Journal
JOURNAL OF CLINICAL PERIODONTOLOGY
Volume 28, Issue 5, Pages 404-410Publisher
MUNKSGAARD INT PUBL LTD
DOI: 10.1034/j.1600-051x.2001.028005404.x
Keywords
gingivitis; histatin; supragingival plaque; antimicrobial mouthrinse; clinical trial
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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.
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