Potencial anticárie dos dentifrícios fluoretados distribuídos em Unidades Básicas de Saúde de Manaus-AM

Abstract

The distribution of fluoride dentifrice in Basic Health Units (BHU) in Brazil is part of the national public oral health policy. To show anticaries benefit to a population, the dentifrice distributed should have fluoride, not only chemically soluble (potentially bioavailable in the form of F- or FPO32- ions), but also in adequate concentration in dentifrices formulations. The objective of the study was to estimate the anticaries potential of the dentifrices distributed by BHU to the population of Manaus-AM and to evaluate if the dentifrices distributed complies with Brazilian legislation of National Health Surveillance Agency (ANVISA) Resolution 79, in relation to fluoride concentration. Ninety-nine dentifrice tubes from four commercial brands were collected between in BHU (n=16) in the period between 10/7/2019 and 10/11/2019 and were coded by brand and BHU of origin. The lots of dentifrices acquired were different in the same BHU. According to the label, of the 99 dentifrices collected, 33 tubes (12 lots) were brand A, 48 (19 lots) B, 10 (2 lots) C and 8 (2 lots) brand D. All dentifrices were formulated with sodium monofluorophosphate (Na2FPO3) and the majority (91%) had calcium carbonate (CaCO3) as abrasive in exception of dentifrice D which was formulated with silica (SiO2). The dentifrices analyzed were within their validity period, except for one sample. The concentrations of as total fluoride (TF = TSF + IF) and total soluble fluoride (TSF = F- or FPO32-) were determined, to certify if they are in accordance with the Brazilian ANVISA Resolution 79 (maximum 1500 ppm TF) and anticaries potential (minimum of 1000 ppm TSF). The analyzes were performed between 10/18/2019 and 11/7/2019 at the oral biochemistry laboratory of the School of Dentistry, University of Campinas (UNICAMP), Brazil, using the direct technique with the ion-selective electrode (F-ISE) according to a methodology validated. For data analysis, the mean and deviation of the TF and TSF concentration for each duplicate of dentifrice was analyzed and the percentage of insoluble fluoride (% IF = (TF - TSF) / TF × 100) was calculated. The TF concentration (ppm F: mg F / kg) (mean ± SD; n) found in dentifrices A (1502.3 ± 45.6; n = 33), B (1135.5 ± 52.7; n = 48) and D (936.8 ± 20.5; n = 8) were close to that described on the label, 1500, 1100 and 1000 ppm F, respectively. In dentifrice C, an average of 274.1 ± 219.7 ppm F (n = 10) of TF was found, differing from the of 1500 ppm F declared, which reflected in the SD 80% of the average. In addition, the five tubes from lot 11681118 of dentifrice C were not fluoridated. Regarding TSF, except dentifrice D (937.9 ± 40.29), the other brands presented concentrations lower than their respective TF, with 36, 57 and 70% of IF in dentifrices C, A and B, respectively. In dentifrice B (lot 099), expired when collected, 90% of the fluoride present was insoluble (inactive against caries). The dentifrices were classified according to their anticaries potential in the following decreasing order (Good to None): D> A> B = C (lote11684118)> C (lote11681118). Serious problems of quantity and quality of fluoride in the dentifrices distributed in Manaus by the Unified Health System (UHS), were observed, showing the necessity of sanitary surveillance of these products, and confirming the urgency of the revision of the governmental ANVISA Resolution 79 for the population to use effective dentifrices in the caries control.