title: Effects of an ascorbic acid-derivative dentifrice in patients with gingivitis: a double-masked, randomized, controlled clinical trial.
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).
  
  
  CONCLUSIONS
  These findings indicate that the regular application of an APM-containing dentifrice could reduce gingival inflammation.
authors.affiliation: Department of Periodontology, Osaka University Graduate School of Dentistry, Suita, Japan.
authors.forename: Yoshio
authors.initials: Y
authors.lastname: Shimabukuro
authors.forename: Yohei
authors.initials: Y
authors.lastname: Nakayama
authors.forename: Yorimasa
authors.initials: Y
authors.lastname: Ogata
authors.forename: Kaoru
authors.initials: K
authors.lastname: Tamazawa
authors.forename: Hidetoshi
authors.initials: H
authors.lastname: Shimauchi
authors.forename: Tetsuya
authors.initials: T
authors.lastname: Nishida
authors.forename: Koichi
authors.initials: K
authors.lastname: Ito
authors.forename: Takashi
authors.initials: T
authors.lastname: Chikazawa
authors.forename: Shinsuke
authors.initials: S
authors.lastname: Kataoka
authors.forename: Shinya
authors.initials: S
authors.lastname: Murakami
mesh_terms: D000328:Adult; D000975:Antioxidants / Q000032:analysis / Q000627:therapeutic use*; D001205:Ascorbic Acid / Q000031:analogs & derivatives* / Q000032:analysis / Q000627:therapeutic use; D003802:Dentifrices / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D005884:Gingival Hemorrhage / Q000517:prevention & control; D005891:Gingivitis / Q000517:prevention & control*; D006801:Humans; D057194:Intention to Treat Analysis; D008297:Male; D008875:Middle Aged; D010084:Oxidation-Reduction; D010512:Periodontal Index; D012449:Safety; D012463:Saliva / Q000737:chemistry; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000975:Antioxidants; D003802:Dentifrices; C011669:ascorbate-2-phosphate; D001205:Ascorbic Acid
keywords: Antioxidants; controlled clinical trials; dentifrices, ascorbic acid; gingivitis; randomized; reactive oxygen species; saliva