Abstract | 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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Authors | N Mickels, C McManus, J Massaro, P Friden, V Braman, R D'Agostino, F Oppenheim, M Warbington, S Dibart, T Van Dyke |
Journal | Journal of clinical periodontology
(J Clin Periodontol)
Vol. 28
Issue 5
Pg. 404-10
(May 2001)
ISSN: 0303-6979 [Print] United States |
PMID | 11350502
(Publication Type: Clinical Trial, Comparative Study, Journal Article, Randomized Controlled Trial)
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Chemical References |
- Glycoproteins
- Mouthwashes
- Placebos
- Proteins
- histidine-rich proteins
- Histidine
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Topics |
- Adult
- Bacteria
(classification, drug effects)
- Dental Plaque
(microbiology, prevention & control)
- Dental Plaque Index
- Disease Progression
- Double-Blind Method
- Female
- Gingival Hemorrhage
(prevention & control)
- Gingivitis
(prevention & control)
- Glycoproteins
(administration & dosage, therapeutic use)
- Histidine
(administration & dosage, therapeutic use)
- Humans
- Male
- Middle Aged
- Mouthwashes
(therapeutic use)
- Periodontal Index
- Periodontium
(microbiology)
- Placebos
- Prevotella intermedia
(drug effects)
- Proteins
(administration & dosage, therapeutic use)
- Safety
- Statistics as Topic
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