IADR Abstract Archives
Effectiveness and Safety of SnF2/H2O2 Daily Hygiene: Inclusive Clinical Meta-Analysis
Objectives: This research systematically evaluated the clinical trials safety and effectiveness evidence for a two-step stannous fluoride plus hydrogen peroxide daily oral hygiene sequence.
Methods: An inclusive meta-analysis was conducted of 20 prospective parallel design clinical trials where one group was assigned sequential brushing with a 0.454% stannous fluoride dentifrice followed by a 3% hydrogen peroxide gel (Crest® Pro-Health [HD]™) for at least one-week duration. The diverse research included both supervised and unsupervised product use for periods of 7-360 days among general and specialized populations, with efficacy measured using clinical and/or instrumental methods. While the trials used different controls, methods and examiners, safety was measured consistently as adverse events from clinical examination/report collected blind to treatment. Pooled safety responses were compared 2-sided to negative and positive controls at 5% significance levels.
Results: The pooled sample included 1085 subjects (18-80 years), 56% with the sequence, 23% with negative (regular paste) controls, and 21% with various positive controls. For efficacy, integrated analysis demonstrated significant (p<0.05) improvements in plaque, gingival bleeding and sensitivity, with similar improvements in malodor, calculus and stain for the two-step sequence. For safety, there were a total of 82 adverse events, with minor oral irritation being the most common finding. These findings were noted for 9%, 2% and 10% of subjects in the sequence, negative and positive controls, respectively, with the sequence and positive control categories differing significantly (p<0.05) from negative control on occurrence. There were no serious or severe adverse events, treatment duration did not contribute to occurrence, and categories did not differ on adverse event severity.
Conclusions: An inclusive meta-analysis (all studies and subjects) provides robust and consistent evidence of effectiveness for a stannous fluoride + hydrogen peroxide brushing sequence without meaningful adverse events.
Methods: An inclusive meta-analysis was conducted of 20 prospective parallel design clinical trials where one group was assigned sequential brushing with a 0.454% stannous fluoride dentifrice followed by a 3% hydrogen peroxide gel (Crest® Pro-Health [HD]™) for at least one-week duration. The diverse research included both supervised and unsupervised product use for periods of 7-360 days among general and specialized populations, with efficacy measured using clinical and/or instrumental methods. While the trials used different controls, methods and examiners, safety was measured consistently as adverse events from clinical examination/report collected blind to treatment. Pooled safety responses were compared 2-sided to negative and positive controls at 5% significance levels.
Results: The pooled sample included 1085 subjects (18-80 years), 56% with the sequence, 23% with negative (regular paste) controls, and 21% with various positive controls. For efficacy, integrated analysis demonstrated significant (p<0.05) improvements in plaque, gingival bleeding and sensitivity, with similar improvements in malodor, calculus and stain for the two-step sequence. For safety, there were a total of 82 adverse events, with minor oral irritation being the most common finding. These findings were noted for 9%, 2% and 10% of subjects in the sequence, negative and positive controls, respectively, with the sequence and positive control categories differing significantly (p<0.05) from negative control on occurrence. There were no serious or severe adverse events, treatment duration did not contribute to occurrence, and categories did not differ on adverse event severity.
Conclusions: An inclusive meta-analysis (all studies and subjects) provides robust and consistent evidence of effectiveness for a stannous fluoride + hydrogen peroxide brushing sequence without meaningful adverse events.