Method: A total of 50 adults with mild-to-moderate gingival bleeding were randomly assigned to combination oral hygiene or a dental prophylaxis. The combination group received a flexible crisscross manual brush (Oral-B® Pro-Health Clinical Pro-flex), 0.454% stannous fluoride paste (Crest® Pro-Health Clinical Plaque Control), 0.1% cetylpyridinium chloride rinse (Crest® Pro-Health Clinical), and floss (Oral-B® Glide), while the control group received a dental prophylaxis, regular anticavity paste and standard manual brush. Test products were dispensed in blinded kits, usage was unsupervised at-home, and whole mouth gingivitis was measured by a treatment-blinded examiner to quantify change in bleeding sites after 7 days.
Result: The diverse general population had a mean (SD) age of 27.8 (8.3) years. At baseline, gingival bleeding was mild-to-moderate, with a mean (SD) 8.2 (5.1) sites, and an upper limit of 26 sites. A total of 48 subjects completed week 1 (24 per group). Relative to baseline, both the combination group and the prophylaxis control exhibited significant (p<0.0001) reductions in bleeding sites at 1-week. Comparing treatments, the adjusted bleeding site means (SE) were 2.4 (0.35) and 4.2 in the combination group and prophylaxis control, respectively. Groups differed significantly (p=0.0008) on bleeding sites after 1-week, favoring the combination group. There was one adverse event (oral irritation in the combination group), and all treatment was well-tolerated.
Conclusion: Use of combination daily oral hygiene regimen with an advanced manual brush, therapeutic paste and rinse plus floss resulted in a highly significant 43% greater incremental reduction in gingival bleeding than dental prophylaxis.