title: Effects of new over-the-counter periodontal ointment-containing applicator with single-tuft brush on cytokine levels in gingival crevicular fluid during supportive periodontal therapy phase: a randomized double-blind clinical trial.
abstract: OBJECTIVE
  The biochemical effects of an over-the-counter (OTC) medication were studied, which consists of a single-tuft brush containing cetylpyridinium chloride as a bactericidal agent, dipotassium glycyrrhizate as an anti-inflammatory drug and allantoin as a promoter of cell proliferation and wound healing, for delivery to hardly brushed sites.
  
  
  METHODS
  This randomized controlled double-blind study was performed in 61 subjects with chronic periodontitis in supportive periodontal therapy phase (test group: n = 27; placebo group: n = 28; dropout: n = 6). The OTC medication was self-applied twice a day for 12 wk to two molars with probing pocket depths of 4-6 mm. Biochemical indicators were evaluated at baseline and 12 wk using the suspension array system for eight cytokines and chemokines (interleukin [IL]-1β, IL-1ra, IL-4, IL-6, IL-8, IL-10, monocyte chemoattractant protein-1 and tumor necrosis factor [TNF]-α) in gingival crevicular fluid.
  
  
  RESULTS
  The levels of IL-1β, IL-6, IL-8 and TNF-α remained significantly lower in the test group compared to the placebo group. In the placebo group, when the probing pocket depth at baseline was 4 mm, IL-1β increased, particularly in the second molar tooth, and the greatest increase was seen when PPD at baseline was 5-6 mm. In the test group, IL-1β decreased markedly in cases with furcation involvement and low bleeding on probing at baseline. In both groups, IL-1β, IL-6 and TNF-α were closely correlated with each other.
  
  
  CONCLUSIONS
  This OTC medication is biochemically effective for steady chronic periodontitis in the supportive periodontal therapy phase.
authors.affiliation: Department of Pathophysiology-Periodontal Science, Dentistry and Pharmaceutical Sciences, Okayama University Graduate School of Medicine, Okayama, Japan.
authors.forename: K
authors.initials: K
authors.lastname: Takeuchi-Hatanaka
authors.affiliation: R&D Department of Sunstar Inc., Takatsuki, Osaka, Japan.
authors.forename: T
authors.initials: T
authors.lastname: Yasuda
authors.affiliation: Department of Pathophysiology-Periodontal Science, Dentistry and Pharmaceutical Sciences, Okayama University Graduate School of Medicine, Okayama, Japan.
authors.forename: K
authors.initials: K
authors.lastname: Naruishi
authors.affiliation: Department of Pathophysiology-Periodontal Science, Dentistry and Pharmaceutical Sciences, Okayama University Graduate School of Medicine, Okayama, Japan.|Department of Dentistry, National Sanatorium Oshima-Seishoen, Takamatsu, Kagawa, Japan.
authors.forename: K
authors.initials: K
authors.lastname: Katsuragi-Fuke
authors.affiliation: R&D Department of Sunstar Inc., Takatsuki, Osaka, Japan.
authors.forename: J
authors.initials: J
authors.lastname: Inubushi
authors.affiliation: R&D Department of Sunstar Inc., Takatsuki, Osaka, Japan.
authors.forename: H
authors.initials: H
authors.lastname: Ootsuki
authors.affiliation: Department of Pathophysiology-Periodontal Science, Dentistry and Pharmaceutical Sciences, Okayama University Graduate School of Medicine, Okayama, Japan.
authors.forename: H
authors.initials: H
authors.lastname: Maeda
authors.affiliation: Department of Pathophysiology-Periodontal Science, Dentistry and Pharmaceutical Sciences, Okayama University Graduate School of Medicine, Okayama, Japan.
authors.forename: S
authors.initials: S
authors.lastname: Takashiba
mesh_terms: D000368:Aged; D000481:Allantoin / Q000627:therapeutic use; D002594:Cetylpyridinium / Q000627:therapeutic use; D018932:Chemokine CCL2 / Q000032:analysis; D018925:Chemokines / Q000032:analysis / Q000187:drug effects*; D055113:Chronic Periodontitis / Q000188:drug therapy*; D016207:Cytokines / Q000032:analysis / Q000187:drug effects*; D003774:Dental Plaque Index; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005883:Gingival Crevicular Fluid / Q000187:drug effects*; D019695:Glycyrrhizic Acid / Q000627:therapeutic use; D006801:Humans; D053590:Interleukin 1 Receptor Antagonist Protein / Q000032:analysis; D016753:Interleukin-10 / Q000032:analysis; D053583:Interleukin-1beta / Q000032:analysis; D015847:Interleukin-4 / Q000032:analysis; D015850:Interleukin-6 / Q000032:analysis; D016209:Interleukin-8 / Q000032:analysis; D007564:Japan; D008297:Male; D008875:Middle Aged; D004366:Nonprescription Drugs / Q000627:therapeutic use*; D009823:Ointment Bases / Q000627:therapeutic use*; D017622:Periodontal Attachment Loss; D010512:Periodontal Index; D014099:Toothbrushing / Q000295:instrumentation; D014409:Tumor Necrosis Factor-alpha / Q000032:analysis
chemical_list: C111835:CCL2 protein, human; D018932:Chemokine CCL2; D018925:Chemokines; D016207:Cytokines; C508609:IL10 protein, human; D053590:Interleukin 1 Receptor Antagonist Protein; D053583:Interleukin-1beta; D015850:Interleukin-6; D016209:Interleukin-8; D004366:Nonprescription Drugs; D009823:Ointment Bases; D014409:Tumor Necrosis Factor-alpha; D016753:Interleukin-10; D015847:Interleukin-4; D000481:Allantoin; D019695:Glycyrrhizic Acid; D002594:Cetylpyridinium
keywords: inflammatory cytokine; over-the-counter medication; self-medication; supportive periodontal therapy