IADR Abstract Archives
Randomized Controlled Trial Evaluating Oral Health Effects of Two-Step Hygiene
Objectives: A randomized controlled trial evaluated the safety and effectiveness of two-step daily oral hygiene using stannous fluoride followed by hydrogen peroxide.
Methods: After IRB approval and informed consent, baseline measurements were obtained, and eligible adults with plaque and gingivitis were randomized equally to a daily oral hygiene using an experimental two-step 0.454% SnF2 then 3% H2O2 paste/polish sequence or regular 0.76% NaMFP dentifrice, which served as the negative control. All test products were over-labeled and dispensed in a blinded kit along with a flat manual brush and instructions for home use over an 11-week period. Visits included baseline, product assignment, Week 5 and Week 11. Clinical evaluations at each visit included an intraoral examination for safety, whole mouth Loe-Silness gingivitis quantified as bleeding sites, and whole mouth disclosed plaque (Turesky).
Results: 101 subjects were screened, 91 were randomly assigned treatment, and 84 completed the study. Subjects ranged in age from 20-78 years (mean = 33.4), 76% were female. Groups were balanced (p>0.60) on demographics and exhibited approximately 12.5 bleeding sites overall. At Week 5, ANCOVA adjusted bleeding site means (SE) were 5.5 (1.3) and 9.7 (1.2) for the experimental and control groups, respectively. Outcomes were similar at Week 11, with adjusted means (SE) of 6.4 (1.3) for the two-step hygiene compared to 11.1 (1.2) for the regular control. Groups differed significantly on bleeding at Week 5 (p=0.018) and Week 11 (p=0.009). Plaque response was generally similar, one subject (in the control group) had clinical oral irritation, and no subjects discontinued treatment “for cause”.
Conclusions: Daily use of two-step stannous fluoride then hydrogen peroxide for oral hygiene yielded approximately 43% less gingival bleeding over an 11-week period compared to routine care.
Methods: After IRB approval and informed consent, baseline measurements were obtained, and eligible adults with plaque and gingivitis were randomized equally to a daily oral hygiene using an experimental two-step 0.454% SnF2 then 3% H2O2 paste/polish sequence or regular 0.76% NaMFP dentifrice, which served as the negative control. All test products were over-labeled and dispensed in a blinded kit along with a flat manual brush and instructions for home use over an 11-week period. Visits included baseline, product assignment, Week 5 and Week 11. Clinical evaluations at each visit included an intraoral examination for safety, whole mouth Loe-Silness gingivitis quantified as bleeding sites, and whole mouth disclosed plaque (Turesky).
Results: 101 subjects were screened, 91 were randomly assigned treatment, and 84 completed the study. Subjects ranged in age from 20-78 years (mean = 33.4), 76% were female. Groups were balanced (p>0.60) on demographics and exhibited approximately 12.5 bleeding sites overall. At Week 5, ANCOVA adjusted bleeding site means (SE) were 5.5 (1.3) and 9.7 (1.2) for the experimental and control groups, respectively. Outcomes were similar at Week 11, with adjusted means (SE) of 6.4 (1.3) for the two-step hygiene compared to 11.1 (1.2) for the regular control. Groups differed significantly on bleeding at Week 5 (p=0.018) and Week 11 (p=0.009). Plaque response was generally similar, one subject (in the control group) had clinical oral irritation, and no subjects discontinued treatment “for cause”.
Conclusions: Daily use of two-step stannous fluoride then hydrogen peroxide for oral hygiene yielded approximately 43% less gingival bleeding over an 11-week period compared to routine care.