A Randomized, Double-blind, Placebo-controlled, Crossover Study to Examine the Effects of Granule-containing Toothpaste in Patients During the Maintenance Period of Periodontal Disease

  • SUGIHARA Naoki
    Tokyo Dental College Department of Epidemiology and Public Health
  • TAKAYANAGI Atsushi
    Tokyo Dental College Department of Epidemiology and Public Health
  • ISHIZUKA Yoichi
    Tokyo Dental College Department of Epidemiology and Public Health
  • SATOU Ryouichi
    Tokyo Dental College Department of Epidemiology and Public Health
  • SUZUKI Seitaro
    Tokyo Dental College Department of Epidemiology and Public Health
  • ONOSE Yuki
    Tokyo Dental College Department of Epidemiology and Public Health
  • IMAI Mitsue
    Tokyo Dental College Department of Epidemiology and Public Health
  • EGUCHI Takako
    Tokyo Dental College Department of Epidemiology and Public Health Tokyo Dental Junior College Department of Dental Hygiene

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Other Title
  • 歯周病メインテナンス期における顆粒配合歯磨剤の効果 ─ 無作為化二重盲検プラセボ対照クロスオーバー比較試験 ─
  • 歯周病メインテナンス期における顆粒配合歯磨剤の効果 : 無作為化二重盲検プラセボ対照クロスオーバー比較試験
  • シシュウビョウ メインテナンスキ ニ オケル カリュウ ハイゴウ ハミガキザイ ノ コウカ : ムサクイカ ニジュウ モウケンプラセボ タイショウ クロスオーバー ヒカク シケン

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Abstract

<p> Background: It has been 30 years since granule-containing toothpaste was first marketed for the purpose of improving the cleaning effects. However, there are few reports of randomized crossover studies on the effects of blending disintegrating granules, and the effects have not been clarified.</p> <p> Objective: The purpose of this study was to evaluate the effects of granule-containing toothpaste on plaque removal and the gingival condition.</p> <p> Method: The subjects were 36 patients who were recalled to five dental clinics in the Tokyo metropolitan area for periodontal disease maintenance and who signed the consent form. One of them lost the third medical checkup form at the dental clinic, one dropped out after the third medical checkup, and the another’s records were lost at the dental clinic. In total, 33 men and women (8 men and 25 women aged 36 to 71 years old) completed all the surveys. The study design was a randomized double-blind cross-over study. Toothpaste containing granules (test dentifrice) and that without granules (control dentifrice) were used for 3 months each with a washout period of 1 month. At the start and end of the use of each toothpaste, a dental examination was performed by the same dentist. The items examined were the current dental status (DMFT), cleaning status (PCR, QHI), gingival status (GI, BOP) pocket depth, presence of residual granules in the gingival sulcus or periodontal pocket, and intraoral photo.</p> <p> Results: The PCR value was 51.7% before use of the test toothpaste and 46.4% after use, and 48.2% before use of the control toothpaste and 50.2% after use. Significant improvement was observed when the test toothpaste was used (p = 0.036) based on comparison using the Wilcoxon-rank test. There was no significant difference in the other values, but after using the test toothpaste, improvements were observed in all examination items. Furthermore, there was no significant difference between the first and second stages (p = 0.929) in the carrying effect in the crossover test based on the Mann-Whitney U test of the PCR value. Only one patient had residual granules in the gingival crevices and periodontal pockets, but no inflammation or deterioration was observed.</p> <p> Conclusion: This study demonstrated that adding granules to toothpaste improves the plaque-removing effects. However, there was no difference in the effects on periodontal tissue on comparison with the control toothpaste.</p>

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