title: Assessment of Krillase chewing gum for the reduction of gingivitis and dental plaque.
abstract: OBJECTIVE
  The aim of the study was to evaluate the effect of Krillase chewing gum on gingival inflammation and dental plaque formation. Krillase is a standardized purified extract of proteolytic enzymes, including a synergistic composition of endo- and exopeptidases, isolated from Antarctic krill (Euphausia superba). This clinical study follows a previous laboratory study demonstrating that Krillase disintegrates bacterial surface adhesive proteins and hampers colonization of dental surfaces.
  
  
  METHODS
  Ten healthy male volunteers, aged 21-45 years (average age 22.4 years), chewed for 10 minutes after meals in conjunction with normal oral hygiene measures. The test gums contained either 6.0 or 0.06U of Krillase versus a placebo, and were chewed four times a day during a 10-day test period. Each participant concluded three consecutive trial periods for each gum in a double-blind cross-over design. The severity of gingival bleeding was measured by probing gingival pockets at selected teeth, including first molar and forward in each jaw, initially and after each test period. In parallel, a plaque index was administered to the same patients.
  
  
  RESULTS
  The results demonstrated that a therapeutic dose of 0.06U Krillase in the chewing gum reduced the mean gingival bleeding index by 54% compared to baseline (p < 0.05) and significantly better (p < 0.05) than the placebo reduction of 21% compared to baseline. Also, the mean Simplified Debris Index decreased by 60% from its initial status for the 0.06U Krillase gum (p < 0.05), and 14% as compared to the placebo gum. The high dose (Krillase, 6.0U) did not improve the efficacy. There was no significant statistical difference between the Krillase gums and placebo on the Simplified Debris Index. None of the subjects reported any adverse reactions or events during the trial period. The chewing gum was reported to be neutral in taste.
  
  
  CONCLUSIONS
  This study demonstrated that a process of pathogenic plaque formation is disturbed by Krillase, possibly via disruption of oral biofilm and affecting adhesive properties of the oral bacteria, resulting in a numerical decrease of plaque formation and a significant reduction of gingival bleeding compared to a placebo chewing gum.
authors.affiliation: Specialistkliniken, Stortorget 13 Helsingborg, Sweden. dentique@algonet.se
authors.forename: Kristian
authors.initials: K
authors.lastname: Hellgren
mesh_terms: D000328:Adult; D018441:Biofilms / Q000187:drug effects; D002638:Chewing Gum; D003773:Dental Plaque / Q000517:prevention & control*; D003774:Dental Plaque Index; D005891:Gingivitis / Q000517:prevention & control*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010512:Periodontal Index; D012697:Serine Endopeptidases / Q000494:pharmacology*; D018709:Statistics, Nonparametric; D016896:Treatment Outcome
chemical_list: D002638:Chewing Gum; D012697:Serine Endopeptidases; C409227:euphauserase