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

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.

The enhanced anticaries efficacy of a sodium fluoride and dicalcium phosphate dihydrate dentifrice in a dual-chambered tube. A 2-year caries clinical study on children in Brazil.

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.

Effect of an essential oil-containing dentifrice on dental plaque microbial composition.

PURPOSE: To determine the effect of 6 months use of an essential oil-containing (EO) antiplaque/antigingivitis fluoride dentifrice on the balance of the oral microbial flora and on the emergence of resistant microbial forms by analysis of dental plaque and saliva. MATERIALS AND METHODS: The dentifrice essential oils consisted of a fixed combination of thymol, menthol, methyl salicylate, and eucalyptol. An identical fluoride-containing dentifrice without the essential oils served as the control. A subgroup of 66 subjects from a clinical trial population of 321 was randomly selected for characterization of their dental plaque microflora. Saliva was also cultured to monitor for the emergence of opportunistic pathogens. Supragingival plaque and saliva were harvested at baseline, after which subjects received a dental prophylaxis. Subjects were sampled again after 3 and 6 months of product use prior to clinical examination. Plaque was characterized for microbial content by phase contrast microscopy for recognizable cellular morphotypes and by cultivation on nonselective and selective culture media. Determination of the minimum inhibitory concentrations of the test agent against selected Actinomyces and Veillonella isolated bacterial species was conducted at all time points to monitor for the potential development of bacterial resistance. RESULTS: There were no statistically significant differences between the microbial flora obtained from subjects using the essential oil-containing dentifrice and the vehicle control for all parameters and time periods except for the percentage of spirochetes at 6 months and for percentage of "other" microorganisms at 3 months. The EO group exhibited a lower adjusted mean for both parameters. Additionally, there was no evidence of the development of bacterial resistance to the antimicrobial activity of the essential oils or the emergence of opportunistic pathogens.

A six-week clinical efficacy study of four commercially available dentifrices for the removal of extrinsic tooth stain.

The objective of this double-blind clinical study was to compare the efficacy for extrinsic tooth stain removal of four commercially available dentifrices: Colgate Tartar Control with Baking Soda & Peroxide Fluoride Toothpaste; Aquafresh Advanced Whitening Toothpaste with Fluoride; Rembrandt Tartar Control Low Abrasion Fluoride Whitening Toothpaste; and Crest Regular Fluoride Toothpaste. Following a baseline examination for extrinsic tooth stain on the anterior six mandibular and maxillary teeth, qualifying adult male and female subjects from the Philadelphia, Pennsylvania area were randomized into four treatment groups which were balanced for age, gender, tobacco habits, and level of extrinsic tooth stain. Subjects were instructed to brush their teeth twice daily (morning and evening) for one minute with their assigned dentifrice using a soft-bristled toothbrush. Examinations for extrinsic tooth stain were repeated after six weeks' use of the study dentifrices. One hundred eighty (180) subjects complied with the protocol, and completed the entire study. At the six-week examination, subjects assigned to the Colgate Tartar Control with Baking Soda & Peroxide Fluoride Toothpaste treatment group exhibited statistically lower levels of extrinsic tooth stain area and extrinsic tooth stain intensity than did those subjects assigned to the Crest Regular Fluoride treatment group. Subjects assigned to the Aquafresh Advanced Whitening treatment group exhibited significantly lower levels of extrinsic tooth stain area than did those assigned the Crest Regular Fluoride group. No other significant differences among the four study dentifrices were noted. Thus, the results of this double-blind clinical study support the conclusion that Colgate Tartar Control with Baking Soda & Peroxide Fluoride Toothpaste provides significantly greater control of extrinsic tooth stain than does Crest Regular Fluoride, a sodium fluoride/silica dentifrice.

A short-term brushing model for assessing antiplaque/antigingivitis dentifrice effectiveness: a pilot study.

This pilot clinical study was conducted to evaluate the utility of a short-term brushing model for assessing the inhibition of supragingival plaque and gingivitis by an essential oil-containing dentifrice formulation. Forty-two qualifying subjects entered and completed this double-blind, parallel group, controlled study. At baseline, subjects received an oral soft and hard tissue examination and were also scored for plaque, gingivitis and bleeding, both visually and invasively. Subjects received a supragingival prophylaxis and were randomly assigned to an experimental essential oil-containing dentifrice or its vehicle control. Subjects brushed unsupervised for one minute, twice daily for three weeks, after which all clinical examinations were repeated. All examinations were performed by a qualified and calibrated examiner. Analyses of covariance were used to compare inter-group means for each of the three outcome variables. Compared to its vehicle control, the experimental dentifrice produced statistically significant (p < 0.0001) reductions of 39.6% for plaque, 10.8% for gingivitis, and 65.4% for bleeding. No adverse events were observed or reported. The results of this pilot study suggest that three weeks of conventional use may be an adequate duration to demonstrate effectiveness of an essential oil-containing dentifrice. Confirmation of these results in a duplicate study is desirable to assess the reliability of the model. Furthermore, the utility of this model to determine the effects of formula modifications to the antiplaque and antigingivitis activity of active agents needs to be explored.

The clinical effectiveness of a dentifrice containing triclosan and a copolymer for providing long-term control of breath odor measured chromatographically.

The objective of this double-blind clinical study was to investigate the effectiveness of a commercially available dentifrice containing triclosan and a copolymer (Colgate Total Toothpaste) for controlling long-term, i.e., seven-hour and overnight breath odor. In particular, a comparison was made between the level of control of breath odor provided by the test dentifrice, and that provided by a placebo dentifrice which did not contain triclosan or a copolymer. This study followed a two-treatment, two-period crossover design. Prospective subjects were provided with a supply of a commercially available fluoride dentifrice, which was used for a one-week period prior to the two seven-day treatment periods. During each treatment period, subjects were instructed to brush their teeth twice a day, morning and evening, for sixty seconds with their assigned study dentifrice, using the soft-bristled toothbrush which had been provided. On the morning following the seventh day of each treatment period, subjects reported to the clinical facility for overnight breath odor assessments. Directly following this, subjects brushed their teeth, ate and drank normally, and reported once again to the clinical facility at seven hours post-toothbrushing for another breath odor assessment. Prior to the overnight breath odor assessments, subjects refrained from brushing their teeth, rinsing their mouths or using breath mints, and from eating or drinking anything on the morning of the evaluation. Subjects refrained from the use of tobacco products, and from eating onions, garlic, or strong spices throughout the entire study. Breath odor was instrumentally evaluated by measuring the level of volatile sulfur compounds in the mouth air using a 565 Tracor gas chromatograph equipped with a flame photometric detector. Measurements were taken in duplicate, and then averaged. Levels of volatile sulfur compounds were expressed in nanograms per milliliter (ng/ml) of mouth air. The two dentifrices exhibited statistically significant differences (p < 0.05) with respect to both overnight breath odor and seven-hour post-toothbrushing breath odor. The mean overnight breath odor scores were 9.63 ng/ml for Colgate Total Toothpaste, and 12.64 ng/ml for the placebo dentifrice. For seven-hour breath odor, the mean scores were 5.62 ng/ml for Colgate Total Toothpaste, and 7.10 ng/ml for the placebo dentifrice. Thus, the results of this double-blind clinical study on 19 subjects support the conclusion that Colgate Total Toothpaste provides effective seven-hour and overnight control of breath odor.