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document
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 < 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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Intervention_Pharmacological
histatin-containing mouthrinse
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Intervention_Pharmacological
P-113 , a 12 amino acid histatin-based peptide
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Intervention_Pharmacological
mouthrinse formulation
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Intervention_Pharmacological
self-administered either 0.005 % , 0.01 % , 0.05 % P-113
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Intervention_Control
placebo
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Intervention_Pharmacological
P-113 mouthrinse
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Intervention_Pharmacological
P-113
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Intervention_Pharmacological
P-113 mouthrinse
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Outcome_Physical
safety , anti-plaque , and anti-gingivitis effects
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Outcome_Physical
plaque
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Outcome_Physical
reduction in gingivitis
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Outcome_Physical
plaque
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Outcome_Physical
bleeding on probing
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Outcome_Adverse-effects
adverse events
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Outcome_Physical
shifts in supragingival microflora
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Outcome_Physical
plaque , gingivitis and gingival bleeding