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Widespread use of fluoride has been a major factor in the decline in the prevalence and severity of dental caries (i.e., tooth decay) in the United States and other economically developed countries. When used appropriately, fluoride is both safe and effective in preventing and controlling dental caries. All U.S. residents are likely exposed to some degree to fluoride, which is available from multiple sources. Both health-care professionals and the public have sought guidance on selecting the best way to provide and receive fluoride. During the late 1990s, CDC convened a work group to develop recommendations for using fluoride to prevent and control dental caries in the United States. This report includes these recommendations, as well as a) critical analysis of the scientific evidence regarding the efficacy and effectiveness of fluoride modalities in preventing and controlling dental caries, b) ordinal grading of the quality of the evidence, and c) assessment of the strength of each recommendation.
Because frequent exposure to small amounts of fluoride each day will best reduce the risk for dental caries in all age groups, the work group recommends that all persons drink water with an optimal fluoride concentration and brush their teeth twice daily with fluoride toothpaste. For persons at high risk for dental caries, additional fluoride measures might be needed. Measured use of fluoride modalities is particularly appropriate during the time of anterior tooth enamel development (i.e., age <6 years).
The recommendations in this report guide dental and other health-care providers, public health officials, policy makers, and the public in the use of fluoride to achieve maximum protection against dental caries while using resources efficiently and reducing the likelihood of enamel fluorosis. The recommendations address public health and professional practice, self-care, consumer product industries and health agencies, and further research. Adoption of these recommendations could further reduce dental caries in the United States and save public and private resources.NATIONAL GUIDELINES FOR FLUORIDE USE
PHS recommendations for fluoride use include an optimally adjusted concentration of fluoride in community drinking water to maximize caries prevention and limit enamel fluorosis. This concentration ranges from 0.7 ppm to 1.2 ppm depending on the average maximum daily air temperature of the area (66–68). In 1991, PHS also issued policy and research recommendations for fluoride use (8). The U.S. Environmental Protection Agency (EPA), which is responsible for the safety and quality of drinking water in the United States, sets a maximum allowable limit for fluoride in community drinking water at 4 ppm and a secondary limit (i.e., nonenforceable guideline) at 2 ppm (69,70). The U.S. Food and Drug Administration (FDA) is responsible for approving prescription and over-the-counter fluoride products marketed in the United States and for setting standards for labeling bottled water (71) and over-the-counter fluoride products (e.g., toothpaste and mouthrinse) (72).
Nonfederal agencies also have published guidelines on fluoride use. The American Dental Association (ADA) reviews fluoride products for caries prevention through its voluntary Seal of Acceptance program; accepted products are listed in the ADA Guide to Dental Therapeutics (73). A dosage schedule for fluoride supplements for infants and children aged <16 years, which is scaled to the fluoride concentration in the community drinking water, has been jointly recommended by ADA, the American Academy of Pediatric Dentistry (AAPD), and the American Academy of Pediatrics (AAP) (Table 1) (44,74,75). In 1997, the Institute of Medicine published age-specific recommendations for total dietary intake of fluoride (Table 2). These recommendations list adequate intake to prevent dental caries and tolerable upper intake, defined as a level unlikely to pose risk for adverse effects in almost all persons.
FLUORIDE SOURCES AND THEIR EFFECTS
Fluoridated community drinking water and fluoride toothpaste are the most common sources of fluoride in the United States and are largely responsible for the low risk for dental caries for most persons in this country. Persons at high risk for dental caries might require more frequent or more concentrated exposure to fluoride and might benefit from use of other fluoride modalities (e.g., mouthrinse, dietary supplements, and topical gel, foam, or varnish). The effects of each of these fluoride sources on dental caries and enamel fluorosis are described.
Fluoridated Drinking Water and Processed Beverages and Food
Fluoridated drinking water contains a fluoride concentration effective for preventing dental caries; this concentration can occur naturally or be reached through water fluoridation, which is the controlled addition of fluoride to a public water supply. When fluoridated water is the main source of drinking water, a low concentration of fluoride is routinely introduced into the mouth. Some of this fluoride is taken up by dental plaque; some is transiently present in saliva, which serves as a reservoir for plaque fluoride; and some is loosely held on the enamel surfaces (76). Frequent consumption of fluoridated drinking water and beverages and food processed in fluoridated areas maintains the concentration of fluoride in the mouth.
Estimates of fluoride intake among U.S. and Canadian adults have ranged from <1.0 mg fluoride per day in nonfluoridated areas to 1–3 mg fluoride per day in fluoridated areas (77–80). The average daily dietary fluoride intake for both children and adults in fluoridated areas has remained relatively constant for several years (11). For children who live in optimally fluoridated areas, this average is approximately 0.05 mg/kg/day (range: 0.02–0.10); for children who live in nonfluoridated areas, the average is approximately half (11). In a survey of four U.S. cities with different fluoride concentrations in the drinking water (range: 0.37–1.04 ppm), children aged 2 years ingested 0.41–0.61 mg fluoride per day and infants aged 6 months ingested 0.21–0.54 mg fluoride per day (81,82).
In the United States, water and processed beverages (e.g., soft drinks and fruit juices) can provide approximately 75% of a person’s fluoride intake (83). Many processed beverages are prepared in locations where the drinking water is fluoridated. Foods and ingredients used in food processing vary in their fluoride content (11). As consumption of processed beverages by children increases, fluoride intake in communities without fluoridated water will increase whenever the water source for the processed beverage is fluoridated (84). In fluoridated areas, dietary fluoride intake has been stable because processed beverages have been substituted for tap water and for beverages prepared in the home using tap water (11).
A study of Iowa infants estimated that the mean fluoride intake from water during different periods during the first 9 months of life, either consumed directly or added to infant formula or juice, was 0.29–0.38 mg per day, although estimated intake for some infants was as high as 1.73 mg per day (85). As foods are added to an infant’s diet, replacing some of the formula prepared with fluoridated water, the amount of fluoride the infant receives typically decreases (86). The Iowa study also reported that infant formula and processed baby food contained variable amounts of fluoride. Since 1979, U.S. manufacturers of infant formula have voluntarily lowered the fluoride concentration of their products, both ready-to-feed and concentrates, to <0.3 ppm fluoride (87).
Drinking Water
Community Water. During the 1940s, researchers determined that 1 ppm fluoride was the optimal concentration in community drinking water for climates similar to the Chicago area (88,89). This concentration would substantially reduce the prevalence of dental caries, while allowing an acceptably low prevalence (i.e., 10%–12%) of very mild and mild enamel fluorosis and no moderate or severe enamel fluorosis. Water fluoridation for caries control began in 1945 and 1946, when the fluoride concentration was adjusted in the drinking water supplying four communities in the United States and Canada (2–5). This public health approach followed a long period of epidemiologic research into the effects of naturally occurring fluoride in drinking water (53,57,88,89).
Current federal fluoridation guidelines, maintained by the PHS since 1962, state that community drinking water should contain 0.7–1.2 ppm fluoride, depending on the average maximum daily air temperature of the area. These temperature-related guidelines are based on epidemiologic studies conducted during the 1950s that led to the development of an algebraic formula for determining optimal fluoride concentrations (67,90–92). This formula determined that a lower fluoride concentration was appropriate for communities in warmer climates because persons living in warmer climates drank more tap water. However, social and environmental changes since 1962 (e.g., increased use of air conditioning and more sedentary lifestyles) have reduced the likelihood that persons in warmer regions drink more tap water than persons in cooler regions (7).
By 1992, fluoridated water was reaching 144 million persons in the United States (56% of the total population and 62% of those receiving municipal water supplies) (93). Approximately 10 million of these persons were receiving water containing naturally occurring fluoride at a concentration of >0.7 ppm. In 11 states and the District of Columbia, >90% of the population had such access, whereas <5% received this benefit in two states. In 2000, a total of 38 states and the District of Columbia provided access to fluoridated public water supplies to >50% of their population (CDC, unpublished data, 2000) (Figure 2).
Initial studies of community water fluoridation demonstrated that reductions in childhood dental caries attributable to fluoridation were approximately 50%–60% (94–97). More recent estimates are lower — 18%–40% (98,99). This decrease in attributable benefit is likely caused by the increasing use of fluoride from other sources, with the widespread use of fluoride toothpaste probably the most important. The diffusion or "halo" effect of beverages and food processed in fluoridated areas but consumed in nonfluoridated areas also indirectly spreads some benefit of fluoridated water to nonfluoridated communities. This effect lessens the differences in caries experience among communities (100).
Quantifying the benefits of water fluoridation among adults is more complicated because adults are rarely surveyed, their fluoride histories are potentially more varied, and their tooth loss or restorations might be caused by dental problems other than caries (e.g., trauma or periodontal diseases). Nevertheless, adults are reported to receive caries-preventive benefits from community water fluoridation (99,101–103). These benefits might be particularly advantageous for adults aged >50 years, many of whom are at increased risk for dental caries. Besides coronal caries, older adults typically experience gingival recession, which results in teeth with exposed root surfaces. Unlike the crowns of teeth, these root surfaces are not covered by enamel and are more susceptible to caries. Because tooth retention among older age groups has increased in recent decades in the United States (39), these groups’ risk for caries will increase as the country’s population ages. Older adults also frequently require multiple medications for chronic conditions, and many of these medications can reduce salivary output (104). Drinking water containing an optimal concentration of fluoride can mitigate the risk factors for caries among older adults. Studies have reported that the prevalence of root caries among adults is inversely related to fluoride concentration in the community drinking water (105–107).
Water fluoridation also reduces the disparities in caries experience among poor and nonpoor children (108–111). Caries experience is considerably higher among persons in low SES strata than among those in high SES strata (39,46,112). The reasons for this discrepancy are not well understood; perhaps persons in low SES strata have less knowledge of oral diseases, have less access to dental care, are less likely to follow recommended self-care practices, or are harder to reach through traditional approaches, including public health programs and private dental care (48). Thus, these persons might receive more benefit from fluoridated community water than persons from high SES strata. Regardless of SES, water fluoridation is the most effective and efficient strategy to reduce dental caries (112).
Enamel fluorosis occurs among some persons in all communities, even in communities with a low natural concentration of fluoride. During 1930–1960, U.S. studies documented that, in areas with a natural or adjusted concentration of fluoride of approximately 1.0 ppm in the community drinking water, the permanent teeth of 7%– 16% of children with lifetime residence in those areas exhibited very mild or mild forms of enamel fluorosis (53,113,114). Before 1945, when naturally fluoridated drinking water was virtually the only source of fluoride, the moderate and severe forms of this condition were not observed unless the natural fluoride concentration was >2 ppm (53). The likelihood of a child developing the mild forms of enamel fluorosis might be higher in a fluoridated area than in a nonfluoridated area, but prevalence might not change in every community (115,116). The most recent national study of this condition indicated that its prevalence had increased in both fluoridated and nonfluoridated areas since the 1940s, with the relative increase higher in nonfluoridated areas. In communities with drinking water containing 0.7–1.2 ppm fluoride, the prevalence was 1.3% for the moderate form of enamel fluorosis and zero for the severe form; thus, few cases of enamel fluorosis were likely to be of cosmetic consequence (8,61). Because combined fluoride intake from drinking water and processed beverages and food by children in fluoridated areas has reportedly remained stable since the 1940s, the increase in fluoride intake resulting in increased enamel fluorosis almost certainly stems from use of fluoride-containing dental products by children aged <6 years (11).
Two studies reported that extended consumption of infant formula beyond age 10–12 months was a risk factor for enamel fluorosis, especially when formula concentrate was mixed with fluoridated water (62,63). These studies examined children who used pre-1979 formula (with higher fluoride concentrations). Whether fluoride intake from formula that exceeds the recommended amount during only the first 10–12 months of life contributes to the prevalence or severity of enamel fluorosis is unknown.
Fluoride concentrations in drinking water should be maintained at optimal levels, both to achieve effective caries prevention and because changes in fluoride concentration as low as 0.2 ppm can result in a measurable change in the prevalence and severity of enamel fluorosis (52,117). Since the late 1970s, CDC has provided guidelines and recommendations for managers of fluoridated water supply systems at state and local levels to help them establish and maintain appropriate fluoride concentrations. CDC periodically updates these guidelines; the most recent revision was published in 1995 (68).
School Water Systems. In some areas of the United States where fluoridating a community’s drinking water was not feasible (e.g., rural areas), the alternative of fluoridating a school’s public water supply system was promoted for many years. This method was used when a school had its own source of water and was not connected to a community water supply system (i.e., stand-alone systems). Because children are at school only part of each weekday, a fluoride concentration of 4.5 times the optimal concentration for a community in the same geographic area was recommended (118) to compensate for the more limited consumption of fluoridated water. At the peak of this practice in the early 1980s, a total of 13 states had initiated school water fluoridation in 470 schools serving 170,000 children (39). Since then, school water fluoridation has been phased out in several states; the current extent of this practice is not known.
Studies of the effects of school water fluoridation in the United States reported that this practice reduced caries among schoolchildren by approximately 40% (118–122). A more recent study indicated that this effect might no longer be as pronounced (123).
Several concerns regarding school water fluoridation exist. Operating and maintaining small fluoridation systems (i.e., those serving <500 persons) create practical and logistical difficulties (68). These difficulties have occasionally caused higher than recommended fluoride concentrations in the school drinking water, but no lasting effects among children have been observed (124–126). In schools that enroll preschoolers in day care programs, children aged <6 years might receive more than adequate fluoride.