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.


METHODS
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.


CONCLUSIONS
These data suggest that P-113 mouthrinse is safe and reduces plaque, gingivitis and gingival bleeding in the human experimental gingivitis model.
Mickels
N
N
Boston University Goldman School of Dental Medicine, MA, USA.
McManus
C
C
Massaro
J
J
Friden
P
P
Braman
V
V
D'Agostino
R
R
Oppenheim
F
F
Warbington
M
M
Dibart
S
S
Van Dyke
T
T
D000328:Adult; D001419:Bacteria / Q000145:classification / Q000187:drug effects; D003773:Dental Plaque / Q000382:microbiology / Q000517:prevention & control; D003774:Dental Plaque Index; D018450:Disease Progression; D004311:Double-Blind Method; D005260:Female; D005884:Gingival Hemorrhage / Q000517:prevention & control; D005891:Gingivitis / Q000517:prevention & control*; D006023:Glycoproteins / Q000008:administration & dosage / Q000627:therapeutic use*; D006639:Histidine / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009067:Mouthwashes / Q000627:therapeutic use*; D010512:Periodontal Index; D010519:Periodontium / Q000382:microbiology; D010919:Placebos; D018713:Prevotella intermedia / Q000187:drug effects; D011506:Proteins / Q000008:administration & dosage / Q000627:therapeutic use*; D012449:Safety; D013223:Statistics as Topic; D000099053:Histidine-Rich Glycoprotein
D006023:Glycoproteins; D009067:Mouthwashes; D010919:Placebos; D011506:Proteins; D000099053:Histidine-Rich Glycoprotein; D006639:Histidine