Effect of a dentifrice containing triclosan and a copolymer on plaque formation and gingivitis.
A total of one hundred twenty-one (121) adult male and female subjects completed a 6-month, double-blind clinical study comparing the effect on supragingival plaque formation and gingivitis of a dentifrice containing 0.3% Triclosan and 2.0% of a copolymer of methoxyethylene and maleic acid to a placebo dentifrice. Both the Triclosan/copolymer and placebo dentifrices contained 0.243% sodium fluoride in a silica base. Subjects were stratified into two balanced groups according to baseline plaque and gingivitis scores. They then received an oral prophylaxis and were assigned to use either the Triclosan/copolymer dentrifrice or the placebo dentifrice for the next 6 months. Subjects were evaluated for supragingival plaque formation and gingivitis after 3 and 6 months' use of the dentifrices. After 6 months, the Triclosan/copolymer dentifrice was shown to provide a 32.32% statistically significant reduction (99% level of confidence) in supragingival plaque formation, as compared to the placebo dentifrice. Also, after 6 months, the Triclosan/copolymer dentifrice was shown to provide a 25.64% statistically significant reduction (99% level of confidence) in gingivitis, as compared to the placebo dentifrice. It thus can be concluded from this clinical study that the twice daily use of the dentifrice containing 0.3% Triclosan and 2.0% of a copolymer in a 0.243% sodium fluoride/silica base provides statistically significant reductions in both supragingival plaque formation and gingivitis.