RESUMEN
PURPOSE: 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 dihydrate (Test Dentifrice delivering 0.243% sodium fluoride), to a dentifrice containing 0.243% sodium fluoride in a silica base (Positive Control Dentifrice). MATERIALS AND METHODS: This study was conducted in harmony with the published 1988 American Dental Association guidelines for studies geared toward the comparison of fluoride dentifrices. This 2-yr caries clinical 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 Lares area of Puerto Rico. Qualifying subjects were stratified according to age and sex, and were randomly assigned to the two treatment groups, with multiple subjects in the same household all assigned to the dentifrice randomly allocated to the first among them. Caries examinations were conducted in accordance with U.S. Food and Drug Administration guidelines for the clinical evaluation of drugs to prevent dental caries. Two calibrated examiners performed all the measurements. After treatment assignment, study participants were instructed to brush their teeth at home with their assigned dentifrice at least twice daily. Brushing instructions were reinforced by indoctrination in proper oral hygiene techniques by dental professionals, supplemented by pamphlets supplied by the sponsor and yearly mailings to participants, 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: Two thousand five hundred six (2,506) subjects completed this 2-yr study. For these subjects, the mean caries scores (DMFS, decayed, missing and filled tooth surfaces) at baseline were 2.29 for the Test Dentifrice group, and 2.47 for the 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 Positive Control Dentifrice group. Finally, after 2 yrs, the mean caries increments were 1.25 for the Test Dentifrice group, and 1.46 for the Positive Control Dentifrice group. No statistically significant difference was indicated between the treatment groups at baseline or between the 1-yr caries increment scores. However, there was a statistically significant difference in the 2-yr caries increment scores between the treatment groups. Relative to the Positive Control Dentifrice group, the Test Dentifrice group presented a 14.38% reduction in caries increment scores at 2 yrs. In accordance with the procedures and standards provided by the published guidelines of the American Dental Association for the comparison of the anticaries efficacy of fluoride dentifrices, the results of this study support the conclusion that the dentifrice system in a dual-chambered tube, wherein one chamber contained sodium fluoride in a silica base and the other chamber contained dicalcium phosphate dihydrate, delivering 0.243% sodium fluoride, provided a superior level of anticaries efficacy than did the dentifrice containing 0.243% sodium fluoride in a silica base.
Asunto(s)
Fosfatos de Calcio/farmacología , Cariostáticos/farmacología , Caries Dental/prevención & control , Fluoruro de Sodio/farmacología , Pastas de Dientes/uso terapéutico , Adolescente , Análisis de Varianza , Fosfatos de Calcio/administración & dosificación , Cariostáticos/administración & dosificación , Niño , Preescolar , Índice CPO , Caries Dental/epidemiología , Método Doble Ciego , Sistemas de Liberación de Medicamentos , Femenino , Florida/epidemiología , Humanos , Masculino , Puerto Rico/epidemiología , Fluoruro de Sodio/administración & dosificación , Pastas de Dientes/farmacología , Resultado del TratamientoRESUMEN
PURPOSE: 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 dihydrate (Test Dentifrice delivering 0.243% sodium fluoride), to a dentifrice containing 0.243% sodium fluoride in a silica base (Positive Control Dentifrice). MATERIALS AND METHODS: This study was conducted in harmony with the published 1988 American Dental Association guidelines for studies geared toward the comparison of fluoride dentifrices. This 2-yr caries clinical study employed a double-blind, parallel-group design, and involved 6-10 yr-old children from the metropolitan area of Maceio, Alagoas, Brazil. Qualifying subjects were stratified according to age and sex, and were randomly assigned to the two treatment groups, with multiple subjects in the same household all assigned to the dentifrice randomly allocated to the first among them. Caries examinations were conducted in accordance with U.S. Food and Drug Administration guidelines for the clinical evaluation of drugs to prevent dental caries. One calibrated examiner performed all the measurements. After treatment assignment, study participants were instructed to brush their teeth at home with their assigned dentifrice at least twice daily. Brushing instructions were reinforced by indoctrination in proper oral hygiene techniques by dental professionals, supplemented by pamphlets supplied by the sponsor and yearly mailings to participants, 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: Two thousand four hundred thirty-two (2,432) subjects completed this 2-yr study. For these subjects, the mean caries scores (DMFS, decayed, missing and filled tooth surfaces) at baseline were 3.84 for the Test Dentifrice group, and 4.06 for the Positive Control Dentifrice group. For caries increments after 1 yr, the respective means were 2.02 for the Test Dentifrice group and 2.12 for the Positive Control Dentifrice group. Finally, after 2 yrs, the mean caries increments were 4.30 for the Test Dentifrice group, and 4.83 for the Positive Control Dentifrice group. No statistically significant difference was indicated between the treatment groups at baseline or between the 1-yr caries increment scores. However, there was a statistically significant difference in the 2-yr caries increment scores between the treatment groups. Relative to the Positive Control Dentifrice group, the Test Dentifrice group presented a 10.97% reduction in caries increment scores at 2 yrs. In accordance with the procedures and standards provided by the published guidelines of the American Dental Association for the comparison of the anticaries efficacy of fluoride dentifrices, the results of this study support the conclusion that the dentifrice system in a dual-chambered tube, wherein one chamber contained sodium fluoride in a silica base and the other chamber contained dicalcium phosphate dihydrate, delivering 0.243% sodium fluoride, provided a superior level of anticaries efficacy than did the dentifrice containing 0.243% sodium fluoride in a silica base.
Asunto(s)
Fosfatos de Calcio/administración & dosificación , Caries Dental/prevención & control , Fluoruro de Sodio/administración & dosificación , Pastas de Dientes/uso terapéutico , Brasil/epidemiología , Niño , Índice CPO , Caries Dental/epidemiología , Método Doble Ciego , Sistemas de Liberación de Medicamentos , Femenino , Humanos , Masculino , Pastas de Dientes/farmacología , Resultado del TratamientoRESUMEN
PURPOSE: To provide a head-to-head comparison of the anticaries efficacy associated with two commercially-available and American Dental Association-accepted dentifrices: Crest Cavity Fighting Toothpaste with Fluoristat, containing 0.243% sodium fluoride in a silica base, and Colgate Great Regular Flavor Fluoride Toothpaste, containing 0.76% sodium monofluorophosphate in a dicalcium phosphate dihydrate base. The study was conducted in harmony with the published 1988 American Dental Association guidelines for studies geared toward this purpose. MATERIALS AND METHODS: The study employed a double-blind, parallel-groups, multi-center two-treatment design, and involved third, fourth, and fifth grade schoolchildren from Newark, New Jersey, and from the Cidra and Lares areas of Puerto Rico. Qualifying subjects were stratified according to age and sex, and were randomly assigned to the two treatment groups, with multiple subjects in the same household all assigned to the dentifrice randomly allocated to the first among them. Caries examinations were conducted in accordance with U.S. Food and Drug Administration guidelines for the clinical evaluation of drugs to prevent dental caries. After treatment assignment, study participants were instructed to brush their teeth at home with their assigned dentifrice at least twice daily. Brushing instructions were reinforced by the presentation of educational films and lectures at school, by semi-annual mailings to parents, and through the periodic distribution of small novelty gifts along with the dentifrice deliveries, in order to enhance the interest and enthusiasm of study participants. Post-baseline examinations were performed after 1 and after 2 yrs of product use. Two thousand four hundred seventy-nine (2,479) subjects completed this 2-yr study. For these subjects, the mean (S.D.) DFS scores at baseline were 2.77 (3.35) for the Crest group, and 2.66 (3.18) for the Colgate group. For caries increment after 1 yr, the respective means were 1.68 (2.53) and 1.70 (2.57). After 2 yrs, the mean caries increments were 3.56 (4.11) for the Crest group, and 3.56 (4.05) for the Colgate group. RESULTS: The analysis of the 2-yr caries increment scores support the conclusion that the anticaries efficacy associated with Colgate Great Regular Flavor Fluoride Toothpaste is equivalent to that associated with Crest Cavity Fighting Toothpaste with Fluoristat, in accordance with the procedures and standards provided by the published guidelines of the American Dental Association. Further, consistent with those same standards, the results of this study serve to lend additional support to the conclusion that dentifrices formulated with sodium monofluorophosphate provide an equivalent level of anticaries efficacy as to those formulated with sodium fluoride.
Asunto(s)
Cariostáticos/uso terapéutico , Caries Dental/prevención & control , Dentífricos/uso terapéutico , Fluoruros/uso terapéutico , Fosfatos/uso terapéutico , Fluoruro de Sodio/uso terapéutico , Fosfatos de Calcio , Cariostáticos/administración & dosificación , Niño , Intervalos de Confianza , Índice CPO , Método Doble Ciego , Femenino , Fluoruros/administración & dosificación , Estudios de Seguimiento , Humanos , Masculino , New Jersey , Educación del Paciente como Asunto , Fosfatos/administración & dosificación , Puerto Rico , Dióxido de Silicio , Fluoruro de Sodio/administración & dosificación , Estadística como Asunto , Cepillado Dental/métodos , Resultado del TratamientoRESUMEN
To determine the effect of chewing sugar-free gum on caries incidence, the authors conducted a randomized clinical study. A total of 1,402 children in Puerto Rico, in grades 5 through 7 at baseline, completed the study. They were randomized by classroom into a control group or chewing gum group; those in the gum group were instructed to chew sugar-free gum for 20 minutes after each of three meals a day. Clinical and radiographic evaluations were performed at baseline and after two and three years. The results show that all subjects and high-risk subjects, respectively, in the gum group developed 7.9 percent and 11.0 percent fewer decayed, missing or filled surfaces than subjects in the control group. Based on these findings, the authors concluded that chewing sorbitol-based sugar-free gum after eating significantly reduces the incidence of dental caries.