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.

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.

Extrinsic stain removal efficacy of a new dentifrice containing 0.3% triclosan, 2.0% PVM/MA copolymer, 0.243% NaF and specially-designed silica for sensitivity relief and whitening benefits as compared to a dentifrice containing 0.3% triclosan, 2% PVM/MA copolymer, 0.243% NaF and to a negative control dentifrice containing 0.243% NaF: a 6-week study.

PURPOSE: This single-center, double-blind, randomized, parallel-group clinical study was designed to investigate the extrinsic stain removal efficacy of a new antisensitivity dentifrice containing 0.3% triclosan, 2% polyvinylmethyl ether/maleic acid copolymer (PVM/MA copolymer), 0.243% NaF and a new silica specially-designed to occlude dentin tubules, relative to a Positive Control dentifrice and a Negative Control dentifrice. METHODS: 117 qualifying adults were stratified by baseline Lobene Stain Index scores and randomly assigned to brush twice daily using a soft-bristled toothbrush and one of three dentifrices: (1) the Test Dentifrice; (2) a previously clinically proven dentifrice variant containing 0.3% triclosan, 2% PVM/MA copolymer, 0.243% NaF in a high cleaning silica base (Positive Control); and (3) a dentifrice containing 0.243% NaF in a silica base (Negative Control). Extrinsic stain area and stain intensity examinations were repeated after 3 and 6 weeks of product use. RESULTS: Relative to the Negative Control group, the Test group and the Positive Control group exhibited statistically significant improvements in mean Lobene composite stain scores after 3 weeks of product use (39.8% and 40.7% respectively) and after 6 weeks of product use (58.8% and 61.8% respectively). There were no statistically significant differences observed between the stain removal performance of the Test Dentifrice and the Positive Control Dentifrice after 3 and 6 weeks of product use.

Clinical studies to assess the extrinsic stain prevention and stain removal efficacy of a variant of a commercially available dentifrice containing a new dual silica system.

OBJECTIVE: The objective of these two six-week, double-blind clinical studies was to compare the extrinsic stain prevention (Study #1) and stain removal (Study #2) efficacy of a new dentifrice (Colgate Total Advanced Toothpaste) containing 0.3% triclosan/ 2.0% polyvinylmethyl ether/maleic acid (PVM/MA) copolymer/0.243% sodium fluoride in a 17% dual silica base, to a commercially available fluoride dentifrice without tooth whitening ingredients (Crest Cavity Protection Toothpaste) containing 0.243% sodium fluoride in a silica base. METHODS: Following baseline examinations for extrinsic tooth stain and an oral tissue examination, qualifying adult male and female subjects from the northern and central New Jersey, USA areas were randomized for each study into two treatment groups which were balanced for gender and level of extrinsic tooth stain. Subjects received a full oral prophylaxis at the start of Study #1 only. All subjects were provided with their assigned product and a soft-bristled adult toothbrush for home use. Subjects were instructed to brush their teeth for one minute twice daily (morning and evening) using only the dentifrice and toothbrush provided, and to refrain from using any other oral hygiene products for the entire six weeks of the study. There were no restrictions regarding diet or smoking habits during the course of the study. Examinations for extrinsic tooth stain and oral tissue assessments were repeated after three weeks and six weeks of product use. RESULTS: One-hundred fourteen (114) subjects participating in Study #1 and 119 subjects participating in Study #2 complied with the protocol and completed the entire study. In both studies, at the three-week and the six-week examinations, subjects who used the new dentifrice exhibited statistically significantly lower levels of extrinsic tooth stain area and extrinsic tooth stain intensity than did those subjects who used the commercially available fluoride control dentifrice. CONCLUSION: A new dentifrice containing 0.3% triclosan/2.0% PVM/MA copolymer/0.243% sodium fluoride in a 17% dual silica base is more efficacious in the prevention and removal of extrinsic tooth stain than a commercially marketed fluoride dentifrice.

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.

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.

Comparative 3-week clinical tooth-shade evaluation of a novel liquid whitening gel containing 18% carbamide peroxide and a commercially available whitening dentifrice.

A randomized, controlled, examiner-blind, parallel-group clinical trial was performed to compare the tooth-whitening benefits of a novel, nontray, "paint-on" liquid gel containing 18% carbamide peroxide (Colgate Simply White Clear Whitening Gel) to those of a commercially available whitening dentifrice. Efficacy was measured by using Vita shade scores obtained at baseline and after 2 and 3 weeks of product use. Eighty subjects were first balanced according to gender, age, and shade scores into two groups. Half were then randomly assigned to either alpha 3-week routine of tooth-brushing (using a nonwhitening dentifrice) and twice-daily 18% carbamide peroxide gel application or a 3-week routine of twice-daily brushing with the commercially available whitening dentifrice. At the completion of the study, the results showed that subjects' teeth in the liquid whitening gel-treated group exhibited a statistically significant (P < .05) 4.12 mean tooth-shade improvement compared to baseline and exhibited a mean score that was 3.7 units higher than the corresponding mean score of the group assigned to use the whitening dentifrice (statistically significant, P < .05). It can therefore be concluded that the combined use of Colgate Simply White Clear Whitening Gel immediately after brushing with a regular toothpaste is clinically superior at whitening teeth than solely using a clinically proven, commercially available whitening dentifrice.

Efficacy of a novel, nontray, paint-on 18% carbamide peroxide whitening gel.

A double-blind, 3-week, randomized, placebo-controlled, parallel-group clinical trial was conducted to evaluate the tooth-whitening efficacy of a novel nontray, "paint-on" liquid whitening gel containing 18% carbamide peroxide (Colgate Simply White Clear Whitening Gel). Efficacy was based on measured Vita tooth-shade scores collected at baseline and after 2 and 3 weeks of product use. Eighty healthy volunteers were balanced into 2 groups based on gender, age, and shade scores (A3 or higher). The duration of product usage was 30 minutes, twice daily, for 3 weeks. Results from this clinical study showed that subjects' teeth in the liquid whitening gel-treated group exhibited an overall mean 3.84-shade improvement and a 3.5-shade difference compared with teeth in the placebo gel group (statistically significant, P < .05) after 3 weeks. Furthermore, this improvement exceeds the minimum requirement to claim "clinical efficacy" as established by the "Guidelines for the Acceptance of Peroxide-Containing Oral Hygiene Products," published by the American Dental Association in 1994. Therefore, it can be concluded that Colgate Simply White Clear Whitening Gel significantly whitens teeth.

A six-week clinical study to compare the stain removal efficacy of three dentifrices.

The objective of this double-blind clinical study was to compare the tooth whitening efficacy (stain removal) of a new commercially available tooth whitening dentifrice (Colgate Total Plus Whitening Toothpaste) containing 0.2% triclosan and 3.0% PVM/MA copolymer in a 0.243% sodium fluoride/high cleaning silica base, with that of two commercially available dentifrices, Crest Multi-Care Advanced Cleaning Toothpaste and Colgate Winterfresh Gel Fluoride Toothpaste. Following a baseline examination to assess extrinsic tooth stain, qualifying adult male and female subjects were randomized into three treatment groups which were balanced for gender, age and level of extrinsic tooth stain. Subjects were asked to brush their teeth twice (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 and twenty-three (123) subjects complied with the protocol and completed the study. At the six-week examination, subjects assigned to the Colgate Total Plus Whitening Toothpaste treatment group exhibited statistically significant reductions in extrinsic tooth stain area and extrinsic tooth stain intensity relative to those subjects assigned to the Crest Multi-Care Advanced Cleaning Toothpaste and the Colgate Winterfresh Gel Fluoride Toothpaste.

Comparative clinical investigation of the tooth whitening efficacy of two tooth whitening gels.

OBJECTIVE: The objective of this randomized, double-blind, parallel-group clinical study was to compare the tooth whitening efficacy of two tooth whitening gel products--Colgate Simply White Night Clear Whitening Gel containing either 25% carbamide peroxide, or 8.7% hydrogen peroxide--when used once daily at night. METHODOLOGY: Following a baseline tooth shade evaluation using the Vita Shade Guide, qualifying adult male and female subjects from the Central New Jersey area were randomized into two treatment groups, which were balanced for baseline Vita Shade Guide scores, gender and age. The treatment groups were: 1) a tooth whitening gel containing 25% carbamide peroxide; or 2) a tooth whitening gel containing 8.7% hydrogen peroxide. All subjects were given a commercially available, non-whitening dentifrice and a soft-bristled toothbrush at the beginning of the study. In addition, they were also given one of the two tooth whitening gel products. All subjects were instructed to brush their teeth for one minute twice daily (morning and evening) with the non-whitening toothpaste. The subjects were further instructed to apply their assigned tooth whitening gel product once daily at night, per the instructions provided. Evaluations of tooth shade for each subject were repeated after two weeks, and again after three weeks of product use. RESULTS: Fifty-nine (59) subjects complied with the protocol and completed the three-week study. At both the two-week and three-week examinations, all subjects exhibited statistically significant (p < 0.05) tooth shade lightening relative to baseline tooth shade. Further, there was no statistically significant difference in tooth shade lightening between the two tooth whitening gel products. CONCLUSION: The results of this clinical study indicate that after once daily use at night for two or three weeks, a tooth whitening gel containing 25% carbamide peroxide and a tooth whitening gel containing 8.7% hydrogen peroxide both provided statistically significant tooth shade lightening relative to baseline tooth shade. The results also showed that there was no statistical difference in tooth whitening efficacy between the two tooth whitening gel products.

Comparative efficacy of two battery-powered toothbrushes on overnight plaque removal: a single-use clinical study in New Jersey.

OBJECTIVE: The objective of this single-use, examiner-blind clinical study, was to evaluate the efficacy of a newly designed Colgate Actibrush (battery-powered toothbrush) relative to the Crest SpinBrush (battery-powered toothbrush) for the removal of supragingival plaque. METHODOLOGY: This study included the assessment of plaque removal via the comparison of pre- and post-brushing plaque levels. A total of 80 adult male and female subjects from the central New Jersey area reported to the clinical facility for a baseline (pre-brushing) plaque examination after having refrained from all oral hygiene procedures and chewing gum for 24 hours, and from eating, drinking, or smoking for four hours. Subjects were entered into the study and stratified into two balanced groups based on their baseline plaque scores. Subjects were instructed to brush their teeth for one minute under supervision with their assigned toothbrush and a commercially available toothpaste (Colgate Cavity Protection Great Regular Flavor Fluoride Toothpaste), after which they were once again evaluated for supragingival plaque (post-brushing). RESULTS: All 80 subjects complied with the protocol, and completed the single-use clinical study. The subjects assigned to the Colgate Actibrush group exhibited a statistically significant 44.5% greater whole-mouth plaque reduction after a single brushing than did those subjects assigned to the Crest SpinBrush group. Relative to the pre-brushing baseline scores, the Colgate Actibrush group exhibited a statistically significant 63.7% reduction in whole-mouth plaque removal. CONCLUSION: The results of this single-use, examiner-blind, clinical study support the conclusion that the newly designed Colgate Actibrush provides significantly greater efficacy for the removal of supragingival plaque than does the Crest SpinBrush.

Comparison of plaque removal efficacy of a battery-powered toothbrush and a manual toothbrush: a single-use clinical study in New Jersey.

OBJECTIVE: This single-use, examiner-blind clinical study evaluated the efficacy of a newly introduced battery-powered toothbrush (Colgate Motion Toothbrush) relative to a manual toothbrush (Oral-B CrossAction toothbrush) for the removal of supragingival plaque. METHODOLOGY: This study assessed plaque removal via the comparison of pre- and post-brushing plaque levels. A total of 126 adult male and female subjects from the northern New Jersey area reported to the clinical facility for a baseline (pre-brushing) plaque examination after having refrained from all oral hygiene procedures and chewing gum for 24 hours, and from eating, drinking or smoking for four hours. Subjects were entered into the study and stratified into two balanced groups based on their baseline plaque scores. Subjects were instructed to brush their teeth for one minute under supervision with their assigned toothbrush and a commercially available dentifrice, after which they were once again evaluated for supragingival plaque (post-brushing). RESULTS: All 126 subjects completed all aspects of the single-use clinical study. The subjects who used the Colgate Motion toothbrush exhibited a statistically significant 42.1% greater plaque reduction after a single tooth brushing than did those subjects who used the Oral-B CrossAction toothbrush. Relative to the pre-brushing baseline scores, the Colgate Motion toothbrush group exhibited a statistically significant 59.0% reduction in plaque removal. CONCLUSION: The results of this single-use, examiner-blind, clinical study support the conclusion that the battery-powered Colgate Motion toothbrush provides significantly greater efficacy for the removal of supragingival plaque than does the manual Oral-B Cross-Action toothbrush.