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In vitro studies of the anticalculus efficacy of an improved whitening dentifrice.

Crystal growth inhibition and plaque biofilm calcification laboratory studies were conducted to confirm the anticalculus potential of an enhanced cleaning and whitening dentifrice, based upon a novel enamel-safe, abrasive-polishing silica and pyrophosphate tartar control source with sodium fluoride as the anticaries ingredient. Calcium hydroxyapatite crystal growth following direct supernate treatments was significantly inhibited by the advanced whitening dentifrice. Similarly, plaque biofilm calcification was significantly inhibited by supernate treatments of the advanced whitening dentifrice. In both protocols, the advanced whitening dentifrice produced activity similar to formulations clinically proven for antitartar activity. These results provide support for the antitartar clinical activity of this new dentifrice.

Biofilms↗

Removal of extrinsic stain using a tartar control whitening dentifrice: a randomized clinical trial.

A nine-week, double blind clinical trial was conducted to evaluate the effectiveness of a novel tartar control whitening dentifrice with a silica-based abrasive system on induced dental stain. The study model involved three weeks of stain induction followed by six weeks of unsupervised brushing to assess efficacy. To induce stain, 222 healthy adult volunteers received a dental prophylaxis, and then began a limited brushing regimen supplemented by three-times daily rinsing with tea and once daily rinsing with 15 ml of 0.12% chlorhexidine. This regimen was suspended, and 187 subjects with tooth stain were entered into a six-week clinical trial where they were randomized to either a silica-based tartar control whitening dentifrice or a marketed regular dentifrice control, balancing for stain levels and smoking status. At baseline, three and six weeks, stain area and stain intensity were measured on the 8 anterior teeth using the Lobene Index. After six weeks' use, composite Lobene means were 35% lower for the whitening dentifrice compared to the regular control. In addition to the overall reductions, there were statistically significant reductions in stain area (p < 0.015) and stain intensity (p < 0.01) at both three and six weeks. The tartar control whitening dentifrice was effective in removing stain on the gingival margins and elsewhere on the body of the tooth. Safety profiles for the two test dentifrices were generally similar. After three and six weeks' use, the tartar control whitening dentifrice reduced chlorhexidine and tea stain compared to the marketed control.

Adult↗

Maintenance of tooth color after prophylaxis: comparison of three dentifrices.

Pellicle rapidly accumulates on tooth surfaces after prophylaxis and may acquire cosmetically unacceptable levels of stain. A three-month clinical trial was conducted to evaluate stain prevention by a new silica-based tartar control whitening dentifrice (Crest Extra Whitening) compared to marketed tartar control baking soda peroxide whitening and regular dentifrice controls. Prior to the trial, a one-month screening exercise was conducted to identify adult subjects who accumulated extrinsic tooth stain after dental prophylaxis. A total of 672 subjects were stratified based on tooth whiteness, gender and tobacco usage, then given a dental prophylaxis and randomized into one of three dentifrice treatment groups. All product use was unsupervised. Change in tooth whiteness (delta L*) was determined by comparing colorimeter measurements collected on the facial surfaces of the four central incisors at months 1 and 3 to baseline. Ninety-six percent of subjects completed the three-month study. At both one and three months, the two whitening dentifrices did not differ from baseline in terms of delta L*. In contrast, the regular control had delta L* values of -0.26 and -0.39 at one and three months, respectively, differing significantly from baseline at both time points. Each of the whitening dentifrices differed statistically from the regular control in stain accumulation (p < or = 0.001) at one and three months, but were not different from each other. In general, all three test dentifrices were well tolerated. These data demonstrate the effectiveness of the new tartar control whitening dentifrice in preventing stain accumulation after dental prophylaxis compared to the marketed regular dentifrice control.

Adult↗

Comparative seven-day clinical evaluation of two tooth whitening products.

A 1-week study was conducted to compare the tooth whitening efficacy of two carbamide peroxide-based products (one containing 5% carbamide peroxide and one containing 10% carbamide peroxide). In addition, the perception of transient tooth hypersensitivity associated with the use of these products was subjectively evaluated. Sixty participants took part in a double-blind, randomized, parallel clinical study. Change in tooth color was measured by chroma meter and Vita shade guide at the initiation of the study and after 7 days of product use. Color change (delta E) was calculated using the color-difference equation established by the Commission Internationale de L'Eclairage. Data concerning dental hypersensitivity was assessed by subjective panelist questionnaires administered after the day 7 recall examination. Results of the whitening data showed that there was no significant difference between the two products. After 1 week, the mean delta E for the product containing 5% carbamide peroxide was 4.43 +/- 1.89 and the mean delta E for the product containing 10% carbamide peroxide was 4.05 +/- 1.84. However, the subjective data collected on tooth hypersensitivity showed that the product containing 5% carbamide peroxide was associated with less discomfort. Of the group using the 5% carbamide peroxide product, 20% reported transient sensitivity of their teeth after product use for 1 week compared with 53% of the group using the product with 10% carbamide peroxide. Statistical analysis using a 2-tailed t test showed significant differences between the two groups (P < .05). The data suggest that these products are clinically equivalent for tooth whitening; however, the product containing 5% carbamide peroxide was associated with less tooth hypersensitivity after 1 week of application.

Adult↗

Extrinsic stain removal with a sodium hexametaphosphate-containing dentifrice: comparisons to marketed controls.

Repeated exposure to chlorhexidine and tea has long been recognized to promote extrinsic tooth stain. Previously, the merits of a modified, rapid clinical trial model using chlorhexidine and tea in combination with restricted brushing to accelerate staining have been established. A nine-week randomized and controlled, examiner blind, parallel group clinical trial was conducted to compare selected chemical and mechanical approaches for stain removal using this model. After prophylaxis, stain was induced during a 3-week pre-treatment period, and then the healthy adult volunteers were randomized to one of three treatment groups: an experimental whitening dentifrice containing a combination of sodium hexametaphosphate and soluble pyrophosphate; a marketed alumina-based high abrasive dentifrice; or a lower abrasive control dentifrice. At baseline, three and six weeks, dental stain was measured on the facial and lingual surfaces of the eight anterior teeth using the Lobene index. A total of 94 subjects completed the study. Both the chemical and abrasive dentifrices showed statistically significant reductions in stain area (p < 0.05) relative to the control after three weeks. After six weeks, adjusted mean stain area scores were 0.35, 0.41 and 0.49 for the sodium hexametaphosphate, alumina and regular dentifrice groups, respectively. While the alumina dentifrice showed only a directional benefit, the sodium hexametaphosphate differed statistically (p = 0.023) from the control. Subjects in both the chemical and abrasive dentifrice groups showed statistically significant reductions relative to baseline for Lobene composite stain, stain area and stain intensity (p < 0.05) at six weeks. There were no statistically significant differences in stain levels between the sodium hexametaphosphate and alumina dentifrice groups at any time. This study demonstrates that following six weeks of treatment, sodium hexametaphosphate-containing dentifrices are effective in removing extrinsic tooth stain, with performance at least comparable to that seen with more abrasive dentifrices.

Adult↗

Extrinsic stain prevention with a combination dentifrice containing calcium phosphate surface active builders compared to two marketed controls.

A six-week, randomized and controlled, examiner blind, parallel group clinical trial was conducted to evaluate the stain prevention efficacy of an experimental whitening dentifrice containing a combination of sodium hexametaphosphate and soluble pyrophosphate relative to a marketed high-abrasive dentifrice and a marketed control dentifrice. Following the collection of baseline stain scores and subsequent prophylaxis, healthy volunteers were randomized to one of three treatment regimens, balancing for stain levels and smoking status. Throughout the six-week treatment period, subjects brushed twice daily with the assigned dentifrice while following a rinse regimen of three times daily tea and once daily chlorhexidine. At baseline, three and six weeks, dental stain was measured on the facial and lingual surfaces of the eight anterior teeth using the Lobene Index. A total of 96 subjects completed the study. At three and six weeks, adjusted stain scores were highest in the control group and generally lowest in the sodium hexametaphosphate group for all Lobene parameters (intensity, area and composite). At three weeks, stain area and composite stain scores for the sodium hexametaphosphate dentifrice were statistically significantly (p < 0.05) lower relative to the control, representing reductions of 30% and 33%, respectively. Similar numerical trends were observed after six weeks, with the sodium hexametaphosphate group showing reductions of 21% (p = 0.068) in stain area and 26% (p = 0.055) in composite stain relative to the control. The high-abrasive dentifrice was directionally, though not statistically superior to the control at three and six weeks. All three test products were well-tolerated.

Adult↗

Laboratory studies on the chemical whitening effects of a sodium hexametaphosphate dentifrice.

Laboratory studies were developed to permit the evaluation of chemical actions of toothpaste components in the non-abrasive prevention and removal of tea stains. Powdered hydroxyapatites were used as substrates for adsorption of tea chromogens. Pre-treatment with a sodium hexametaphosphate dentifrice (Crest Dual Action Whitening) reduced tea adsorption to powdered apatite, while post-treatments of pre-stained powder resulted in desorption of tea components. These results exemplified the chemical actions of condensed calcium phosphate surface active builders toward dental stain removal and prevention. A cycling synamel chip model permitted the study of stain prevention, including salivary pellicle formation and chlorhexidine enhancement of dental staining by tea chromogens. Staining was evaluated by image analysis of color development. Under these conditions, condensed phosphate dentifrices were observed to produce superior prevention of stain accumulations, with Crest Dual Action Whitening dentifrice providing stain prevention superior to a variety of commercial dentifrices, including Colgate Total, Aquafresh Whitening, Colgate Tartar Control Whitening, Mentadent Baking Soda and Peroxide Whitening, Close-Up Whitening, Crest Tartar Control and Crest Regular Cavity Protection.

Adsorption↗

Anticalculus efficacy and safety of a novel whitening dentifrice containing sodium hexametaphosphate: a controlled six-month clinical trial.

This study was undertaken to establish the tartar control efficacy and long-term safety of a new dentifrice containing sodium hexametaphosphate. In a randomized, examiner blind, parallel group clinical trial, the experimental dentifrice with 7% sodium hexametaphosphate (5% hexametaphosphate anion), a non-abrasive cleaning agent that provides whitening and tartar control benefits, was compared to two currently marketed controls, a regular sodium fluoride dentifrice and a triclosan/copolymer dentifrice. The 8-month trial model included a 2-month pretest period to establish calculus formation after prophylaxis, and a 6-month test period to evaluate anti-calculus efficacy and safety. Following the pretest period, 551 subjects were allocated to one of the three treatment groups and then monitored for calculus accumulation and soft tissue tolerance. After 6 months, the sodium hexametaphosphate group exhibited superior calculus inhibition compared to the regular sodium fluoride dentifrice and triclosan/copolymer dentifrice (p < 0.01). Over the 6-month observation period, the sodium hexametaphosphate and the marketed control dentifrices were comparable in terms of adverse event type and severity, and no subject discontinued treatment due to an oral soft tissue adverse event.

Adolescent↗

Removal of extrinsic stain using a 7.0% sodium hexametaphosphate dentifrice: a randomized clinical trial.

A nine-week, randomized and controlled clinical trial was conducted to compare the stain removal efficacy of a 0.243% sodium fluoride dentifrice containing 7% sodium hexametaphosphate (5% hexametaphosphate anion) to that of a 0.243% sodium fluoride control dentifrice. Following prophylaxis and a three-week pre-treatment period to induce extrinsic stain, healthy adult volunteers with tooth stain were randomized to the sodium hexametaphosphate dentifrice or the control. Stain area and intensity were assessed at baseline, three and six weeks. At both three and six weeks, the sodium hexametaphosphate dentifrice was statistically significantly superior to the control for all overall stain measures (p < 0.04). After six weeks of product usage, the sodium hexametaphosphate dentifrice demonstrated reductions of 29% in composite stain, 24% in stain intensity, and 25% in stain area relative to the control. Significant reductions in composite stain were seen on both gingival and body regions for the sodium hexametaphosphate dentifrice versus the control at three and six weeks. Both products demonstrated favorable safety profiles, as determined by oral soft tissue evaluations and recording of subject-reported adverse events.

Adolescent↗

Management of dental staining: can low-abrasive dentifrices play a role?

Dental staining, while always a significant problem, has become more important in recent years with the introduction and increased use of chlorhexidine-based mouthrinses. Not only do these rinses themselves cause staining, they also enhance staining from other sources, such as diet or tobacco use. An understanding of the etiologies of dental stains will help today's practitioners become more effective in managing dental stains in their practices. Important strategies for managing stain are patient education about the causes of staining, careful consideration of product recommendations for home use, and routine office visits for prophylaxis. Ideal products for patient use are those with effective stain-removal properties and low abrasivity, which minimizes tooth wear.

Anti-Infective Agents, Local↗

A microbiological and clinical study of the safety and efficacy of baking-soda dentifrices.

This article reports the results of a study that examined the clinical and microbiological changes associated with regular use of baking-soda dentifrices. Two dentifrice formulations were examined in a 6-month longitudinal study of 101 adult subjects with assessments for plaque, gingival inflammation, and stain at baseline and 3 and 6 months during the active phase of the study, and at 3 months after cessation of product use. One dentifrice contained 52% baking soda and 3% sodium percarbonate (Arm & Hammer PeroxiCare) while the other dentifrice contained 65% baking soda (Arm & Hammer Dental Care). Both dentifrices resulted in statistically significant reductions in dental plaque, gingival inflammation, and stain at all time periods compared to baseline. Dental plaque and buccal soft-tissue samples were obtained for microbiological analysis from a 50-subject subset. Microbiological assays, including bacterial culture, phase-contrast microscopy, and immunofluorescence microscopy, confirmed the safety of both formulations. Beneficial alterations in dental plaque bacteria were noted, including significant reductions in the levels of Actinomyces species. The data from this study indicate that dentifrices containing high levels of baking soda are clinically effective and microbiologically safe.

Actinomyces↗

Effect of age on colour of dentition of Baghdad patients.

The aim of this study was to assess the effect of age on tooth colour and to record the range of tooth colour in patients in Baghdad, Iraq. A total of 650 patients who were treated by fixed prosthesis were included in the study. In younger patients the commonest colours found in teeth were white-red and yellow. The proportion of patients with grey colour and red-grey increased with age. Since each tooth might possess different shades in its surface, the quadrant method of shade selection is recommended.

Adolescent↗

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.

Adult↗

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.

Adult↗

The clinical efficacy of a new tooth whitening dentifrice formulation: a six-month study in 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 for extrinsic tooth stain, qualifying adult male and female subjects from New Jersey and Florida 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', three-months' and six-months' use of the study dentifrices. Eighty-six (86) subjects complied with the protocol and completed the entire study. At the six-month 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. Thus, the results of this double-blind clinical study support the conclusion that the new dentifrice formulation variant is efficacious, compared to the control dentifrice, for the removal of extrinsic tooth stain.

Adult↗