ANTIPLAQUE AND ANTIGINGIVITIS EFFECTS OF A NOVEL ORAL CARE REGIMEN FEATURING STANNOUS FLUORIDE TOOTHPASTE, A UNIQUE TOOTHBRUSH, AND CETYLPYRIDINIUM CHLORIDE MOUTHWASH: A RANDOMIZED CLINICAL TRIAL

Abstract

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.