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.

Desarrollo y validación de una nueva tecnología, basada en arginina al 1.5%, un compuesto de calcio insoluble y fluoruro, para el uso diario en la prevención y tratamiento de la caries dental.

OBJETIVO: este artículo discute brevemente la prevalencia de caries, la naturaleza multifactorial de su etiología, el riesgo de caries y el papel y eficacia del fluoruro. Resalta también la investigación sobre el metabolismo bacteriano, que ha aportado conocimientos sobre la defensa natural oral contra la caries y la base para el desarrollo de una nueva tecnología para la prevención diaria y el tratamiento de la caries. Por último, se resume la evidencia que respalda que la tecnología complementa y mejora la eficacia anti-caries de la crema dental con fluoruro. CONCLUSIONES: los datos globales muestran que a pesar de la exitosa introducción del fluoruro, la caries dental es una enfermedad prevalente. La experiencia de caries depende del balance entre el consumo de azúcares, la higiene oral y el uso del fluoruro. Hay tres conceptos científicos que son fundamentales en las nuevas mediciones para detectar, tratar y monitorear la caries: (1) la caries dental es un proceso dinámico, (2) la caries dental es un proceso continuo de etapas que van desde reversible (pre-clínica) hasta irreversible (lesiones clínicamente detectables), y (3) el proceso de la caries es un balance de factores patológicos y protectores que pueden modularse para el manejo de la caries. El fluoruro funciona como factor protector al detener y revertir el proceso de la caries, pero el fluoruro no previene los factores patológicos que inician el proceso. Se ha identificado una tecnología novedosa, basada en arginina y un compuesto insoluble de calcio, que está dirigida a la placa dental para prevenir la iniciación del proceso de caries al reducir los factores patológicos. Como los mecanismos de acción de la arginina y el fluoruro son altamente complementarios, se ha desarrollado un nuevo dentífrico que combina la arginina y el fluoruro, y se ha probado clínicamente que brinda una prevención superior contra la caries.

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.

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.

The development and validation of a new technology, based upon 1.5% arginine, an insoluble calcium compound and fluoride, for everyday use in the prevention and treatment of dental caries.

OBJECTIVE: This paper briefly discusses caries prevalence, the multi-factorial nature of caries etiology, caries risk and the role and efficacy of fluoride. The paper also highlights research on bacterial metabolism which provided understanding of the mouth's natural defenses against caries and the basis for the development of a new technology for the everyday prevention and treatment of caries. Finally, evidence that the technology complements and enhances the anti-caries efficacy of fluoride toothpaste is summarized. CONCLUSIONS: Global data show that dental caries is a prevalent disease, despite the successful introduction of fluoride. Caries experience depends on the balance between consumption of sugars and oral hygiene and the use of fluoride. Three scientific concepts are fundamental to new measures to detect, treat and monitor caries: (1) dental caries is a dynamic process, (2) dental caries is a continuum of stages from reversible, pre-clinical to irreversible, clinically detectable lesions, and (3) the caries process is a balance of pathological and protective factors that can be modulated to manage caries. Fluoride functions as a protective factor by arresting and reversing the caries process, but fluoride does not prevent pathological factors that initiate the process. A novel technology, based upon arginine and an insoluble calcium compound, has been identified which targets dental plaque to prevent initiation of the caries process by reducing pathological factors. As the mechanisms of action of arginine and fluoride are highly complementary, a new dentifrice, which combines arginine with fluoride, has been developed and clinically proven to provide superior caries prevention.

The anti-caries efficacy of a dentifrice containing 1.5% arginine and 1450 ppm fluoride as sodium monofluorophosphate assessed using Quantitative Light-induced Fluorescence (QLF).

OBJECTIVE: To compare the efficacy of a new dentifrice containing 1.5% arginine, an insoluble calcium compound and 1450 ppm fluoride to arrest and reverse naturally occurring buccal caries lesions in children relative to a positive control dentifrice containing 1450 ppm fluoride alone. STUDY DESIGN: Participants from Chengdu, Sichuan Province, China tested three dentifrices: a new dentifrice containing 1.5% arginine, an insoluble calcium compound, and 1450 ppm fluoride, as sodium monofluorophosphate, a positive control dentifrice containing 1450 ppm fluoride, as sodium fluoride, in a silica base, and a matched negative control dentifrice without arginine and fluoride. Quantitative Light-induced Fluorescence (QLF) was used to assess buccal caries lesions at baseline and after 3 and 6 months of product use. RESULTS: 438 participants (initial age 9-13 years (mean 11.1±0.78) and 48.6% female) completed the study. No adverse events attributable to the products were reported during the course of the study. The subject mean ΔQ (mm(2)%), representing lesion volume, was 27.26 at baseline. After 6 months of product use, the ΔQ values for the arginine-containing, positive and negative control dentifrices were 13.46, 17.99 and 23.70 representing improvements from baseline of 50.6%, 34.0% and 13.1%. After 6 months product use, the differences between the pair wise comparisons for all three groups were statistically significant (p<0.01). The arginine-containing dentifrice demonstrated an improvement after only 3 months that was almost identical to that achieved by the conventional 1450 ppm fluoride dentifrice after 6 months. CONCLUSION: The new dentifrice containing 1.5% arginine, an insoluble calcium compound, and 1450 ppm fluoride provides statistically significantly superior efficacy in arresting and reversing buccal caries lesions to a conventional dentifrice containing 1450 ppm fluoride alone.

Comparison of the efficacy of a dentifrice containing 1.5% arginine and 1450 ppm fluoride to a dentifrice containing 1450 ppm fluoride alone in the management of early coronal caries as assessed using Quantitative Light-induced Fluorescence.

OBJECTIVE: To compare the efficacy of a new dentifrice containing 1.5% arginine, an insoluble calcium compound, and 1450 ppm fluoride to a matched, positive control dentifrice containing 1450 ppm fluoride in arresting and reversing early coronal caries lesions in children using Quantitative Light-induced Fluorescence (QLF). STUDY DESIGN: 331 children from Chiang Mai, Thailand, aged 7-14 years, with one or more visible early enamel caries lesions on the upper anterior teeth, completed the study. The new dentifrice contained 1.5% arginine, an insoluble calcium compound, and 1450 ppm fluoride, as sodium monofluorophosphate; the matched positive control contained 1450 ppm fluoride only. Subjects brushed twice daily at home and additionally once on school days under teacher's supervision. Digital images of the upper six anterior teeth were captured at the baseline, 3- and 6-month examinations using a custom apparatus for reproducible acquisition of Quantitative Light-induced Fluorescence data. RESULTS: At the 3-month examination, the ΔQ (representing lesion volume) for the test group decreased from a mean of 28.62 at baseline to 20.53 mm(2)% and for the positive control group to 23.38 mm(2)%. The difference between groups was not statistically significant (p=0.055). At the 6-month examination, the ΔQ decreased for the test group to 15.85 mm(2)% and for the positive control group to 20.35 mm(2)%. The difference between groups was statistically significant (p<0.001). CONCLUSION: A new dentifrice containing 1.5% arginine, an insoluble calcium compound, and 1450 ppm fluoride, as sodium monofluorophosphate, provided statistically significant superior efficacy in arresting and reversing active coronal caries lesions in children than brushing with a matched positive control dentifrice containing fluoride alone.

Comparing the efficacy of a dentifrice containing 1.5% arginine and 1450 ppm fluoride to a dentifrice containing 1450 ppm fluoride alone in the management of primary root caries.

OBJECTIVE: To compare the efficacy of a new dentifrice containing 1.5% arginine and 1450 ppm fluoride to a positive control dentifrice containing 1450 ppm fluoride alone in arresting and reversing primary root caries lesions in adults. STUDY DESIGN: A total of 3779 subjects from Piracicaba, Säo Paulo, Brazil were screened; 284 had at least one leathery primary root caries lesion and were eligible for the study. The new dentifrice contained 1.5% arginine, an insoluble calcium compound, and 1450 ppm fluoride, as sodium monofluorophosphate; the matched positive control dentifrice contained 1450 ppm fluoride. One lesion for each subject was selected for inclusion in the study and was examined at baseline, 3 and 6 months. RESULTS: A total of 253 subjects completed the study with 129 of 144 subjects included in the final statistical analysis for the test dentifrice and 124 of 140 for the positive control. The mean age of subjects was 45.7 (±9.19) years and 56.5% were female. After 6 months product use, 70.5% of root caries lesions improved for subjects using the arginine-containing dentifrice compared to 58.1% for subjects using the positive control. The difference in the number of root caries lesions becoming hard in the two groups was statistically significant (p=0.038). CONCLUSION: A new dentifrice containing 1.5% arginine, an insoluble calcium compound, and 1450 ppm fluoride, as sodium monofluorophosphate, provided statistically significantly superior efficacy in arresting and reversing active root caries lesions in adults compared to a matched positive control dentifrice containing fluoride alone.

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.

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.

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.