Abstract | OBJECTIVE: P-113, a 12 amino acid histatin-based peptide, was evaluated in a mouthrinse formulation for safety and efficacy in a phase 2 multi-center clinical study. METHOD: 294 healthy subjects abstained from oral hygiene procedures and self-administered either 0.01% P-113, 0.03% P-113 or placebo mouthrinse formulations twice daily over a 4-week treatment period. During this time, the safety, anti- gingivitis, and anti-plaque effects of P-113 were evaluated. RESULTS: There was a significant reduction in the change from baseline to Day 22 in bleeding on probing in the 0.01% P-113 treatment group of the intent to treat population (p=0.049). Non-significant trends in the reduction of the other parameters were observed in this population (p> or =0.159). A sub-group of subjects which developed significant levels of disease within the four-week timeframe of the study was identified based on baseline gingival index scores > or =0.75. Significant findings were observed for bleeding on probing, gingival index and plaque index within this population (p<0.05). There were no treatment-related adverse events, and there were no adverse shifts in supragingival microflora during the study. Significant amounts of the peptide were retained in the oral cavity following rinsing. CONCLUSION: These data suggest that P-113 mouthrinse is safe and reduces the development of gingival bleeding, gingivitis and plaque in the human experimental gingivitis model.
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Authors | Thomas Van Dyke, David Paquette, Sara Grossi, Virginia Braman, Joseph Massaro, Ralph D'Agostino, Serge Dibart, Phillip Friden |
Journal | Journal of clinical periodontology
(J Clin Periodontol)
Vol. 29
Issue 2
Pg. 168-76
(Feb 2002)
ISSN: 0303-6979 [Print] United States |
PMID | 11895545
(Publication Type: Clinical Trial, Clinical Trial, Phase II, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)
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Chemical References |
- DNA, Bacterial
- Glycoproteins
- Mouthwashes
- Placebos
- Proteins
- histidine-rich proteins
- Histidine
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Topics |
- Adult
- Analysis of Variance
- Bacteria
(classification)
- DNA, Bacterial
(analysis)
- Dental Plaque
(microbiology, prevention & control)
- Dental Plaque Index
- Female
- Follow-Up Studies
- Gingival Hemorrhage
(prevention & control)
- Gingivitis
(prevention & control)
- Glycoproteins
(administration & dosage, pharmacokinetics, therapeutic use)
- Histidine
(administration & dosage, pharmacokinetics, therapeutic use)
- Humans
- Male
- Mouth
(metabolism)
- Mouthwashes
(therapeutic use)
- Nucleic Acid Hybridization
- Periodontal Index
- Placebos
- Proteins
(administration & dosage, pharmacokinetics, therapeutic use)
- Safety
- Statistics as Topic
- Treatment Outcome
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