BEST PRACTICES: FLUORIDE THERAPY

Fluoride Therapy
Latest Revision

How to Cite: American Academy of Pediatric Dentistry. Fluoride
therapy. The Reference Manual of Pediatric Dentistry. Chicago, Ill.:
American Academy of Pediatric Dentistry; 2023:352-8.

2023

Abstract
This best practice provides information for practitioners regarding the use of fluoride as an aid in preventing and controlling dental caries inpediatric dental patients. These recommendations address systemic fluoride (water fluoridation, dietary fluoride supplements), topical fluoride delivery via professional application (acidulated phosphate fluoride gel or foam, sodium fluoride varnish, silver diamine fluoride), andhome-use products (toothpastes, mouthrinses) as well as the associated risks of fluoride agents. The standard level for community water
fluoridation (0.7 parts per million fluoride) helps balance the risk of caries and the possibility of dental fluorosis from excessive fluoride
ingestion during the early years of tooth development. Specific recommendations for dietary supplementation of fluoride for children ages
six months through 16 years are based on fluoride levels in the drinking water, other dietary sources of fluoride, use of a fluoridated toothpaste, and caries risk. The specific needs of each patient determine the appropriate use of systemic and topical fluoride products, whetherdelivered in a professional clinical or a home setting. Fluoride has proven to be an effective therapy in reducing the prevalence of dental
caries in infants, children, adolescents, and persons with special needs.
Through a collaborative effort of the American Academy of Pediatric Dentistry Councils on Clinical Affairs and Scientific Affairs, this bestpractice was revised to offer updated information and recommendations to assist healthcare practitioners and parents in using fluoride
therapy for management of caries risk in pediatric patients.
KEYWORDS: ADOLESCENT; CHILD; FLUORIDATION; FLUORIDE; ORAL HEALTH; SILVER DIAMINE FLUORIDE; TOOTHPASTE

PurposeThe American Academy of Pediatric Dentistry intends theserecommendations to help practitioners make decisions concerning appropriate use of fluoride as part of the comprehensive
oral health care for infants, children, adolescents, and persons
with special health care needs.

Methods
This document was initially developed by the Liaison with
Other Groups Committee, adopted in 19671 and last revisedby the Council on Clinical Affairs in 2018 2. To update thisguidance, an electronic search of the PubMed /MEDLINE
database was conducted using the terms: fluoride caries prevention, fluoridation, fluoride gel, fluoride varnish, fluoride
toothpaste, fluoride therapy, silver diamine fluoride, and topicalfluoride; fields: all; limits: within last five years, English. Because 4077 papers were identified through these electronic
searches, an alternate strategy of limiting the information
gathering to systematic review using the term fluoride caries
prevention yielded 116 new systematic reviews or trials since2017. Expert opinions and clinical practices also were relied
upon for these recommendations.

®

Background
Fluoride has been a major factor in the decline in prevalenceand severity of dental caries in the United States (U.S.) andother economically developed countries. It has several cariesprotective mechanisms of action. Topically, low levels of
fluoride in plaque and saliva inhibit the demineralization ofsound enamel and enhance the remineralization of demineralized

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enamel.3,4 The topical effect may be enhanced when combinedwith good oral hygiene practices at home and use of a fluoride
dentifrice.5 Fluoride also inhibits dental caries by affecting themetabolic activity of cariogenic bacteria.6 High levels of fluoride, such as those attained with the use of topical gels or
varnishes, produce a temporary layer of calcium fluoride-likematerial on the enamel surface. The fluoride is released when the
pH drops in response to acid production and becomes available
to remineralize enamel or affect bacterial metabolism.7 Althoughfluoride-rich enamel is less acid-soluble than enamel with lessfluoride, the topical and remineralization effects of fluoride
have been found to have a greater impact on caries prevention
than incorporation of fluoride into developing teeth.8
Community water fluoridation
Fluoridation of community drinking water is the most equitable
and cost-effective method of delivering fluoride to all membersof most communities. 9 As of 2018, 73 percent of the U.S.
population on community water systems had access to fluoridated water. 10 Water fluoridation at the level of 0.7-1.2
milligrams (mg) fluoride ion per liter (i.e., parts per million
fluoride [ppm F]) was introduced in the U.S. in the 1940s.
Since community water is now one of several sources of fluoride,
ABBREVIATIONS
CaF: Calcium fluoride. F: Fluoride. FSIQ: Full scale intelligent quotient. IQ: Intelligence quotient. mg: Milligrams. mg/kg: Milligrams
per kilogram. NaFV: Sodium fluoride varnish. ppm F: Parts per
million fluoride. SDF: Silver diamine fluoride. U.S.: United States.

BEST PRACTICES: FLUORIDE THERAPY

the U.S. Department of Health and Human Services revisedthese recommendations in 2015 to a standardized level of 0.7
ppm F to balance the benefits of preventing dental caries while
reducing the chance of fluorosis.11
Community water fluoridation has been associated with the
decline in caries prevalence in U.S. adolescents, from 90 percent in at least one permanent tooth in 12-17-year-olds in the
1960s, to 60 percent in a 1999-2004 survey,12,13 with more
recent estimates of 35 percent caries reduction in primary teeth
and 26 percent in permanent teeth of children14. Additionally,a Cochrane review found that water fluoridation led to a 15
percent increase in caries-free children in primary dentition and
14 percent increase in caries-free children with permanentdentition.14
Consuming fluoridated drinking water is both safe andeffective in preventing and controlling dental caries. Although adverse health effects (e.g., decreased cognitive ability,
endocrine disruption, cancer) have been ascribed to the use offluoride over the years, the preponderance of evidence fromlarge cohort studies and systematic reviews does not support anassociation of such health issues and consumption of fluoridated
water at the recommended concentration.11 Regarding cognitive
ability, a recent study of mothers’ urinary fluoride levels andtheir child’s intelligence quotient (IQ) levels suggested an
association with exposure levels much greater than those recommended in the U.S. for water fluoridation.15 Also utilizing
maternal urinary fluoride levels, a multicenter prospective
cohort study 16 followed children born in Canada between
2008 and 2012. Forty-one percent of followed patients lived influoridated communities. This study assessed IQ at ages threeand four years using the Wechsler Preschool and Primary Scaleof Intelligence with Full Scale Intelligence Quotient (FSIQ) as
the primary outcome.16 Results indicated that a one mg increase
in daily fluoride intake (e.g., an extra six cups of optimallyfluoridated water each day) during pregnancy was associatedwith a 4.49 point lower FSIQ score in boys but did not significantly impact girls.16 The study results suggested maternal
exposure to high fluoride levels was associated with lower IQ
scores in boys and girls; however, it overlooked confounding
variables that did not adjust for differences in socioeconomic
status or maternal IQ, and there was no IQ difference whenevaluating the full population.16 Moreover, a prospective study
in New Zealand did not support an association between fluoridated water and IQ measurements17, and a national sample in
Sweden found no relationship between fluoride levels in watersupplies and cognitive ability, noncognitive ability, and education18. The current evidence does not support that consumingwater fluoridated at the level 0.7 ppm F is associated with
reductions in IQ.
Repeated consumption of fluoride at levels higher thanthose recommended in this document during enamel development, however, can cause dental fluorosis (children 15-30
months of age being most susceptible for fluorosis of thepermanent incisors). 19 The National Health and Nutrition
Examination Survey (NHANES) 1999-2004 study found 23

percent of the U.S. population aged six through 49 had very
mild or mild fluorosis.20 Very mild and mild levels of fluorosis
are associated with decreased caries experience and presents
clinically as an increase in diffuse or lacy appearing white opacities of the enamel and generally are not considered an esthetic
problem.21,22 The Iowa Fluoride Study was a longitudinal study
that gathered data on fluoride intake from multiple sources(water, beverages, foods, fluoride supplements, and dentifrices)on subjects from birth to 36 months.23 Those subjects were
examined at about age nine to assess permanent incisors andfirst molars for fluorosis using the Fluorosis Risk Index.24 This
study found the prevalence of mild fluorosis was 13 percent
among those children with average fluoride intakes of 0.04 mg
per kilogram (mg/kg) body weight and increased to 23 percent
when intakes were between 0.04 to 0.06 mg/kg.24 When fluoride intakes average 0.06 mg/kg or more per day, mild fluorosis
prevalence was 38 percent.24 A more recent study found mild
fluorosis levels increased to over 60 percent for adolescents ages
16 and 17 in 2011-2012 compared to 29.4 percent in 20012002; this is a greater than 31 percent increase.25
Fluoride fluoridation, supplements, and infant formula
Fluoride supplements are effective in reducing prevalence ofdental caries and may be considered for children at high caries
risk who drink fluoride-deficient (less than 0.6 ppm F) water26 (see Table). Fluoride supplementation schedules were last
revised in the early 1990s27 and have not been adjusted since1) fluoride concentration in municipal water was standardized
and 2) recommendations to use fluoridated toothpaste withthe eruption of the first tooth were promulgated.
Before prescribing supplements, determination of dietary
fluoride intake from all sources can help reduce intake of excess fluoride. Sources of dietary fluoride may include drinking
water from home, day care, and school; beverages such as
soda 28, juice 29, and infant formula 30; prepared food 31; andtoothpaste. Concentrated infant formulas requiring reconstitution with water have raised concerns regarding an increased
risk of fluorosis.32 Infants may be particularly susceptible because of the large consumption of such liquid while the bodyweight is relatively low4 and the enamel is mineralizing. An
evidence-based review found that consumption of reconstituted
Table.

DIETARY FLUORIDE SUPPLEMENTATION SCHEDULE

Age<0.3 ppm F

0.3 to 0.6 ppm F>0.6 ppm F

Birth to 6 months

0

0

0

6 months to 3 years

0.25 mg0

0

3 to 6 years

0.50 mg

0.25 mg0

6 to at least 16 years

1.00 mg

0.50 mg0Note: The recommendations in this table have not been revised since fluoride
concentration in municipal water was standardized and use of fluoridated
toothpaste for dentate infants was promulgated. All dietary sources of fluoride
should be taken into consideration before recommending fluoride supplementsfor patients with fluoride-deficit community water.

THE REFERENCE MANUAL OF PEDIATRIC DENTISTRY

353

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infant formula can be associated with an increased risk of mild
fluorosis but recommended the continued use of fluoridated
water.33 One study has shown that dental fluorosis levels do
not vary in fluoridated areas regardless of premixed versus
reconstituted formula.34 Nevertheless, over-supplementation offluoride, even for patients residing in areas with unfluoridated
water, can cause fluorosis.35 Since standardization of the optimal
fluoride levels in drinking water to 0.7 ppm F in 2015, dental
fluorosis is less likely to occur. However, caution is indicatedwhen considering the use of fluoride supplements for children
under age six due to their continued dental development andconsumption of fluoride from a variety of sources.
Professionally-applied fluoride varnish, gel, and foam
Professionally-applied topical fluoride treatments are efficacious
in reducing prevalence of dental caries. The most commonlyused agents for professionally-applied fluoride treatments are
five percent sodium fluoride varnish ([NaFV]; 2.26 percent
fluoride [F], 22,600 ppm F) and acidulated phosphate fluoride([APF]; 1.23 percent F, 12,300 ppm F). Meta-analyses of 23
clinical trials, most with twice yearly application, favors the useof fluoride varnish in primary and permanent teeth to prevent
decay.36 Fluoride varnish appears to be effective at preventing
caries in higher-risk children younger than five years of age.37
Unit doses of five percent fluoride varnish are the only professional topical fluoride agent recommended for children
younger than age six for safety reasons. 36 Meta-analyses ofplacebo-controlled trials show that fluoride gels, applied atthree-months to one-year intervals, also are efficacious in reducing caries in permanent teeth.38,39 Some topical fluoride gel
and foam products are marketed with recommended treatment
times of less than four minutes, but there are no clinical trials
showing efficacy of shorter than four-minute application
times.40 Evidence that topical fluoride foams are efficacious inchildren is limited.36 Children at risk for caries should receive
a professional fluoride treatment at least every six months.40 In
2014, the U.S. Preventive Services Task Force recommended
a schedule for fluoride varnish application specifically by nondental personnel to provide this preventive strategy to children
in medical settings, especially when children are more likely to
see a medical provider rather than a dental provider.41,42 Recent
meta-analyses tried to determine whether professionally-applied
fluoride can reverse incipient/white spot caries lesions43-45 but,due to heterogeneity of studies included in the systematic
review coupled with home use of fluoride dentifrices by researchsubjects, a valid conclusion could not be made43. Yet anotherstudy has shown that incipient enamel lesions (International
Caries Detection and Assessment System Code 2) can bearrested with semiannual applications of five percent NaFV.46
Silver diamine fluoride
Thirty-eight percent silver diamine fluoride ([SDF]; five percent
F, 44,800 ppm F) has been cleared by the U.S. Food and Drug
Administration as a dentin desensitizer in adults.47 It currently
is used frequently to arrest cavitated caries lesions. SDF is354

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thought to arrest caries by the antibacterial effect of silver andremineralization of enamel and dentin by fluoride.48 Silver
ions have an antimicrobial effect mainly in the treated carious
dentin49, and the combination of silver and fluoride in an alkaline solution have a synergistic effect that creates an unfavorable
environment for collagen enzyme activation, thereby reducing
dentin degradation.50 Clinical trials show caries arrest rates
ranging from 35 to 80 percent51, but such studies have a highrisk of bias and a high heterogeneity between them, leading toconditional recommendations for its use.52 Numerous clinical
trials conclude that biannual application of SDF results inhigher caries arrest in dentin caries lesions as compared to fluoride
varnish.47.53 Thus, SDF is an important adjunct therapy in theindividualized comprehensive care plan for children and adolescents for whom access to definitive dental restorative care may
be limited for a variety of reasons or preferentially postponed.
As the product is highly concentrated, less than a drop isneeded to treat several caries lesions, making it cost-effective.
SDF is best used as part of an ongoing caries management
plan within the context of a dental home.54,55
SDF is safe to use in children and adults when delivered inaccordance with dosing and application criteria.56 While current
data on the systemic effects of silver is limited47, data supports
a cytotoxic effect to the dental pulp cells when applied directlyon pulp tissue57-59. SDF solution, when applied to deep caries
lesions (0.25-0.5 millimeters dentin thickness remaining), canbe rapidly absorbed into dentin and produce a mild inflammation.60 Whether tertiary dentin formation is a response tocariogenic bacteria or to the SDF remains undetermined.60
Two investigations61,62 have evaluated SDF as an indirect pulp
therapy medicament. One study62 found application of SDF
arrested further caries progression but did not significantly
increase the amount of reparative dentin radiographically.
Similarly, the other found no significant difference between
SDF, SDF combined with potassium iodide, and the control(resin-modified glass ionomer) at preventing secondary caries.61
The absence of postoperative pain and maintenance of tooth
vitality indicated that SDF did not adversely affect the pulp
when applied as an indirect pulp therapy agent.61 The otherreported side effects of SDF are that caries lesions stain blackafter treatment and skin and gingiva temporarily stain withcontact.
Home-use fluoride products
The goal of home-use fluoride products for children is tomaximize the time fluoride is in direct contact with the tooth
surface, in lower-dose higher-frequency approaches.63 In children having higher baseline levels of caries, utilizing higher
concentrations of fluoride in the toothpaste, brushing withgreater frequency, and having supervision of brushing were
efficacious in reducing the prevalence of dental caries in permanent teeth.64,65 A meta-analysis of eight clinical trials on caries
increment in preschool children also shows that toothbrushingwith fluoridated toothpaste significantly reduces dental caries
prevalence in the primary dentition.66 Using no more than aBEST PRACTICES: FLUORIDE THERAPY

Recommendations

Figure. Comparison of a smear (left) with a pea-sized (right) amountof toothpaste.

smear or rice-sized amount (0.1 mg F) of fluoridated toothpaste
for children less than three years of age may decrease risk offluorosis. Using no more than a pea-sized amount (0.25 mg F)of fluoridated toothpaste is appropriate for children aged three
to six67.68 (see Figure). To maximize the beneficial effect offluoride in the toothpaste, supervised toothbrushing should
be done twice a day, and rinsing after brushing should be kept
to a minimum or avoided altogether.69 Other topical fluoride
products (e.g., prescription-strength home-use 0.5 percent F
gels and pastes; prescription-strength home-use 0.09 percent
F mouthrinse) have benefit in reducing dental caries in thosepatients at higher risk, such as adolescents, adolescents withspecial health care needs, or patients with fixed orthodontic
appliances; these products are recommended for use in children six years or older.36 Having children spit after brushingand parents supervise the amounts administered to children
will help avoid over-ingestion. Over-ingestion of fluoridated
toothpaste combined with other dietary fluoride sources maylead to daily intake greater than the recommended amountand could lead to development of dental fluorosis.4
Over 20,000 reports per year regarding fluoride ingestion
are received at poison control centers70, and over 80 percent ofsuspected cases occur in the under-six-years age group 71. The
probably-toxic dose for fluoride is five mg/kg body weight.72
Lower dosage may result in gastrointestinal disturbances withhigher doses producing central nervous system side effects suchas seizures or tetany.73 Fifteen mg/kg body weight of fluoride
likely could be fatal for a small child. 74 Over-the-counter
toothpastes approved by the American Dental Association contain at least 1000 ppm F and less than 1500 ppm F.75 Currently
available prescription strength toothpastes may contain 5000
ppm F75 or 605 mg F per 100 milliliters76. Parental dispensingof toothpaste for use by children under the age of three,supervised toothbrushing for all children unable to expectorate,
and keeping prescription fluoride supplements and/or homeuse fluoride products out of reach of young children can
prevent unintended ingestion which has acute (toxicity) as
well as chronic (fluorosis) implications.

The AAPD recommends:
1. the use of fluoride for the prevention and control ofcaries as it is both safe and highly effective in reducing
dental caries prevalence.
2. consumption of optimally-fluoridated community
water as a cost-effective method to prevent and control
caries at the population level.
3. toothbrushing at least twice daily with an ageappropriate amount of over-the-counter fluoridecontaining toothpaste to prevent caries as first line forcaries prevention.
4. professionally-applied topical fluoride treatments suchas five percent NaFV or 1.23 percent F gel preparationsat least twice per year to reduce incidence of dental caries.
5. 38 percent SDF be used to arrest cavitated caries lesions in primary teeth and permanent teeth as part of acomprehensive caries management program.
6. prescription-strength home-use 0.5 percent F gels andpastes and 0.02-0.09 percent F mouth rinses to reduce
dental caries in high-risk patients over six years of age.
7. decisions concerning the administration of fluoride be
based on the unique needs of each patient, including
the risks and benefits (e.g., risk of mild or moderate
fluorosis versus the benefits of decreasing caries increment and, in some cases, preventing devastating dental
disease).
8. fluoride dietary supplements be cautiously considered
for children at caries risk who drink less than optimallyfluoridated water as supplementation, in the face of
all other sources of fluoride, could exceed the recommended amount of daily fluoride intake.

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