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(R) Plus Gum Care-currently marketed in U.S.) comprised of 0.45 tlc SnF2, in a stabilized silica abrasive base; and a formulation containing triclosan (Colgate(R) Total, currently marketed outside the U.S. in numerous countries) comprised of 0.30% triclosan, 2.0% Gantrez(TM) 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 er al. plaque, Loe-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.