Fluoridated Toothpaste and the Prevention of Early Childhood Caries

Fluoridated Toothpaste and the Prevention of Early Childhood Caries

C O M M E N TA RY GUEST EDITORIAL Editorials represent the opinions of the authors and not those of the American Dental Association. GUEST EDITORIAL...

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C O M M E N TA RY GUEST EDITORIAL

Editorials represent the opinions of the authors and not those of the American Dental Association.

GUEST EDITORIAL

Fluoridated toothpaste and the prevention of early childhood caries A failure to meet the needs of our young It is time for the dental profession, the dental industry and the government to reconsider instructions to parents regarding the use of fluoridated toothpaste for children younger than 2 years.

Peter M. Milgrom, DDS; Colleen E. Huebner, PhD, MPH; Kiet A. Ly, MD, MPH

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n the United States, dental caries is on the rise in children, especially among the very young and the poor.1 The cause is not fully understood but likely is related to the consumption of increasingly available, inexpensive foods containing excess sugars, as well as to the now-ubiquitous habit of snacking and drinking sweetened drinks throughout the day.2,3 Dental services for low-income children in the United States, covered through the Early Periodic Screening, Diagnosis and Treatment (EPSDT) Program—Medicaid’s child health insurance program— have achieved limited success in reducing dental caries. Access to dentists accepting Medicaid payment remains a major obstacle for these children.4 As a consequence, in some states, public health officials have encouraged medical care providers to screen children from birth to 24 months of age for dental care needs and to apply sodium fluoride varnish during primary care visits.5 Researchers are investigating other strategies, such as combining povidone-iodine and fluoride varnish or xylitol syrups and confections.6,7 A more accessible and less costly strategy to prevent caries among young children is the regular use of fluoridated toothpaste. Concerned about the rising rates of early childhood caries (ECC), an expert panel convened in 2007 by the U.S. government recommended that children younger than 2 years who are at high risk of experiencing caries brush twice per day with a “smear” of regular U.S. fluoride toothpaste (typically containing about 1,100 parts per million fluoride) and that children aged 2 to 6 years brush twice daily with no more than a pea-sized amount of U.S. fluoridated toothpaste.8 Regular toothpaste typically contains about 1,100 parts per million fluoride. However, there is resistance among dentists, physicians and parents in the United States to using regular fluoridated toothpaste with very young children; the U.S. Food and Drug Administration (FDA) Drug Facts label discourages its use in this population. Fluoridated toothpaste is packaged with the mandatory warning: “Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or con-

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tact a Poison Control Center right away.”9 The intention behind the choice of the terms “smear” and “pea-sized” in the expert report was to limit children’s excess exposure to fluoride. However, without evidence of the benefits and risks associated with fluoride use, the expert panel recommendation will have little impact, particularly while the FDA limits the directions for use to “adults and children 2 years of age and older.”9 The concentration of fluoride in toothpaste varies from country to country in accord with government regulations, which makes it difficult to compare study results. The FDA allows dentifrices containing 850 to 1,150 ppm total fluoride for use by children 2 years and older and 1,500 ppm fluoride for use by those 6 years and older. However, consumers and health care providers often do not understand the distinction. The labeling is confusing because of the different forms of fluoride used and the use of percent weight/volume measures; understanding these technical terms requires health literacy beyond that of many Americans. It is time for the dental profession, the dental industry and the government to reconsider instructions to parents regarding the use of fluoridated toothpaste for children younger than 2 years. Unfortunately, the literature concerning toothpaste use in the very young is scant. Fluoridated toothpaste is highly effective in preventing caries in children’s permanent dentition,10 but only one study has demonstrated its efficacy in doing so in the primary dentition of very young children. Described by its authors as an 630

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effectiveness study of a program for parents with low incomes, not a trial of toothpaste’s efficacy, it nonetheless provided a comparison of the use of fluoridated toothpaste—either 440 ppm (monosodium fluoride 0.304 percent weight/volume) or 1,450 ppm (sodium fluoride 0.32 percent weight/volume)—with no use of fluoridated toothpaste.11 The investigators assigned families to receive toothpaste and educational materials regularly by mail while their children were aged 1 to 51/2 years. Clinical examinations conducted when the children were 5 to 6 years old found an advantage for children in the 1,450-ppm fluoride group relative to those in the 440-ppm group and to those in the untreated control group. Overall, they found that the 440-ppm fluoride intervention had no advantage relative to the control. In a study of 1,100-ppm fluoride toothpaste used by preschool children in China, You and colleagues12 reported equivocal findings. This latter study does not meet FDA scientific standards for a randomized clinical trial of a regulated drug, but its results suggest that further investigation of fluoridated toothpaste in very young children is warranted. The benefit identified by Davies and colleagues11 of use of the 1,450-ppm toothpaste was not without associated risk. A follow-up study found that those who received the 1,450-ppm fluoride toothpaste had significantly more fluorosis—some with fluorosis scores in the range considered esthetically objectionable according to standardized measures used in public health—than did those who received the 440-ppm fluoride

toothpaste.13 Scores observed in the objectionable range were among children who lived in relatively less deprived communities, suggesting an association between better adherence to home hygiene goals (that is, brushing begun at an early age) and greater risk of developing fluorosis. Data from Bentley and colleagues14 suggested the same. Instructing parents to use a smear or a pea-sized amount of fluoride toothpaste with their young children is not universally effective in reducing the amount applied to the toothbrush. Also, it may be possible to apply too little toothpaste. Itthagarun and colleagues15 concluded, “Reduction of the amount of fluoride toothpaste to less than a pea-size in order to minimize the risk of fluorosis should be undertaken with caution because it may compromise the cariostatic effects of the toothpaste, as shown by in vitro studies.” Other researchers had reached a similar conclusion in an earlier study involving salivary fluoride analyses.16 Thus, the amounts of U.S. 1,100-ppm fluoride toothpaste being recommended for use by our youngest children may be ineffective. In the United States, in contrast to some other countries (such as England and Australia), no fluoridated toothpaste has been formulated for use by infants and toddlers, and none has been tested.10,17 Furthermore, using no toothpaste or using only nonfluoridated toothpaste (such as Baby Orajel Tooth and Gum Cleanser [Church and Dwight, Princeton, N.J.]) is regarded as the standard of care for children of this age. There is nothing in the portfolio of research supported by the National Institute of

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Dental and Craniofacial Research or sponsored by the Centers for Disease Control and Prevention on this topic; we do not know what investigations, if any, manufacturers are sponsoring. Formally testing the benefits and secondary effects of the use of 1,100-ppm fluoridated toothpaste with infants and toddlers in the United States who are at high risk of developing caries— and changing instructions for use on toothpaste labels, if appropriate—can benefit many children at little cost relative to current investments in dental research and profits from oral care products. Parents and professionals in poor and minority communities in the United States have told us in the course of our research that they would support a randomized placebo-controlled study of a special fluoridated toothpaste for infants and toddlers. Thus, we conclude on the basis of existing science and the rising levels of dental caries that clinical trials of fluoridated toothpaste for very young children in the United States are overdue. ■ Dr. Milgrom is a professor, Department of Dental Public Health Sciences, and director, Northwest Center to Reduce Oral Health Disparities, University of Washington, Box 357475, Seattle, Wash. 98195-7475, e-mail

LETTERS

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ADA welcomes letters from readers on articles that have appeared in The Journal. The Journal reserves the right to edit all communications and requires that all letters be signed. Letters must be no more than 550 words

[email protected]”. Address reprint requests to Dr. Milgrom. Dr. Huebner is an associate professor, Department of Health Services, University of Washington, Seattle, and the director, graduate program in Maternal and Child Health Public Health Leadership, University of Washington, Seattle. Dr. Ly is an acting assistant professor, Department of Dental Public Health Sciences, University of Washington, Seattle. Disclosure. None of the authors reported any disclosures. The development of this article was supported in part by grant U54DE019346 from the National Institute of Dental and Craniofacial Research, National Institutes of Health, Bethesda, Md. 1. U.S. Department of Health and Human Services. Figure 21-1: Progress quotient chart for focus area 21—oral health. In: Healthy People 2010 Midcourse Review. Modified April 9, 2007. “www.healthypeople.gov/Data/ midcourse/html/tables/pq/PQ-21.htm”. Accessed April 16, 2009. 2. Ismail AI, Lim S, Sohn W, Willem JM. Determinants of early childhood caries in lowincome African American young children. Pediatr Dent 2008;30(4):289-296. 3. Thitasomakul S, Piwat S, Thearmontree A, Chankanka O, Pithpornchaiyakul W, Madyusoh S. Risks for early childhood caries analyzed by negative binomial models. J Dent Res 2009;88(2):137-141. 4. Milgrom P, Weinstein P, Huebner C, Graves J, Tut O. Empowering Head Start to improve access to good oral health for children from low income families (published online ahead of print Feb. 2, 2008). Matern Child Health J. 5. dela Cruz GG, Rozier RG, Slade G. Dental screening and referral of young children by pediatric primary care providers. Pediatrics 2004;114(5):e642-e652. 6. Berkowitz RJ, Koo H, McDermott MP, et al. Adjunctive chemotherapeutic suppression of mutans streptococci in the setting of severe early childhood caries: an exploratory study. J Public Health Dent (in press). 7. Milgrom P, Ly KA, Tut OK, et al. Xylitol pediatric topical oral syrup to prevent dental caries: a double blind, randomized clinical

and must cite no more than five references. No illustrations will be accepted. A letter concerning a recent JADA article will have the best chance of acceptance if it is received within two months of the article’s publication. For instance, a letter about an article that appeared in April JADA usually will be considered for acceptance only until the end of June. You may submit your letter via e-mail to “jadaletters@ JADA, Vol. 140

trial of efficacy. Arch Pediatr Adolesc Med (in press). 8. Health Resources and Services Administration, Maternal and Child Health Bureau. Appendix A: Decision support matrix—topical fluoride recommendations. In: Topical Fluoride Recommendations for HighRisk Children: Development of Decision Support Matrix, Recommendations from Maternal and Child Health Bureau Expert Panel. Washington: Altarum Institute; 2009. “mohealthysmiles.typepad.com/ Topical%20fl%20recommendations%20for%20 hi%20risk%20children.pdf”. Accessed April 16, 2009. 9. Anticaries drug products for over-thecounter human use, 21 CFR 355;2006. 10. 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. 11. Davies GM, Worthington HV, Ellwood RP, et al. A randomised controlled trial of the effectiveness of providing free fluoride toothpaste from the age of 12 months on reducing caries in 5-6 year old children. Community Dent Health 2002;19(3):131-136. 12. You BJ, Jian WW, Sheng RW, et al. Caries prevention in Chinese children with sodium fluoride dentifrice delivered through a kindergarten-based oral health program in China. J Clin Dent 2002;13(4):179-184. 13. Tavener JA, Davies GM, Davies RM, Ellwood RP. The prevalence and severity of fluorosis in children who received toothpaste containing either 440 or 1,450 ppm F from the age of 12 months in deprived and less deprived communities. Caries Res 2006; 40(1):66-72. 14. Bentley EM, Ellwood R, Davies RM. Fluoride ingestion from toothpaste by young children. Br Dent J 1999;186(9):460-462. 15. Itthagarun A, King NM, Rana R. Effects of child formula dentifrices on artificial caries like lesions using in vitro pH-cycling: preliminary results. Int Dent J 2007;57(5):307-313. 16. DenBesten P, Ko HS. Fluoride levels in whole saliva of preschool children after brushing with 0.25 g (pea-sized) as compared to 1.0 g (full-brush) of a fluoride dentifrice. Pediatr Dent 1996;18(4):277-280. 17. Twetman S, Axelsson S, Dahlgren H, et al. Caries-preventive effect of fluoride toothpaste: a systematic review. Acta Odontol Scand 2003;61(6):347-355.

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