The enhanced anticaries efficacy of a sodium fluoride and dicalcium phosphate dihydrate dentifrice in a dual-chambered tube. A 2-year caries clinicalstudy on children in the United States of America

(Purpose) under bar: To clinically evaluate and compare a dentifrice system in a dual-chambered tube, wherein one chamber contained sodium fluoride in a silica base and the other chamber contained dicalcium phosphate dihydrat e (Test Dentifrice delivering 0.243% sodium fluoride), to a dentifrice cont aining 0.243% sodium fluoride in a silica base (Positive Control Dentifrice ). (Materials and Methods) under bar: This study was conducted in harmony w ith the published 1988 American Dental Association guidelines for studies g eared toward the comparison of fluoride dentifrices. This 2-yr caries clini cal study employed a double-blind, parallel-group design, and involved 5-17 yr-old children from the Central and South areas of Florida and from the L ares area of Puerto Rico. Qualifying subjects were stratified according to age and sex, and were randomly assigned to the two treatment groups, with m ultiple subjects in the same household all assigned to the dentifrice rando mly allocated to the first among them. Caries examinations were conducted i n accordance with U.S. Food and Drug Administration guidelines for the clin ical evaluation of drugs to prevent dental caries. Two calibrated examiners performed all the measurements. After treatment assignment, study particip ants were instructed to brush their teeth at home with their assigned denti frice at least twice daily. Brushing instructions were reinforced by indoct rination in proper oral hygiene techniques by dental professionals, supplem ented by pamphlets supplied by the sponsor and yearly mailings to participa nts, emphasizing good oral hygiene and the need to enforce compliance with the study. Post-baseline examinations were performed after 1 yr of product use, and again after 2 yrs of product use. (Results) under bar: Two thousan d five hundred six (2,506) subjects completed this 2-yr study. For these su bjects, the mean caries scores (DMFS, decayed, missing and filled tooth sur faces) at baseline were 2.29 for the Test Dentifrice group, and 2.47 for th e Positive Control Dentifrice group. For caries increments after 1 yr, the respective means were 0.69 for the Test Dentifrice group and 0.81 for the P ositive Control Dentifrice group. Finally, after 2 yrs, the mean caries inc rements were 1.25 for the Test Dentifrice group, and 1.46 for the Positive Control Dentifrice group. No statistically significant difference was indic ated between the treatment groups at baseline or between the l-yr caries in crement scores. However, there was a statistically significant difference i n the 2-yr caries increment scores between the treatment groups. Relative t o the Positive Control Dentifrice group, the Test Dentifrice group presente d a 14.38% reduction in caries increment scores at 2 yrs. In accordance wit h the procedures and standards provided by the published guidelines of the American Dental Association for the comparison of the anticaries efficacy o f fluoride dentifrices, the results of this study support the conclusion th at the dentifrice system in a dual-chambered tube, wherein one chamber cont ained sodium fluoride in a silica base and the other chamber contained dica lcium phosphate dihydrate, delivering 0.243% sodium fluoride, provided a su perior level of anticaries efficacy than did the dentifrice containing 0.24 3% sodium fluoride in a silica base.