N. Mickels et al., Clinical and microbial evaluation of a histatin-containing mouthrinse in humans with experimental gingivitis, J CLIN PER, 28(5), 2001, pp. 404-410
Objective: P-113, a 12 amino acid histatin-based peptide, was evaluated in
a mouthrinse formulation for safety prevention of the development of experi
mental gingivitis, and for its effects on periodontal flora.
Method: 159 periodontally healthy subjects abstained from oral hygiene proc
edures and self-administered either 0.005%, 0.01%, 0.05% P-113 or placebo m
outhrinse formulations twice daily over a four week treatment period. Durin
g 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 redu
ction 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 bl
eeding on probing in the 0.01% P-113 group. There were no treatment-related
adverse events, and there were no adverse shifts in supragingival microflo
ra during the study.
Conclusion: These data suggest that P-113 mouthrinse is safe and reduces pl
aque, gingivitis and gingival bleeding in the human experimental gingivitis
model.