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Clinical and microbial evaluation of a histatin‐containing mouthrinse in humans with experimental gingivitis

2001; Wiley; Volume: 28; Issue: 5 Linguagem: Inglês

10.1034/j.1600-051x.2001.028005404.x

1600-051X

Nancy Mickels, Colleen McManus, Joseph M. Massaro, Phillip Friden, Virginia Braman, Ralph B. D’Agostino, Frank G. Oppenheim, Martha L. Warbington, Serge Dibart, Thomas E. Van Dyke,

Peptidase Inhibition and Analysis

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. Method: 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. Conclusion: These data suggest that P‐113 mouthrinse is safe and reduces plaque, gingivitis and gingival bleeding in the human experimental gingivitis model.