Comparative Efficacy of a Soft Toothbrush with Tapered-tip Bristles and an ADA Reference Toothbrush on Established Gingivitis and Supragingival Plaque over a 12-Week Period.

OBJECTIVES: Evaluation of the efficacy of a soft toothbrush with tapered-tip bristles (Test Toothbrush) and an ADA reference soft toothbrush (ADA Toothbrush) on established gingivitis and supragingival plaque over a 12-week period. METHODS: This randomized, single-center, examiner-blind, two-cell, parallel clinical research study assessed plaque removal by the comparison of pre- to- post-brushing after a single use, and again after six- and 12-weeks' use, using the Quigley-Hein Plaque Index, Turesky Modification. The study also assessed gingivitis after six weeks and 12 weeks using the Löe & Silness Gingival Index. Adult male and female subjects from the Central New Jersey, USA area refrained from all oral hygiene procedures for 24 hours. They reported to the study site after refraining from eating, drinking, and smoking for four hours. Subjects had the study procedure explained to them both orally and by written instructions. Subjects then gave written consent to participate before entry into the study. Following an examination for plaque (pre-brushing) and gingivitis (baseline), the subjects were randomized into two balanced groups, each group assigned to one of the two study toothbrushes. Subjects were instructed to brush their teeth for one minute under supervision with their assigned toothbrush and a commercially available fluoride toothpaste (Colgate© Cavity Protection Toothpaste), after which they were again evaluated for plaque (post-brushing). Subjects were dismissed from the study site with their assigned toothbrush and toothpaste, and instructed to brush twice daily at home for the next 12 weeks. The subjects were instructed to brush for one minute during each tooth brushing. The subjects reported to the study site after six weeks and 12 weeks of product use, at which time they were evaluated for plaque and gingivitis. RESULTS: Seventy-one (71) subjects complied with the protocol and completed the clinical study. Compared to the ADA Toothbrush, the Test Toothbrush provided statistically significantly (p < 0.05) greater reductions of 71.1% in whole mouth plaque index scores, 43.8% in plaque severity index scores, and 81.3% in interproximal sites plaque scores after a single tooth brushing. After six weeks' use, the Test Toothbrush provided statistically significantly (p < 0.05) greater reductions of 700% in whole mouth gingival index scores, 700% in gingivitis severity index scores, and 400% in interproximal sites gingival scores compared to the ADA Toothbrush. Also after six weeks' use, the Test Toothbrush provided statistically significantly (p < 0.05) greater reductions of 188.9% in whole mouth plaque index scores, 165% in plaque severity index scores, and 203% in interproximal sites plaque scores compared to the ADA Toothbrush. After 12 weeks' use, the Test Toothbrush provided statistically significantly (p < 0.05) greater reductions of 266.7% in whole mouth gingival index scores, 300% in gingivitis severity index scores, and 250% in interproximal sites gingival scores compared to the ADA Toothbrush. Also after 12 weeks' use, the Test Toothbrush provided statistically significantly (p < 0.05) greater reductions of 158.1% in whole mouth plaque index scores, 143.5% in plaque severity index scores, and 145.4% in interproximal sites plaque scores compared to the ADA Toothbrush. CONCLUSIONS: This study demonstrated that a soft toothbrush with tapered-tip bristles provided a significantly greater reduction in supragingival plaque after a single tooth brushing, as well as after six and 12 weeks of twice-daily use, compared to the ADA Toothbrush. After six and 12 weeks of twice-daily use, it also provided a significantly greater reduction in gingivitis as compared to the ADA Toothbrush.

Comparative Efficacy of a Soft Toothbrush with Tapered-tip Bristles to an ADA Reference Toothbrush on Gingival Abrasion over a 12-Week Period.

OBJECTIVES: Evaluation of the impact of a soft toothbrush with tapered-tip (Test Toothbrush) bristles and an ADA reference toothbrush (ADA Toothbrush) on gingival abrasion over a 12-week period. METHODS: This was a randomized, single-center, examiner-blind, two-cell, parallel clinical research study and used the Danser Gingival Abrasion Index to assess the level of gingival abrasion after a single brushing, as well as after six weeks and 12 weeks of twice-daily brushing. Adult male and female subjects from the Central New Jersey, USA area refrained from all oral hygiene procedures for 24 hours. They reported to the study site after refraining from eating, drinking, and smoking for four hours. Following a qualifying examination using plaque and gingivitis scores along with a baseline gingival abrasion examination, subjects were randomized into two balanced groups, each group using one of the two study toothbrushes. Subjects were instructed to brush their teeth for one minute, under supervision, with their assigned toothbrush and a commercially available fluoride toothpaste (Colgate© Cavity Protection Toothpaste), after which they were again evaluated for gingival abrasion. Subjects were dismissed from the study site with their assigned toothbrush and toothpaste, and instructed to brush twice daily at home for the next 12 weeks. The subjects were instructed to brush for one minute during each tooth brushing. The subjects reported to the study site after six weeks and 12 weeks of product use, at which time they were evaluated for gingival abrasion. RESULTS: Seventy-one (71) subjects complied with the protocol and completed the clinical study. The results of this study showed that the Test Toothbrush provided statistically significantly (p < 0.05) greater reductions in gingival abrasion scores as compared to the gingival abrasion scores of the ADA Toothbrush after a single tooth brushing, after six weeks, and after 12 weeks of product use (75.0%, 85.5%, 73.9%, respectively). CONCLUSIONS: The soft toothbrush with tapered-tip bristles produced significantly less gingival abrasion after 12 weeks of product use as compared to the ADA reference toothbrush.

Efficacy of CPC and essential oils mouthwashes compared to a negative control mouthwash in controlling established dental plaque and gingivitis: A 6-week, randomized clinical trial.

PURPOSE: To evaluate the clinical efficacy of a mouthwash containing 0.075% cetylpyridinium chloride (CPC) in a fluoride-free, alcohol-free base and a mouthwash containing essential oils in a fluoride-free, 21.6% alcohol base as compared to a fluoride-free, alcohol-free non-antibacterial mouthwash in controlling established dental plaque and gingivitis after 6 weeks of twice daily use. METHODS: A 6-week, parallel-group, randomized double blind clinical trial was conducted in Santo Domingo, Dominican Republic. Recruited subjects were randomly assigned to one of three treatment groups: (1) a mouthwash containing 0.075% CPC in a fluoride-free, alcohol-free base (CPC); (2) a commercially-available mouthwash containing essential oils in a fluoride-free, 21.6% alcohol base (EO); or (3) a fluoride-free, alcohol-free non-antibacterial mouthwash (NC). Subjects were instructed to rinse with the assigned mouthwash, after tooth brushing, twice daily (morning and evening). After 4 and 6 weeks of product use, subjects were examined for gingivitis (Whole Mouth Gingival, Gingival Interproximal, Gingival Severity Indexes) and plaque (Whole Mouth Plaque, Plaque Interproximal, and Plaque Severity Indexes) parameters. For treatment group comparisons, ANCOVA and post hoc Tukey's pair-wise comparisons (α = 0.05) were performed. RESULTS: 132 subjects were screened; 120 were enrolled; and 116 completed the study. After 6 weeks of product use, subjects using the CPC and EO mouthwashes exhibited statistically significant (P < 0.001) reductions of all gingival and plaque measurements compared to subjects using the NC mouthwash. Subjects using the CPC mouthwash did not exhibit a statistically significant (P > 0.05) reduction with respect to gingival severity and all plaque measures (Whole, Interproximal, and Severity) when compared to EO mouthwash. Subjects using the CPC mouthwash exhibited statistically significant (P < 0.05) reductions in Gingival Index scores of 5.1% (P = 0.005), and Gingival Interproximal Index scores of 5.5% (P = 0.016) relative to subjects using the EO mouthwash. These reductions were not considered clinically significant.

Randomized controlled trial comparing a powered toothbrush with distinct multi-directional cleaning action to a manual flat trim toothbrush.

PURPOSE: To compare the plaque and gingivitis efficacy of a power toothbrush with distinct multi-directional cleaning action (Colgate® ProClinical® A1500 Power Toothbrush) against a manual flat-trim toothbrush (Oral-B Indicator). METHODS: This randomized control trial was a single-center, examiner-blind, parallel-group, design and assessed plaque removal after a single brushing, as well as plaque removal and gingivitis reduction after 4 weeks and 12 weeks of brushing. Qualifying subjects used their assigned toothbrush to brush their teeth under supervision after which they were evaluated for plaque (post-brushing). Over the next 12 weeks, subjects brushed unsupervised at home with their assigned toothbrush. After 4 weeks and 12 weeks, subjects returned to the center for plaque and gingivitis examinations. RESULTS: 80 subjects were screened for eligibility and randomized into the study. 79 subjects completed the study. Both toothbrushes provided statistically significant reductions in all plaque index scores at all time points in comparison to the pre-brushing scores. After 4 weeks and 12 weeks, statistically significant reductions in gingivitis and gingivitis severity scores were observed for subjects using the power toothbrush, whereas statistically significant increases in gingivitis and gingivitis severity were observed for subjects using the manual toothbrush. In conclusion, relative to the manual toothbrush, the power toothbrush provided statistically significantly (P < 0.05) greater removal of plaque: whole-mouth (131%), gumline (97.4%), and interproximal (220%), as well as reductions in gingivitis (400%), and gingivitis severity (320%) after 12 weeks of use. Compared to the manual flat-trim toothbrush, the power toothbrush with distinct multi-directional cleaning action demonstrates statistically and clinically significantly greater levels of plaque removal and gingivitis reduction at all time points.

Efficacy of two different toothbrush heads on a sonic power toothbrush compared to a manual toothbrush on established gingivitis and plaque.

OBJECTIVE: To evaluate the efficacy of a power toothbrush with distinct multi-directional cleaning action using two different heads (Colgate ProClinical C200 toothbrush with either a triple clean head or a sensitive head) as compared to a manual flat-trim toothbrush (Oral B Indicator toothbrush) on supragingival plaque and established gingivitis. METHODS: This examiner-blind, randomized, controlled, three-treatment, parallel-group clinical research study assessed plaque removal via the comparison of pre- to post-brushing after a single use and again after four weeks of use, using the Rustogi Modified Navy Plaque Index. This study also assessed gingivitis at four weeks using the Löe-Silness Gingival Index. Qualifying adult male and female subjects from the central New Jersey, USA area reported to the study site after refraining from any oral hygiene procedures for 24 hours, and from eating, drinking, and smoking for four hours. Following an examination for plaque and gingivitis, they were randomized into three balanced groups. Subjects were instructed to brush their teeth for two minutes under supervision with their assigned toothbrush and a commercially available toothpaste (Colgate Cavity Protection toothpaste), after which they were again evaluated for plaque. Subjects were dismissed from the study site with the toothpaste and their assigned toothbrush to use at home twice daily for the next four weeks. They reported to the study site after four weeks of product use, at which time they were evaluated for plaque and gingivitis. RESULTS: One hundred twenty (120) enrolled subjects complied with the protocol and completed the clinical study. The results of the study indicated that all three test products provided statistically significant reductions in pre-brushing to post-brushing plaque scores for whole mouth and interproximal sites after a single use. For gingival margin plaque sites, only the Colgate ProClinical C200 toothbrush, with either the triple clean head or the sensitive head, provided statistically significant reductions in pre- to post-brushing plaque scores. After four weeks of product use, all three test products provided statistically significant reductions in baseline to four-week whole mouth and interproximal site plaque scores, but only the Colgate ProClinical C200 toothbrush, with either the triple clean head or the sensitive head, provided a statistically significant reduction in plaque scores at gingival margin sites. All three test products provided statistically significant reductions in gingival and gingivitis severity index scores after four weeks of product use. Relative to the manual toothbrush group, after a single tooth brushing the Colgate ProClinical C200 toothbrush, with either the triple clean head or sensitive head, provided statistically significantly greater reductions in whole mouth plaque index scores (51.9% and 59.3%, respectively), in gingival margin plaque index scores (700% and 650%, respectively), and interproximal plaque index scores (64.2% and 60.4%, respectively). Relative to the manual toothbrush group, after four weeks of use the Colgate ProClinical C200 toothbrush, with either the triple clean head or sensitive head, provided statistically significantly greater reductions in whole mouth plaque index scores (78.6%, and 82.1%, respectively), in gingival margin plaque index scores (3700% and 3400%, respectively), and interproximal plaque index scores (50.8% and 52.5%, respectively). Relative to the manual toothbrush group, after four weeks of use the Colgate ProClinical C200 toothbrush, with either the triple clean head or sensitive head, provided statistically significantly greater reductions in gingival index scores of 900% and 833%, respectively, and in gingivitis severity index scores of 466.7% and 600%, respectively. All statistically significant reductions were at the p ≤ 0.05 level. There were no statistically significant differences between the scores of the Colgate ProClinical C200 toothbrush with triple clean head and the scores of the Colgate ProClinical C200 toothbrush with sensitive head at any comparison time point. CONCLUSION: The Colgate ProClinicaI C200 toothbrush, with either a triple clean head or a sensitive head, provides statistically significant and clinically relevant levels of efficacy in the removal of supragingival dental plaque in the whole mouth, at the gingival margin, and interproximally after a single tooth brushing and after four weeks of use, as well as a statistically significantly greater level of efficacy in the reduction of gingivitis and gingival bleeding when compared to a manual flat-trim toothbrush.

Comparative efficacy of a specially engineered sonic powered toothbrush with unique sensing and control technologies to two commercially available power toothbrushes on established plaque and gingivitis.

OBJECTIVE: To evaluate the efficacy on plaque and established gingivitis of a new specially engineered sonic powered toothbrush with unique sensing and control technologies as compared to two commercially available power toothbrushes. METHODS: This examiner-blind, three-treatment, parallel clinical study assessed plaque reduction via the comparison of pre- to postbrushing after a single use, and following four weeks' use measured by the Rustogi Modification of the Modified Navy Plaque Index. This study also assessed gingivitis using the Löe and Silness Gingival Index after four weeks' use. Qualifying adult male and female subjects from the northern New Jersey area reported to the study site after refraining from all oral hygiene procedures for 24 hours, and from eating, drinking, or smoking for four hours. Following an examination for gingivitis and plaque (pre-brushing), they were randomized into three balanced groups, each group using one of the three study toothbrushes in the order specified by a predetermined randomization plan. Subjects were instructed to brush their teeth for two minutes under supervision with their assigned toothbrush according to the manufacturers' instructions and a commercially available toothpaste (Colgate Cavity Protection), after which they were once again evaluated for plaque (post-brushing). Subjects were then dismissed from the study site with the toothpaste and their assigned toothbrush to use at home twice daily for the next four weeks. They again reported to the study site at which time they were evaluated for plaque and gingivitis. RESULTS: One-hundred eighty-four subjects complied with the protocol and completed the clinical study. Relative to the two commercially available toothbrushes, the new specially engineered sonic powered toothbrush with unique sensing and control technologies provided statistically significantly (p < 0.05) greater reductions in whole mouth plaque index scores (21.9 and 25.8%, respectively), gingival margin plaque index scores (14.5% and 18.9%, respectively), interproximal plaque index scores (160.0% and 136.4%, respectively), facial plaque index scores (17.9% for both), lingual plaque index scores (29.2% for both), and interproximal lingual plaque index scores (200.0% and 350.0%, respectively) after a single tooth brushing. Relative to the two commercially available toothbrushes, the new sonic powered toothbrush also provided statistically significantly (p < 0.05) greater reductions in whole mouth plaque index scores (47.4% and 40.0%, respectively), gingival margin plaque index scores (46.2% and 40.7%, respectively), interproximal plaque index scores (650% and 1400%, respectively), facial plaque index scores (47.6% and 40.9%, respectively), lingual plaque index scores (47.1% and 31.6%, respectively), and interproximal lingual plaque index scores (350.0% and 500.0%, respectively) after four weeks. There was no statistically significant (p > 0.05) difference between the two commercially available toothbrushes for any plaque index score comparison. Relative to one of the commercially available toothbrushes, the new sonic powered toothbrush provided statistically significant reductions (p < 0.05) in gingival index scores (25.0%) and gingivitis severity scores (33.3%) after four weeks of product use. There were no statistically significant (p > 0.05) differences in gingivitis or gingivitis severity index scores between the new sonic powered toothbrush and the other commercially available toothbrush. CONCLUSION: A new specially engineered sonic powered toothbrush with unique sensing and control technologies provides significantly greater levels of efficacy on the removal of dental plaque after a single tooth brushing and after four weeks' use when compared to two commercially available power toothbrushes. The new sonic powered toothbrush also provides significantly greater levels of efficacy on the reduction of gingivitis and gingival bleeding when compared to one of the commercially available power toothbrushes.

A clinical study comparing the supragingival plaque and gingivitis efficacy of a specially engineered sonic powered toothbrush with unique sensing and control technologies to a commercially available manual flat-trim toothbrush.

OBJECTIVE: This study was designed to evaluate the efficacy of a new specially engineered sonic powered toothbrush with unique sensing and control technologies, as compared to a manual flat-trim toothbrush on supragingival plaque and established gingivitis. METHODS: This examiner-blind, two-treatment, parallel clinical research study assessed plaque removal via the comparison of pre- to post-brushing after a single use, and again after four- and 12-weeks' use using the Rustogi Modification of the Modified Navy Plaque Index. This study also assessed gingivitis at four and 12 weeks using the Löe and Silness Gingival Index. Qualifying adult male and female subjects from the southern Florida area reported to the study site after refraining from any oral hygiene procedures for 24 hours, and from eating, drinking, and smoking for four hours. Following an examination for plaque (pre-brushing) and gingivitis, they were randomized (for both plaque and gingivitis) into two balanced groups, each group using one of the two study toothbrushes. Subjects were instructed to brush their teeth for two minutes under supervision with their assigned toothbrush according to the manufacturer's instructions, and commercially available toothpaste (Colgate Cavity Protection Toothpaste), after which they were again evaluated for plaque (post-brushing). Subjects were then dismissed from the study site with the toothpaste and their assigned toothbrush to use at home twice daily for the next 12 weeks. They again reported to the study site after four and 12 weeks of product use, at which time they were evaluated for plaque and gingivitis. RESULTS: Seventy-six out of 82 enrolled subjects complied with the protocol and completed the clinical study. The new specially engineered sonic powered toothbrush with unique sensing and control technologies provided statistically significant reductions in gingival and gingivitis severity index scores after four and 12 weeks of product use. The manual toothbrush provided a statistically significant reduction in gingival index score only at the 12-week time point. Relative to the manual toothbrush group, after a single tooth brushing and after four and 12 weeks, the new sonic powered toothbrush provided statistically significantly greater reductions in whole mouth plaque index scores (1.6, 2.05, and 1.9 times, respectively), gingival margin plaque index scores (12.0, 90.0, and 8.2 times, respectively), and interproximal plaque index scores (2.0, 3.2, and 2.1 times, respectively). Relative to the manual toothbrush group after four and 12 weeks, the new sonic powered toothbrush provided statistically significant reductions in gingival index scores of 11.0 and 7.0 times, respectively, and in gingivitis severity index scores of 3.0 and 3.5 times, respectively. All statistically significant reductions were at the p < or = 0.05 level. CONCLUSION: The new specially engineered sonic powered toothbrush unique sensing and control technologies provides statistically significant and clinically relevant levels of efficacy in the removal of supragingival dental plaque after a single tooth brushing, and after four and 12 weeks' use. The new sonic powered toothbrush also provides statistically significantly greater levels of efficacy in the reduction of supragingival plaque, gingivitis, and gingival bleeding when compared to a manual flat-trim toothbrush.

Comparative investigation of a dentifrice containing triclosan/copolymer/sodium fluoride and specially-designed silica and a dentifrice containing 0.243% sodium fluoride in a silica base for the control of established supra-gingival plaque and gingivitis: a 6-month clinical study.

PURPOSE: To investigate the efficacy of a dentifrice containing 0.3% triclosan, 2.0% PVM/MA copolymer, 0.243% sodium fluoride, and specially-designed silica in controlling established dental plaque and gingivitis. METHODS: Qualifying adult male and female subjects from the West Palm Beach, Florida area were randomly assigned into one of two treatment groups: (1) a dentifrice containing 0.3% triclosan, 2.0% PVM/MA copolymer, 0.243% sodium fluoride, and specially-designed silica (Test Dentifrice); and (2) a dentifrice containing 0.243% sodium fluoride in a silica base (Negative Control Dentifrice). All subjects received an oral soft and hard tissue examination, baseline plaque and gingivitis were assessed, and subjects were dispensed their assigned dentifrice product along with a soft-bristled adult toothbrush for home use. Subjects were instructed to brush their teeth for 1 minute, twice daily (morning and evening), using only the dentifrice provided. Examinations for plaque and gingivitis, and oral soft and hard tissue assessments were repeated after 3 and 6 months of product use. RESULTS: 115 subjects complied with the protocol, and completed the 6-month examination. After 6 months of product use, subjects assigned to the Test Dentifrice group exhibited statistically significant reductions from baseline with respect to Plaque Index, Plaque Severity Index, Gingival Index, and Gingivitis Severity Index scores; and subjects assigned to the Negative Control Dentifrice group exhibited statistically significant reductions from baseline with respect to Gingival Index scores only. Relative to the Negative Control Dentifrice group, the Test Dentifrice group exhibited an 18.8% reduction in Plaque Index; a 50% reduction in Plaque Severity Index; a 19.6% reduction in Gingival Index; and a 60% reduction in Gingivitis Severity Index after 6 months, all of which were statistically significant.

Assessment of hypersensitivity reduction of a dentifrice containing 0.3% triclosan, 2.0% PVM/MA copolymer, 0.243% NaF and specially-designed silica as compared to a dentifrice containing 0.454% stannous fluoride, sodium hexametaphosphate and zinc lactate and to a dentifrice containing 0.243% NaF on dentin hypersensitivity reduction: an 8-week study.

PURPOSE: To evaluate the 8-week dentin hypersensitivity efficacy of three toothpastes: (1) a dentifrice containing 0.3% triclosan, 2.0% PVM/MA copolymer, 0.243% sodium fluoride and specially-designed silica (Test Dentifrice 1); (2) a commercially-available dentifrice containing 0.454% stannous fluoride in a silica base with sodium hexametaphosphate and zinc lactate (Test Dentifrice 2); and (3) a commercially-available non-sensitive dentifrice containing 0.243% sodium fluoride in a silica base (Negative Control Dentifrice). METHODS: For this 8-week randomized controlled clinical study, qualifying subjects had to have at least two hypersensitive teeth with a tactile hypersensitivity score (Yeaple Probe) between 10 and 50 grams of force, and air blast hypersensitivity score of 2 or 3 (Schiff Cold Air Sensitivity Scale). Subjects brushed twice daily for 1 minute, using the assigned toothpaste and toothbrush. Dentin hypersensitivity assessments, as well as examinations of oral hard and soft tissues, were conducted at the baseline examination and after 4 and 8 weeks of brushing. RESULTS: 118 subjects complied with the protocol, and completed the 8-week study. At baseline, the mean tactile sensitivity scores for toothpastes (1), (2) and (3) were 13.6, 14.1 and 13.1; at 4 weeks 28.75, 20.13, and 20.00; and after 8 weeks 33.1, 24.0 and 20.5, respectively. The mean air blast scores for toothpastes (1), (2), and (3) at baseline were 2.5, 2.5, and 2.4; at 4 weeks 1.25, 1.50 and 1.85; and after 8 weeks 0.99, 1.36 and 1.5, respectively. At all time points after the baseline examination, for both tactile and air blast sensitivity scores, the differences between Test Dentifrice 1 and the Negative Control Dentifrice were statistically significant (P < 0.05). The differences between Test Dentifrice 1 and Test Dentifrice 2 were statistically significant (P < 0.05) at 4 and 8 weeks after baseline examination for tactile sensitivity scores and at 8 weeks after baseline examination for air blast sensitivity scores.

A clinical investigation of the efficacy of three commercially available dentifrices for controlling established gingivitis and supragingival plaque.

OBJECTIVE: To assess the efficacy ofa dentifrice containing 0.3% triclosan/2.0% PVM/MA copolymer/0.243% sodium fluoride for controlling established gingivitis and supragingival plaque relative to that of a dentifrice containing 0.454% stannous fluoride, sodium hexametaphosphate, and zinc lactate, and a dentifrice containing 0.243% sodium fluoride as a negative control. METHODS: Following a baseline examination for gingivitis and supragingival plaque, qualifying adult male and female subjects from the Piscataway, NJ, USA area were randomized into three dentifrice groups. Subjects were instructed to brush their teeth twice daily (morning and evening) for one minute with their assigned dentifrice and a soft-bristled toothbrush. Examinations for gingivitis and supragingival plaque were repeated after six weeks of product use. RESULTS: One-hundred and seventy-one (171) subjects complied with the protocol and completed the study. Relative to the group using the dentifrice with 0.243% sodium fluoride alone, the 0.3% triclosan/2.0% PVM/MA copolymer/0.243% sodium fluoride group exhibited statistically significant reductions in gingival index and supragingival plaque index scores of 25.3% and 33.0%, respectively, after six weeks of product use. Similarly, relative to the group using the 0.243% sodium fluoride dentifrice, the 0.454% stannous fluoride, sodium hexametaphosphate, and zinc lactate dentifrice group exhibited statistically significant reductions in gingival index and plaque index scores of 8.1% and 14.1% after six weeks of product use. Further, relative to the 0.454% stannous fluoride, sodium hexametaphosphate, and zinc lactate dentifrice group, the 0.3% triclosan/2.0% PVM/MA copolymer/0.243% sodium fluoride dentifrice group exhibited statistically significant reductions in gingival index and plaque index scores of 18.7% and 22%, respectively. CONCLUSION: The overall results of this double-blind clinical study support the conclusion that a dentifrice containing 0.3% triclosan/2.0% PVM/MA copolymer/0.243% sodium fluoride is efficacious for the control of established gingivitis and supragingival plaque as compared to a regular fluoride dentifrice, and that it provides a greater level of efficacy for the control of gingivitis and supragingival plaque than does a dentifrice containing 0.454% stannous fluoride, sodium hexametaphosphate, and zinc lactate.

Efficacy of three toothbrushes on established gingivitis and plaque.

PURPOSE: To evaluate the efficacy of three toothbrushes [Colgate 3600 Deep Clean (AFT version), the Colgate 3600 Deep Clean (stapled version) and the Oral B Indicator] on the removal of established gingivitis and plaque. METHODS: This examiner-blind, three-treatment, parallel clinical research study assessed plaque removal via the comparison of pre-to- post-brushing and 4-week plaque removal measured by the Rustogi Modification of the Modified Navy Plaque Index. This study also assessed gingivitis using the Löe & Silness Gingival Index. Qualifying adult male and female subjects from the Northern New Jersey area reported to the study site after refraining from any oral hygiene procedures for 12 hours; and from eating, drinking, or smoking for 4 hours. Following an examination for gingivitis and plaque (pre-brushing), they were randomized into three balanced groups, each group using one of the three study toothbrushes in the order specified by a pre-determined randomization plan. Subjects were instructed to brush their teeth for 1 minute under supervision with their assigned toothbrush and a commercially-available toothpaste (Colgate Cavity Protection), after which they were once again evaluated for plaque (post-brushing). Subjects were then dismissed from the study site with the toothpaste and their assigned toothbrush to use at home twice daily for the next 4 weeks. They again reported to the study site at which time they were evaluated for plaque and gingivitis. RESULTS: 109 subjects complied with the protocol and completed the clinical study. For plaque removal, comparisons were made for whole mouth, at the gingival margin and at interproximal sites. The results of the study indicated that all three test toothbrushes provided statistically significantly reductions in pre- to post-brushing plaque index scores of up to 44.0%, 38.6% and 23.6% respectively, after a single toothbrushing. Relative to the Oral B Indicator toothbrush, the Colgate 360 degree Deep Clean toothbrush (AFT version) and Colgate 360 degrees Deep Clean toothbrush (stapled version) provided a statistically significantly greater removal of plaque of up to 107% and 93.0%, respectively, after a single toothbrushing. Also, the group using the Colgate 360 degree Deep Clean toothbrush (AFT version) and the Colgate 360 degree Deep Clean toothbrush (stapled version) exhibited a statistically significantly greater removal of plaque of up to 575% and 400%, respectively, when compared to the Oral B Indicator toothbrush after 4 weeks. The group using the Colgate 3600 Deep Clean toothbrush (AFT version) and the Colgate 3600 Deep Clean toothbrush (stapled version) exhibited statistically significantly greater reductions in gingivitis of up to 23% and 17%, respectively, and greater reductions in gingivitis severity (bleeding sites) of up to 73% and 52% respectively, as compared to the Oral B Indicator toothbrush after 4 weeks. There was no statistically significant difference between the two Colgate 3600 toothbrushes for any parameter and at any comparison time.

Clinical effectiveness of a dentifrice containing triclosan and a copolymer for controlling breath odor.

PURPOSE: To investigate in a double-blind clinical study the effectiveness of a dentifrice containing triclosan and a copolymer (Colgate Total Toothpaste) for controlling breath odor 12 hours after brushing the teeth. METHODS: A panel of four expert judges using a nine-point hedonic scale evaluated breath odor. Following a baseline evaluation of breath odor, prospective study subjects who presented breath odor 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 mouthrinses for the next 12 hours, after which they were once again evaluated for breath odor. 76 adult male and female subjects from the Mississauga, Ontario, Canada area participated in the study. RESULTS: At 12 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 12-hour breath odor score for the Colgate Total group was 4.65, which is within the range of values corresponding to pleasant breath odor; whereas the mean 12-hour breath odor score for the placebo group was 6.11, which is above the threshold value corresponding to unpleasant breath odor. Thus, the results of this double-blind study, conducted according to Guidelines by the Council on Scientific Affairs of the American Dental Association, support the conclusion that Colgate Total dentifrice provides effective control of breath odor at 12 hours after brushing the teeth.

Comparative efficacy of a new battery-powered toothbrush and a commercially available manual toothbrush on the removal of established supragingival plaque: a single-use crossover study in adults.

OBJECTIVE: The objective of this single-use, examiner-blind, two-treatment crossover clinical study was to evaluate the efficacy of a new battery-powered toothbrush (Colgate MicroSonic) relative to that of a currently marketed manual toothbrush (Oral-B Indicator) for the removal of supragingival plaque. This study included the assessment of plaque removal in the whole mouth, at the gumline, and at interproximal sites via the comparison of pre- and post-brushing plaque levels measured using the Rustogi Modification of the Modified Navy Plaque Index. METHODOLOGY: Qualifying adult male and female subjects from the Newark, New Jersey area were provided with a commercially available toothbrush (Colgate Plus Toothbrush) and dentifrice (Colgate Cavity Protection Great Regular Flavor Fluoride Toothpaste) to use at home for three days before beginning the first phase of the crossover study. Subjects returned to the study site after refraining from any oral hygiene procedures for twenty-four hours, and from eating, drinking, or smoking for four hours. Following an examination for supragingival plaque (pre-brushing), they were stratified, based on their plaque scores, into two balanced groups, each of which used the two study toothbrushes in the order specified by a pre-determined randomization plan. Subjects were instructed to brush their teeth for one minute under supervision with their first assigned toothbrush and the commercially available toothpaste provided, after which they were again evaluated for supragingival plaque (post-brushing). Subjects were then dismissed from the study site, and instructed to use the home-use toothbrush and dentifrice. After three days, subjects returned to the study site for the second phase of the crossover study. Pre- and post-brushing evaluations were again performed following the same procedure, with each of the two subject groups now using the second toothbrush in the assigned treatment order. RESULTS: Of the forty-two (42) subjects entered into the study, thirty-nine (39) complied with the protocol and completed the clinical study. The results of the study indicate that the Colgate MicroSonic battery-powered toothbrush provided a statistically significant reduction in pre- to post-brushing plaque index scores of up to 52.9%. Relative to the manual toothbrush, the Colgate MicroSonic battery-powered toothbrush provided a statistically significant greater reduction in supragingival plaque scores of up to 200%. CONCLUSION: The results of this study support the conclusion that the new Colgate MicroSonic battery-powered toothbrush provides a clinically acceptable level of efficacy for the removal of supragingival plaque. Further, the Colgate MicroSonic battery-powered toothbrush exhibited significantly greater levels of efficacy for the removal of supragingival plaque when compared to the Oral-B Indicator Toothbrush.

Clinical efficacy of a new manual toothbrush on gingivitis reduction and plaque removal.

PURPOSE: To evaluate the safety and efficacy of a new manual toothbrush by comparing plaque removal and gingivitis reduction after 4 weeks of use. METHODS: This monadic clinical study included 46 subjects from the Northern New Jersey area who reported to the clinical facility for a baseline plaque and gingivitis examination after having refrained from all oral hygiene procedures and chewing gum for 8 hours, and from eating, drinking, or smoking for 4 hours. The population was comprised of healthy adult male and female subjects aged 27-68 years. Subjects were instructed to brush their teeth for 1 minute, twice a day with their assigned toothbrush and a commercially-available fluoride toothpaste (Colgate Cavity Protection Great Regular Flavor). After 4 weeks of use, subjects returned to the clinical facility for a final gingivitis and plaque examination. RESULTS: All 46 subjects complied with the protocol and completed the 4-week clinical study. The results of the study indicated that the new manual toothbrush was significantly effective in reducing gingivitis and removing plaque after 4 weeks of use. Specifically, the results indicated a 17-39% reduction in gingival sites. In addition, the results indicated plaque removal of up to 96.5% in some parts of the mouth.

Comparative investigation of the desensitizing efficacy of a new dentifrice containing 5.5% potassium citrate: an eight-week clinical study.

OBJECTIVE: This double-blind clinical study was designed to investigate the relative effectiveness of a new desensitizing test dentifrice containing 5.5% potassium citrate, 1.14% sodium monofluorophosphate (MFP) and 10% high-cleaning silica (HCS) in a silica base for reducing dentinal hypersensitivity over an eight-week period, to that of a commercially available desensitizing positive control dentifrice containing 3.75% potassium chloride, 0.32% sodium fluoride and 0.3% triclosan in a silica base. METHODOLOGY: A total of 80 subjects were entered into the study, and stratified into two balanced groups according to their baseline mean thermal (air blast) and baseline mean tactile (Yeaple Probe) sensitivity scores. The two groups were randomly assigned to use either the test dentifrice containing potassium citrate/MFP/HCS, or the positive control dentifrice containing potassium chloride/sodium fluoride/triclosan. The two groups were well balanced with regard to their mean baseline thermal and 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 sensitivity and thermal sensitivity, were conducted at baseline, four weeks, and eight weeks. Examinations were conducted by the same dental examiner on the subjects at each examination. RESULTS: After four weeks' use of their assigned products, those subjects in the test dentifrice group demonstrated no statistically significant difference for controlling dentinal hypersensitivity as compared to the positive control dentifrice group in tactile and air blast. After eight weeks' use of their assigned products, those subjects in the test dentifrice group again demonstrated no statistically significant difference in tactile and air blast sensitivity as compared to the positive control dentifrice group. CONCLUSION: The results of this double-blind clinical study indicate that the use of a commercially available test dentifrice containing 5.5% potassium citrate, 1.14% sodium monofluorophosphate and 10% high-cleaning silica in a silica base demonstrates no statistically significant difference in tactile and air blast sensitivity compared to the commercially available desensitizing positive control dentifrice containing 3.75% potassium chloride, 0.32% sodium fluoride and 0.3% triclosan in a silica base.

Comparison of the clinical efficacy of a new manual toothbrush on gingivitis reduction and plaque removal.

The objective of this controlled, examiner blind, 4-week clinical study was to evaluate and compare the safety and efficacy of a newly designed manual toothbrush, the Colgate 360 degrees toothbrush, to the Oral-B Indicator toothbrush for the control of supragingival plaque and gingivitis. A total of 82 subjects from the northern New Jersey area reported to the clinical facility for a baseline plaque and gingivitis examination after having refrained from all oral hygiene procedures for 12 hours and from eating, drinking, or smoking for 4 hours. The population was comprised of healthy adult men and women 30 to 68 years of age. After the baseline examinations, qualifying subjects were randomized into two groups and assigned to one of the two test toothbrushes. All subjects were instructed to brush their teeth for 1 minute under supervision, after which they were again examined for supragingival plaque. They were then instructed to brush their teeth twice a day for 1 minute with their assigned toothbrush and a commercially available toothpaste (Colgate Cavity Protection Great Regular Flavor Fluoride Toothpaste) for the next 4 weeks. After 4 weeks, subjects returned to the clinical facility for a final gingivitis and plaque examination. Eighty-one subjects complied with the protocol and completed the 4-week clinical study. The results of the study indicated that the new manual toothbrush was statistically significantly effective in reducing gingivitis after 4 weeks and in removing plaque after a single toothbrushing and after 4 weeks of use. Also, the new manual toothbrush exhibited a statistically significant greater reduction in gingivitis and in gingivitis-related bleeding sites after 4 weeks of use as well as statistically significant greater plaque removal after a single toothbrushing and after 4 weeks of use, as compared to the Oral B Indicator toothbrush. This superior plaque-removal performance was found in separate analyses of the whole mouth, at interproximal surfaces, and at the gumline.

A clinical comparison of the gingivitis reduction and plaque-removal efficacy of a new manual toothbrush.

The objective of this controlled, examiner-blind, 4-week clinical study was to evaluate and compare the safety and efficacy of a newly designed manual toothbrush (Colgate 360 degrees toothbrush) to the Oral-B CrossAction toothbrush for the control of supragingival plaque and gingivitis. A total of 80 subjects from the central New Jersey area reported to the clinical facility for a baseline plaque and gingivitis examination after having refrained from all oral hygiene procedures for 12 hours and from eating, drinking, or smoking for 4 hours. The population was comprised of healthy adult men and women 18 to 67 years of age. After the baseline examinations, qualifying subjects were randomized into two groups and assigned to one of the two test toothbrushes. All subjects were instructed to brush their teeth for 1 minute under supervision, after which they were again examined for supragingival plaque. They were then instructed to brush their teeth twice a day for 1 minute with their assigned toothbrush and a commercially available toothpaste (Colgate Cavity Protection Great Regular Flavor Fluoride Toothpaste) for the next 4 weeks. After 4 weeks of use, subjects returned to the clinical facility for a final gingivitis and plaque examination. Seventy-eight subjects complied with the protocol and completed the 4-week clinical study. The results of the study indicated that the new manual toothbrush was statistically significantly effective in reducing gingivitis after 4 weeks and in removing plaque after a single toothbrushing and after 4 weeks of use. Also, the group using the new manual toothbrush exhibited a statistically significant greater reduction in plaque of up to 40% and no statistically significant difference in gingivitis reduction after 4 weeks of use, as compared to the Oral-B CrossAction toothbrush.

The clinical efficacy of Colgate Total Plus Whitening Toothpaste containing a special grade of silica and Colgate Total Fresh Stripe Toothpaste in the control of plaque and gingivitis: a six-month clinical study.

The objective of this six-month, placebo-controlled, double-blind clinical study, conducted in harmony with American Dental Association guidelines, was to provide an assessment of the effectiveness of a new dentifrice formulation of Colgate Total Toothpaste containing a special grade of silica (Colgate Total Plus Whitening Toothpaste), vs. Colgate Total Fresh Stripe Toothpaste as a control, and a placebo dentifrice without triclosan and the copolymer, for the control of supragingival dental plaque and gingivitis. Adult male and female subjects from the state of New Jersey were entered into the study, and stratified into three treatment groups which were balanced for baseline Quigley-Hein Plaque Index scores and baseline Löe-Silness Gingival Index scores. Subjects received an oral prophylaxis, and 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 supragingival plaque and gingivitis were conducted after three-months' and again after six-months' participation in the study. One-hundred ten (110) subjects complied with the protocol and completed the entire six-month clinical study. At both the three- and six-month study examinations, the Colgate Total Plus Whitening Toothpaste group and the Colgate Total Fresh Stripe Toothpaste group exhibited statistically significantly less supragingival plaque and gingivitis than did the placebo toothpaste group. At the six-month examination, the magnitude of these differences exceeded 23.0% for all four parameters measured in the Colgate Total Plus Whitening Toothpaste group (29.9% for Plaque Index, 59.2% for Plaque Severity Index, 23.2% for Gingival Index, and 75.1% for Gingivitis Severity Index). Also, at the six-month examination, the magnitude of these differences exceeded 21.0% for each of the four parameters measured in the Colgate Total Fresh Stripe Toothpaste group (27.9% for Plaque Index, 54.9% for Plaque Severity Index, 21.4% for Gingival Index and 69.2% for Gingivitis Severity Index). The results of this six-month clinical study support the conclusion that Colgate Total Plus Whitening Toothpaste and Colgate Total Fresh Stripe Toothpaste provided a statistically significant, clinically relevant level of efficacy for the control of supragingival plaque and gingivitis, in accordance with the criteria provided by current American Dental Association guidelines.

A study to assess the tooth whitening efficacy of a new dentifrice formulation variant containing a special grade of silica: a six-week study on adults.

The objective of this double-blind clinical study was to investigate the tooth whitening efficacy of a formulation variant of a commercially available dentifrice (Colgate Total Plus Whitening Toothpaste) obtained by the addition of high cleaning silica, relative to that of its currently marketed formulation (Colgate Total Toothpaste). Following a baseline examination, qualifying adult male and female subjects were randomized into two 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. After one, and again after two weeks' use of the assigned dentifrices, a randomly selected panel of subjects was examined for soft tissue findings. Examinations for extrinsic tooth stain were repeated for all subjects after six weeks' use of the study dentifrices. Ninety-seven (97) subjects complied with the protocol and completed the entire study. At the six-week examination, subjects assigned to the new dentifrice formulation group exhibited statistically significantly (p < 0.05) lower levels of extrinsic tooth stain area and extrinsic tooth stain intensity than did those subjects assigned to the Colgate Total Toothpaste group. Thus, the results of this double-blind clinical study support the conclusion that the new dentifrice formulation variant is efficacious for the removal of extrinsic tooth stain.

Clinical efficacy of a new tooth whitening dentifrice.

The objective of this double-blind clinical study was to investigate the tooth whitening efficacy of a variation in formula of a commercially available dentifrice (Colgate Total Toothpaste). The variation (Colgate Total Plus Whitening Toothpaste) was the addition of high cleaning silica to the existing formulation. Following a baseline examination for extrinsic tooth stain, qualifying adult male and female subjects from the Mississauga, Ontario, Canada 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. Ninety-three (93) subjects complied with the protocol and completed the entire study. At the six-week examination, subjects assigned to the new dentifrice formulation group exhibited statistically significantly lower levels of extrinsic tooth stain area and extrinsic tooth stain intensity than did those subjects assigned to the Colgate Total Toothpaste group.