Use of a toothpaste containing 8% arginine and calcium carbonate for immediate and lasting relief of dentin hypersensitivity: A simple and effective in-office procedure.

PURPOSE: To evaluate the effectiveness in reducing dentin hypersensitivity (DH) of a commercial toothpaste containing 8% arginine, calcium carbonate and fluoride when applied by a dental professional immediately prior to a professional dental prophylaxis and again after subjects brushed twice daily with the toothpaste at home for 2 weeks, and additionally to assess whether the % reductions in DH observed in the study are comparable to those found in previously published pivotal studies. METHODS: This clinical study was a single-center, user-blind, monadic study conducted in Mississauga, Canada. Adult subjects who presented with a tactile hypersensitivity score (Yeaple Probe) between 10 and 50 grams of force and an air blast hypersensitivity score of 2 or 3 (Schiff Cold Air Sensitivity Scale) and met all inclusion and exclusion criteria were entered into the study. Immediately following baseline assessment, qualifying subjects received a single topical application of the test toothpaste to two selected hypersensitive teeth by a dental professional using a fingertip and massage for 1 minute per tooth, after which they received a professional dental prophylaxis. Subjects then brushed at-home twice daily for 1 minute with their assigned toothpaste for a period of 2 weeks. Tactile and air blast sensitivity examinations were conducted after the dental cleaning procedure and again after 2 weeks of routine twice daily tooth brushing. RESULTS: 39 subjects complied with the protocol and completed the clinical study. Immediately post-prophylaxis, subjects exhibited statistically significant reductions from baseline of 228.9% (P< 0.001) in tactile hypersensitivity and 48.9% (P< 0.001) in air blast hypersensitivity. Furthermore, after brushing twice daily (morning and evening) for a period of 2 weeks, subjects exhibited statistically significant reductions from baseline of 317.8% (P< 0.001) in tactile hypersensitivity and 90.1% (P< 0.001) in air blast hypersensitivity. These results are consistent with the results of previously published clinical studies, which demonstrated similar % reductions in DH to a single in-office professional application of the desensitizing prophylaxis paste and to a single direct topical self-application of the desensitizing toothpaste. CLINICAL SIGNIFICANCE: The results of this clinical study, together with the results of published pivotal studies, demonstrate that a desensitizing toothpaste containing 8% arginine and calcium carbonate, with or without fluoride, provides statistically significant reductions in dentin hypersensitivity when applied by a dental professional prior to a professional dental prophylaxis. The results also demonstrate that this desensitizing toothpaste provides statistically significant reductions in dentin hypersensitivity when used subsequently as an adjunct to routine twice daily tooth brushing.

Randomized clinical trial of two oral care regimens in reducing and controlling established dental plaque and gingivitis.

PURPOSE: To evaluate the efficacy of a test regimen (TR) integrating the use of a commercially available triclosan, PVM/MA copolymer, and sodium fluoride containing toothpaste, an alcohol-free, fluoride-free cetylpyridinium chloride (CPC) mouthwash, and a manual toothbrush with cheek and tongue cleaner compared to a negative control regimen (NCR) integrating a commercially available 0.76% sodium monofluorophosphate toothpaste, a manual toothbrush and a fluoride-free and alcohol-free non-antibacterial mouthwash in the reduction and control of established plaque and gingivitis after 4 weeks of product use. METHOD: A 4-week, two-cell, double-blind, parallel-group, randomized clinical study was conducted in Cedar Knolls, New Jersey, USA. Recruited subjects were randomly assigned to two regimens: (1) a commercially available toothpaste containing triclosan, PVM/MA copolymer, and 0.243% sodium fluoride, a manual toothbrush with cheek and tongue cleaner, and commercially available mouthwash containing 0.075% CPC in a fluoride-free and alcohol-free base (TR), or (2) a commercially available 0.76% sodium monofluorophosphate toothpaste, a manual toothbrush with rounded/polished bristles, and a fluoride-free and alcohol-free non-antibacterial mouthwash (NCR). Subjects were examined for dental plaque and gingivitis. Gingival, Gingival Severity, Gingival Interproximal, Plaque, Plaque Severity and Plaque Interproximal Index scores were calculated. For regimen comparison, independent t-test and ANCOVA analyses were performed. RESULTS: 130 subjects were screened; 120 enrolled; and 115 subjects completed the randomized clinical trial (RCT). After 4 weeks of product use, subjects using TR exhibited statistically significant (P < 0.001) reductions of 22.3%, 27.8% and 20.4% in mean Gingival, Gingival Severity and Gingival Interproximal Index scores, respectively, as compared to subjects using NCR. After 4 weeks of product use, subjects using TR exhibited statistically significant (P < 0.001) reductions of 28.2%, 60.7% and 27.6% in mean Plaque, Plaque Severity and Plaque Interproximal Index scores, respectively, as compared to subjects using NCR.

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 comparative investigation to evaluate the clinical efficacy of an alcohol-free CPC-containing mouthwash as compared to a control mouthwash in controlling dental plaque and gingivitis: a six-month clinical study on adults in San Jose, Costa Rica.

OBJECTIVE: This study was designed to evaluate the clinical efficacy of an antiplaque alcohol-free mouthwash containing 0.075% cetylpyridinium chloride (CPC) and 0.05% sodium fluoride (NaF), as compared to a control mouthwash containing only 0.05% NaF, in controlling established dental plaque and gingivitis after three and six months of product use. METHODS: This was a single-center, parallel-group, two-cell, double-blind, randomized clinical study. Prospective adult male and female subjects from San Jose, Costa Rica reported to the clinical facility having refrained from all oral hygiene procedures for 12 hours, and from eating, drinking, or smoking for four hours prior to their visit. Qualifying subjects who presented with Gingival Index scores (Löe and Silness Index) of at least 1.0 and Plaque Index scores (Turesky Modified Quigley-Hein Index) of at least 1.5 were allowed to participate in this study. Subjects were randomly assigned to one of two treatment groups according to their baseline gingival and plaque scores. In the first treatment group (Test), subjects used an alcohol-free mouthwash containing 0.075% CPC and 0.05% NaF, whereas in the second treatment group (Control), subjects used a mouthwash containing only 0.05% NaF. Gingivitis and plaque assessments, and examinations of oral hard and soft tissues were conducted after three months and six months of product use. RESULTS: One-hundred and ten (110) subjects complied with the protocol and completed the six-month study. After six months of product use, the Test Mouthwash group exhibited statistically significant reductions from baseline with respect to Gingival (33.5%), Gingival Interproximal (34.5%), Gingival Severity (63.2%), Plaque (33.6%), Plaque Interproximal (30.0%), and Plaque Severity (73.6%) Index scores. After six months of product use, the Control Mouthwash group exhibited statistically significant increases from baseline with respect to Gingival (6.9%), Plaque Interproximal (7.2%), and Plaque Severity (32.7%) Index scores. Furthermore, after six months of product use, the Control Mouthwash group exhibited reductions from baseline with respect to Plaque (6.1%), Gingival Interproximal (3.6%), and Gingival Severity (1.1%) Index scores which were not statistically significant. After three months of product use, the Test Mouthwash group exhibited statistically significant reductions in Gingival (25.0%), Gingival Interproximal (22.3%), Gingival Severity (38.9%), Plaque (26.1%), Plaque Interproximal (22.4%), and Plaque Severity (75.0%) Index scores as compared to the Control Mouthwash group. After six months of product use, the Test Mouthwash group exhibited statistically significant reductions in Gingival (38.1%), Gingival Interproximal (37.1%), Gingival Severity (63.6%), Plaque (36.5%), Plaque Interproximal (33.2%), and Plaque Severity (78.5%) Index scores as compared to the Control Mouthwash group. CONCLUSION: The results of this double-blind clinical study support that 1) an alcohol-free mouthwash containing a combination of 0.075% CPC and 0.05% NaF produces statistically significant reductions in dental plaque and gingivitis after three and six months compared to baseline, and 2) the alcohol-free CPC mouthwash provides a statistically significantly greater level of efficacy in controlling established dental plaque and gingivitis after three and six months of product use as compared to the Control Mouthwash containing only NaF.

A comparison of the efficacy of a triclosan/copolymer/sodium fluoride dentifrice, a stannous fluoride/sodium hexametaphosphate/zinc lactate dentifrice, and a sodium fluoride dentifrice for the control of established supragingival plaque and gingivitis: a six-week clinical study.

OBJECTIVE: To compare the efficacy ofa dentifrice containing 0.3% triclosan, 2.0% PVM/MA copolymer, and 0.243% sodium fluoride in controlling established gingivitis and supragingival plaque to that of a commercially available dentifrice containing 0.454% stannous fluoride, sodium hexametaphosphate, and zinc lactate, and a commercially available dentifrice containing 0.243% sodium fluoride. METHODS: Following a baseline examination for gingivitis and supragingival plaque, qualifying adult male and female subjects from the Mississauga, Ontario, Canada 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 eighty-two (182) subjects complied with the protocol and completed the study. Relative to the 0.243% sodium fluoride 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 supragingival plaque index scores of 26.5% and 29.4%, respectively, after six weeks of product use. Similarly, relative to the 0.243% sodium fluoride dentifrice group, the 0.454% stannous fluoride/sodium hexametaphosphate/zinc lactate dentifrice group exhibited statistically significant reductions in gingival index and plaque index scores of 12.7% and 12.6%, respectively, after six weeks of product use. Further, relative to the 0.454% stannous fluoride/sodium hexametaphosphate/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 15.8% and 19.2%, 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, and 0.243% sodium fluoride is efficacious for the control of established gingivitis and supragingival plaque, 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.

Comparing the efficacy in reducing dentin hypersensitivity of a new toothpaste containing 8.0% arginine, calcium carbonate, and 1450 ppm fluoride to a commercial sensitive toothpaste containing 2% potassium ion: an eight-week clinical study on Canadian adults.

OBJECTIVE: This paper presents the results of one of two eight-week dentin hypersensitivity clinical studies in which the efficacy of a novel toothpaste containing 8.0% arginine, calcium carbonate, and 1450 ppm fluoride as sodium monofluorophosphate (MFP) was compared to that of a benchmark commercial toothpaste containing 2% potassium ion, dosed as 3.75% potassium chloride, and 1450 ppm fluoride as sodium fluoride (NaF). METHODS: An eight-week clinical study, with seventy-seven patients, was conducted in Mississauga, Canada using a double-blind, stratified, two-treatment design. Tactile sensitivity assessments, as well as air blast sensitivity assessments, were used to compare the efficacy of the two products. RESULTS: This clinical study demonstrated that the new toothpaste, containing 8.0% arginine and 1450 ppm MFP in a calcium carbonate base, provided a significant reduction in dentin hypersensitivity when used over a period of eight weeks. The study also showed that this new arginine toothpaste provided significantly greater reductions (p < 0.05) in dentin hypersensitivity in response to tactile (16.2%, 22.4%, and 21.4%) and air blast (16.2%, 29.2%, and 63.4%) stimuli than the benchmark commercial toothpaste containing 2% potassium ion and 1450 ppm NaF in a silica base, after two, four, and eight weeks of product use, respectively. CONCLUSION: A new toothpaste containing 8.0% arginine, calcium carbonate, and 1450 ppm fluoride, as sodium monofluorophosphate (MFP), provides significantly greater hypersensitivity relief (p < 0.05) compared to a commercial sensitive toothpaste containing 2% potassium ion after two, four, and eight weeks of product use.

The stain prevention efficacy of two tooth whitening dentifrices.

An 8-week randomized, double-blind, parallel group clinical study was conducted to assess the extrinsic stain prevention efficacy of three commercially available dentifrices: 1) a dentifrice containing 0.243% sodium fluoride with copolymer, tetrasodium pyrophosphate, and sodium tripolyphosphate in a silica base (Product 1); 2) a dentifrice containing 0.243% sodium fluoride, baking soda and peroxide, tetrasodium pyrophosphate, and sodium tripolyphosphate in a silica base (Product 2); and 3) a dentifrice containing 0.243% sodium fluoride in a silica base (Product 3). After the collection of baseline stain scores by a trained examiner and a subsequent oral prophylaxis, 126 volunteers were randomized to one of the three treatment groups (balanced for composite extrinsic stain scores). Throughout the 8-week treatment period, subjects brushed their teeth twice daily with their assigned dentifrice. At baseline, 4-, and 8-week evaluations, extrinsic dental stain was measured on the facial surfaces of the six maxillary anterior teeth and on the facial and lingual surfaces of the six mandibular anterior teeth using the Lobene Index. A total of 120 subjects completed the study. No adverse events were reported, and subjects who discontinued the study did so for reasons unrelated to the dentifrices. At the 4-week evaluation, composite stain scores were statistically significantly lower (P < .05) for both Product 1 (44.9%) and for Product 2 (34.6%) relative to Product 3. At the 8-week evaluation, composite stain scores were statistically significantly lower (P < .05) for both Product 1 (28.4%) and for Product 2 (29.6%) relative to Product 3. The results of this clinical study demonstrate that both dentifrices, one containing 0.234% sodium fluoride with copolymer, tetrasodium pyrophosphate, and sodium tripolyphosphate in a silica base; and one with 0.243% sodium fluoride with copolymer, tetrasodium pyrophosphate, and sodium tripolyphosphate in a silica base are more effective in preventing natural extrinsic stain formation on teeth as compared with a marketed control dentifrice.

Clinical comparison of the stain-removal efficacy of a novel liquid whitening gel containing 18% carbamide peroxide and a commercially available whitening dentifrice.

The objective of this examiner-blind clinical study was to compare the extrinsic tooth-stain removal efficacy of a novel, nontray, "paint-on" liquid whitening gel containing 18% carbamide peroxide (Colgate Simply White Clear Whitening Gel) with a commercially available whitening dentifrice. After a baseline examination for extrinsic tooth stain, qualifying adult men and women from Canada were randomized into two treatment groups balanced for age, gender, and level of extrinsic tooth stain. Subjects were instructed to brush their teeth twice daily (morning and evening) for 1 minute with their assigned dentifrice (Group 1: nonwhitening dentifrice; Group 2: whitening dentifrice). The subjects in Group 1 also were instructed to use the paint-on whitening gel for 30 minutes twice daily. Examinations for extrinsic tooth stain were repeated after 2 and 3 weeks. Ninety-seven subjects complied with the protocol and completed the entire study. At both the 2- and 3-week examinations, subjects assigned to the liquid whitening gel-treatment group exhibited statistically significant reductions in extrinsic tooth stain (P < .05) with respect to stain area (22.7% reduction at 3 weeks), stain intensity (26.3% reduction at 3 weeks), and overall stain removal (32% reduction at 3 weeks) compared with the commercially available whitening dentifrice group. Thus, the results of the examiner-blind clinical study support the conclusion that Colgate Simply White Clear Whitening Gel provides a significantly greater level of extrinsic tooth-stain removal efficacy than a commercially available whitening dentifrice.

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.