Background: Antibacterial ingredients for oral care products are typically measured through single product forms. This study assessed the overall health outcome of using multiple forms: a stabilized stannous fluoride toothpaste, an enhanced cetylpyridinium chloride mouthwash and a unique toothbrush to deliver antibacterial performance.
Methods: A 12-week, single-center, phase III, masked, 2-arm, parallel-group, randomized controlled trial was conducted to assess the reduction of established dental plaque and gingivitis with a novel antibacterial oral regimen comprised of 0.454% stannous fluoride toothpaste stabilized with nitrate and phosphates, 0.075% cetylpyridinium chloride and 0.28% zinc lactate mouthwash, and rapid foaming manual toothbrush compared to a nonantibacterial commercially available regimen of toothpaste containing 0.76% sodium monofluorophosphate, no mouthwash, and commercially available manual toothbrush to represent standard toothbrushing practices.
Results: Adherence to this novel oral care regimen provided significant reduction in plaque and gingivitis compared to the control starting at 1 week (P < .01) and continuing over 12 weeks (P < .001) across all plaque and gingival score indices. At week 1, participants in the Antibacterial Regimen Group showed 15 times more plaque reduction than control (P < .001). After 3 weeks of regimen adherence, 100% of Antibacterial Regimen participants had improved gingival index scores compared to baseline.
Conclusions: Within the limitations of the study, the results showed statistically significantly reduced gingival inflammation and improved plaque control from 1 week continuing through 12 weeks of adherence to this novel oral care regimen compared to standard toothbrushing practices.
Keywords: Cetylpyridinium chloride; Gingivitis; Oral care; Plaque; Stannous fluoride.
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