title: Clinical and microbial evaluation of a histatin-containing mouthrinse in humans with experimental gingivitis.
abstract: OBJECTIVE
  P-113, a 12 amino acid histatin-based peptide, was evaluated in a mouthrinse formulation for safety, prevention of the development of experimental gingivitis, and for its effects on periodontal flora.
  
  
  METHODS
  159 periodontally healthy subjects abstained from oral hygiene procedures and self-administered either 0.005%, 0.01%, 0.05% P-113 or placebo mouthrinse formulations twice daily over a four week treatment period. During this time, the safety, anti-plaque, and anti-gingivitis effects of P-113 were evaluated.
  
  
  RESULTS
  There was a significant reduction in plaque (p=0.046) and a reduction in gingivitis (p=0.086) for subjects using 0.01% P-113 mouthrinse. Significantly more subjects in the 0.01% and 0.05% treatment groups showed a small increase in plaque index of <0.25 as compared to the placebo group (p<0.05). Similar trends were noted for changes in the % of sites with bleeding on probing in the 0.01% P-113 group. There were no treatment-related adverse events, and there were no adverse shifts in supragingival microflora during the study.
  
  
  CONCLUSIONS
  These data suggest that P-113 mouthrinse is safe and reduces plaque, gingivitis and gingival bleeding in the human experimental gingivitis model.
authors.affiliation: Boston University Goldman School of Dental Medicine, MA, USA.
authors.forename: N
authors.initials: N
authors.lastname: Mickels
authors.forename: C
authors.initials: C
authors.lastname: McManus
authors.forename: J
authors.initials: J
authors.lastname: Massaro
authors.forename: P
authors.initials: P
authors.lastname: Friden
authors.forename: V
authors.initials: V
authors.lastname: Braman
authors.forename: R
authors.initials: R
authors.lastname: D'Agostino
authors.forename: F
authors.initials: F
authors.lastname: Oppenheim
authors.forename: M
authors.initials: M
authors.lastname: Warbington
authors.forename: S
authors.initials: S
authors.lastname: Dibart
authors.forename: T
authors.initials: T
authors.lastname: Van Dyke
mesh_terms: D000328:Adult; D001419:Bacteria / Q000145:classification / Q000187:drug effects; D003773:Dental Plaque / Q000382:microbiology / Q000517:prevention & control; D003774:Dental Plaque Index; D018450:Disease Progression; D004311:Double-Blind Method; D005260:Female; D005884:Gingival Hemorrhage / Q000517:prevention & control; D005891:Gingivitis / Q000517:prevention & control*; D006023:Glycoproteins / Q000008:administration & dosage / Q000627:therapeutic use*; D006639:Histidine / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009067:Mouthwashes / Q000627:therapeutic use*; D010512:Periodontal Index; D010519:Periodontium / Q000382:microbiology; D010919:Placebos; D018713:Prevotella intermedia / Q000187:drug effects; D011506:Proteins / Q000008:administration & dosage / Q000627:therapeutic use*; D012449:Safety; D013223:Statistics as Topic; D000099053:Histidine-Rich Glycoprotein
chemical_list: D006023:Glycoproteins; D009067:Mouthwashes; D010919:Placebos; D011506:Proteins; D000099053:Histidine-Rich Glycoprotein; D006639:Histidine