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Evaluation clinique et microbiologique d'un bain de bouche contenant de l'histatine chez des adultes avec gingivite expérimentale: une étude multicentrique phase 2
Author(s) -
Van Dyke Thomas,
Paquette David,
Grossi Sara,
Braman Virginia,
Massaro Joseph,
D'Agostino Ralph,
Dibart Serge,
Friden Phillip
Publication year - 2002
Publication title -
journal of clinical periodontology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.456
H-Index - 151
eISSN - 1600-051X
pISSN - 0303-6979
DOI - 10.1034/j.1600-051x.2002.290212.x
Subject(s) - gingivitis , medicine , placebo , oral hygiene , dentistry , adverse effect , population , clinical trial , population study , bleeding on probing , periodontal disease , pathology , alternative medicine , environmental health
Objective: P‐113, a 12 amino acid histatin‐based peptide, was evaluated in a mouthrinse formulation for safety and efficacy in a phase 2 multi‐center clinical study. Method: 294 healthy subjects abstained from oral hygiene procedures and self‐administered either 0.01% P‐113, 0.03% P‐113 or placebo mouthrinse formulations twice daily over a 4‐week treatment period. During this time, the safety, anti‐gingivitis, and anti‐plaque effects of P‐113 were evaluated. Results: There was a significant reduction in the change from baseline to Day 22 in bleeding on probing in the 0.01% P‐113 treatment group of the intent to treat population ( p =0.049). Non‐significant trends in the reduction of the other parameters were observed in this population ( p 0.159). A sub‐group of subjects which developed significant levels of disease within the four‐week timeframe of the study was identified based on baseline gingival index scores 0.75. Significant findings were observed for bleeding on probing, gingival index and plaque index within this population ( p <0.05). There were no treatment‐related adverse events, and there were no adverse shifts in supragingival microflora during the study. Significant amounts of the peptide were retained in the oral cavity following rinsing. Conclusion: These data suggest that P‐113 mouthrinse is safe and reduces the development of gingival bleeding, gingivitis and plaque in the human experimental gingivitis model.