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.

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.

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.

A six-week clinical efficacy study of a new 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 dentifrice (Colgate Tartar Control Plus Whitening Fluoride Toothpaste) for the removal of extrinsic tooth stain, through a comparison with two commercially available dentifrices, Aquafresh Whitening Toothpaste with Fluoride, and Crest Regular Fluoride Toothpaste. Following a baseline examination for extrinsic tooth stain area and intensity, qualifying adult male and female subjects from the Mississauga, Ontario, Canada area were randomized into three treatment groups which were balanced for age, gender, 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 twenty-two (122) subjects complied with the protocol and completed the entire study. At the six-week examination, subjects assigned to the Colgate Tartar Control Plus Whitening treatment group and subjects assigned to the Aquafresh Whitening treatment group exhibited statistically lower levels (p < 0.0001) of extrinsic tooth stain area and intensity than did those subjects assigned to the Crest Regular Fluoride treatment group. Further, subjects assigned to the Colgate Tartar Control Plus Whitening treatment group exhibited significantly lower levels of extrinsic tooth stain area and intensity than did those assigned to the Aquafresh Whitening treatment group (p < 0.0001).

The clinical anticalculus efficacy of a tartar control whitening dentifrice for the prevention of supragingival calculus in a three-month study.

The objective of this double-blind clinical study was to compare the effect of a new dentifrice (Colgate Tartar Control Plus Whitening Fluoride Toothpaste) for the prevention of supragingival calculus, with that of a commercially available calculus-inhibiting dentifrice (Crest Tartar Control Toothpaste). The study involved adult male and female subjects who had pre-qualified for participation by developing sufficient supragingival calculus (greater than 7.0 on the Volpe-Manhold Calculus Index) during an eight-week screening period. Subjects received a full oral prophylaxis, and were stratified into two treatment groups balanced for age, sex and qualifying calculus score. 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 performed after twelve weeks' use of the study dentifrices, using the Volpe-Manhold Calculus Index, Fifty-eight (58) subjects complied with the protocol and completed the entire study. The Colgate Tartar Control Plus Whitening group exhibited a statistically significant (p < 0.001) 34.6% reduction in mean calculus score compared to the Crest Tartar Control group.

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

The objective of this double-blind clinical study was to compare the extrinsic tooth stain removal efficacy of three commercially available dentifrices: Colgate Platinum Whitening Toothpaste with Fluoride, Aquafresh Advanced Whitening Toothpaste with Fluoride, and Crest Regular Fluoride Toothpaste. Following a baseline examination for extrinsic tooth stain, qualifying adult male and female subjects from the Toronto, Ontario, Canada are were randomized into three treatment groups which were balanced for age, gender, tobacco habits, and level of extrinsic tooth stain using the Lobene Stain Index. 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 forty-nine (149) subjects complied with the protocol and completed the entire study. At the six-week examination, subjects assigned to the Colgate Platinum treatment group exhibited statistically significant reductions (p < 0.05) from baseline level with respect to extrinsic tooth stain area (49.4% reduction) and extrinsic tooth stain intensity (52.4% reduction). Statistically significant reductions (p < 0.05) for both extrinsic tooth stain parameters were also exhibited by the subjects assigned to the Aquafresh Whitening treatment group (14.0% reduction for area, 15.5% reduction for intensity). Both tooth whitening treatments provided statistically significantly greater reductions (p < 0.05) in extrinsic tooth stain than did the Crest Regular Fluoride dentifrice, which exhibited a small increase in the extrinsic tooth stain parameters over the course of the study. Additionally, the Colgate Platinum dentifrice provided statistically significantly (p < 0.05) greater removal of extrinsic tooth stain over the course of this six-week study than did the Aquafresh Whitening dentifrice. Thus, the results of the double-blind clinical study support the conclusion that the two tooth whitening dentifrices, Colgate Platinum and Aquafresh Whitening, provide significantly greater (p < 0.05) removal of extrinsic tooth stain than does Crest Regular Fluoride, a sodium fluoride/silica dentifrice. Further, the results of the study support the conclusion that Colgate Platinum dentifrice provides a greater (p < 0.05) level of extrinsic tooth stain removal efficacy than does Aquafresh Whitening dentifrice.

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.

The clinical effectiveness of a dentifrice containing triclosan and a copolymer for controlling breath odor measured organoleptically twelve hours after toothbrushing.

The objective of this double-blind clinical study was to investigate the effectiveness of a dentifrice containing triclosan and a copolymer, Colgate Total Toothpaste, for controlling breath odor twelve hours after brushing the teeth compared to a placebo dentifrice which did not contain triclosan or a copolymer. Breath odor was evaluated by a panel of four expert judges using a nine-point hedonic scale. Following a baseline evaluation of breath odor, prospective study subjects who presented scores above the threshold value for unpleasant breath odor were stratified by score, and randomized into two treatment groups. Subjects were provided with a soft-bristled toothbrush, and brushed their teeth thoroughly in their regular and customary manner with their assigned dentifrice. Subjects refrained from dental hygiene, breath mints, or mouth rinses for the next twelve hours, after which they were once again evaluated for breath odor. Sixty-three (63) adult male and female subjects from the Mississauga, Ontario, Canada area participated in the study. At twelve hours after brushing their teeth, subjects in both dentifrice treatment groups presented mean breath odor scores which were statistically significantly lower than the mean scores observed at baseline. However, the difference between the mean twelve-hour breath odor scores differed significantly between the two dentifrices. The mean twelve-hour breath odor score for the Colgate Total Toothpaste group was 4.77, which is within the range of values corresponding to pleasant breath odor; the mean twelve-hour breath odor score for the placebo group was 6.05, which is above the value corresponding to unpleasant breath odor. Thus, the results of this double-blind clinical study support the conclusion that Colgate Total Toothpaste provides effective control of breath odor at twelve hours after brushing the teeth.

[The efficacy on natural extrinsic stain of Colgate whitening dentifrice--eight-week study].

OBJECTIVE: To assess the effect on natural extrinsic dental stain by use of a dentifrice containing 1% tetrasodium polyphosphate (TSPP), 7% sodium tripolyphosphate (STPP), 0.243% sodium fluoride and 10% high cleaning silica (HCS) over an eight-week period was compared to a sodium fluoride/silica placebo dentifrice without stain removal ingredients. METHODS: Ninety one subjects were selected and stratified into two balanced groups randomly assigned to use the test dentifrice or the placebo dentifrice. The two groups were well balanced with regard to their mean baseline stain index scores, gender and tobacco habits. 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. Extrinsic dental stain examinations, which included mean stain area and mean stain intensity, were conducted at baseline, four and eight weeks. The same dental examiner conducted examinations on the subjects at each examination. RESULTS: After eight-week use of their assigned products, those subjects in the TSPP/STPP/HCS dentifrice group demonstrated a statistically significant (P = 0.0001) stain reduction of 37.1%, as compared to the fluoride placebo dentifrice group without stain removal ingredients. CONCLUSION: The use of a dentifrice containing 1% tetrasodium polyphosphate, 7% sodium tripolyphosphate, 0.243% sodium fluoride and 10% high cleaning silica is effective in reducing natural extrinsic dental stain, when compared to a placebo fluoride dentifrice.

Efficacy of a dentifrice containing zinc citrate for the control of plaque and gingivitis: a 6-month clinical study in adults.

The objective of this 6-month, double-blind, clinical study, conducted in harmony with American Dental Association (ADA) guidelines, was to evaluate the efficacy of a dentifrice containing 2% zinc citrate and 0.76% sodium monofluorophosphate in a silica base (zinc citrate dentifrice) for the control of supragingival plaque and gingivitis, compared to a control dentifrice containing 0.76% sodium monofluorophosphate in a silica base (control dentifrice). Adult men and women from the Atlanta, Georgia, area were entered in the study and stratified into two treatment groups, which were balanced for baseline Quigley-Hein Plaque Index scores and baseline Löe-Silness Gingival Index scores. Participants received an oral prophylaxis and were instructed to brush their teeth twice daily (morning and evening) for 1 minute with their assigned dentifrice, using a soft-bristled toothbrush. Examinations for supragingival plaque and gingivitis were conducted after 3 months and again after 6 months' use of the study dentifrices. Ninety-nine participants complied with the protocol and completed the entire 6-month clinical study. At both the 3- and 6-month study examinations, the zinc citrate dentifrice group exhibited statistically significant reductions in both plaque and gingivitis compared to the control dentifrice group, based on whole-mouth data. At the 6-month examination, the magnitude of these reductions met or exceeded 18% for both plaque and gingivitis (25.3% for plaque; 18.8% for gingivitis). The effect of the zinc citrate dentifrice was most pronounced on the more severe manifestations of plaque and gingivitis, indicating a statistically significant (50.2%) reduction in severe plaque and a statistically significant (66.7%) reduction in severe gingivitis over the control dentifrice after 6 months of use. Similar findings were observed for data obtained from proximal, lingual, and posterior sites. Among the sites that indicated a tendency toward high levels of plaque or gingivitis based on the baseline scores, substantially fewer sites tended to continue to present such high levels at follow-up exams in the zinc citrate dentifrice group than in the control dentifrice group. Thus, in accordance with the 1986 guidelines published by the ADA and the 1994 revision published by the Task Force on Design and Analysis in Dental and Oral Research, the results of this study support the conclusion that a dentifrice containing 2% zinc citrate and 0.76% sodium monofluorophosphate in a silica base is clinically efficacious for the control of supragingival plaque and gingivitis.

Efficacy of a mouthrinse containing 0.05% cetylpyridinium chloride for the control of plaque and gingivitis: a 6-month clinical study in adults.

The objective of this 6-month, double-blind, clinical study, conducted following the American Dental Association (ADA) guidelines, was to provide an assessment of the effectiveness of a newly developed mouthrinse containing 0.05% cetylpyridinium chloride (CPC) for the control of supragingival dental plaque and gingivitis. Adult men and women from the Manchester, England, area were entered in the study, and stratified into two treatment groups (CPC mouthrinse and control mouthrinse), which were balanced for baseline Quigley-Hein Plaque Index scores and baseline Löe-Silness Gingival Index scores. Participants were given an oral prophylaxis and instructed to brush their teeth twice daily (morning and evening) for 1 minute with a soft-bristled toothbrush and fluoride dentifrice provided, immediately followed by rinsing for 30 seconds with 15 cc of their assigned mouthrinse. Examinations for supragingival plaque and gingivitis were conducted after 3 months' and again after 6 months' participation in the study. One hundred eleven participants complied with the protocol and completed the entire 6-month clinical study. At both the 3- and 6-month study examinations, the CPC mouthrinse group exhibited statistically significantly less supragingival plaque and gingivitis than did the control mouthrinse group. At the 6-month examination, the magnitude of these differences met or exceeded 24% for all 4 parameters measured (28.2% for Quigley-Hein Plaque Index, 63.4% for Plaque Severity Index, 24.0% for Löe-Silness Gingival Index, and 66.9% for Gingivitis Severity Index). The magnitude of the reductions in supragingival plaque and gingivitis were adequately large to support a claim of efficacy, in accordance with the criteria provided by the published guidelines of the ADA for the demonstration of the efficacy of a chemotherapeutic agent for the control of supragingival plaque and gingivitis. Thus, the results of this 6-month clinical study support the conclusion that a newly developed mouthrinse containing 0.05% cetylpyridinium chloride provides a statistically significant, clinically relevant level of efficacy for the control of supragingival plaque, and for the control of gingivitis, in accordance with the criteria provided by current ADA guidelines.

Clinical efficacy of an optimized stannous fluoride dentifrice, Part 2: A 6-month plaque/gingivitis clinical study, northeast USA.

The objective of this 6-month, double-blind clinical study, conducted following the American Dental Association guidelines, was to investigate the efficacy of Colgate Optimized Stannous Fluoride (COSF) dentifrice for the control of supragingival dental plaque and gingivitis. This dentifrice contains 0.454% stannous fluoride, stannous chloride, polyphosphate, and citrate in a silica base. At the 3- and 6-month study examinations, the COSF dentifrice group exhibited statistically significant reductions in both plaque and gingivitis compared to the control dentifrice group. At the 6-month examination, the magnitude of these percent reductions exceeded 20% for all 4 parameters measured. Thus, the results of this study support the conclusion that the COSF dentifrice is efficacious for the control of supragingival plaque and gingivitis.

Clinical efficacy of an optimized stannous fluoride dentifrice, Part 3: A 6-month plaque/gingivitis clinical study, southeast USA.

This 6-month, double-blind clinical study, also following the American Dental Association guidelines, investigated the efficacy of Colgate Optimized Stannous Fluoride (COSF) dentifrice in controlling supragingival dental plaque and gingivitis. The same dentifrice, containing 0.454% stannous fluoride, stannous chloride, polyphosphate, and citrate in a silica base was used. Adult men and women from the Atlanta, Georgia, area received an oral prophylaxis and were instructed to brush their teeth twice daily (morning and evening) for 1 minute with their assigned dentifrice, using a soft-bristled toothbrush. As in the first study, plaque and gingivitis examinations were conducted after 3 months and again after 6 months of using the dentifrices. At both the 3- and 6-month study examinations, the COSF dentifrice group exhibited statistically significant reductions in both plaque and gingivitis compared to the control dentifrice group. At the 6-month examination, the magnitude of these percent reductions exceeded 20% for all 4 parameters measured. Thus, the results of this study reflect those found in the New Jersey study, i.e., supporting the conclusion that the COSF dentifrice is efficacious for the control of supragingival plaque and gingivitis.

Clinical efficacy of an optimized stannous fluoride dentifrice, Part 4: A 3-month calculus clinical study, northwest USA.

The objective of this 3-month, double-blind study was to investigate the efficacy of Colgate Optimized Stannous Fluoride (COSF) dentifrice for the control of supragingival dental calculus accumulation. After 3 months' use, the COSF dentifrice group exhibited a statistically significant 56.6% reduction in supragingival calculus formation, as compared to the control dentifrice group. The results of this study support the conclusion that the COSF dentifrice is efficacious for controlling the accumulation of supragingival calculus.