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 comparative plaque removal efficacy of two advanced manual toothbrush designs in two independent clinical studies.

Two independent studies were conducted to evaluate and compare the clinical performance of two commercially available manual toothbrushes (Colgate Total Professional and the Oral-B Cross Action). Study I was a short-term, examiner-blind crossover clinical trial (N = 30) designed to measure the removal of 24-hour plaque build-up. All 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 Modified Navy Plaque Index. Patients then received one of the two study toothbrushes and brushed their teeth for a timed one minute. They were then re-assessed for plaque. The data showed that the Colgate Total Professional toothbrush performed better than the Oral-B Cross Action toothbrush in reducing whole-mouth plaque scores (p < 0.001). Study II was a definitive six-week, single-blind clinical trial (N = 55), conducted in harmony with American Dental Association guidelines, to assess the ability of the two toothbrushes to reduce supragingival plaque and gingivitis. In this study, the subjects were stratified into two balanced groups based on their baseline plaque and gingivitis scores. Subjects were then instructed to continue with their normal brushing technique twice daily for one minute with their assigned toothbrush and a commercially available dentifrice. Examinations for plaque (Rustogi Modified Navy Plaque Index), and gingivitis (Loe-Silness Gingival Index) were conducted by the same examiner at baseline, after three weeks, and again after six weeks. The data from this long-term clinical trial showed that the Colgate Total Professional toothbrush exhibited statistically significantly lower plaque and gingivitis scores than did the Oral-B Cross Action toothbrush. The magnitudes of these differences were 29.5% for plaque and 31.1% for gingivitis. These reductions are adequate to support the claim that the Colgate Total Professional toothbrush provides clinically superior control of supragingival plaque and gingivitis, when studied in accordance with the criteria provided by the 1999 Guidelines of the American Dental Association for determining superiority.

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.

A new desensitizing dentifrice--an 8-week clinical investigation.

An 8-week, double-blind, three-way clinical trial compared the dentinal hypersensitivity-reducing effectiveness of a new dentifrice containing 5.0% potassium nitrate and 0.454% stannous fluoride in a silica base (Colgate Sensitive Maximum Strength Toothpaste, Colgate-Palmolive Co.) with a commercially available desensitizing dentifrice containing 5.0% potassium nitrate and 0.243% sodium fluoride in a silica base (Sensodyne Fresh Mint Toothpaste, Block Drug Company, Inc.) and a nondesensitizing dentifrice containing 0.243% sodium fluoride in a silica base (Colgate Winterfresh Gel, Colgate-Palmolive Co.). One hundred nine subjects were stratified into three balanced groups according to gender, age, mean baseline tactile (Yeaple Probe), and thermal (air blast) scores. The test products were randomly assigned to each group with instructions to brush twice daily. Oral examinations with tactile and thermal assessments were repeated after 4 and 8 weeks. The new dentifrice group demonstrated statistically significant improvements in tactile and thermal sensitivity over the two control groups.

Comparative investigation of the desensitizing efficacy of a new dentifrice: a 14-day clinical study.

The effect on dentinal hypersensitivity from the use of a new formulation dentifrice containing 5.0% potassium nitrate and 0.454% stannous fluoride in a silica base (Colgate Sensitive Maximum Strength Toothpaste, Colgate-Palmolive Co.) over a 14-day period was compared to a commercially available, nondesensitizing control dentifrice (Colgate Winterfresh Gel, Colgate-Palmolive Co.). A total of 66 subjects were entered into and completed the study. They were stratified into two balanced groups according to their baseline mean tactile (Yeaple Probe) sensitivity scores and air blast (thermal) sensitivity scores. The two groups were randomly assigned to use either the new formulation dentifrice or the commercially available control dentifrice. Participants were instructed to brush their teeth twice daily (morning and evening) for 1 minute with their assigned dentifrice and a commercially available soft-bristled toothbrush. Dentinal hypersensitivity examinations (tactile and air blast sensitivity) were conducted at baseline and after 3, 7, 10, and 14 days' use of the products. All examinations were conducted by the same examiner. Participants who used the new formulation dentifrice containing potassium nitrate/stannous fluoride/silica demonstrated a statistically significant improvement in both tactile sensitivity and air blast sensitivity after 10 and 14 days' use of the dentifrice (p < 0.05), as compared to a commercially available control dentifrice. It was concluded that a new dentifrice formulation containing 5.0% potassium nitrate and 0.454% stannous fluoride in a silica base provided a statistically significant reduction in dentinal hypersensitivity after only 10 days, as compared to a commercially available nondesensitizing control dentifrice.

Clinical study to compare extrinsic stain formation in subjects using three dentifrice formulations.

The purpose of this study was to compare the degree of extrinsic dental stain formed with the use of three dentifrices: (1) a new dentifrice formulation containing 5.0% potassium nitrate and 0.454% stannous fluoride in a silica base (Colgate Sensitive Maximum Strength Toothpaste, Colgate-Palmolive Co.); (2) a commercially available dentifrice containing 5.0% potassium nitrate and 0.243% sodium fluoride in a silica base (Sensodyne Fresh Mint Toothpaste, Block Drug Company, Inc.); and (3) a dentifrice containing 0.243% sodium fluoride in a silica base (Colgate Winterfresh Gel, Colgate-Palmolive Co.). A total of 121 participants were entered into the study and stratified into 3 balanced groups according to baseline mean Lobene Stain Index scores. A thorough dental prophylaxis was completed on each participant after completion of the baseline examination. The three groups were randomly assigned to use one of the three dentifrices. The groups were well balanced with regard to mean baseline stain index scores, gender, and tobacco habits. Participants were instructed to brush their teeth twice daily (morning and evening) for 1 minute with their assigned dentifrice and a commercially available soft-bristled toothbrush. Extrinsic dental stain examinations, which measured dental stain area and dental stain intensity, were conducted at baseline and 4 and 8 weeks. Examinations were conducted by the same dental examiner at each examination. After 4 and 8 weeks' use of the test dentifrices, there was no statistically significant difference regarding extrinsic stain formation with the use of any of the dentifrices. Thus, it can be concluded from this study that the use of a new formulation dentifrice containing 5.0% potassium nitrate and 0.454% stannous fluoride in a silica base will not result in a greater formation of extrinsic dental staining than that which is formed by two commercially available dentifrices not known to cause extrinsic dental stain.

A randomized clinical trial of the desensitizing efficacy of three dentifrices.

The effect on dentinal hypersensitivity from the use of a new dentifrice containing 5.0% potassium nitrate and 0.454% stannous fluoride in a silica base (Colgate Sensitive Maximum Strength Toothpaste, Colgate-Palmolive Co.) over an 8-week period was compared to a commercially available dentifrice containing 5.0% potassium nitrate and 0.243% sodium fluoride in a silica base (positive control [Sensodyne Fresh Mint Toothpaste, Block Drug Company, Inc.]) and to a commercially available nondesensitizing dentifrice containing 0.243% sodium fluoride in a silica base (negative control [Colgate Winterfresh Gel, Colgate-Palmolive Co.]). A total of 120 participants were stratified into 3 balanced groups according to baseline mean air blast (thermal) and tactile (Yeaple Probe) sensitivity scores, gender, and age. Participants brushed their teeth twice daily (morning and evening) for 1 minute. Dentinal hypersensitivity examinations were conducted at baseline, 4 weeks, and 8 weeks by the same dental examiner. After 4- and 8-weeks' use of their assigned products, participants in the new dentifrice group demonstrated statistically significant improvements (p < 0.05) in tactile and air blast sensitivity, as compared to those using the positive and negative control dentifrices.

Comparison of gingivitis and plaque efficacy of a battery-powered toothbrush and an ADA-provided manual toothbrush.

This examiner-blind clinical study evaluated the efficacy of a new battery-powered toothbrush with oscillating head (Colgate Actibrush) on established gingivitis and plaque at 15 days and again at 30 days, as compared to a control manual toothbrush (American Dental Association [ADA]-provided toothbrush, full head, soft bristles). A total of 63 participants completed the study. They were stratified into two balanced groups according to their mean baseline prebrushing plaque scores and were randomly assigned to use the battery-powered test toothbrush or the manual control toothbrush. Participants were instructed to brush their teeth twice daily (mornings and evenings) for 1 minute with their assigned toothbrush for the 30-day duration of the study. Gingivitis and plaque (pre- and postbrushing) examinations were conducted by the same dental examiner at baseline, after 15 days, and again after 30 days. The Colgate Actibrush demonstrated a significantly greater reduction of plaque (46.53%) and gingivitis (18.57%) when compared to the ADA-provided toothbrush after 30 days of use. Additionally, a comparison of the plaque scores for the battery-powered toothbrush at 15 and 30 days shows a continued reduction in plaque of more than 25% for a cumulative difference from baseline of 73%. These results support the conclusion that the new battery-powered toothbrush is clinically superior in plaque removal efficacy and gingivitis efficacy to the manual toothbrush, and continues to significantly improve plaque scores even up to 30 days of use.

Comparative efficacy of the Colgate Actibrush battery-powered toothbrush vs Oral-B CrossAction toothbrush on established plaque and gingivitis: a 6-week clinical study.

The objective of this clinical program was to compare the efficacy of the Colgate Actibrush battery-powered toothbrush and the Oral-B CrossAction Toothbrush (full head, soft bristle) for the control of supragingival plaque and gingivitis. Two independent clinical studies were conducted: Study 1 (repeated 3 times) was a single-use, examiner-blind clinical study designed to measure the removal of plaque after 24 hours of no oral hygiene. Study 2 was a definitive 6-week, examiner-blind clinical study designed to determine plaque and gingivitis efficacy at 3 and 6 weeks. Sixty-one men and women, who had refrained from using oral hygiene procedures for 24 hours, were entered into the study and stratified into 2 balanced groups according to baseline (prebrushing) plaque and gingivitis scores. For Study 1, Modified Navy Plaque Index (Rustogi Refinement) scores were obtained prebrushing and after a 1-minute supervised brushing with the assigned toothbrush and a commercially available toothpaste. On 3 separate occasions, after 24 hours of no oral hygiene, the Colgate Actibrush battery-powered toothbrush removed significantly more plaque than did the CrossAction Toothbrush. For Study 2, subjects were instructed to brush their teeth twice daily for 1 minute with the assigned toothbrush. Plaque Index scores and Löe-Silness Gingival Index scores were assessed after 3 and 6 weeks. At the 6-week examination, the group using the Colgate Actibrush battery-powered toothbrush exhibited a statistically significant reduction in both supragingival plaque and gingivitis, compared with the group that used the CrossAction Toothbrush. The results of these clinical studies support the conclusion that the Colgate Actibrush battery-powered toothbrush is clinically superior for the control of both supragingival plaque and gingivitis, as compared with the Oral-B CrossAction manual toothbrush.

Effectiveness of a battery-powered toothbrush on plaque removal: comparison with four manual toothbrushes.

The objective of these four clinical studies was to evaluate the efficacy of the Colgate Actibrush battery-powered toothbrush in comparison with four top-selling manual European toothbrushes (Dr. Best Flex Toothbrush [Germany]; Reach Triple Action Ultra Clean Toothbrush [Germany]; Jordan Multi-Action Toothbrush [Norway]; and Sanogyl Systeme In'Side Double Action Toothbrush [France]) for plaque removal. Each clinical study used a single-use, examiner-blind design in which the Colgate Actibrush battery-powered toothbrush was compared with one of the 4 manual toothbrushes for removal of plaque in adult subjects after 24 hours of no oral hygiene. Supragingival plaque formation was assessed prebrushing and after a 1-minute supervised brushing with either the battery-powered toothbrush or 1 of the manual toothbrushes. After 24 hours of no oral hygiene, Colgate Actibrush removed statistically significantly more plaque than did all 4 of the manual toothbrushes. The results of these clinical studies support the conclusion that Colgate Actibrush is clinically superior for the control of supragingival plaque, compared with the leading selling European manual toothbrushes.

Comparative efficacy of a new battery-powered toothbrush and an electric toothbrush on plaque removal.

This single-use, examiner-blind clinical study evaluated the plaque-removal efficacy of a new, battery-powered toothbrush (Colgate Actibrush) compared to a commercially available electric toothbrush (Braun Oral-B Plaque Remover) after 24 hours of no oral hygiene. Adult men and women reported to the clinical facility having refrained from oral hygiene procedures for 24 hours, and were stratified into 2 balanced groups according to plaque (prebrushing) scores. Participants then brushed their teeth for 1 minute, under supervision, with their assigned toothbrush and a commercially available toothpaste (Colgate Cavity Protection Great Regular Flavor Fluoride Toothpaste) and again were evaluated for supragingival plaque (postbrushing). The same dental examiner conducted the prebrushing and postbrushing plaque examinations. The study found no statistically significant difference in plaque removal between the group using the battery-powered toothbrush and the group using the electric toothbrush. Both power toothbrushes were found clinically to be equally effective with regard to the removal of 24-hour plaque accumulation.

Comparative efficacy of Colgate Actibrush battery-powered toothbrush and Colgate Plus (manual) toothbrush on established plaque and gingivitis: a 30-day clinical study in New Jersey.

The objective of this 30-day clinical study, conducted in harmony with American Dental Association guidelines, was to evaluate the efficacy of a new battery-powered toothbrush (Colgate Actibrush) relative to a manual toothbrush (Colgate Plus Diamond Head Toothbrush, Full Head, Soft Bristle) in the control of supragingival plaque and gingivitis. A total of 110 adult men and women from the Northern New Jersey area were entered into the study and stratified into 2 balanced groups according to baseline plaque and gingivitis scores. Participants were instructed to brush twice daily (morning and evening) for 1 minute with their assigned toothbrush and a commercially available toothpaste (Colgate Cavity Protection Great Regular Flavor Fluoride Toothpaste). Examinations for plaque and gingivitis were conducted by the same dental examiner at baseline, after 15 days, and again after 30 days of product use. All 110 participants complied with the protocol and completed the 30-day clinical study. At the 30-day examinations, the group using the Colgate Actibrush battery-powered toothbrush exhibited a statistically significant greater reduction in plaque (26.7%) and in gingivitis (25.8%) than did the group who used the Colgate Plus Diamond Head Toothbrush. The results of this 30-day clinical study support the conclusion that the Colgate Actibrush battery-powered toothbrush provides a clinically superior level of efficacy for the control of supragingival plaque and for the control of gingivitis when compared with a manual toothbrush.

Comparative efficacy on supragingival plaque and gingivitis of a manual toothbrush (Colgate Plus) and a battery-powered toothbrush (Colgate Actibrush) over a 30-day period.

This clinical study compared the effect of Colgate Actibrush, a battery-powered toothbrush, and Colgate Plus Diamond Head, a full-head, soft-bristled manual toothbrush, on established supragingival plaque and gingivitis over a 30-day period. Sixty-two healthy adult men and women were entered in the study. The subjects were stratified into two balanced groups according to their mean baseline plaque and gingivitis scores. Each group was randomly assigned to the use of one of the two toothbrushes. Subjects were instructed to brush their teeth at home twice daily (morning and evening) for 1 minute with their assigned toothbrush and a commercially available tooth-paste for the 30-day duration of the study. Gingivitis and plaque examinations, as well as a soft-tissue evaluation, were conducted by the same dental examiner at baseline and after 15 and 30 days of toothbrush use. Plaque and gingivitis scores were reduced significantly from baseline after the use of both toothbrushes for 30 days. However, improvement in both supragingival plaque and gingivitis scores was significantly greater in the group using Colgate Actibrush. In conclusion, although both toothbrushes provided a significant plaque and gingivitis benefit when used as part of a normal oral hygiene regimen, the efficacy of the Colgate Actibrush was demonstrated to be superior to that of the Colgate Plus Toothbrush after 30 days of use.

A clinical comparison of two calculus-inhibiting dentifrices.

The objective of this double-blind clinical study, conducted in harmony with the Volpe-Manhold design for studies of dental calculus, was to compare the effect on supragingival calculus formation of a dentifrice containing pyrophosphate, tripolyphosphate and a copolymer in a 0.243% sodium fluoride/silica base (Test Dentifrice), to that of a commercially available calculus-inhibiting dentifrice containing tetrapotassium pyrophosphate, disodium pyrophosphate and tetrasodium pyrophosphate in a 0.243% sodium fluoride/silica base (Positive Control Dentifrice). Adult male and female subjects from the Buffalo, New York area were entered into the study, provided a full oral prophylaxis, and assigned the use of a placebo (non-calculus-inhibiting) dentifrice for fourteen weeks. At the completion of this initial period, subjects were assessed for baseline Volpe-Manhold Calculus Index scores, provided another full prophylaxis, and stratified into two treatment groups which were balanced for age, sex and baseline calculus. 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 dental calculus were again performed after twelve weeks' use of the study dentifrices. Ninety-one (91) subjects complied with the protocol and completed the entire study. At the three-month examination, the Test Dentifrice group exhibited a statistically significant 27.3% reduction in mean Volpe-Manhold Calculus Index score as compared to the Positive Control Dentifrice group. The results of this clinical study support the conclusion that a new calculus-inhibiting dentifrice, containing pyrophosphate, tripolyphosphate and a copolymer in a 0.243% sodium fluoride/silica base, is efficacious for the control of the development of supragingival calculus, and provides a level of benefit greater than that provided by a commercially available calculus-inhibiting dentifrice containing tetrapotassium pyrophosphate, disodium pyrophosphate and tetrasodium pyrophosphate in a 0.243% sodium fluoride/silica base.

A calculus clinical study comparing the efficacy of two commercially available dentifrices.

The objective of this double-blind clinical study, conducted in harmony with the Volpe-Manhold design for studies of dental calculus, was to compare the effect on supragingival calculus formation of a dentifrice containing pyrophosphate, tripolyphosphate and a copolymer in a 0.243% sodium fluoride/silica base (Test Dentifrice), to that of a commercially available calculus-inhibiting dentifrice containing tetrapotassium pyrophosphate, disodium pyrophosphate, and tetrasodium pyrophosphate in a 0.243% sodium fluoride/silica base (Positive Control Dentifrice). Adult male and female subjects from the Northern New Jersey area were entered into the study, provided a full oral prophylaxis and assigned the use of a placebo (non-calculus-inhibiting) dentifrice for eight weeks. At the completion of this initial period, subjects were assessed for baseline Volpe-Manhold Calculus Index scores, provided another full prophylaxis and stratified into two treatment groups which were balanced for age, sex and baseline calculus. 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 dental calculus were again performed after twelve weeks' use of the study dentifrices. Eighty-nine (89) subjects complied with the protocol and completed the entire study. At the three-month examination, the Test Dentifrice group exhibited a statistically significant 31.0% reduction in the mean Volpe-Manhold Calculus Index score compared to the Positive Control Dentifrice group. The results of this clinical study support the conclusion that a new calculus-inhibiting dentifrice containing pyrophosphate, tripolyphosphate, and a copolymer in a 0.243% sodium fluoride/silica base is efficacious for the control of the development of supragingival calculus, and provides a level of benefit greater than that provided by a commercially available calculus-inhibiting dentifrice containing tetrapotassium pyrophosphate, disodium pyrophosphate, and tetrasodium pyrophosphate in a 0.243% sodium fluoride/silica base.

A twelve-week clinical comparison of two tartar control dentifrices.

The objective of this double-blind clinical study, conducted using the Volpe-Manhold evaluation method for dental calculus, was to compare the effect on supragingival calculus formation of a dentifrice containing tetrasodium pyrophosphate, sodium tripolyphosphate, and a copolymer in a 0.243% sodium fluoride/silica base (Test Dentifrice), to that of a commercially available calculus-inhibiting dentifrice containing tetrasodium pyrophosphate and a copolymer in a 0.243% sodium fluoride/silica base (Positive Control Dentifrice). Adult male and female subjects from the northern New Jersey area were entered into the study based on a pre-test (baseline) Volpe-Manhold Calculus Index score of 7.0 or greater, provided a full oral prophylaxis, and stratified into two treatment groups which were balanced for age, sex and baseline calculus scores. 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 dental calculus were again performed after twelve weeks' use of the study dentifrices. Seventy-three (73) subjects complied with the protocol, and completed the entire study. At the twelve-week examination, the Test Dentifrice group exhibited a statistically significant 43.5% reduction in mean Volpe-Manhold Calculus Index scores compared to the Positive Control Dentifrice group. The results of this clinical study support the conclusion that a new calculus-inhibiting dentifrice, containing tetrasodium pyrophosphate, sodium tripolyphosphate, and a copolymer in a 0.243% sodium fluoride/silica base, is efficacious for the control of the development of supragingival calculus, and provides a level of benefit greater than that provided by a commercially available calculus-inhibiting dentifrice containing tetrasodium pyrophosphate and a copolymer in a 0.243% sodium fluoride/silica base.

A six-week clinical tooth whitening study of a new calculus-inhibiting dentifrice formulation.

This six-week double-blind clinical study compared the toothwhitening effects of a new calculus-inhibiting dentifrice containing pyrophosphate, tripolyphosphate and copolymer in a 0.243 sodium fluoride/silica base (Test Dentifrice) with two commercially available dentifrices: Aquafresh Whitening Toothpaste with Fluoride and Crest Regular Fluoride Toothpaste. After a baseline examination for extrinsic tooth stain, qualifying adult males and females from Manchester, United Kingdom and from Mississauga, Ontario, Canada were randomly assigned into three test groups. Each group was balanced for gender, tobacco habits and levels of tooth stain. Subjects were to brush their teeth twice daily with a soft-bristled toothbrush using the assigned toothpaste. One-hundred and twenty-eight (128) subjects complied with instructions and completed the trial. Subjects using the Test Dentifrice exhibited statistically less stain area and less stain intensity than did either the Aquafresh or Crest groups. Crest Regular Fluoride toothpaste was statistically less effective than Aquafresh Whitening toothpaste in removing stain. Results in this trial support the conclusion that a new dentifrice formulation containing pyrophosphate, tripolyphosphate and a copolymer, in a 0.243% sodium fluoride/silica base, effectively removes extrinsic tooth stain.

A six-week clinical efficacy study of a tooth whitening tartar control dentifrice for the removal of extrinsic tooth stain.

The objective of this double-blind clinical study was to investigate the tooth whitening efficacy of a new commercially available calculus-inhibiting dentifrice (Colgate Tartar Control Plus Whitening Fluoride dentifrice) containing tetra-sodium pyrophosphate, sodium tripolyphosphate, and PVM/MA copolymer in a 0.243% sodium fluoride/silica base (test dentifrice), compared to a commercially available, non-tooth whitening dentifrice containing 0.243% sodium fluoride in a silica base (control dentifrice). Following a baseline examination for, extrinsic tooth stain, qualifying adult male and female subjects from the Manchester, United Kingdom area were randomized into two treatment groups which were balanced for gender, age 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. Seventy-nine(79) subjects complied with the protocol and completed the entire study. At the six-week examination, subjects assigned to the test dentifrice treatment group exhibited statistically significant reductions of over 40% with respect to both extrinsic tooth stain area and extrinsic tooth stain intensity relative to those subjects assigned to the control dentifrice treatment group.