Effects of an ascorbic acid-derivative dentifrice in patients with gingivitis: a double-masked, randomized, controlled clinical trial

J Periodontol. 2015 Jan;86(1):27-35. doi: 10.1902/jop.2014.140138.

Abstract

Background: Reactive oxygen species might be associated with the onset and progression of gingival inflammation. The aim of this study is to investigate the effect of a dentifrice containing L-ascorbic acid 2-phosphate magnesium salt (APM), a long-acting ascorbic acid derivative with antioxidant properties, on gingival inflammation.

Methods: The clinical effects of APM were investigated in a multicenter, randomized, parallel-group, controlled clinical trial comprising 300 individuals with gingivitis. Half of the participants were given an APM-containing dentifrice and half were given a control dentifrice. The primary outcome was the gingival index (GI) at 3 months. Secondary outcomes included gingival redness as an indicator of the degree of local gingival inflammation, gingival bleeding as a measure of the gingivitis severity index, and total antioxidant activity of the saliva.

Results: Under the intent-to-treat analysis, GI did not significantly differ between the groups (P = 0.12). However, under the per-protocol analysis, GI was significantly lower in the APM group (P = 0.01) than in the control group. In the APM group, gingival redness was significantly lower, and the difference from the baseline gingivitis severity index was significantly greater (P = 0.04 and P = 0.02, respectively). The total antioxidant activity of the saliva was significantly higher in the APM group (P = 0.03). The incidence of adverse events did not significantly differ between the groups (P > 0.15).

Conclusion: These findings indicate that the regular application of an APM-containing dentifrice could reduce gingival inflammation.

Trial registration: ClinicalTrials.gov NCT02102295.

Keywords: Antioxidants; controlled clinical trials; dentifrices, ascorbic acid; gingivitis; randomized; reactive oxygen species; saliva.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Antioxidants / analysis
  • Antioxidants / therapeutic use*
  • Ascorbic Acid / analogs & derivatives*
  • Ascorbic Acid / analysis
  • Ascorbic Acid / therapeutic use
  • Dentifrices / therapeutic use*
  • Double-Blind Method
  • Female
  • Follow-Up Studies
  • Gingival Hemorrhage / prevention & control
  • Gingivitis / prevention & control*
  • Humans
  • Intention to Treat Analysis
  • Male
  • Middle Aged
  • Oxidation-Reduction
  • Periodontal Index
  • Safety
  • Saliva / chemistry
  • Treatment Outcome
  • Young Adult

Substances

  • Antioxidants
  • Dentifrices
  • ascorbate-2-phosphate
  • Ascorbic Acid

Associated data

  • ClinicalTrials.gov/NCT02102295