The comparative anticaries efficacy of a dentifrice containing 0.3% triclosan and 2.0% copolymer in a 0.243% sodium fluoride/silica base and a dentifrice containing 0.243% sodium fluoride/silica base: a two-year coronal caries clinical trial on adults in Israel.

The purpose of this two-year clinical study was to provide a comparison of the anticaries efficacy associated with two commercially available, American Dental Association-accepted dentifrices: Colgate Total Toothpaste, which contains 0.3% triclosan and 2% copolymer in a 0.243% sodium fluoride/silica base; and Crest Cavity Fighting Toothpaste with Fluoristat, which contains 0.243% sodium fluoride in a silica base. The study was conducted in harmony with the published 1988 American Dental Association guidelines for studies geared toward the comparison of fluoride dentifrices. The study employed a double-blind parallel-group design, and involved adults living in communities throughout Israel. Qualifying subjects 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 of 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 ensure compliance with the study. Post-baseline examinations were performed after one year of product use, and again after two years of product use. Three-thousand, three-hundred and ninety-two (3,392) subjects completed this two-year study. For these subjects, the mean caries scores (DFS, decayed or filled surfaces) at baseline were 21.96 for the Colgate Total Toothpaste group, and 21.49 for the Crest Cavity Fighting Toothpaste with Fluoristat group. For caries increment after one year, the respective means were 1.37 for the Colgate Total Toothpaste group, and 1.56 for the Crest Cavity Fighting Toothpaste with Fluoristat group. After two years, the mean caries increments were 1.46 for the Colgate Total Toothpaste group, and 1.75 for the Crest Cavity Fighting Toothpaste with Fluoristat group. No statically significant difference was indicated between the treatment groups at baseline. However, for both the one-year and two-year increments, there was a statistically significant difference between treatment groups. Relative to the Crest Cavity Fighting Toothpaste with Fluoristat group, the Colgate Total Toothpaste group presented a 12.2% reduction in caries increment scores at one year, and a 16.6% reduction in caries increment scores at two years. 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 Colgate Total Toothpaste provides a superior level of coronal anticaries efficacy compared to Crest Cavity Fighting Toothpaste with Fluoristat.

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.

Efficacy of a dentifrice containing 5% potassium nitrate and 1500 PPM sodium monofluorophosphate in a precipitated calcium carbonate base on dentinal hypersensitivity.

The effect on dentinal hypersensitivity from the use of a dentifrice containing 5.0% potassium nitrate, 1500 ppm sodium monofluorophosphate in a precipitated calcium carbonate (PCC) base over an eight-week period was compared to a placebo dentifrice without potassium nitrate. A total of forty-eight subjects were entered into the study and stratified into two balanced groups according to their baseline mean thermal (air blast) and tactile (Yeaple Probe) sensitivity scores. The two groups were randomly assigned to use either the potassium nitrate/PCC dentifrice or a placebo dentifrice without potassium nitrate. The two groups were well balanced with regard to their mean baseline thermal tactile sensitivity scores, sex and age. Subjects were instructed to brush their teeth twice daily (morning and evening) for one minute with their assigned dentifrice and a commercially available soft-bristled toothbrush. Dentinal hypersensitivity examinations, which included tactile and thermal sensitivity, were conducted at baseline, four weeks, and eight weeks. Examinations were conducted by the same dental examiner (TS) on the subjects at each examination. After four weeks' use of their assigned products, those subjects in the potassium nitrate/PCC dentifrice group demonstrated statistically significant improvements (p < 0.0001), as compared to the placebo dentifrice without potassium nitrate, in tactile and thermal sensitivity. After eight weeks' use of their assigned products, those subjects in the potassium nitrate/PCC dentifrice group again demonstrated statistically significant improvements (p < 0.0001), in tactile and thermal sensitivity, as compared to the placebo dentifrice without potassium nitrate. Thus it can be concluded from this study that the use of a dentifrice containing 5.0% potassium nitrate and 1500 ppm sodium monofluorophosphate in a precipitated calcium carbonate (PCC) base is a clinically effective method for reducing dentinal hypersensitivity.

Enhanced anticaries efficacy of a 0.243% sodium fluoride/10% xylitol/silica dentifrice: 3-year clinical results.

PURPOSE: To evaluate the efficacy of a sodium fluoride (NaF)/silica/xylitol dentifrice compared with that of a positive control NaF/silica dentifrice on caries increments in school children over a 3-year period in an area without an optimal level of fluoride in the drinking water (mean level <0.1 ppm). MATERIALS AND METHODS: A 3-year, double-blind clinical caries study was conducted in 2,630 children initially aged 8-10 years at 17 schools in the San Jose, Costa Rica metropolitan area. Clinical dental examinations were performed at participating schools utilizing portable dental equipment. Caries evaluations employed conventional tactile/visual methodology consisting of artificial light, dental mirrors and single-edge #23 explorers. Children accepted into the study were stratified by age and sex into two balanced groups within each school, and randomly assigned to use either a positive control dentifrice containing 0.243% NaF/silica or a test dentifrice containing 0.234% NaF/silica/10% xylitol. Children were instructed to brush with the assigned dentifrice twice daily. Caries evaluations were conducted at baseline, 2 years, and 3 years. RESULTS: After 3 years, subjects using the 0.234% NaF/silica/10% xylitol dentifrice had statistically significantly reduced decayed/filled surfaces (DFS; -12.3% reduction; P < or = 0.001) and decayed/filled buccal and lingual surfaces (DFS-BL; -10.5% reduction; P < or = 0/01).

The clinical effects on plaque and gingivitis over three-month's use of four complex-design manual toothbrushes.

The Colgate Total (formerly Colgate Precision) was evaluated along with the New Improved Crest Complete, Reach Advanced Design and Oral-B Advantage toothbrushes to compare six-week and three-month effects on plaque and gingivitis. One-hundred and ninety-three male and female participants completed a three-month, unsupervised toothbrushing study, brushing their teeth twice daily with one of these four products and a standard fluoride dentifrice. Plaque was quantified using the Rustogi et al. refinement of the Modified Navy Plaque Index. Gingivitis levels were measured using the Lobene et al Modified Gingival index. After initial screening examinations, the qualifying population (0.6 plaque, 1.8 gingivitis) was given a complete oral prophylaxis and instructed to return after forty-eight hours of no oral hygiene for baseline evaluations. The study population was split into four balanced groups after baseline examinations and assigned, by group, to use a particular toothbrush for the study duration. Subjects returned after six weeks and three months for safety and efficacy evaluations. There were no reported or observed untoward effects at any examination time in the study. Plaque and gingivitis mean values were not significantly different at baseline between the four groups. Results from this three-month clinical study demonstrated a significant reduction (p<.0001) in plaque levels and gingivitis for all of the four toothbrushes compared to baseline. At both six weeks and three months, gingivitis and plaque means were significantly lower (p<.01) in the Colgate Total group compared to the other three toothbrushes tested. When changes from six weeks to three months were statistically analyzed only the Colgate Total toothbrush significantly reduced (p<.001) gingivitis mean scores.

Clinical effect of a triclosan-containing dentifrice on plaque and gingivitis: a six-month study.

A total of 294 adult male and female subjects completed a 6-month, double-blind clinical trial designed to evaluate the effects of a dentifrice which contained 0.3% triclosan in conjunction with 2% of a methoxyethylene/maleic acid copolymer in a 0.243% sodium fluoride/silica base, relative to a control dentifrice, on supragingival plaque accumulation and gingivitis. Plaque and gingivitis were scored after 3 and 6-month use of the assigned dentifrice. At the end of the study, the triclosan group showed an average reduction, relative to the control group, of 12% in plaque accumulation and 20% in gingivitis. Both were statistically significant at p < or = 0.0001. The effect of the triclosan dentifrice was most pronounced on the more severe manifestations of plaque and gingivitis. The improvement in the gingival parameters at 6-months relative to the control dentifrice was statistically significant at p < or = 0.0001. It was concluded that the twice-daily use of the triclosan-containing dentifrice resulted in significant reduction in supragingival plaque formation and a significant improvement in gingival health without the presence of any extrinsic staining or objectionable taste.

Comparative plaque removal efficacy of three toothbrushes in two independent clinical studies.

Two independent studies were conducted to evaluate and compare the clinical performance of three toothbrushes on plaque removal. Both studies were carried out under the same protocol. A total of 73 adult male and female subjects who met the inclusion/exclusion criteria completed Study I and 78 different subjects completed Study II. Subjects were initially screened for dental plaque eligibility. After plaque was scored on the facial and lingual surfaces of all natural teeth using the Rustogi, et al. index, qualifying subjects were randomly assigned to one of three groups on the basis of initial plaque scores and number of teeth. Subjects were then dismissed and scheduled to return for Visit 1 a week later, having abstained from all oral hygiene procedures for a prior 24-hour period. At Visit 1, each group was evaluated for plaque before brushing with their assigned toothbrush for sixty seconds. They were again scored for plaque after brushing. Subjects were dismissed and instructed to resume their normal routine and return to the clinical site for two more weekly visits. At each visit, a different test toothbrush was assigned to each group in a cross-over design. Plaque evaluations and brushing procedures were performed as in Visit 1 of the study. In both studies, the Colgate Precision toothbrush was significantly more effective (p < 0.01) than both the Oral-B 40 and Reach Full-Head soft toothbrushes in reducing the whole mouth plaque scores, as well as plaque at the gumline and at interproximal areas. The Oral-B 40 and Reach toothbrushes were not significantly different from each other with regard to plaque removal.

Clinical studies regarding the plaque removal efficacy of manual toothbrushes.

Two independent cross-over design studies were performed to compare two toothbrushes for their ability to remove plaque. In Study I, the Colgate Precision toothbrush was compared to the Oral-B 40 toothbrush; in Study II, the Colgate Precision toothbrush was compared to the Reach Full-Head soft toothbrush. A total of 54 and 72 adult male and female subjects who met the inclusion/exclusion criteria completed Study I and Study II, respectively. In each study, subjects refrained from brushing for 24 hours, and were screened for dental plaque on the facial and lingual surfaces of all natural teeth, using the Rustogi, et al. index. Based on mean scores and number of teeth, qualifying subjects were randomly assigned to one of two groups. Subjects were then scheduled to return one week later, having again abstained from all oral hygiene procedures for a 24-hour period. At this visit, each subject was evaluated for plaque, then brushed with his/her assigned toothbrush for sixty seconds, and was again scored for plaque after brushing. Subjects were instructed to resume their normal routine and return to the clinical site one week later. At this visit, a different test toothbrush was assigned to each group in a cross-over design. Plaque evaluations and toothbrushing procedures were again performed. In both studies, the Colgate Precision toothbrush was significantly more effective (p < 0.01) than either the Oral-B 40 toothbrush or the Reach Full-Head soft toothbrush in reducing whole mouth plaque scores, plaque scores at the gumline, and plaque scores at interproximal areas.

Refinement of the Modified Navy Plaque Index to increase plaque scoring efficiency in gumline and interproximal tooth areas.

To improve the assessment of plaque present on teeth, a new index, based on the original Modified Navy Plaque Index, has been developed. The primary modifications to the original Modified Navy Plaque Index were: (1) extending areas F (distal) and D (mesial) into the region just below the interproximal contact point, and (2) extending areas C and A so as to increase the gumline (or marginal gingiva) region. The new index assesses the amount of plaque in the tooth area bounded by the tooth contact, the free gingival margin, and mesial or distal line angles. The use of this new index enables the examiner to evaluate and record both the gumline (or marginal areas) and interproximal areas of the tooth, thus giving these an anatomical areas an increased importance. A pilot clinical assessment study was conducted to utilize this new index in evaluating the plaque removal efficacy of five manual toothbrushes. The results from this pilot study indicated that, when the new plaque scoring index was used, significant differences between pre-toothbrushing and post-toothbrushing plaque scores (as well as among toothbrush groups) could be demonstrated. Further, these differences (plaque removal efficacy) were demonstrated on an interproximal (mesial and distal) basis and a gumline (or gingival margin) basis, as well as on a whole mouth basis.

The clinical effect of a dentifrice containing triclosan and a copolymer in a sodium fluoride/silica base on plaque formation and gingivitis: a six-month clinical study.

A six-month, double-blind clinical study was entered into by three hundred twenty-five (325) male and female adult subjects to assess the efficacy of a dentifrice containing 0.3% triclosan (Irgacare MP, Ciba-Geigy Corp.) and 2.0% of a copolymer of methoxyethylene and maleic acid (Gantrez, ISP Corp.) on supragingival plaque formation and gingivitis, compared to a placebo dentifrice over a six-month period. Each dentifrice, the triclosan and the placebo, contained 0.243% sodium fluoride in a silica base. Only those subjects who were free of periodontal disease (no pockets > 4 mm), demonstrated a level of at least mild gingivitis (modified Loe-Silness score > or = 1.0) and had a modified Quigley-Hein Plaque Index score of > or = 1.5 were admitted into the study. Baseline plaque and gingivitis scores were used to stratify the subjects into two balanced groups. A thorough oral prophylaxis was administered to all subjects. They were then assigned either the triclosan/copolymer dentifrice or the placebo dentifrice to use for the next six months. Evaluation for gingivitis and supragingival plaque formation was made after three and six months. Evaluations made after six (6) months demonstrated a 17.0% statistically significant (at the 99% level of confidence) reduction in supragingival plaque formation was provided by the triclosan/copolymer dentifrice, compared to the placebo dentifrice. An 18.6% statistically significant (at the 99% level of confidence) reduction in plaque formation on the tooth surfaces with the highest plaque formation was provided by the triclosan/copolymer dentifrice, compared to the placebo dentifrice.(ABSTRACT TRUNCATED AT 250 WORDS)