Fluoride concentration in toothpaste marketed to children in Brazil and Mexico, and discussion on current regulations

Resumo Os dentifrícios fluoretados comercializados para crianças devem conter concentração mínima de 1000 ppm de fluoreto (F), que deve ser quimicamente solúvel para ter efeito anticárie. Portanto, determinamos as concentrações de fluoreto total (FT) e fluoreto solúvel total (FST) em dentifrícios comercializados para crianças no Brasil e no México e analisamos as regulamentações vigentes em ambos os países. Vinte e quatro marcas foram encontradas e adquiridas no Brasil (19 formuladas com NaF/SiO2, três com Na2FPO3/CaCO3 e duas com Na2FPO3/SiO2) e seis no México (todas com NaF/SiO2). As concentrações de FT e FST foram determinadas após a compra (amostras frescas), e a estabilidade do fluoreto nas formulações de Na2FPO3/CaCO3 foi verificada após 18 meses. As análises foram realizadas com eletrodo íon-específico e os resultados expressos em ppm F (mg F/kg). As concentrações de FT encontradas variaram de 476,0 a 1.385,3 ppm F e foram próximas às declaradas pelos fabricantes (500 a 1.450 ppm F). As concentrações de FT encontradas não ultrapassaram 1.500 ppm F, de acordo com as regulamentações vigentes de ambos os países. No entanto, dentifrícios com concentrações de FST inferiores a 1.000 ppm F foram encontrados tanto em dentifrício com baixa concentração (500 ppm F) formulado com NaF/SiO2 como em dentifrícios com Na2FPO3/CaCO3 frescos e envelhecidos, originalmente fabricados com 1.000-1.100 ppm de FT. Em conclusão, embora a maioria dos dentifrícios analisados apresentasse concentração de FST superior a 1.000 ppm F, as regulamentações vigentes em ambos os países permitem que produtos que não estejam de acordo com a melhor evidência disponível estejam presentes no mercado.

Abstract Fluoride toothpastes market to children should contain a minimum concentration of 1000 ppm of fluoride (F), which must be chemically soluble to provide anti-caries effect. Therefore, we determined the concentrations of total fluoride (TF) and total soluble fluoride (TSF) in toothpastes marketed to children in Brazil and Mexico and analyzed the current regulations in force in both countries. Twenty-four brands were found and purchased in Brazil (19 formulated with NaF/SiO2, three with Na2FPO3/CaCO3 and two with Na2FPO3/SiO2) and six in Mexico (all with NaF/SiO2). TF and TSF concentrations were determined after the purchase (fresh samples) but fluoride stability in Na2FPO3/CaCO3-formulations was checked after 18 months. The analyses were performed with an ion-specific electrode and the results expressed in ppm F (mg F/kg). The TF concentrations found ranged from 476.0 to 1385.3 ppm F and they were close the declared by the manufactures (500 to 1450 ppm F). The TF concentrations found were not greater than 1500 ppm F, in accordance with the current regulations of both countries. However, toothpastes presenting TSF concentrations lower than 1000 ppm F were found either in low fluoride toothpaste (500 ppm F) formulated with NaF/SiO2 as in fresh and aged Na2FPO3/CaCO3-toothpastes, originally fabricated with 1000-1100 ppm of TF. In conclusion, although most toothpastes analyzed showed TSF concentration higher than 1000 ppm F, the regulations in force in both countries allow that products not in agreement with the best available evidence are available in the market.

Fluoride bioavailability on demineralized enamel by commercial mouth rinses

Abstract The ability of mouth rinses, available in the international market, to form reaction products on demineralized enamel (bioavailability test) was evaluated in vitro. Nine mouth rinses purchased in Chile were evaluated; eight formulated with NaF (one containing 100 µg F/mL and seven containing 226) and one with Na2FPO3 (226 µg F/mL as ion F). Demineralized enamel slabs (n=15 per mouth rinse) were sectioned; one half was subjected to the assigned mouth rinse treatment for 10 min and the other half was used to obtain baseline data. Loosely bound and firmly bound fluoride formed on enamel were determined with an ion-specific electrode and the values were expressed in µg F/cm2. The concentration of fluoride and the pH of the mouth rinses were previously determined. Concentrations of loosely bound and firmly bound fluoride formed on enamel were independently analyzed by ANOVA and Tukey's test (α=5%). The loosely bound and firmly bound fluoride concentrations (µg F/cm2) formed ranged from 3.2 to 36.2 and 0.4 to 1.7, respectively. Loosely bound fluoride formed on enamel was significantly more effective in discriminating the effect of different commercial mouth rinses than firmly bound fluoride. Mouth rinses with 226 ppm F as NaF and low pH presented significantly greater bioavailability of fluoride on enamel than those with higher pH or lower NaF concentration. The mouth rinse with Na2FPO3 showed low reactivity. Although further studies are necessary, the findings showed that commercial fluoride-containing mouth rinses have important variations in enamel fluoride bioavailability, which may result in differences on anticaries efficacy.

Resumo Os enxaguatórios bucais comerciais fluoretados diferem na concentração e tipo de sal de fluoreto, no pH e têm alguns ingredientes que podem interferir na reatividade do fluoreto com o esmalte desmineralizado. A capacidade de enxaguatórios bucais comerciais de formar produtos de reação em esmalte desmineralizado (teste de biodisponibilidade) foi avaliada in vitro. Nove enxaguatórios bucais adquiridos no Chile foram avaliados, oito formulados com NaF (um contendo 100 µg F/mL e sete contendo 226) e um com Na2FPO3 (226 µg F/mL como íon F). Os blocos de esmalte desmineralizados (n=15 por grupo) foram seccionados, uma metade foi submetida ao tratamento com o enxaguatório designado por 10 min e a outra metade foi usada para dados baseline. Fluoreto fracamente e firmemente ligados formados no esmalte foram determinados com um eletrodo íon-específico e os valores foram expressos em µg F /cm2. A concentração de fluoreto e o pH dos enxaguatórios foi previamente determinada. As concentrações de fluoreto tipo fluoreto fracamente ligado e fortemente ligado formadas no esmalte foram analisadas independentemente por ANOVA e teste de Tukey (α=5%). As concentrações de fluoreto fracamente ligado e fortemente ligado formados variaram de 3,2 a 36,2 e 0,4 a 1,7, respectivamente. O fluoreto fracamente ligado formado no esmalte foi significativamente mais eficaz para discriminar o efeito dos diferentes enxaguatórios bucais comerciais do que o fluoreto firmemente ligado. Enxaguatórios bucais com 226 ppm F na forma de NaF e baixo pH apresentaram significativamente maior biodisponibilidade de fluoreto no esmalte do que aqueles com maior pH ou menor concentração de NaF. O enxaguatório com Na2FPO3 apresentou reatividade muito baixa. Embora mais estudos sejam necessários, os resultados mostraram que os enxaguatórios bucais comerciais contendo fluoreto apresentam variações importantes na biodisponibilidade do fluoreto, o que poderia resultar em diferenças na eficácia anticárie.

Fluoride bioavailability on demineralized enamel by commercial mouthrinses

Abstract The ability of mouthrinses, available in the international market, to form reaction products on demineralized enamel (bioavailability test) was evaluated in vitro. Nine mouthrinses purchased in Chile were evaluated; eight formulated with NaF (one containing 100 µg F/mL and seven containing 226) and one with Na2FPO3 (226 µg F/mL as ion FPO3 ). Demineralized enamel slabs (n=15 per mouthrinse) were sectioned; one half was subjected to the assigned mouthrinse treatment for 10 min and the other half was used to obtain baseline data. Loosely bound and firmly bound fluoride formed on enamel were determined with an ion-specific electrode and the values were expressed in µg F/cm2. The concentration of fluoride and the pH of the mouthrinses were previously determined. Concentrations of loosely bound and firmly bound fluoride formed on enamel were independently analyzed by ANOVA and Tukey's test (α=5%). The loosely bound and firmly bound fluoride concentrations formed ranged from 3.2 to 36.2 and 0.4 to 1.7, respectively. Loosely bound fluoride formed on enamel was significantly more effective in discriminating the effect of different commercial mouthrinses than firmly bound fluoride. Mouthrinses with 226 ppm F as NaF and low pH presented significantly greater bioavailability of fluoride on enamel than those with higher pH or lower NaF concentration. The mouthrinse with Na2FPO3 showed low reactivity. Although further studies are necessary, the findings showed that commercial fluoride-containing mouthrinses have important variations in enamel fluoride bioavailability, which may result in differences on anticaries efficacy.

Resumo Os enxaguatórios bucais comerciais fluoretados diferem na concentração e tipo de sal de fluoreto, no pH e têm alguns ingredientes que podem interferir na reatividade do fluoreto com o esmalte desmineralizado. A capacidade de enxaguatórios bucais comerciais de formar produtos de reação em esmalte desmineralizado (teste de biodisponibilidade) foi avaliada in vitro. Nove enxaguatórios bucais adquiridos no Chile foram avaliados, oito formulados com NaF (um contendo 100 µg F/mL e sete contendo 226) e um com Na2FPO3 (226 µg F/mL como íon F). Os blocos de esmalte desmineralizados (n=15 por grupo) foram seccionados, uma metade foi submetida ao tratamento com o enxaguatório designado por 10 min e a outra metade foi usada para dados baseline. Fluoreto fracamente e firmemente ligados formados no esmalte foram determinados com um eletrodo íonespecífico e os valores foram expressos em µg F /cm2. A concentração de fluoreto e o pH dos enxaguatórios foi previamente determinada. As concentrações de fluoreto tipo fluoreto fracamente ligado e fortemente ligado formadas no esmalte foram analisadas independentemente por ANOVA e teste de Tukey (α=5%). As concentrações de fluoreto fracamente ligado e fortemente ligado formados variaram de 3,2 a 36,2 e 0,4 a 1,7, respectivamente. O fluoreto fracamente ligado formado no esmalte foi significativamente mais eficaz para discriminar o efeito dos diferentes enxaguatórios bucais comerciais do que o fluoreto firmemente ligado. Enxaguatórios bucais com 226 ppm F na forma de NaF e baixo pH apresentaram significativamente maior biodisponibilidade de fluoreto no esmalte do que aqueles com maior pH ou menor concentração de NaF. O enxaguatório com Na2FPO3 apresentou reatividade muito baixa. Embora mais estudos sejam necessários, os resultados mostraram que os enxaguatórios bucais comerciais contendo fluoreto apresentam variações importantes na biodisponibilidade do fluoreto, o que poderia resultar em diferenças na eficácia anticárie

Fluoride concentration in mouth rinses marketed in Chile and Brazil, and a discussion regarding their legislations

Abstract For fluoride to be effective in controlling caries, it should be bioavailable in commercial products, so that it can be released into the mouth in the products it contains. We chemically determined the available fluoride and pH in nine mouth rinses marketed in Chile, and eleven, in Brazil, and then discussed the legislation in force in both countries, regarding the anticaries potential of these oral hygiene products. The fluoride was analyzed with an ion-selective electrode (F-ISE), using the direct technique. The determinations were made in duplicate, and the results were expressed in ppm F (μg F/mL). The total fluoride concentration found in all the mouth rinses evaluated ranged from 94.7 to 233.5 ppm F, and closely matched what was declared by the manufacturers (100.0 to 226.2 ppm F). However, some mouth rinses showed lower fluoride concentrations (90 and 180 ppm F) in both countries. A Na2FPO3-formulated mouth rinse was found only in Chile, with 216.8 ppm F as the FPO32- ion, and 4.9 ppm F as the F-. The findings show that fluoride was potentially bioavailable in all the mouth rinses evaluated. Regarding the national legislations, although the mouthwashes sold in Brazil comply with the Brazilian legislation, discrepancies were found for Chile. However, neither country had a legislation matching the best available evidence on fluoride mouthwash efficacy for caries control. Thus, some products with low fluoride concentrations (below 226 ppm F), or manufactured with a fluoride salt other than NaF (Na2FPO3) are being sold in the Brazilian and Chilean markets.