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Fluoride Varnish for Caries Prevention

  • Date: Nov 09 2010
  • Policy Number: 201010

Key Words: Dental Health, Medicaid, Research

Related Policies

APHA Policy Statement 97-06: Evidence-Based Dental Care1 APHA Policy Statement 2008-7: Community Water Fluoridation in the United States2

In addition to promoting fluoridated water and fluoridated toothpaste, fluoride varnish programs should be established or expanded to reach underserved populations at high-risk of tooth decay. Dental caries, commonly known as tooth decay (the process, as distinguished from the cavity, the final phase of the process), affect people of all ages. Although tooth decay can be prevented or controlled, 28% of all US children ages 2 to 5 years have dental caries in primary teeth (20% of all children in this age group have untreated caries); 54% of children ages 2 to 11 years living at less than 100% of the Federal Poverty Level have dental caries in primary teeth (33% of all children in this age group have untreated caries)3; 23% of 6 to 11year olds living at less than 100% of the Federal Poverty Level have untreated permanent tooth caries.3 In 2005, 4.7 million US children ages 2 to 17 years had unmet dental needs because their families could not afford dental care.4 Untreated disease may lead to acute pain, abscess, cellulitis, tooth loss, failure to thrive, dysfunctional speech patterns, diminished self-image, and decreased school or work attendance.5 Adults from some racial and ethnic minority groups and those who have less than a high school education, live in poverty, or have certain medically compromising conditions have a higher prevalence of dental caries.5 Institutionalized elderly patients are more likely to experience dental caries than those living in their own homes.6 For a variety of reasons, many people have difficulty accessing dental preventive and treatment services; for example, only 10% of 1-year-old children, 24% of 2-year-old children, and 51% of 3-year-old children were reported by parents to have had a preventive dental care visit in 2003.7,8 This can include those with dental coverage, for example, only 34% of children enrolled in Medicaid and State Children’s Health Insurance Program (CHIP) had a dental visit in 2004.7,8 Those at high risk for dental caries, regardless of age, should receive the preventive regimens necessary to maintain a healthy dentition.

Fluoride is a naturally occurring element that has been found to have a major influence on the decrease in dental caries.9,10 Although fluoride has both a topical and systemic action, the topical action is the more important,11 especially when combined with supervised brushing of the child’s teeth twice a day.12–14 Fluoride varnish is a lacquer that contains a high concentration of fluoride [5% NaF, 22,600 ppm (2.26%) fluoride]; it is painted on teeth to prevent dental caries. Fluoride varnish inhibits demineralization and promotes remineralization of tooth enamel, thereby preventing or reversing the first stage of tooth decay (commonly referred to as “white spots”).15 Fluoride varnish sets on contact with teeth in the presence of saliva, which is advantageous where it is difficult to maintain a dry oral environment, as in young children and those with neurodevelopmental or intellectual disabilities15 and where other topical fluorides might be ingested. Its application is noninvasive and takes 3 min or less to complete. Plasma fluoride levels after application of fluoride varnish are comparable to or lower than other topical fluoride regimens.16,17 The US Food and Drug Administration (FDA) has approved fluoride varnish products as medical devices to be used as cavity liners and for the treatment of hypersensitive teeth, but they can be used off-label as caries-preventive agents.15 Although no US pharmaceutical company has invested in a multiyear longitudinal study of the efficacy of fluoride varnish for caries prevention as a drug claim, numerous trials conducted outside the United States have conclusively shown its use to be safe and effective.15 Without US-generated data, the FDA will not consider an on-label designation. Although used off label, because of its safety, fluoride varnish can be applied by trained dental and medical personnel (doctor, nurse practitioner, physician assistant, registered nurse, licensed practical nurse, certified medical assistant) to at-risk children and adults in dental and medical offices as well as in a variety of nonmedical clinic venues, for example, Women, Infants, and Children (WIC) program clinics, immunization clinics, community health centers, schools, day care settings, extended or long-term care facilities and private homes of medically compromised homebound patients, Head Start/Early Head Start programs, and the like, none of which requires a dental operatory or specialized equipment (e.g., compressed air or suction).12,18 These nondental settings may be especially productive for reaching people at risk who otherwise have difficulty gaining access to preventive dental services and treatment. In a personal communication on June 14, 2010, Amos Deinard noted that the number of state Medicaid programs that reimburse primary care medical providers for fluoride varnish application has recently increased from 35 to 43.19,2

Fluoride varnish is efficacious when applied topically to permanent teeth of school-aged children and adolescents14,15,21–25 and to primary teeth of preschool children24–28 when applied according to American Dental Association (ADA) recommendations for moderate and high-risk children.25,29 Based on evidence of effectiveness in permanent teeth in children and adolescents, and in reducing root caries in older adults, it has also been recommended by the ADA for adults who are susceptible to dental caries.25,30 Populations at risk (see ADA recommendations)25,29 for dental caries include the following: people with little or no access to routine comprehensive dental care (e.g., low-income families, those covered by Medicaid/CHIP), those with xerostomia or taking medications on a chronic basis that reduce salivary flow, those with disabilities, and those in nursing or assisted-living homes. People with specific caries risk indicators such as suboptimal fluoride exposure; cariogenic diets consisting of fermentable carbohydrates, such as sugars and cooked starches; high cariogenic bacterial levels or low salivary fluoride levels; and recent past caries experience also may be targeted.22,25,31 Topical fluoride varnish is not a substitute for community water fluoridation, dietary fluoride supplements, use of fluoride toothpaste as part of twice-daily brushing of teeth, or dental sealants, and it does not obviate the need for regular dental care. Although more expensive than community water fluoridation or fluoride toothpaste, application of fluoride varnish for Medicaid-enrolled children may be cost saving under certain conditions.32

Therefore, the American Public Health Association urges the following:

  1. Public health authorities and health care providers should establish coordinated fluoride varnish programs in various public health, dental, and medical settings, using appropriately trained personnel to reach those at moderate to high risk for dental caries as an adjunct to effective public health programs, such as water fluoridation.
  2.  Public health authorities should ensure that appropriate assessments are in place to determine a population’s risk for dental caries and offer fluoride varnish application and education through organized programs.
  3. Those considered for fluoride varnish application and their parents or caregivers should receive age, culturally, and linguistically appropriate oral health anticipatory guidance about caries etiology and prevention and the role of fluoride varnish and other preventive measures.
  4.  Federal, state, and local governments; insurers; and foundations should provide financial support and incentives for fluoride varnish programs for all at-risk populations.
  5. Federal programs should provide financial support for additional fluoride varnish research in populations other than children and in alternative delivery settings to improve our understanding of efficacy, effectiveness, applicability, program adoption, reach, and cost-effectiveness compared with other topical fluoride and caries prevention regimens.


  1. American Public Health Association. APHA Policy Statement 97-06: Evidence-Based Dental Care. Washington, DC: American Public Health Association; 1997. Available at: www.apha.org/advocacy/policy/policysearch/default.htm?id=140. Accessed December 30, 2010.
  2. American Public Health Association. APHA Policy Statement 2008-7: Community Water Fluoridation in the United States. Washington, DC: American Public Health Association; 2008. Available at: www.apha.org/advocacy/policy/policysearch/default.htm?id=1373. Accessed December 30, 2010.
  3. Dye BA, Tan S, Smith V, et al. Trends in oral health status: United States, 1988–1994 and 1999–2004. Vital Health Stat 11. 2007; No. 248:1–92.
  4. Bloom B, Dey AN, Freeman G. Summary health statistics for US children: national health interview survey, 2005. Vital Health Stat 10. 2006; No. 231:1–84.
  5. US Department of Health and Human Services. Oral Health in America: A Report of the Surgeon General. Rockville, Md: US Department of Health and Human Services, National Institute of Dental and Craniofacial Research, National Institutes of Health, 2000.
  6. Longhurst RH. Availability of domiciliary dental care for the elderly. Prim Dent Care. 2002;9(4):147–150.
  7. Edelstein BL, Chinn CH. Update on disparities in oral health and access to dental care for America’s children. Acad Pediatr. 2009:9(6):415–419.
  8. Maserejian NN, Trachtenberg F, Link C, Tavares M. Underutilization of dental care when it is freely available: a prospective study of the New England Children’s Amalgam Trial. J Public Health Dent. 2008;68(3):139–148.
  9. Centers for Disease Control and Prevention. Ten great public health achievements: United States, 1900–1999. MMWR Morb Mortal Wkly Rep. 1999;48(12):241–243.
  10. Peterson, PE, Lennon, MA. Effective use of fluoride for the prevention of dental caries in the 21st century: the WHO approach. Community Dent Oral Epidemiol. 2004;32(5):319–332.
  11. Hellwig E, Lennon AM. Systemic versus topical fluoride. Caries Res. 2009;38(3):258–262.
  12. Milgrom P, Tut OK. Evaluation of Pacific Islands Early Childhood Caries Prevention Project: Republic of the Marshall Islands. J Public Health Dent. 2009.69(3):201–203.
  13. Adair SM. Evidence-based use of fluoride in contemporary pediatric dental practice. Pediatr Dent. 2006;28(2):133–142.
  14. American Academy of Pediatric Dentistry, Liaison With Other Groups Committee. Guidelines on fluoride therapy. Pediatr Dent. 2008;31(6):128–131.
  15. Beltran-Aguilar ED, Goldstein JW, Lockwood SA. Fluoride varnishes. A review of their clinical use, cariostatic mechanism, efficacy and safety. J Am Dent Assoc. 2000;131(5):589–596.
  16. Ekstrand J. Plasma fluoride concentration and urinary fluoride excretion in children following application of the fluoride-containing varnish duraphat. Caries Res. 1980;14:185–189.
  17. Ekstrand J. Pharmacokinetic aspects of topical fluorides. J Dent Res. 1987;66:1061–1065.
  18. Rozier RG, Sutton BK, Bawden JW, Haupt K, Slade GD, King RS. Prevention of early childhood caries in North Carolina medical practices: implications for research and practice. J Dent Educ. 2003;67(8):876–885.
  19. Cantrell C. Engaging Primary Care Medical Providers in Children’s Oral Health. Portland, Me: National Academy for State Health Policy; 2009. Available at: www.nashp.org/sites/default/files/EngagingPrimaryCareMedicalProvidersCOH.pdf. Accessed June 9, 2010.
  20. Pew Center on the States. The Cost of Delay: State Dental Policies Fail One in Five Children. Washington, DC: Pew Center on the States; 2010. Available at: www.pewcenteronthestates.org/uploadedFiles/Cost_of_Delay_web.pdf. Accessed June 9, 2010.
  21. Rozier RG. Effectiveness of methods used by dental professionals for the primary prevention of dental caries. J Dent Educ. 2001;65(10):1063–1072.
  22. US National Institutes of Health. Diagnosis and management of dental caries throughout life. National Institutes of Health Consensus Statement. 2001;18(1):1–23. Available at: http://consensus.nih.gov/2001/2001DentalCaries115html.htm. Accessed December 16, 2010.
  23. Azarpazhooh A, Main PA. Fluoride varnish with prevention of dental caries in children and adolescents: A systematic review. J Can Dent Assoc. 2008;74(1):73–79.
  24.  Marinho VCC, Higgins JPT, Logan S, Sheinam A. Fluoride varnishes for preventing dental caries in children and adolescents. Cochrane Database of Systematic Reviews. 2002;3:Art. No.: CD002279. doi: 10.1002/14651858.CD002279
  25. American Dental Association Council on Scientific Affairs. Professionally applied topical fluoride: Evidence-based clinical recommendations. J Am Dent Assoc. 2006;137:1151–1159.
  26. Weintraub JA, Ramos-Gomez F, Jue B, et al. Fluoride varnish efficacy in preventing early childhood caries. J Dent Res. 2006;85(2):172–176.
  27. Lawrence HP, Binguis D, Douglas J, et al. A 2-year community-randomized controlled trial of fluoride varnish to prevent early childhood caries in aboriginal children. Community Dent Oral Epidemiol. 2008;36(60):503–516.
  28. Holve S. An observational study of the association of fluoride varnish applied during well-child visits and the prevention of early childhood caries in American Indian children. Matern Child Health J. 2008;12(suppl 1):64–67.
  29. Ramaswani N. Fluoride varnish: a primary prevention tool for dental caries. J Mich Dent Assoc. 2008:90(1):44–47.
  30. Innes N, Evans D. Caries prevention for older people in residential care homes. Evid Based Dent. 2009;10(3):83–87.
  31. Holve S. Fluoride varnish applied at well child care visits can reduce early childhood caries. IHS Prim Care Provid. 2006;31(10):243–245.
  32. Quinonez RB, Stearns SC, Talekar BS, Rozier RG, Downs SM. Simulating cost-effectiveness of fluoride varnish during well-child visits for Medicaid-enrolled children. Arch Pediatr Adolesc Med. 2006;160(2):164–170.

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