Comparison of a dentifrice containing 0.243% sodium fluoride, 0.3% triclosan, and 2.0% copolymer in a silica base, and a dentifrice containing 0.243% sodium fluoride in a silica base: a three-year clinical trial of root caries and dental crowns among adults.

OBJECTIVE: Colgate Total toothpaste has been demonstrated to be highly effective in plaque and gingivitis control. The effect of triclosan on root caries and on the survival of dental crowns (fixed dental prosthetic treatment) has not been evaluated. In order to examine these important variables, a randomized controlled clinical trial was conducted comparing Colgate Total toothpaste with triclosan, and an identical fluoride toothpaste without triclosan. METHODS: Adult subjects were randomly assigned to a test group using Colgate Total plus Whitening toothpaste with triclosan, and a control group using Colgate sodium fluoride toothpaste without triclosan. By the end of the study, following three years of product use, an evaluation was performed to compare baseline data to the three-year data for root caries and dental crown survival. Clinical root caries was evaluated by the Katz RCI- Root Caries Index. Within-treatment analysis for each dentifrice was conducted using a paired t-test. Between-treatment analysis was performed using Analysis of Covariance (ANCOVA). For fixed dental prosthetic treatment evaluation, dental crowns were dichotomized for success and failure at the end of the study. Within-treatment analysis for each dentifrice was conducted using a paired t-test. Between-treatment analysis was performed using the Bonferroni test. RESULTS: One-thousand, three-hundred, and fifty-seven subjects (1,357) completed the study. Regarding root caries, at termination of the study the Colgate Total group presented a mean score of 1.14 +/- 1.75 and a +5.6% change from baseline, while the sodium fluoride toothpaste presented a mean of 1.25 +/- 1.88 and a +43.2% change from baseline (p < 0.001). The adjusted mean root caries increment was 0.07 +/- 0.03 for the Colgate Total group, and 0.38 +/- 0.03 for the sodium fluoride toothpaste group (p < 0.001). Regarding crowns, at termination of the study the Colgate Total group presented a mean score of 5.38 +/- 3.70 and a +1.1% change from baseline, while the sodium fluoride toothpaste without triclosan presented a mean of 5.75 +/- 3.86 and a +3.8% change from baseline (p < 0.001). The mean (adjusted for multiple comparisons) dental crowns failure increment was 0.09 +/- 0.03 for the Colgate Total group, and 0.31 +/- 0.02 for the sodium fluoride toothpaste group (p < 0.001). CONCLUSION: A comparison between the two study groups revealed a statistically significant difference for root caries and dental crown failure scores, both favoring the triclosan toothpaste (Colgate Total). The significantly lower root caries and observed dental crown failure scores among the Colgate Total toothpaste users indicate an effect of the triclosan and the copolymer system. These results are important and could provide a strong and valuable public health measure.