FLUORIDATED TOOTHPASTE FOR ECC: FAILURE TO MEET THE NEEDS OF OUR YOUNG

In the United States and other affluent countries, tooth decay is on the rise in children, especially the very young and the poor (U.S. Department of Health and Human Services, 2007). The cause is not fully understood but is likely related to the consumption of increasingly available, inexpensive foods containing excess sugars, and the now-ubiquitous habit of snacking and drinking sweetened drinks throughout the day (Alm et al., 2008).

Dental services for low-income children in the U. S., covered through the EPSDT Program--Medicaid’s child health insurance program--have achieved limited success in reducing tooth decay. Access to dentists accepting Medicaid payment remains a major obstacle (Milgrom et al., 2008). As a consequence, in some states, medical providers have been encouraged to screen for dental needs and to apply sodium fluoride varnish during primary care visits from birth to 24 months of age (de la Cruz, Rozier & Slade, 2004).

More accessible and less costly is regular use of fluoridated toothpaste. In the U.S., however, there is no fluoridated toothpaste formulated for use with infants and toddlers and none has been tested (Twetman et al., 2003; Marinho et al., 2003); non-fluoridated toothpaste (e.g., Baby Orajel^® Tooth and Gum Cleanser) is the standard of care. There is nothing in the portfolio of research supported by the National Institute of Dental and Craniofacial Research on this topic; we do not know what, if anything, manufacturers are sponsoring.

The concentration of fluoride in toothpaste varies from country to country in accord with government regulations which makes studies hard to compare. The U.S. Food and Drug Administration (F.D.A.) allows dentifrices containing 850 to 1150 ppm total fluoride for children age two and up and 1500 ppm fluoride for age six and up. However, consumers and health providers often do not understand the distinction. The labeling is confusing because of the different forms of fluoride used and the use of % w/v measures. Concerned about the rising Early Childhood Caries a recent expert panel convened by the U.S. government (Maternal and Child Health Bureau, 2007) recommended use of a “smear” of regular U.S. fluoride toothpaste (typically about 1100 ppm) for children under two. The intention behind the choice of the term “smear” was to limit excess exposure to fluoride. However, without evidence of the benefits and risks, the recommendation will have little impact, particularly while the F.D.A. limits the directions for use to “Adults and children 2 years of age and older.”

There is resistance among dentists, physicians, and parents in the U.S. to use regular fluoridated toothpaste with children under two; the F.D.A. Drug Facts label discourages its use. Fluoride 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 contact a Poison Control Center right away” (U.S. F.D.A., 2008).

It is time to re-consider instructions to parents and their consequences for children under two. Unfortunately, the literature is scant. Although fluoridated toothpaste is highly effective in preventing caries in the young permanent dentition, there has been only one study to demonstrate its efficacy for the primary dentition in very young children. Described as an effectiveness study in a program for low-income parents, not a toothpaste efficacy trial (Davies et al., 2002), it nonetheless provides a comparison of 440 (monosodium fluoride .304% w/v) and 1450 ppm (sodium fluoride .32% w/v) fluoride toothpaste or none. Families were assigned to receive toothpaste and education materials regularly by mail when children were 1 to 5½ years. Clinical exams conducted when the children were 5 to 6 found an advantage for children in the 1450 ppm fluoride group relative to the 440 ppm group and to the untreated control. Overall, no advantage was found for the 440 ppm fluoride intervention relative to the control. A study by You and colleagues (2002) of 1100 ppm fluoride toothpaste used by preschool children in China reported equivocal findings. The study does not meet F.D.A. standards, but the results suggest further investigation of fluoridated toothpaste with the very young is warranted.

The benefit identified by Davies and colleagues (2002) for the 1450 ppm toothpaste was not without risk. A follow-up study (Tavener et al., 2006) found those who received the 1450 ppm toothpaste had significantly more fluorosis--some with fluorosis scores in the range considered aesthetically objectionable--than the 440 ppm group. Scores observed in this objectionable range were among children who lived in relatively less deprived communities, suggesting an association between better adherence to home hygiene goals (viz. early brushing) and greater risk of fluorosis. Data from Bentley and colleagues (1999) suggested the same.

Instructing parents to use a “pea size” or “smear” of fluoride toothpaste is not universally effective to reduce the amount applied to the toothbrush. Also, it may be possible to apply too little toothpaste. Itthagarun and colleagues (2007) 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. A similar conclusion was reached earlier (DenBesten & Ko, 1996) from salivary fluoride analyses. Thus, the use of a “smear” of U.S. 1100 ppm toothpaste may be ineffective.

Formally testing the benefits and secondary effects of 1100 ppm toothpaste with high-risk infants and toddlers in the U.S., and changing toothpaste labeling 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 of the U.S. have told us they would support a randomized placebo-controlled study of a “special [fluoride] toothpaste for babies. Thus, we conclude on the basis of existing science and the rising levels of tooth decay that clinical trials in U.S. are overdue and that the failure of NIDCR, other government agencies, and industry to mount such trials is inexcusable.