Note: This draft Recommendation Statement is not the final recommendation of the U.S. Preventive Services Task Force. This draft is distributed solely for the purpose of pre-release review. It has not been disseminated otherwise by the USPSTF. It does not represent and should not be interpreted to represent a USPSTF determination or policy.
This draft Recommendation Statement is based on an Evidence Report that is also available for public comment. To read the accompanying draft Evidence Report and provide comments, go to http://www.uspreventiveservicestaskforce.org/draftrep.htm.
The USPSTF makes recommendations about the effectiveness of specific clinical preventive services for patients without related signs or symptoms.
It bases its recommendations on the evidence of both the benefits and harms of the service, and an assessment of the balance. The USPSTF does not consider the costs of providing a service in this assessment.
The USPSTF recognizes that clinical decisions involve more considerations than evidence alone. Clinicians should understand the evidence but individualize decisionmaking to the specific patient or situation. Similarly, the USPSTF notes that policy and coverage decisions involve considerations in addition to the evidence of clinical benefits and harms.
This draft Recommendation Statement is available for comment from May 21 until June 17, 2013 at 5:00 PM ET. You may wish to read the entire Recommendation Statement before you comment. A fact sheet that explains the draft recommendations in plain language is available here.
Prevention of Dental Caries in Children From Birth Through Age 5 Years: U.S. Preventive Services Task Force Recommendation Statement
Summary of Recommendations and Evidence
The U.S. Preventive Services Task Force (USPSTF) recommends that primary care clinicians prescribe oral fluoride supplementation starting at age 6 months for children whose water supply is deficient in fluoride, and apply fluoride varnish to the primary teeth of infants and children starting at the age of primary tooth eruption.
This is a B recommendation.
The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of routine screening for dental caries in children from birth to age 5 years by primary care clinicians.
This is an I statement.
Dental caries is the most common chronic disease in children in the United States (1). According to the 1999–2004 National Health and Nutrition Examination Survey (NHANES), approximately 42% of children ages 2 to 11 years have dental caries in their primary teeth. After decreasing from the early 1970s to the mid-1990s, the prevalence of dental caries in children has been increasing, particularly in young children ages 2 to 5 years (2).
Detection and Recognition of Risk Status
The USPSTF found adequate evidence that primary care practitioners can accurately identify existing dental caries and identify young children in need of dental referral because of caries.
Benefits of Detection and Recognition of Risk Status
The USPSTF found adequate evidence that oral fluoride supplementation, also known as dietary fluoride supplementation, in children who have low levels of fluoride in their water and application of fluoride varnish can each provide moderate benefit in preventing dental caries. The USPSTF found insufficient evidence on the benefits of parental education, dental referral, and other preventive medications, such as xylitol.
The USPSTF found no studies addressing the direct effect of oral screening by primary care clinicians on improved clinical outcomes in children younger than age 5 years. However, early detection allows for early referral to a dentist for treatment of caries and precaries (noncavitated caries) lesions.
Harms of Detection and Recognition of Risk Status
The USPSTF found adequate evidence of a link between early childhood exposure to systemic fluoride and enamel fluorosis. No studies reported on the risk of fluorosis with fluoride varnish. Trials reported diarrhea associated with xylitol use, and harms were poorly reported in trials of other caries preventions. The USPSTF concludes that there is limited evidence about the harms associated with fluoride varnish or other preventive treatments for dental caries, but that these risks are likely small.
The USPSTF found no studies addressing the magnitude of harms of screening children from birth to age 5 years for dental caries or future risk of dental caries. The harms of screening are likely no greater than small. The harms of treatment of identified caries by dentists is beyond the scope of this recommendation.
The USPSTF concludes with moderate certainty that there is a moderate net benefit of preventing future dental caries with oral fluoride supplementation at recommended doses in children older than age 6 months who reside in communities with inadequate water fluoride (<0.6 ppm F), and a moderate net benefit of fluoride varnish application in children starting at the age of eruption of primary teeth to age 5 years.
The USPSTF concludes that the evidence for screening for dental caries in children from birth to age 5 years is insufficient, and the balance of benefits and harms of screening cannot be determined.
Patient Population Under Consideration
These recommendations apply to children age 5 years or younger.
Assessment of Risk
All children are at risk for dental caries; those whose primary water supply is deficient in fluoride are at particular risk. While there are no available validated screening tools for determining which children are at higher risk for dental caries, there are a number of identified factors that put children at risk (2). Higher prevalence and severity of dental caries are found in minority and economically disadvantaged children. Other risk factors for caries in children include frequent sugar exposure, inappropriate bottle feeding, developmental defects of the tooth enamel, and previous caries. Maternal factors can also increase children's risk. These factors include poor oral hygiene, low socioeconomic status, recent maternal caries, and frequent snacking. Additional factors associated with dental caries in young children include lack of access to dental care; inadequate preventive measures, such as community water fluoridation or use of fluoride-containing toothpastes; and lack of parental knowledge about oral health (3).
Interventions to Prevent Dental Caries
As noted previously, oral fluoride supplementation in patients with inadequate water fluoridation prevents dental caries. All children can benefit from application of fluoride varnish, regardless of the levels of fluoride in their water. Additional potential treatments, such as xylitol gum and wipes, show some promise, but there is currently not enough evidence to recommend these treatments (3). Although the USPSTF did not review the evidence on counseling on tooth brushing, it is accepted that regular tooth brushing by children once the teeth have erupted is very important in preventing dental caries.
Timing and Dosage of Preventive Medications
No studies specifically addressed the dosage and timing of oral fluoride supplementation in children with inadequate water fluoridation. The American Dental Association's (ADA's) recommendations on the dosage of and age at which to start oral fluoride supplementation (which they refer to as dietary fluoride supplements) take into account the amount of fluoride in the child's water source (4). These dosing recommendations are also referenced by the American Academy of Pediatrics (AAP) (5).
There is some evidence that fluoride varnish does not need to be applied more frequently than every 6 months to be effective; however, no studies addressed the optimal frequency of application or the appropriate ages at which to start and stop treatment (6-8).
Studies show that with 2 to 4 hours of training, pediatricians can be taught to appropriately identify children with dental caries and children who require a dental referral (9, 10). No studies assessed an appropriate screening interval.
Suggestions for Practice Regarding the I Statement
In deciding whether to screen for dental caries in children from birth to age 5 years, clinicians should consider the following.
Potential Preventable Burden
Dental caries is the most common chronic disease in children in the United States. It is four times more common than childhood asthma and seven times more common than hay fever. According to the NHANES, the prevalence of dental caries has risen from 24% to 28% between 1988–1994 and 1999–2004 (2). Approximately 20% of surveyed children with caries had not received treatment. Dental caries in children are associated with pain, loss of teeth, impaired growth, and decreased weight gain, and can affect appearance, self-esteem, speech, and school performance. Dental-related concerns lead to the loss of more than 54 million school hours each year (11).
No studies examined the harms of primary care screening for dental caries in children from birth to age 5 years (3). However, given the noninvasive nature of screening, these harms would be expected to be minimal.
The AAP has developed an oral health risk assessment tool for primary care pediatricians to use in screening patients starting at the 6-month visit (12). In one study, most pediatricians agreed with the AAP's oral health recommendations; however, only about half reported examining the teeth of half of their patients ages 0 to 3 years. Only 4% of pediatricians reported regularly applying fluoride varnish to the teeth of patients in this age group (13). The AAP recommends an oral health assessment for all children by age 6 months and a first dental visit by age I year (14).
Other Approaches to Prevention
In 2002, the Community Preventive Services Task Force found that community water fluoridation is effective in reducing tooth decay among populations. On the basis of strong evidence of effectiveness, it recommended that community water fluoridation be included as part of a comprehensive strategy to prevent or control tooth decay in communities (15).
Many primary care providers already prescribe oral fluoride supplementation to patients with low levels of fluoride in their water; however, application of fluoride varnish is not a common practice in primary care offices. Although the techniques for application are simple and easy to learn, providers and other qualified staff may require some training prior to offering this procedure.
According to the National Business Group on Health, the cost of oral fluoride supplementation is approximately $33 (16). The price of fluoride varnish application ranges from $1 to $50. State Medicaid coverage for the procedure ranges from $9 to $30 when applied by a variety of licensed providers who have had appropriate training, including physicians, physician assistants, nurse practitioners, registered nurses, and licensed practical nurses (varying by State) (17).
Research Needs and Gaps
Although demographic factors such as socioeconomic status and lack of adequate water fluoridation can guide a provider's decisionmaking on oral fluoride supplementation and fluoride varnish application, studies that validate risk assessment tools and efficacy in these populations are needed.
The benefits of fluoride varnish have only been studied when provided by dental practitioners. The treatment is simple and easy to apply; thus, one could reasonably extrapolate these results to provision by primary care providers. Studies of fluoride varnish application, and any other potential treatments for preventing dental caries, should be conducted in primary care settings to better understand the overall benefits in primary care.
Racial and ethnic minority children are at significantly increased risk of caries compared with white children. Future studies on risk assessment and preventive interventions should enroll sufficient numbers of racial and ethnic minority children to understand the benefits and harms of interventions in these populations.
Further studies investigating the effectiveness of xylitol and other potential treatments for preventing dental caries would also be useful to expand the range of preventive interventions. All studies should also evaluate possible harms.
Burden of Disease
Dental caries is the most common chronic disease in children in the United States, and is increasing in prevalence among young children (1). According to the NHANES, the prevalence of tooth decay in primary teeth in children ages 2 to 5 years increased from approximately 24% to 28% between 1988–1994 and 1999–2004 (2). Approximately 20% of surveyed children with caries had not received treatment for the condition.
Additionally, the NHANES found that among children ages 2 to 11 years, 54% of children in households living below the federal poverty threshold had primary dental caries, as well as one third of children in households living 200% above the poverty threshold. Fifty-five percent of Mexican American children have dental caries compared with 43% of African American children and 39% of white children. Mexican American children are also more likely to have untreated dental caries (33%) than African American (28%) and white (20%) children (2).
Early childhood caries can cause pain, loss of teeth, caries later in life, impaired growth/weight gain, missed school days, and negative effects on quality of life. Caries in early childhood are associated with failure to thrive and can affect speech, appearance, and school performance. They are also associated with an increased risk of caries in additional primary or permanent teeth. More than 51 million hours of school are missed each year because of childhood dental concerns (11).
Scope of Review
To update the 2004 recommendation, the USPSTF commissioned a systematic review of the evidence on prevention of dental caries by primary care clinicians in children age 5 years or younger. The review focused on screening for caries, assessment of risk for future caries, and the effectiveness of various medications that have possible benefits in preventing caries. The USPSTF reviewed evidence on xylitol and other interventions not included in the previous recommendation.
Risk Assessment and Accuracy of Screening
No studies assessed the effectiveness of formal risk assessment by primary care clinicians in identifying children at risk for dental caries. Although there are tools available from several professional organizations for use in the primary care setting, no studies evaluated their use.
Two studies assessed the accuracy of screening for caries by primary care clinicians. One older, fair-quality study included in the 2004 review found that after 4 hours of training, a pediatrician's oral health evaluation of children ages 18 to 36 months had a sensitivity of 1.0 and a specificity of 0.87 for identifying nursing caries compared with an examination by a pediatric dentist (10). A more recent good-quality study evaluated primary care pediatricians' ability to identify caries in children younger than age 36 months after 2 hours of oral health education (9). Compared with an examination by a pediatric dentist, examination by a pediatrician had a sensitivity of 0.76 and a specificity of 0.95 for identifying children with one or more cavities, sensitivity of 0.49 and specificity of 0.99 for identifying a tooth with a cavity, and sensitivity of 0.63 and specificity of 0.98 for identifying children in need of a dental referral because of caries.
Effectiveness of Preventive Interventions
Six older studies (18-23) assessed the effectiveness of fluoride supplementation; the USPSTF found no new studies since its previous 2004 review. Although the studies had some methodological limitations, such as lack of adjustment for potential confounders, inadequate blinding, or unreported attrition, and were fairly heterogeneous, they support the conclusion that oral fluoride supplementation leads to decreased dental caries in children age 5 years or younger who have inadequate fluoridation in their water. The single randomized trial (n=140; fluoridation level <0.1 ppm F) found that 0.25 mg fluoride drops or chews were associated with decreased risk of caries versus no fluoride supplementation in Taiwanese children age 2 years at enrollment (22). Reductions ranged from 52% to 72% for decayed, missing, and filled teeth and from 51% to 81% for decayed, missing, and filled tooth surfaces. Across all six trials, reductions with fluoride supplementation ranged from 32% to 72% for decayed, missing, and filled teeth and from 38% to 81% for decayed, missing, and filled tooth surfaces versus placebo (vitamin drops) or no supplementation (3).
Seven recent trials assessed professionally applied topical fluoride in children age 5 years or younger. Three trials (two good-quality and one fair-quality) compared fluoride varnish applied every 6 months with no fluoride varnish. Two were conducted in rural Aboriginal populations in Canada and Australia (24, 25) with inadequate levels of fluoride in the water, and the third trial enrolled primarily Latino and Chinese underserved children in an urban U.S. community with adequate water fluoridation (6). All three trials found that fluoride varnish was associated with a decreased risk of dental caries after 2 years. Absolute mean reductions in the number of affected tooth surfaces ranged from 1.0 to 2.4 (3). A poor-quality trial examined fluoride varnish applied every 3 months and reported consistent findings (26).
Two trials in China assessed the effectiveness of other methods of administering topical fluoride. One good-quality trial found that acidulated phosphate fluoride foam applied every 6 months was more effective than placebo at preventing caries (27). A poor-quality trial found that silver diamine fluoride solution administered every 12 months was somewhat more effective than fluoride varnish every 3 months. Neither of these alternative topical fluoride solutions are used in the United States.
Three studies evaluated the frequency of fluoride varnish application (6-8). None of the studies showed benefit to applying the varnish more frequently than every 6 months.
Other Preventive Interventions
Four studies showed no clear effects of xylitol versus no xylitol on caries risk in children younger than age 5 years (28-31). A single small, fair-quality trial of xylitol wipes showed the most promising results with children ages 6 to 35 months, revealing a 91% reduction in decayed, missing, or filled surface increment. The studies used different doses, formulations, and comparators (no xylitol or supervised tooth brushing), which limited the USPSTF's ability to make conclusions about the benefits.
Studies on the effectiveness of other interventions, such as chlorhexidine varnish and povidone-iodine solution, were limited to single trials, preventing reliable conclusions.
Effectiveness of Screening
No studies examined the effectiveness of screening in preventing dental caries. When caries are identified, patients are typically referred to a dentist for treatment; however, no studies evaluated routine referral of children from primary care to dental care.
Potential Harms of Preventive Interventions
The USPSTF considered a recently updated systematic review on fluorosis that includes five new studies not available for the 2004 recommendation. These observational studies consistently found an association between early childhood exposure to systemic fluoride and enamel fluorosis (32). The evidence is limited in that measures of early childhood exposure were based on parental recall (3). Risk estimates ranged from an odds ratio of 10.8 (95% CI, 1.9 to 62) for exposure during the first 2 years of life to a slight increase in risk (odds ratio, 1.1 to 1.7 depending on comparison) (33).
No studies reported the risk of fluorosis with fluoride varnish application; however, the degree of systemic fluoride exposure following varnish application is suspected to be low. Two of the xylitol trials reported diarrhea as a side effect (30, 34).
Potential Harms of Screening
No studies compared harms in children who were screened versus not screened for dental caries (3). Possible harms resulting from treatment of caries by dentists were not evaluated for this recommendation.
Estimate of Magnitude of Net Benefit
The USPSTF concludes with moderate certainty that there is a moderate net benefit to prescribing oral fluoride supplementation at recommended doses starting at age 6 months to children with inadequate fluoride in their water, and there is a moderate net benefit to applying fluoride varnish to the primary teeth of infants and children starting at the age of primary tooth eruption.
The USPSTF found adequate evidence that primary care clinicians can effectively identify dental caries in children age 5 years or younger; however, the USPSTF found inadequate evidence on the effectiveness of screening to improve outcomes and on the harms of screening or treatment. Therefore, the USPSTF concluded that the evidence on the benefits and harms of screening is lacking, and the balance of benefits and harms could not be determined.
How Does Evidence Fit With Biological Understanding?
Systemic fluoride becomes incorporated into tooth structures during their formation. If fluoride is ingested repeatedly during tooth development, it is deposited throughout the tooth surface and provides protection against caries. Topical fluoride treatments, such as varnishes, help protect teeth that are already present. In this method, fluoride is incorporated into the surface layer of the teeth, making them more resistant to decay. Systemic fluoride also provides some measure of topical effects, as it is found in the saliva and bathes the teeth. Thus, providing both systemic and topical fluoride to children during tooth development fits with the biologic understanding of fluoride's protective actions against dental decay.
Update of Previous Recommendation
This is an update of the 2004 USPSTF recommendation that primary care clinicians prescribe oral fluoride supplementation to children age 6 months or older whose primary water source is deficient in fluoride (B recommendation) (35). This recommendation was based on fair evidence that prescription of oral fluoride supplements by primary care clinicians to young children with low fluoride exposure is associated with reduced risk of dental caries that outweighs the potential harms of enamel fluorosis, which primarily manifests in the United States as mild cosmetic discoloration of the teeth. The current statement similarly recommends oral fluoride supplementation, but expands to include the recommendation that primary care providers apply fluoride varnish to the primary teeth of children age 5 years or younger, starting at tooth eruption.
In 2004, the USPSTF concluded that the evidence was insufficient to recommend for or against routine risk assessment of children age 5 years or younger by primary care clinicians for the prevention of dental disease (I statement). The current recommendation concludes that there is still not enough evidence to recommend for or against screening for dental caries in children age 5 years or younger.
Recommendations of Others
The AAP has issued two policy statements related to dental care in children. The first, issued in 2003 and reaffirmed in 2009, encourages providers to incorporate oral health–related services into their practices. Specifically, the AAP recommends an oral health assessment for all children by age 6 months and a first dental visit by age 1 year (14). The second statement supports oral fluoride supplementation and application of fluoride varnish in children at risk for dental caries (36). The ADA recommends that children be seen by a dentist within 6 months of eruption of the first tooth and no later than age 12 months. The ADA also recommends the application of fluoride varnish every 6 months in preschool-age children who are at moderate risk of dental caries and every 3 to 6 months in children who are at high risk (37). Similarly, the American Academy of Family Physicians recommends that clinicians consider dietary fluoride supplementation in children ages 6 months to 16 years who lack access to adequately fluoridated drinking water (38). It recommends doses of dietary fluoride supplementation ranging from 0.25 to 1.0 mg per day, depending on age, level of water fluoridation, and exposure to other dietary fluoride sources. Dietary fluoride supplementation is generally not recommended when water fluoridation levels are greater than 0.6 ppm F (4).
The Centers for Disease Control and Prevention recommend that clinicians counsel parents about appropriate use of fluoridated toothpastes, especially in children age 2 years or younger, prescribe fluoride supplements to children at high risk of dental caries and whose drinking water lacks adequate fluoridation, and limit the use of high-concentration fluoride products, such as varnish and gel, to high-risk individuals (39).
The American Academy of Pediatric Dentistry recommends use of xylitol in age-appropriate formulations for moderate- and high-risk children (40). The ADA recommends xylitol in children age 5 years or older, recommends against the use of chlorhexidine varnish, and found insufficient evidence to determine the effectiveness of povidone iodine (41).
In April 2013, the Community Preventive Services Task Force, which reviews community-based and health-system interventions to improve health, recommended fluoridation of community water sources and school-based dental sealant programs to prevent cavities at a population level.
Table 1: What the Grades Mean and Suggestions for Practice
Table 2: Levels of Certainty Regarding Net Benefit
|Level of Certainty*||Description|
|High||The available evidence usually includes consistent results from well-designed, well-conducted studies in representative primary care populations. These studies assess the effects of the preventive service on health outcomes. This conclusion is therefore unlikely to be strongly affected by the results of future studies.|
|Moderate||The available evidence is sufficient to determine the effects of the preventive service on health outcomes, but confidence in the estimate is constrained by factors such as:
As more information becomes available, the magnitude or direction of the observed effect could change, and this change may be large enough to alter the conclusion.
|Low||The available evidence is insufficient to assess effects on health outcomes. Evidence is insufficient because of:
More information may allow an estimation of effects on health outcomes.
*The U.S. Preventive Services Task Force defines certainty as "likelihood that the USPSTF assessment of the net benefit of a preventive service is correct." The net benefit is defined as benefit minus harm of the preventive service as implemented in a general, primary care population. The USPSTF assigns a certainty level based on the nature of the overall evidence available to assess the net benefit of a preventive service.
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AHRQ Publication No. 12-05170-EF-2
Current as of May 2013
U.S. Preventive Services Task Force .Prevention of Dental Caries in Children From Birth Through Age 5 Years: Draft Recommendation Statement. AHRQ Publication No. 12-05170-EF-2. http://www.uspreventiveservicestaskforce.org/draftrec.htm