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

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