A comparison of stabilized stannous fluoride dentifrice and triclosan/copolymer dentifrice for efficacy in the reduction of gingivitis and gingival bleeding: six-month clinical results.
This parallel-group, double-blind, placebo-controlled clinical trial directly compared the efficacy of two antimicrobial dentifrice formulations for the control of plaque, gingivitis and gingival bleeding during six months of use following a pre-test randomization period. Test antimicrobial dentifrices for the study included: a stabilized stannous fluoride formulation (Crest Plus Gum Care-currently marketed in U.S.) comprised of 0.454% SnF2 in a stabilized silica abrasive base; and a formulation containing triclosan (Colgate Total, currently marketed outside the U.S. in numerous countries) comprised of 0.30% triclosan. 2.0% Gantrez co-polymer and 0.243% NaF in a silica abrasive base. The control dentifrice was a conventional fluoride dentifrice comprised of 0.243% NaF in a silica abrasive base. Clinical evaluations included Turesky et al. plaque, Löe-Silness gingivitis and gingival bleeding, and Meckel stain. The stabilized stannous fluoride dentifrice exhibited significant efficacy in the reduction of both gingivitis (20.5%) and gingival bleeding (33.4%) after six months relative to the placebo control (p < 0.05). In direct comparison, the stabilized stannous fluoride dentifrice reduced gingivitis and gingival bleeding significantly relative to the triclosan/copolymer dentifrice (p < 0.05). These results establish: 1) the superior clinical efficacy of a stabilized stannous fluoride dentifrice relative to a triclosan/copolymer dentifrice in the chemotherapeutic control of gingivitis and gingival bleeding; 2) the important contribution of clinical test design/sensitivity in assessing the therapeutic efficacy of antimicrobial agents; and 3) the value of head-to-head comparative studies in establishing the therapeutic relevance of clinical effects of formulations for the reduction of gingivitis.
McClanahan
S F
SF
Procter and Gamble Company, Health Care Research Center Mason, Ohio, USA.
Beiswanger
B B
BB
Bartizek
R D
RD
Lanzalaco
A C
AC
Bacca
L
L
White
D J
DJ
D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D000891:Anti-Infective Agents, Local / Q000627:therapeutic use*; D003773:Dental Plaque / Q000517:prevention & control*; D003774:Dental Plaque Index; D003802:Dentifrices / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D005891:Gingivitis / Q000517:prevention & control*; D006801:Humans; D008297:Male; D008298:Maleates / Q000627:therapeutic use*; D008875:Middle Aged; D010512:Periodontal Index; D011095:Polyethylenes / Q000627:therapeutic use*; D012969:Sodium Fluoride / Q000627:therapeutic use; D014002:Tin Fluorides / Q000627:therapeutic use*; D016896:Treatment Outcome; D014260:Triclosan / Q000627:therapeutic use*
D000891:Anti-Infective Agents, Local; D003802:Dentifrices; D008298:Maleates; D011095:Polyethylenes; D014002:Tin Fluorides; D014260:Triclosan; D012969:Sodium Fluoride; C043105:poly(methyl vinyl ether-co-maleic anhydride)