Leite Filho Ademir Melo, Valdivia-Tapia Astrid Carolina, Costa Ritta de Cássia Nascimento Pinto, Espinoza Emilia Valenzuela, Ricomini Filho Antônio Pedro, Cury Jaime Aparecido
Piracicaba Dental School, UNICAMP, Piracicaba, SP, Brazil.
Federal University of Maranhão, UFMA, São Luís, MA, Brazil.
Braz Dent J. 2022 Mar-Apr;33(2):52-60. doi: 10.1590/0103-6440202204522.
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.
面向儿童的含氟牙膏应含有最低浓度为1000 ppm的氟化物(F),且该氟化物必须具有化学可溶性才能发挥防龋作用。因此,我们测定了巴西和墨西哥市场上面向儿童销售的牙膏中总氟(TF)和总可溶性氟(TSF)的浓度,并分析了两国现行的相关规定。在巴西发现并购买了24个品牌的牙膏(19个品牌采用NaF/SiO₂配方,3个采用Na₂FPO₃/CaCO₃配方,2个采用Na₂FPO₃/SiO₂配方),在墨西哥发现并购买了6个品牌的牙膏(均采用NaF/SiO₂配方)。购买后(新鲜样品)测定了TF和TSF浓度,但对Na₂FPO₃/CaCO₃配方牙膏的氟化物稳定性在18个月后进行了检查。分析使用离子特异性电极进行,结果以ppm F(mg F/kg)表示。所测得的TF浓度范围为476.0至1385.3 ppm F,与制造商宣称的浓度(500至1450 ppm F)接近。根据两国现行规定,所测得的TF浓度不超过1500 ppm F。然而,无论是采用NaF/SiO₂配方的低氟牙膏(500 ppm F),还是最初含有1000 - 1100 ppm TF的新鲜和老化的Na₂FPO₃/CaCO₃牙膏,都发现了TSF浓度低于1000 ppm F的牙膏。总之,尽管大多数分析的牙膏显示TSF浓度高于1000 ppm F,但两国现行规定允许市场上存在不符合最佳现有证据的产品。