Effects of an Ascorbic Acid–Derivative Dentifrice in Patients With Gingivitis: A Double-Masked, Randomized, Controlled Clinical Trial

Yoshio Shimabukuro; Yohei Nakayama; Dr. Yorimasa Ogata; Kaoru Tamazawa; Hidetoshi Shimauchi; Tetsuya Nishida; Murakami Yan

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Effects of an Ascorbic Acid–Derivative Dentifrice in Patients With Gingivitis: A Double-Masked, Randomized, Controlled Clinical Trial

Yoshio Shimabukuro ^[1] ; Yohei Nakayama ^[2] ; Yorimasa Ogata ^[2] ; Kaoru Tamazawa ^[3] ; Hidetoshi Shimauchi ^[3] ; Tetsuya Nishida ^[2] ; Murakami ^[1]
1. [1] Osaka University
  
  Osaka University
  
  Kita Ku, Japón
2. [2] Nihon University
  
  Nihon University
  
  Japón
3. [3] Tohoku University
  
  Tohoku University
  
  Aoba-ku, Japón
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Localización: Journal of periodontology, ISSN 0022-3492, Vol. 86, Nº. 1, 2015, págs. 27-35
Idioma: inglés
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Resumen
- 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).