virulence may represent the future for guidance on development and proof of effectiveness of new antimicrobial therapies.