Plaque regrowth effects of a triclosan/pyrophosphate dentifrice in a 4-day non-brushing model.
Triclosan is a lipophilic antimicrobial agent which, when present in an aqueous dentifrice vehicle, is complexed by or in close contact with polymers and surface-active molecules, emulsifying agents, flavoring oils and other hydrophobic ingredients. Because of this, dentifrice products containing triclosan may not have triclosan in a bioavailable state and, hence, the products themselves can not be assumed to possess antimicrobial activity. In order to determine the antimicrobial effects on dental plaque of a triclosan/pyrophosphate dentifrice relative to a negative control (without triclosan or pyrophosphate), a crossover 4-day non-brushing study was conducted. Thirty-four subjects were enrolled in this randomized two-period, double-blind crossover investigation with thirty-three subjects completing all aspects. Following a baseline plaque examination and complete plaque removal at the start of the first 4-day treatment period, subjects initiated a twice-daily supervised dosing regimen, during which they rinsed with their first assigned dentifrice in slurry form while refraining from tooth-brushing and all other oral hygiene procedures. Evaluations to quantify test product effects on plaque were conducted on Day 5. After a week-long interim washout period, subjects repeated the twice daily rinsing regimen over Days 1-4 of Treatment Period 2 with their second assigned product, again with examinations on Day 5. Analysis of data demonstrated subjects had significantly (p = 0.0296) less plaque when rinsing with the triclosan/pyrophosphate dentifrice slurry as compared to the negative control dentifrice slurry; the relative treatment difference as determined by the primary examiner was 12.7%. A trainee examiner observed a 16.0% reduction on a subset of subjects (p = 0.0139). This efficacy result compares favorably with results from other studies of triclosan-containing products. The examinations for oral safety demonstrated no meaningful clinical differences between the triclosan/pyrophosphate dentifrice and control dentifrice.
McClanahan
S F
SF
Health Care Research Center, Procter & Gamble Company, Mason, OH, USA. mcclanahan.sf@pg.com
Bollmer
B W
BW
Court
L K
LK
McClary
J M
JM
Majeti
S
S
Crisanti
M M
MM
Beiswanger
B B
BB
Mau
M S
MS
D000328:Adult; D000890:Anti-Infective Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D018592:Cross-Over Studies; D003773:Dental Plaque / Q000517:prevention & control*; D003774:Dental Plaque Index; D003802:Dentifrices / Q000008:administration & dosage / Q000627:therapeutic use*; D011756:Diphosphates; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D014677:Pharmaceutical Vehicles; D055502:Secondary Prevention; D012824:Silicic Acid; D012822:Silicon Dioxide / Q000627:therapeutic use; D012969:Sodium Fluoride / Q000627:therapeutic use; D014100:Toothpastes; D014260:Triclosan / Q000008:administration & dosage / Q000627:therapeutic use*
D000890:Anti-Infective Agents; D003802:Dentifrices; D011756:Diphosphates; D014677:Pharmaceutical Vehicles; D014100:Toothpastes; C546060:hydrated silica gel-based toothpaste; D012824:Silicic Acid; D014260:Triclosan; D012822:Silicon Dioxide; D012969:Sodium Fluoride