Fluoride toothpaste, sanitary surveillance and the SUS: the case of Manaus-AM, Brazil

Authors

DOI:

https://doi.org/10.11606/s1518-8787.2022056003636

Keywords:

Toothpastes, supply & distribution, Dentifrices, chemistry, Fluorides, standards, Dental Caries, prevention & control, Dental Health Services

Abstract

OBJECTIVE: To determine the anticaries potential of toothpastes distributed by the primary health care public clinics (UBS) of Manaus, AM. Methods: Ninety-nine tubes of toothpaste from four commercial brands were collected from October 7, 2019 to October 11, 2019 in 16 UBS. They were assigned a code by brand and source UBS. According to the information on the packaging, the four brands and their batches were formulated with sodium monofluorophosphate (Na2FPO3) and most (91%) had calcium carbonate (CaCO3) as an abrasive. We determined the concentrations of total fluoride (TF = TSF + InsF) and total soluble fluoride (TSF = F ions- or FPO32-), to certify whether they were in compliance with Resolution ANVISA RDC No. 530 (maximum of 1,500 ppm TF) and whether they had anticaries potential (minimum of 1,000 ppm TSF). The analyses were performed with a ion- specific electrode. RESULTS: The concentrations (ppm F) of TF [mean; standard deviation (SD); n] found in toothpaste brands A (1,502.3; SD = 45.6; n = 33), B (1,135.5; SD = 52.7; n = 48) and D (936.8; SD = 20.5; N = 8) were close to those stated on the package, 1,500, 1,100 and 1,000 ppm F, respectively. In toothpaste C, we found a mean of 274.1 ppm (SD = 219.7; n = 10) of TF, which diverges from the declared concentration of 1,500 ppm F. In addition, the five tubes of lot no. 11681118 of toothpaste C did not contain fluoride. Regarding TSF, with the exception of toothpaste D (937.9; SD = 40.29), the others had a lower concentration than their respective TF. CONCLUSION: We found serious problems of quantity and quality of fluoride in toothpaste distributed by the SUS in Manaus, which shows the need for surveillance of these products and confirms the urgency of revising Resolution RDC No. 530.

References

Bratthall D, Hänsel-Petersson G, Sundberg H. Reasons for the caries decline: what do the experts believe? Eur J Oral Sci. 1996;104(4 Pt 2):416-22. https://doi.org/10.1111/j.1600-0722.1996.tb00104.x

Cury JA, Tenuta LMA, Ribeiro CCC, Paes Leme AF. The importance of fluoride dentifrices to the current dental caries prevalence in Brazil. Braz Dent J. 2004;15(3):167-74. https://doi.org/10.1590/s0103-64402004000300001

Cury JA, Tenuta LMA. Evidence-based recommendation on toothpaste use. Braz Oral Res. 2014;28 Spec Nº:1-7. https://doi.org/10.1590/S1806-83242014.50000001

Tenuta LMA, Cury JA. Laboratory and human studies to estimate anticaries efficacy of fluoride toothpastes. Monogr Oral Sci. 2013;23:108-24. https://doi.org/10.1159/000350479

Stookey GK. Are all fluoride dentifrices the same? In: Wei SH, editor. Clinical uses of fluorides. Philadelphia, PA: Lea & Febiger; 1985. p. 105-31.

Coelho CSS, Cury JA, Tabchoury CPM. Chemically soluble fluoride in Na2FPO3/CaCO3-based toothpaste as an indicator of fluoride bioavailability in saliva during and after toothbrushing. Caries Res. 2020;54(2):185-93. https://doi.org/10.1159/000506439

Marinho VC, Higgins JP, Sheiham A, Logan S. Fluoride toothpastes for preventing dental caries in children and adolescents. Cochrane Database Syst Rev. 2003;(1):CD002278. https://doi.org/10.1002/14651858.CD002278

Walsh T, Worthington HV, Glenny AM, Marinho VCC, Jeroncic A. Fluoride toothpastes of different concentrations for preventing dental caries. Cochrane Database Syst Rev. 2019;3(3):CD007868. https://doi.org/10.1002/14651858.CD007868.pub3

Santos APP, Nadanovsky P, Oliveira BH. A systematic review and meta-analysis of the effects of fluoride toothpastes on the prevention of dental caries in the primary dentition of preschool children. Community Dent Oral Epidemiol. 2013;41(1):1-12. https://doi.org/10.1111/j.1600-0528.2012.00708.x

Splieth CH, Banerjee A, Bottenberg P, Breschi L, Campus G, Ekstrand KR, et al. How to intervene in the caries process in children: A Joint ORCA and EFCD Expert Delphi Consensus Statement. Caries Res. 2020;54(4):297-305. https://doi.org/10.1159/000507692

Cury JA, Miranda LFB, Caldarelli PG, Tabchoury CPM. Dentifrícios fluoretados e o SUS-Brasil: o que precisa ser mudado? Tempus Actas Saude Coletiva. 2020;14(1):9-27. https://doi.org/10.18569/tempus.v14i1.2631

Ricomini Filho AP, Tenuta LMA, Fernandes FSF, Calvo AFB, Kusano SC, Cury JA. Fluoride concentration in the top-selling Brazilian toothpastes purchased at different regions. Braz Dent J. 2012;23(1):45-8. https://doi.org/10.1590/s0103-64402012000100008

Cury JA, Dantas EDV, Tenuta LMA, Romão DA, Tabchoury CPM, Nóbrega DF, et al. Concentração de fluoreto nos dentifrícios a base de MFP/CaCO3 mais vendidos no Brasil, ao final dos seus prazos de validade. Rev Assoc Paul Cir Dent. 2015;69(3):248-51.

Goldman AS, Yee R, Holmgren CJ, Benzian H. Global affordability of fluoride toothpaste. Global Health. 2008;4:7. https://doi.org/10.1186/1744-8603-4-7

Ministério da Saúde (BR), Agência Nacional de Vigilância Sanitária. Resolução ANVISA nº 79, de 28 de agosto de 2000. Diário Oficial da União. 31 ago 2000; Seção 1:1415-537.

MERCOSUL. MERCOSUL/GMC/RES Nº 48/02. Regulamento técnico MERCOSUL sobre lista de substâncias que os produtos de higiene pessoal, cosméticos e perfumes não devem conter, exceto nas condições e com as restrições estabelecidas. Brasília (DF): Sistema de Informação do Comércio Exterior; 2002 [citado 4 set 2020]. Disponível en: http://www.sice.oas.org/trade/mrcsrs/resolutions/ res4802p.as

European Union. Statutory Instruments. Consumer Protection: The Cosmetic Products (Safety) Regulations 2008: Nº 1284. London (UK: Stationery Office; 2008 [citado 4 set 2020]. Disponível em: http://www.legislation.gov.uk/uksi/2008/1284/ pdfs/uksi_20081284_en.pdf

Cury JA, Caldarelli PG, Tenuta LMA. Necessity to review the Brazilian regulation about fluoride toothpastes. Rev Saude Publica. 2015;49:74. https://doi.org/10.1590/S0034-8910.2015049005768

Chávez BA, Vergel GB, Cáceres CP, Perazzo MF, Vieira-Andrade RG, Cury JA. Fluoride content in children's dentifrices marketed in Lima, Peru. Braz Oral Res. 2019;33:e051. https://doi.org/10.1590/1807-3107bor-2019.vol33.0051

Cury JA, Oliveira MJL, Martins CC, Tenuta LMA, Paiva SM. Available fluoride in toothpastes used by Brazilian children. Braz Dent J. 2010;21(5):396-400. https://doi.org/10.1590/s0103-64402010000500003

Martinez-Mier EA, Tenuta LMA, Carey CM, Cury JA, Loveren C, Ekstrand KR, et al.; ORCA Fluoride in Toothpaste Analysis Work Group. European Organization for Caries Research Workshop: methodology for determination of potentially available fluoride in toothpastes. Caries Res. 2019;53(2):119-36. https://doi.org/10.1159/000490196

Kassebaum NJ, Smith AGC, Bernabé E, Fleming TD, Reynolds AE, Vos T, et al.; GBD 2015 Oral Health Collaborators. Global, Regional, and National Prevalence, Incidence, and Disability-Adjusted Life Years for Oral Conditions for 195 Countries, 1990-2015: a systematic analysis for the global burden of diseases, injuries, and risk factors. J Dent Res. 2017;96(4):380-7. https://doi.org/10.1177/0022034517693566

Marin LM, Vieira W, Tenuta LMA, Tabchoury COM, Cury JA. Fluoride concentration in local dentifrices from Brazilian regions. Rev Assoc Paul Cir Dent. 2017;71(1):60-5.

Antunes JLF, Narvai PC. Políticas de saúde bucal no Brasil e seu impacto sobre as desigualdades em saúde. Rev Saude Publica. 2010;44(2):360-5. https://doi.org/10.1590/S0034-89102010005000002

Giacaman RA, Carrera CA, Muñoz-Sandoval C, Fernandez C, Cury JA. Fluoride content in toothpastes commercialized for children in Chile and discussion on professional recommendations of use. Int J Paediatr Dent. 2013;23(2):77-83. https://doi.org/10.1111/j.1365-263X.2012.01226.x

Benzian H, Holmgren C, Buijs M, Loveren C, Weijden F, Palenstein Helderman W. Total and free available fluoride in toothpastes in Brunei, Cambodia, Laos, the Netherlands and Suriname. Int Dent J. 2012;62(4):213-21. https://doi.org/10.1111/j.1875-595X.2012.00116.x

Fernández CE, Carrera CA, Muñoz-Sandoval C, Cury JA, Giacaman RA. Stability of chemically available fluoride in Chilean toothpastes. Int J Paediatr Dent. 2017;27(6):496-505. https://doi.org/10.1111/ipd.12288

US Food and Drug Administration. CFR – Code of Federal Regulations. Title 21: Food and drugs. Washington (DC): FDA; 2013 [citado 20 fev 2019]. Chapter I, Food and Drug Administration Department of Health and Human Services, Subchapter D, Drugs from human use (part 355): anticaries drugs products for over the counter human use. Disponível em: https://www.govinfo.gov/content/pkg/CFR-2013-title21-vol5/pdf/CFR-2013-title21-vol5-chapI.pdf

Bureau des Normes de Madagascar. Norme Malagasy. NMG/ISO 11609:2017. Medecine bucco-dentaire – dentifrices: exigences, methodes d’essai et marquage. Madagascar: BNM; 2018 [citado 30 out 2020]. Disponível em: http://blog.aoi-fr.org/wp- content/uploads/2018/11/Normes-Dentifrice-Madagascra-aout-2018.pdf

FDI World Dental Federation. Promoting dental health through fluoride toothpaste. Geneva (CH): FDI; 2018 [citado 4 set 2019]. Disponível em: https://www.fdiworlddental.org/resources/policy-statements/promoting-dental- health-through-fluoride-toothpaste

Published

2022-03-11

Issue

Section

Original Articles

How to Cite

Fluoride toothpaste, sanitary surveillance and the SUS: the case of Manaus-AM, Brazil. (2022). Revista De Saúde Pública, 56, 9. https://doi.org/10.11606/s1518-8787.2022056003636

Funding data