Frontal fibrosing alopecia: survey of severity assessment methods in routine clinical practice and validation of the International Frontal Fibrosing Alopecia Cooperative Group measurement guidance.

BACKGROUND: The lack of validated and responsive outcome measures in the management of frontal fibrosing alopecia (FFA) significantly limits assessment of disease progression and treatment response over time. AIM: To understand how FFA extent and progression is currently assessed in UK specialist centres, to validate components of the International FFA Cooperative Group (IFFACG) statement on FFA assessment, and to identify pragmatic advice to improve FFA management in clinic. METHODS: Consultant dermatologists with a specialist interest in hair loss (n = 17) were invited to take part. Preferred FFA assessment methods were explored using questionnaires and clinical scenarios. Participants were asked to identify and mark the current hairline in 10 frontal and 10 temporal hairline images (Questionnaire 1), with assessment repeated 3 months later to assess intraindividual variability (Questionnaire 2) and 12 months later to test whether interindividual accuracy could be improved with simple instruction (Questionnaire 3). RESULTS: All 17 clinicians (100%) completed the questionnaire at each time interval. We identified a wide variation in assessment techniques used by our experts. Measurements were perceived as the most accurate method of assessing frontal recession whereas photography was preferred for temporal recession. Inter-rater reliability between clinicians measuring the frontal hairline scenarios indicated a moderate strength of agreement [intraclass coefficient (ICC) = 0.61; 95% CI 0.40-0.85], yet intrarater reliability was found to be poor with wide limits of agreement (-8.71 mm to 9.92 mm) on follow-up. Importantly, when clear guidance was provided on how the hairline should be identified (Questionnaire 3), inter-rater reliability improved significantly, with ICC = 0.70, suggesting moderate agreement (95% CI 0.51-0.89; P < 0.001). A similar pattern was seen with temporal hairline measurements, which again improved in accuracy with instruction. CONCLUSION: We found that accuracy of measurements in FFA can be improved with simple instruction and we have validated components of the IFFACG measurement recommendations.

The Superior Anti-caries Efficacy of Fluoride Toothpaste Containing 1.5% Arginine.

Innovation in the dental caries area and the development of new superior efficacy treatments to prevent dental caries are as important today as they have ever been, because caries remains a highly prevalent disease globally. Appropriately designed and well-conducted, randomized clinical trials (RCTs) are best-in-class evidence of the effectiveness of a new intervention in medicine and dentistry, and traditional two- to threeyear caries clinical trials are currently the gold standard for proof of superior caries prevention efficacy. Based upon a detailed understanding of plaque metabolism and the importance of pH rise factors in the prevention of caries, a novel toothpaste containing 1.5% arginine, an insoluble calcium compound, and fluoride has been developed, and its superior efficacy compared to toothpaste with fluoride alone has been validated in an unprecedented series of ten RCTs. The results of these RCTs are summarized, and some of the details of the procedures used in the studies are clarified in order to provide an opportunity for objective assessment of their quality. In addition, the results of studies which explored the mechanism of action of this toothpaste are summarized. The arginine-containing fluoride toothpaste offers its users the opportunity to supplement mechanical plaque control with a new technology that helps maintain the natural oral flora in a state that is compatible with health, so as to retain the beneficial effects of the natural flora while significantly reducing the risk of dental caries compared to conventional fluoride toothpaste.

Two-year caries clinical study of the efficacy of novel dentifrices containing 1.5% arginine, an insoluble calcium compound and 1,450 ppm fluoride.

A 2-year double-blind randomized three-treatment controlled parallel-group clinical study compared the anti-caries efficacy of two dentifrices containing 1.5% arginine, an insoluble calcium compound (di-calcium phosphate or calcium carbonate) and 1,450 ppm fluoride (F), as sodium monofluorophosphate, to a control dentifrice containing 1,450 ppm F, as sodium fluoride, in a silica base. The 6,000 participants were from Bangkok, Thailand and aged 6-12 years initially. They were instructed to brush twice daily, in the morning and evening, with their randomly assigned dentifrice. Three trained and calibrated dentists examined the children at baseline and after 1 and 2 years using the National Institute of Dental Research Diagnostic Procedures and Criteria. The number of decayed, missing and filled teeth (DMFT) and surfaces (DMFS) for the three study groups were very similar at baseline, with no statistically significant differences among groups. After 1 year, there were no statistically significant differences in caries increments among the three groups. After 2 years, the two groups using the dentifrices containing 1.5% arginine, an insoluble calcium compound and 1,450 ppm F had statistically significantly (p < 0.02) lower DMFT increments (21.0 and 17.7% reductions, respectively) and DMFS increments (16.5 and 16.5%) compared to the control dentifrice. The differences between the two groups using the new dentifrices were not statistically significant. The results of this pivotal clinical study support the conclusion that dentifrices containing 1.5% arginine, an insoluble calcium compound and 1,450 ppm F provide significantly greater protection against caries lesion cavitation, in a low to moderate caries risk population, than dentifrices containing 1,450 ppm F alone.

Dental caries: a disease which remains a public health concern in the 21st century--the exploration of a breakthrough technology for caries prevention.

This paper provides an overview of modern concepts of dental caries, including its etiology, prevalence, and risk factors. The multifactorial nature of the disease is reviewed, and the concept of reducing caries initiation and progression by reducing pathological factors and restoring caries balance is discussed. In addition, the role and efficacy of fluoride in reducing and preventing caries is highlighted, demonstrating its successes and limitations. A novel technology, based upon arginine and an insoluble calcium compound, has been identified which targets dental plaque to prevent initiation and progression of the caries process by reducing pathological factors. As the mechanisms of action of arginine and fluoride are highly complementary, a next-generation dentifrice has been developed, which combines arginine, an insoluble calcium compound, and fluoride, and has been clinically proven to provide superior caries prevention.

Fluoride toothpaste containing 1.5% arginine and insoluble calcium as a new standard of care in caries prevention.

In spite of obvious achievements in prevention, caries remains a prevalent disease. Fluorides are effective by inhibiting enamel and dentin demineralization and enhancing remineralization, but have little or no influence on bacterial processes in dental plaque. Dental caries is a continuum of stages from reversible, early lesions to irreversible, pre-cavitated lesions and, ultimately, to cavities. Prevention should focus on strengthening protective and reducing pathological factors, and careful monitoring of the disease state. While fluoride and the mineral aspects of caries have been in focus for decades, new insights into the etiology of caries have generated novel concepts and approaches to its prevention and treatment. The observation that some plaque bacteria can produce alkali metabolites and, thus, raise pH or neutralize acid formed in plaque has long been known. Such pH rise factors are related to caries susceptibility. Nourishing the plaque with substrates that encourage alkali-producing reactions is a protective factor in the caries continuum. This article reviews the results of clinical studies with a novel toothpaste containing 1.5% arginine, an insoluble calcium compound, and fluoride which have demonstrated superior remineralization of white spot enamel lesions and rehardening of root surface lesions, favorable effects on the de-/remineralization balance, as well as superior cavity prevention efficacy compared to toothpaste with fluoride alone. Studies have also confirmed formation of ammonia and elevated pH levels in subjects using the arginine-containing toothpaste. This novel toothpaste effectively combines the established effects of fluoride on de- and remineralization with reduction of caries-inducing pathological factors resulting from plaque metabolism.

A clinical investigation using quantitative light-induced fluorescence (QLF) of the anticaries efficacy of a dentifrice containing 1.5% arginine and 1450 ppm fluoride as sodium monofluorophosphate.

OBJECTIVE: The purpose of this study was to assess the ability of a new dentifrice containing arginine, an insoluble calcium compound, and fluoride to arrest or reverse naturally occurring buccal caries lesions measured using Quantitative Light-induced Fluorescence (QLF). METHODS: Three study groups used dentifrices which contained 1) 1.5% arginine and 1450 ppm fluoride as sodium monofluorophosphate (experimental), 2) 1450 ppm fluoride as sodium monofluorophosphate (positive control), and 3) no fluoride (negative control). All three dentifrices were formulated in the same calcium base. The study participants were from three schools in the city of Chengdu, Sichuan Province, China. A total of 446 of 450 recruited subjects completed the study. Of these, 147 were in the experimental, 148 in the positive control, and 151 in the negative control groups. The initial age of the children was 10-12 years (mean 11.4 +/- 0.54); 47.5% were female. RESULTS: Using QLF, assessments of buccal caries lesions were made at baseline and after three and six months of product use. For AQ, representing lesion volume, the baseline mean value for the three groups was 27.30, and at the three-month examination the mean values were 16.76, 19.25, and 25.89 for the experimental, positive, and negative control dentifrices, respectively. This represents improvements from baseline of 38.6%, 29.5%, and 5.2%. At six months, the deltaQ values for the three groups were 13.46, 18.47, and 24.18, representing improvements from baseline of 50.7%, 32.3%, and 11.4%. For all QLF metrics, deltaF (loss of fluorescence), area, and deltaQ, the differences between the negative control and both the experimental and positive control groups were statistically significant (p < or = 0.01). The differences between the experimental and positive control groups attained statistical significance for deltaQ (p < or = 0.003) at the six-month examination. CONCLUSION: It is concluded that both of the fluoride-containing toothpastes are significantly better at arresting and reversing buccal caries lesions than the non-fluoride toothpaste. Furthermore, it is concluded that the new dentifrice containing arginine, an insoluble calcium compound, and fluoride provides significantly greater anticaries benefit than a dentifrice containing fluoride alone.

A clinical investigation of the efficacy of a dentifrice containing 1.5% arginine and 1450 ppm fluoride, as sodium monofluorophosphate in a calcium base, on primary root caries.

OBJECTIVE: The purpose of this six-month study was to assess the ability of a new dentifrice containing 1.5% arginine, an insoluble calcium compound, and 1450 ppm fluoride, as sodium monofluorophosphate, to arrest and reverse primary root caries lesions in adults. METHODS: Three test groups used dentifrices which contained either: 1) 1.5% arginine and 1450 ppm fluoride as sodium monofluorophosphate in a calcium base (experimental); 2) 1450 ppm fluoride as sodium fluoride in a silica base (positive control); or 3) no fluoride in a calcium base (negative control). The study participants were residents of the city of Chengdu, Sichuan Province, China. In order to take part, subjects had to have at least one non-cavitated primary root caries lesion. A total of 412 subjects completed the study. They were aged from 50 to 70 years (mean age 64 +/- 4.1 years) and 53.6% were female. Efficacy for arresting and reversal of primary root caries was assessed by clinical hardness measures and through the use of the Electrical Caries Monitor. RESULTS: After three months of product use, clinical hardness measures showed that 27.7%, 24.6%, and 13.1% of lesions had improved in the experimental, positive, and negative control groups, respectively, and 0.7%, 4.5%, and 16.8% had become worse, respectively. The differences in the distribution of lesion change between the negative control group and both the experimental (p < 0.001) and positive control (p = 0.001) were statistically significant. The Electrical Caries Monitor was also used as an objective measure of lesion severity. The end values increased from baseline to the three-month examinations, but none of the differences between the groups attained statistical significance. After six months, clinical hardness measures showed that only one lesion (0.7%) was worse than at the baseline examination-in the experimental group compared to 9.0% and 18.2% in the positive and negative control groups, respectively. In addition, 61.7%, 56.0%, and 27.0%, respectively, showed improvement for the three groups. The differences in the distribution of lesion change scores between the negative control group and both the experimental (p < 0.001) and positive control (p < 0.001) were statistically significant, as was the difference between the experimental group and the positive control (p = 0.006). The Electrical Caries Monitor end values for the experimental, positive, and negative control groups at the six-month examination were 7.9, 1.9 mega omega(s), and 387 kilo omegas(s), respectively. The differences between the negative control group and both the experimental (p < 0.001) and positive control (p < 0.001) were statistically significant. The difference between the experimental and positive control groups was also statistically significant (p = 0.03). CONCLUSION: It is concluded that the new toothpaste containing 1.5% arginine and 1450 ppm fluoride, as sodium monofluorophosphate in a calcium base, provided greater anticaries benefits than a conventional toothpaste containing 1450 ppm fluoride. Both fluoride toothpastes demonstrated greater benefits than non-fluoride toothpaste.

In situ clinical effects of new dentifrices containing 1.5% arginine and fluoride on enamel de- and remineralization and plaque metabolism.

OBJECTIVE: The primary objective of the three studies reported in this paper was to evaluate the effects of new dentifrices containing 1.5% arginine, an insoluble calcium compound, and fluoride for their ability to promote remineralization of demineralized enamel, and to prevent mineral loss from sound enamel specimens. A secondary objective was to determine the effects on plaque metabolism with respect to the conversion of arginine to ammonia and sucrose to lactic acid. METHODS: In Study 1, an intraoral remineralization/demineralization clinical model was used to assess the ability to promote remineralization of enamel of two dentifrices containing 1.5% arginine and 1450 ppm fluoride, as sodium monofluorophosphate (MFP), relative to a positive control with dicalcium phosphate dihydrate (Dical) and 1450 ppm fluoride, and a negative control with Dical and 250 ppm fluoride. One of the arginine-containing dentifrices contained Dical, and the other contained calcium carbonate as the source of insoluble calcium. Microradiography and image analysis were used to measure mineral changes. The study used a double-blind crossover design with a two-week treatment period. Each treatment period was preceded by a one-week washout period. Each product was used twice a day for two weeks. In the two other studies, the ability of dentifrices containing 1.5% arginine and fluoride to prevent demineralization of sound enamel blocks was assessed using an intraoral demineralization/remineralization clinical model and a double-blind crossover design with a five-day treatment period. A one-week minimum washout period preceded each treatment phase. Microhardness was used to assess mineral changes. Cariogenic challenges were administered by dipping each intraoral retainer into a 10% sucrose solution four times per day. Each product was used twice per day during the treatment period. Plaque was harvested from the specimens to measure the ability of the plaque to convert arginine to ammonia (Studies 2 and 3) and sucrose to lactic acid (Study 3) at the end of each treatment period. In Study 2, a dentifrice containing 1.5% arginine, Dical, and 1450 ppm fluoride as MFP was compared to a matched positive control containing 1450 ppm fluoride and to a matched negative control containing 250 ppm fluoride. In Study 3, a dentifrice containing 1.5% arginine, calcium carbonate, and 1000 ppm fluoride as MFP was compared to a matched positive control containing 1000 ppm fluoride and to a matched negative control containing 0 ppm fluoride. RESULTS: In Study 1, the percent mineral changes were +18.64, +16.77, +4.08, and -24.95 for the 1.5% arginine/Dical/1450 ppm fluoride, the 1.5% arginine/calcium carbonate/1450 ppm fluoride, the positive control, and negative control dentifrices, respectively. Study validation was successfully achieved by showing that the positive control was statistically significantly better that the negative control in promoting remineralization (p = 0.0001). The two arginine-containing test products were statistically significantly better than the positive control (p < 0.05). No significant difference was observed in efficacy between the two arginine-containing products, indicating that efficacy in promoting remineralization was independent of the choice of Dical or calcium carbonate as the source of insoluble calcium. In Study 2, the percent demineralization values were -8.50, +1.67, and +12.64 for the 1.5% arginine/Dical/1450 ppm fluoride, the positive control, and negative control dentifrices, respectively. Study validation was successfully achieved by showing that the positive control was statistically significantly better at preventing demineralization than the negative control (p < 0.0001). The arginine-containing dentifrice was shown to be statistically significantly better at preventing enamel demineralization than the positive control (p < 0.0001). Plaque metabolism measures for plaque exposed to the three treatments gave the following values for ammonia production after an arginine-sucrose challenge, expressed in nanomoles per milligram plaque: 162.7; 105.4; and 115.9 for the 1.5% arginine/Dical/1450 ppm fluoride, positive control, and negative control dentifrices, respectively. No statistically significant differences were observed between the three treatments, but the arginine-based dentifrice showed directionally higher ammonia production than both the positive and negative controls In Study 3, the percent demineralization values were +1.16, +4.96, and +15.34, for the 1.5% arginine/calcium carbonate/1 000 ppm fluoride, the positive control, and negative control dentifrices, respectively. Study validation was successfully achieved by showing that the positive control was statistically significantly better at preventing demineralization than the negative control (p < 0.0001). The arginine-containing dentifrice was shown to be statistically significantly better at preventing enamel demineralization than the positive control (p < 0.05). Plaque metabolism measures for plaque exposed to the three treatments gave the following values for ammonia production after an arginine-sucrose challenge, expressed in nanomoles per milligram plaque: 99.6; 56.2; and 42.2 for the 1.5% arginine/calcium carbonate/1000 ppm fluoride, the positive control, and negative control dentifrices, respectively. Plaque treated with the arginine- containing dentifrice produced significantly more ammonia than the positive and negative control dentifrices (p < 0.05). No significant difference in ammonia production was observed between the two controls. Lactic acid production after a sucrose challenge gave the following values, expressed as nanomoles per milligram plaque: 4.06; 5.12; and 4.64 for the 1.5% arginine/calcium carbonate/1000 ppm fluoride, the positive control, and negative control dentifrices, respectively. No significant difference was observed between the three treatments, but the arginine-based treatment showed directionally lower lactic acid production. RESULTS: The results of these three studies show that dentifrices containing 1.5% arginine, an insoluble calcium compound, and fluoride have a significantly improved ability to promote remineralization and prevent demineralization of enamel relative to dentifrices containing the same level of fluoride alone. Two different sources of insoluble calcium were evaluated, Dical and calcium carbonate. Dentifrices with Dical and with calcium carbonate, each in combination with 1.5% arginine and fluoride, provided superior efficacy as compared to matched dentifrices with fluoride alone, and the two products demonstrated comparable efficacy in promoting remineralization. The results of these studies demonstrate that the addition of 1.5% arginine to Dical-and calcium carbonate-based fluoride dentifrices provides superior efficacy in preventing demineralization and promoting remineralization, and, further, indicate that he arginine-containing dentifrices enhance the ability of plaque to metabolize arginine to ammonia.

In vivo effects of a new dentifrice containing 1.5% arginine and 1450 ppm fluoride on plaque metabolism.

OBJECTIVE: This paper presents the results of a clinical study assessing the in vivo effects on plaque metabolism of a new dentifrice containing 1.5% arginine, an insoluble calcium compound, and 1450 ppm fluoride compared to a commercially available dentifrice containing 1450 ppm fluoride alone. METHODS: A four-week, parallel, randomized, double-blind clinical study using 54 subjects was conducted at the New York University College of Dentistry Bluestone Center for Clinical Research. Two study groups used the following products for two weeks: 1) a dentifrice containing 1.5% arginine, an insoluble calcium compound, and 1450 ppm fluoride as sodium monofluorophosphate (MFP; test); and 2) a commercial silica dentifrice with 1450 ppm fluoride as sodium fluoride (NaF; control). In the following two-week period, all subjects used the control product. The effects of product use on plaque metabolism in vivo were assessed by conducting ex vivo analyses at baseline, after two weeks of assigned product use, and after two weeks of control product use. These plaque analyses comprised pH measurements before and after an in vivo sucrose rinse, and measurements of ammonia production and lactate production. RESULTS: The study showed that subjects using the test dentifrice, containing 1.5% arginine, an insoluble calcium compound, and 1450 ppm fluoride, had significantly higher plaque pH values before the sucrose challenge than those using the commercially available control dentifrice (p < or = 0.01). Plaque samples from subjects using the arginine-containing dentifrice also produced significantly higher levels of ammonia (p < or = 0.01). Subjects using the arginine-containing dentifrice also had a directionally higher plaque pH after the sucrose challenge, and their plaque samples produced a directionally lower level of lactate during the two-week treatment period compared to subjects using the control dentifrice. Following two weeks of subsequent use of the control product, there were no significant differences in plaque metabolism measures between groups. CONCLUSION: A new dentifrice containing 1.5% arginine, an insoluble calcium compound, and 1450 ppm fluoride has been shown in this study to modulate plaque metabolism, increasing ammonia production and decreasing lactate production, thereby increasing plaque pH to help restore a pH-neutral environment.

Clinical evidence for the superior efficacy of a dentifrice containing 8.0% arginine and calcium carbonate in providing instant and lasting relief of dentin hypersensitivity.

This paper briefly discusses recent scientific and clinical research validating the effectiveness of a toothpaste containing 8.0% arginine and calcium carbonate, known as Pro-Argin technology, including clinical evidence for the superior efficacy of this toothpaste versus a potassium-based desensitizing toothpaste. It also introduces new clinical data which prove that a toothpaste containing 8.0% arginine and calcium carbonate delivers superior instant and lasting relief of dentin hypersensitivity compared to a toothpaste containing 8% strontium acetate.

Advances in the clinical management of dentin hypersensitivity: a review of recent evidence for the efficacy of dentifrices in providing instant and lasting relief.

This paper summarizes the current state of knowledge of the epidemiology, etiology, and clinical management of dentin hypersensitivity, with special emphasis on the evidence for the effectiveness of commonly available sensitivity relief toothpastes. It reviews the scientific and clinical research validating the effectiveness of a recently introduced toothpaste containing 8.0% arginine and calcium carbonate, known as Pro-Argin technology, including clinical evidence for the superior efficacy of this toothpaste versus potassium-based sensitivity relief toothpastes. It critiques recently published studies on a strontium-based sensitivity relief toothpaste. Finally, it summarizes new clinical data from three parallel, randomized, head-to-head studies comparing the efficacy of a toothpaste containing 8.0% arginine and calcium carbonate (positive control) to a strontium-based sensitivity relief toothpaste (test) in delivering superior instant and lasting sensitivity relief. The results of these new clinical studies clearly support the conclusions that 1) a toothpaste containing 8.0% arginine and calcium carbonate provides superior efficacy with respect to both immediate and lasting relief of dentin hypersensitivity compared to a toothpaste containing 8% strontium acetate, and 2) a toothpaste containing 8% strontium acetate is no more effective in providing immediate relief of dentin hypersensitivity than a regular fluoride toothpaste.

Comparison of the effects on dentin permeability of two commercially available sensitivity relief dentifrices.

OBJECTIVE: The in vitro effects of two commercial sensitivity relief dentifrices, one containing 8.0% arginine, calcium carbonate, and 1450 ppm fluoride as sodium monofluorophosphate (MFP), and the other containing 8% strontium acetate and 1040 ppm fluoride as sodium fluoride, in occluding dentin tubules and reducing dentin fluid flow were compared in a blinded study using hydraulic conductance (Flodec). METHODS: Human dentin segments were cut from extracted molars, mounted on acrylic blocks, etched, and connected to a Flodec to measure hydraulic conductance. Segments were divided into two groups (n = 6) and treated for one minute with either the arginine/calcium carbonate dentifrice or the strontium acetate dentifrice. The blocks were rinsed, connected to the Flodec, and the conductance was measured. Blocks were rinsed again and incubated in phosphate-buffered saline (PBS) for at least two hours before the next treatment. The cycle was repeated for a total of three treatments (one using a fingertip and the next two using a toothbrush). After the third treatment, the blocks were incubated in PBS overnight and conductance was re-measured. The two groups were further divided into three sets of two segments each, which were challenged for one minute with either 6% citric acid, orange juice, or grapefruit juice. RESULTS: The hydraulic conductance study showed that the dentifrice containing 8.0% arginine, calcium carbonate, and 1450 ppm fluoride provided a significantly higher percentage reduction in fluid flow immediately after fingertip application, as well as after two brushing cycles, compared to the dentifrice containing 8% strontium acetate and 1040 ppm fluoride. After various acid challenges, the percentage reduction in fluid flow of dentin treated with the arginine/calcium carbonate dentifrice remained significantly higher than that of the strontium acetate dentifrice. These results are highly consistent with the results from an independent clinical study which showed that the arginine/calcium carbonate dentifrice provided dentin hypersensitivity relief immediately after direct topical application with a fingertip and massage for one minute per sensitive tooth, whereas the strontium acetate dentifrice did not. CONCLUSION: Based on this in vitro hydraulic conductance study, the dentifrice containing 8.0% arginine, calcium carbonate, and 1450 ppm fluoride was significantly more effective in reducing fluid flow through dentin tubules as a result of occlusion than the dentifrice containing 8% strontium acetate and 1040 ppm fluoride. Further, the superior occlusion obtained with the arginine/calcium carbonate dentifrice was resistant to acid challenge.

Clinical efficacy in reducing dentin hypersensitivity of a dentifrice containing 8.0% arginine, calcium carbonate, and 1450 ppm fluoride compared to a dentifrice containing 8% strontium acetate and 1040 ppm fluoride under consumer usage conditions before and after switch-over.

OBJECTIVE: The objective of this 16-week, double-blind, randomized, switch-over design study was to compare the efficacy in reducing dentin hypersensitivity of a dentifrice containing 8.0% arginine, calcium carbonate, and 1450 ppm fluoride as sodium monofluorophosphate (Colgate Sensitive Pro-Relief [also marketed as elmex Sensitive Professional]) to a desensitizing dentifrice containing 8% strontium acetate and 1040 ppm fluoride as sodium fluoride (Sensodyne Rapid Relief) under relevant consumer usage conditions. METHODS: Qualifying subjects from the San Francisco, CA, USA area, who presented two hypersensitive teeth 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), participated in this two-phase double-blind study. Subjects were randomly assigned to one of two test groups. The first phase of the study consisted of twice-daily at-home brushing with the first assigned dentifrice for eight weeks. The second phase of the study consisted of switching product use to the second assigned dentifrice for a second eight-week period. Dentin hypersensitivity examinations, which comprised tactile and air blast hypersensitivity measures, as well as examinations of oral hard and soft tissues, were conducted at baseline, at the completion of the first study phase, and at two weeks and eight weeks of the second phase. RESULTS: One-hundred and twenty-one subjects complied with the study protocol and completed the study. Study Phase I: Subjects who brushed twice daily for eight weeks with the arginine/calcium carbonate dentifrice experienced statistically significant improvements in mean tactile and air blast hypersensitivity scores (51.3% and 39.4%, respectively) relative to that experienced by subjects who brushed with the strontium acetate dentifrice. Study Phase II: Subjects who brushed with the arginine/calcium carbonate dentifrice for the first eight weeks of the study and then switched to brush with the strontium acetate dentifrice for the second eight weeks of the study, did not exhibit further improvements in mean tactile or mean air blast hypersensitivity scores after two and eight weeks of switch-over product use. However, subjects who brushed with the strontium acetate dentifrice for the first eight weeks of the study and then switched to brush with the arginine/calcium carbonate dentifrice exhibited statistically significant improvements in mean tactile and air blast hypersensitivity scores two weeks (35.2% and 29.9%, respectively) and eight weeks (40.3% and 35.3%, respectively) after product switch-over. Relative to the subjects who switched from twice-daily brushing with the arginine/calcium carbonate dentifrice to brush with the strontium acetate dentifrice, those who switched from brushing with the strontium acetate dentifrice to brush with the arginine/calcium carbonate dentifrice exhibited statistically significant improvements in mean tactile hypersensitivity scores (10.3%) and in mean air blast hypersensitivity scores (16.3%) eight weeks after product switch-over. CONCLUSION: Eight weeks of brushing with Colgate Sensitive Pro-Relief(elmex Sensitive Professional) provides significant reductions in mean dentin hypersensitivity relative to the identical use of Sensodyne Rapid Relief. Additionally, the dentin hypersensitivity reductions achieved by twice-daily brushing with Sensodyne Rapid Relief are significantly improved by switching to twice-daily brushing with Colgate Sensitive Pro-Relief (elmex Sensitive Professional) for two and eight weeks. Further, the dentin hypersensitivity reductions achieved by twice-daily brushing with Colgate Sensitive Pro-Relief (elmex Sensitive Professional) are not improved by switching to twice-daily brushing with Sensodyne Rapid Relief for two or eight weeks. Eight weeks' use of Colgate Sensitive Pro-Relief (elmex Sensitive Professional), after having used Sensodyne Rapid Relief for an initial eight-week time period, provides statistically significant improvements in dentin hypersensitivity relative to eight weeks' use of the Sensodyne Rapid Relief.

Comparing the efficacy in providing instant relief of dentin hypersensitivity of a new toothpaste containing 8.0% arginine, calcium carbonate, and 1450 ppm fluoride relative to a benchmark desensitizing toothpaste containing 2% potassium ion and 1450 ppm fluoride, and to a control toothpaste with 1450 ppm fluoride: a three-day clinical study in New Jersey, USA.

OBJECTIVE: The objective of this double-blind, randomized, parallel-design clinical study was to compare the efficacy in reducing dentin hypersensitivity of a novel toothpaste containing 8.0% arginine, calcium carbonate, and 1450 ppm fluoride to a benchmark desensitizing toothpaste containing 2% potassium ion and 1450 ppm fluoride, and to a control toothpaste containing 1450 ppm fluoride, instantly after a single direct topical self-application using a fingertip, and after subsequent brushing twice daily for three days. METHODS: Qualifying subjects from the Piscataway, New Jersey, USA area who presented two hypersensitive teeth 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 Sensitivity Scale), participated in this study. The first phase of the study consisted of a single topical application of the assigned product directly onto the hypersensitive surface of each of the two baseline-designated hypersensitive teeth. Study subjects applied a pea-size amount of their assigned toothpaste onto the hypersensitive surface of each tooth and massaged each surface for one minute. The second phase of the study consisted of twice-daily at-home brushing with the assigned toothpaste for three days. Dentin hypersensitivity assessments, as well as examinations of oral hard and soft tissues, were conducted at baseline, immediately after direct topical application, and after three days of product use. RESULTS: One-hundred and twenty-five subjects complied with the study protocol and completed the study. Relative to the benchmark desensitizing toothpaste and the control toothpaste groups, the 8.0% arginine toothpaste group exhibited statistically significant (p < 0.05) reductions in dentin hypersensitivity on both tactile and air blast hypersensitivity scores immediately after direct application. Reductions in sensitivity for the 8.0% arginine toothpaste compared to the benchmark desensitizing toothpaste and control toothpaste were 161.2% and 180.2% (tactile), and 59.8% and 58.0% (air blast), respectively. Relative to the benchmark desensitizing toothpaste and control toothpaste groups, the 8.0% arginine group exhibited statistically significant (p < 0.05) reductions in sensitivity after the subsequent three days of twice-daily regular tooth brushing of 147.1% and 181.2% (tactile), and 70.1% and 70.9% (air blast), respectively. CONCLUSION: A single fingertip topical self-application of a new 8.0% arginine-calcium carbonate toothpaste directly onto the hypersensitive surface of teeth provides significant immediate improvement in dentin hypersensitivity relative to an identical application of a control toothpaste and to a benchmark potassium-based desensitizing toothpaste. Significant improvements in dentin hypersensitivity were also demonstrated after three days of brushing with the 8.0% arginine-calcium carbonate toothpaste, subsequent to the single topical self-application of the product, relative to an identical application of the control toothpaste and to the potassium-based desensitizing toothpaste. The improvement demonstrated by the 8.0% arginine toothpaste after direct application was maintained after three days of twice-daily brushing.

The clinical effect of a single direct topical application of a dentifrice containing 8.0% arginine, calcium carbonate, and 1450 ppm fluoride on dentin hypersensitivity: the use of a cotton swab applicator versus the use of a fingertip.

OBJECTIVE: The primary objective of this examiner-blind, randomized clinical study was to compare the effect of a toothpaste containing 8.0% arginine, calcium carbonate, and 1450 ppm fluoride, as sodium monofluorophosphate (MFP), in providing instant relief of dentin hypersensitivity when delivered as a single direct topical application using a cotton swab applicator versus using a fingertip. A secondary objective was to evaluate the effect on dentin hypersensitivity of the dentifrice after seven days of twice-daily at-home brushing, subsequent to the single direct topical application performed at the beginning of the study. METHODS: Qualifying subjects possessed two baseline-designated hypersensitive teeth with a tactile hypersensitivity score of 10 to 50 grams of force (Yeaple Probe), and an air blast hypersensitivity score of 2 or 3 (Schiff Cold Air Sensitivity Scale). In the first phase of the study, subjects topically self-applied the test product using a fingertip, a previously validated method, for one of the hypersensitive teeth (fingertip test teeth), and a cotton swab applicator for the second hypersensitive tooth (swab test teeth). In the second phase of the study, subjects brushed with the test dentifrice twice daily for seven days. Dentin hypersensitivity assessments, as well as examinations of oral hard and soft tissues, were conducted immediately after direct topical product application, and after the subsequent seven-day brushing period. RESULTS: Eighty-four subjects complied with the study protocol and completed the study. Immediately after direct topical application, the fingertip test teeth and the swab test teeth exhibited statistically significant (p <0.05) improvements from baseline in mean tactile hypersensitivity scores (191.7% and 182.1%, respectively), and mean air blast hypersensitivity scores (58.1% and 56.3%, respectively). After the seven-day brushing period, the fingertip test teeth and the swab test teeth continued to exhibit statistically significant (p < 0.05) improvements from baseline in mean tactile hypersensitivity scores (191.7% and 190.5%, respectively) and mean air blast hypersensitivity scores (57.4% and 58.2%, respectively). No statistically significant (p > 0.05) differences were indicated between the fingertip test teeth and the swab test teeth with respect to mean tactile hypersensitivity scores or mean air blast hypersensitivity scores immediately after topical application (3.4% and 4.4%, respectively), or after seven days of twice-daily brushing with the product (0.41% and -1.90%, respectively). CONCLUSION: The results of this examiner-blind clinical study support the conclusions that 1) both fingertip and cotton swab methods of application provide significant reductions in dentin hypersensitivity immediately after a single direct topical application of the 8.0% arginine-calcium carbonate dentifrice, 2) when topical application is followed by seven days of twice-daily brushing with the dentifrice, the sensitivity relief obtained instantly after topical application is maintained, and 3) after topical application and after seven days of brushing, neither method of topical application provided a level of control of dentin hypersensitivity that differed significantly from the other.

Comparing the efficacy in providing instant relief of dentin hypersensitivity of a new toothpaste containing 8.0% arginine, calcium carbonate, and 1450 ppm fluoride to a benchmark desensitizing toothpaste containing 2% potassium ion and 1450 ppm fluoride, and to a control toothpaste with 1450 ppm fluoride: a three-day clinical study in Mississauga, Canada.

OBJECTIVE: The objective of this double-blind, randomized, parallel-design clinical study was to compare the efficacy in reducing dentin hypersensitivity of a novel toothpaste containing 8.0% arginine, calcium carbonate, and 1450 ppm fluoride to a benchmark desensitizing toothpaste containing 2% potassium ion and 1450 ppm fluoride, and to a control toothpaste containing 1450 ppm fluoride, instantly after a single direct topical self-application using a fingertip, and after subsequent brushing twice daily for three days. METHODS: Qualifying subjects from the Mississauga, Canada area who presented two hypersensitive teeth 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 Sensitivity Scale) participated in this study. The first phase of the study consisted of a single topical application of the assigned product directly onto the hypersensitive surface of each of the two baseline-designated hypersensitive teeth. Study subjects applied a pea-size amount of their assigned toothpaste onto the hypersensitive surface of each tooth, and massaged each surface for one minute. The second phase of the study consisted of twice-daily at-home brushing with the assigned toothpaste for three days. Dentin hypersensitivity assessments, as well as examinations of oral hard and soft tissues, were conducted at baseline, immediately after direct topical application, and after three days of product use. RESULTS: One-hundred and twenty subjects complied with the protocol and completed the study. Relative to the desensitizing toothpaste and the control toothpaste groups, the 8.0% arginine toothpaste group exhibited statistically significant (p < 0.05) reductions in dentin hypersensitivity on both tactile and air blast measures immediately after completion of the first phase of the study. Reductions in sensitivity for the 8.0% arginine toothpaste, compared to the benchmark desensitizing toothpaste and the control toothpaste, were 130.7% and 139.5% (tactile), and 43.8.0% and 49.6% (air blast), respectively. Relative to the benchmark desensitizing toothpaste and control toothpaste groups, the 8.0% arginine group also exhibited statistically significantly (p < 0.05) reductions in sensitivity after completion of the second phase of the study, of 104.9% and 136.1% (tactile), and 44.5% and 53.2% (air blast), respectively. There was no loss of the instant relief effects in the 8.0% arginine group after the brushing period. CONCLUSION: A single fingertip topical self-application of the 8.0% arginine-calcium carbonate toothpaste directly onto the hypersensitive surface of teeth provides significant immediate improvements in dentin hypersensitivity relative to an identical application of the control toothpaste and to the benchmark potassium-based desensitizing toothpaste. Significant improvements in dentin hypersensitivity were also demonstrated after three days of brushing with the 8.0% arginine-calcium carbonate toothpaste, subsequent to the single topical self-application of the product, relative to an identical application of the control toothpaste and to the benchmark potassium-based desensitizing toothpaste. The improvement demonstrated by the 8.0% arginine toothpaste after direct application was maintained after three days of twice-daily brushing.

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

OBJECTIVE: The objective of this double-blind dentin hypersensitivity clinical study was to investigate the effectiveness of a new desensitizing toothpaste containing 8.0% arginine, calcium carbonate, and 1450 ppm fluoride as sodium monofluorophosphate (MFP), compared to that of a benchmark commercially available desensitizing toothpaste containing 2% potassium ion, dosed as 5.0% potassium nitrate, and 1450 ppm fluoride as sodium fluoride (NaF). METHODS: A total of 80 subjects were entered into the study, and stratified into two balanced groups according to their baseline mean tactile and mean air blast sensitivity scores. The two groups were randomly assigned to use either the new arginine toothpaste or the benchmark commercially available desensitizing toothpaste containing 2% potassium ion. Subjects were instructed to brush their teeth twice daily (morning and evening) for one minute with their assigned toothpaste and a commercially available soft-bristled toothbrush. Dentin hypersensitivity examinations, which included tactile and air blast sensitivity measures, were conducted at baseline, one week, two weeks, four weeks, and eight weeks. Subject examinations were conducted by the same dental examiner at each examination period. RESULTS: This clinical study demonstrated that the new toothpaste, containing 8.0% arginine and 1450 ppm fluoride as 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 the new arginine toothpaste provided significantly greater reductions (p < 0.05) in dentin hypersensitivity in response to tactile (38.9%, 28.8%, and 11.6%) and air blast (16.8%, 26.4%, and 33.8%) stimuli than the benchmark commercial desensitizing toothpaste containing 2% potassium ion and 1450 ppm fluoride as NaF in a silica base, after two weeks, four weeks, and eight weeks of product use, respectively. CONCLUSION: A new toothpaste containing 8.0% arginine, calcium carbonate, and 1450 ppm fluoride as MFP provides significantly increased hypersensitivity relief (p < 0.05) as compared to a benchmark commercial desensitizing toothpaste containing 2% potassium ion, dosed as potassium nitrate, after two weeks, four weeks, and eight weeks of product use.

Effect of a triclosan/PVM/MA copolymer/fluoride dentifrice on volatile sulfur compounds in vitro.

OBJECTIVE: The objective of the investigation was to document the in vitro efficacy of a triclosan/PVM/MA copolymer/fluoride (TCF) dentifrice against the formation of volatile sulfur compounds (VSC) as well as the growth of H2S-producing bacteria. Clinical studies using organoleptic judges, gas chromatography, or a portable sulfide monitor have generally been employed in the assessment of treatments for the control of oral malodor. However, these studies are not appropriate for screening purposes because of the expense and time required. METHODS: An in vitro method was developed for the purpose of screening new compounds, agents or formulations for their ability to control VSC formation and for determining bio-equivalence of efficacy when implementing changes in existing formulations. The method combines basic microbiological methods, dynamic flow cell techniques and head space analysis. The in vitro VSC method was validated by comparing the efficacy of two dentifrices containing TCF with a control fluoride dentifrice as the TCF products have been clinically proven to control oral malodor. RESULTS: In the validation studies, the TCF-containing dentifrices were significantly better (P < 0.05) than the control dentifrice in inhibiting VSC formation and reducing H(2)S-producing bacteria. For example, when compared with baseline, the TCF dentifrices reduced VSC formation between 42 and 49% compared with the control dentifrice which reduced VSC formation 3%. There was no significant difference (P > 0.05) between the two TCF dentifrice formulations. CONCLUSION: Using an in vitro breath VSC model, it has been demonstrated that two variants of a dentifrice containing triclosan, PVM/MA copolymer and fluoride have efficacy that is significantly better than a control fluoridated dentifrice and that there is no significant difference between the triclosan/PVM/MA copolymer/fluoride dentifrice variants.