Initial evidence of two-step dentifrice/gel sequence effects on health: Outcomes from three randomized controlled trials.

PURPOSE: Health-related outcomes from three randomized controlled trials represented the initial research on the feasibility of novel, sequential oral hygiene with a stannous fluoride (SnF₂) dentifrice then hydrogen peroxide (H₂O₂) whitening gel. METHODS: One crossover and two parallel clinical trials were conducted independently. Objectives varied, with individual studies assessing short, intermediate or longer-term outcomes from breath, dental plaque or gingivitis, respectively. Treatments were randomly assigned, and blinded test kits were dispensed containing either: 1) a two-step 0.454% SnF₂ dentifrice and then a 3% H₂O₂ whitening gel sequence and instructions specifying 1+1 minute sequential brushing (experimental); or 2) 0.76% sodium monofluorophosphate dentifrice (Colgate Cavity Protection) and instructions for twice daily use (control). Standard methods were used to measure efficacy (volatile sulfur compounds, plaque area coverage or gingival bleeding) and safety (clinical examination and interview), and to compare treatment responses. RESULTS: Overall, 165 subjects participated in the three trials. Relative to baseline, only the experimental group exhibited significant (P< 0.05) improvements at initial and subsequent timepoints in each trial. Between-group comparisons showed significant (P< 0.05) 30-45% reductions in breath malodor (VSC), plaque (area%) and gingivitis (bleeding sites) favoring the experimental group. Adverse event occurrences were infrequent, mild in severity, and unrelated to dropout. CLINICAL SIGNIFICANCE: Important health-related outcomes from three initial clinical trials established the feasibility of sequential brushing with a two-step 0.454% SnF₂ dentifrice and then a 3% H₂O₂ whitening gel.