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

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.

• 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)

Chemical References

• Glycoproteins
• Mouthwashes
• Placebos
• Proteins
• histidine-rich proteins
• Histidine

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