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.
RCT Entities:
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 humanexperimental gingivitis model.
Authors: D M Rothstein; P Spacciapoli; L T Tran; T Xu; F D Roberts; M Dalla Serra; D K Buxton; F G Oppenheim; P Friden Journal: Antimicrob Agents Chemother Date: 2001-05 Impact factor: 5.191
Authors: Yong Pyo Shin; Ho Jin Park; Seo Hwa Shin; Young Shin Lee; Seungmi Park; Sungho Jo; Yong Ho Lee; In Hee Lee Journal: Antimicrob Agents Chemother Date: 2010-04-12 Impact factor: 5.191
Authors: U S Sajjan; L T Tran; N Sole; C Rovaldi; A Akiyama; P M Friden; J F Forstner; D M Rothstein Journal: Antimicrob Agents Chemother Date: 2001-12 Impact factor: 5.191