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

J Evid Based Dent Pract. 2025 Jun;25(2):102123. doi: 10.1016/j.jebdp.2025.102123. Epub 2025 Feb 12.

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.

Keywords: Cetylpyridinium chloride; Gingivitis; Oral care; Plaque; Stannous fluoride.

Publication types

  • Randomized Controlled Trial
  • Clinical Trial, Phase III

MeSH terms

  • Adult
  • Anti-Infective Agents, Local* / therapeutic use
  • Cetylpyridinium* / administration & dosage
  • Cetylpyridinium* / therapeutic use
  • Dental Plaque* / prevention & control
  • Female
  • Gingivitis* / prevention & control
  • Humans
  • Male
  • Middle Aged
  • Mouthwashes* / therapeutic use
  • Tin Fluorides* / therapeutic use
  • Toothbrushing* / instrumentation
  • Toothbrushing* / methods
  • Toothpastes* / therapeutic use

Substances

  • Cetylpyridinium
  • Mouthwashes
  • Toothpastes
  • Tin Fluorides
  • Anti-Infective Agents, Local