Fluoride Therapy

BEST PRACTICES: FLUORIDE THERAPY

352 THE REFERENCE MANUAL OF PEDIATRIC DENTISTRY

Purpose

e American Academy of Pediatric Dentistry intends these

recommendations to help practitioners make decisions concern-

ing appropriate use of uoride 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 1967

and last revised

by the Council on Clinical Affairs in 2018

. To update this

guidance, an electronic search of the PubMed

/MEDLINE

database was conducted using the terms: uoride caries pre-

vention, fluoridation, fluoride gel, fluoride varnish, fluoride

toothpaste, uoride therapy, silver diamine uoride, and topical

uoride; elds: all; limits: within last ve years, English. Be-

cause 4077 papers were identified through these electronic

searches, an alternate strategy of limiting the information

gathering to systematic review using the term uoride caries

prevention yielded 116 new systematic reviews or trials since

2017. Expert opinions and clinical practices also were relied

upon for these recommendations.

Background

Fluoride has been a major factor in the decline in prevalence

and severity of dental caries in the United States (U.S.) and

other economically developed countries. It has several caries-

protective mechanisms of action. Topically, low levels of

uoride in plaque and saliva inhibit the demineralization of

sound enamel and enhance the remineralization of demineralized

enamel.

3,4

e topical eect may be enhanced when combined

with good oral hygiene practices at home and use of a uoride

dentifrice.

Fluoride also inhibits dental caries by aecting the

metabolic activity of cariogenic bacteria.

High levels of uo-

ride, such as those attained with the use of topical gels or

varnishes, produce a temporary layer of calcium uoride-like

material on the enamel surface. e uoride is released when the

pH drops in response to acid production and becomes available

to remineralize enamel or aect bacterial metabolism.

Although

uoride-rich enamel is less acid-soluble than enamel with less

fluoride, the topical and remineralization effects of fluoride

have been found to have a greater impact on caries prevention

than incorporation of uoride into developing teeth.

Community water uoridation

Fluoridation of community drinking water is the most equitable

and cost-eective method of delivering uoride to all members

of most communities.

As of 2018, 73 percent of the U.S.

population on community water systems had access to uori-

dated water.

Water fluoridation at the level of 0.7-1.2

milligrams (mg) uoride ion per liter (i.e., parts per million

uoride [ppm F]) was introduced in the U.S. in the 1940s.

Since community water is now one of several sources of uoride,

ABBREVIATIONS

CaF: Calcium ﬂuoride. F: Fluoride. FSIQ: Full scale intelligent quo-

tient. 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.

Latest Revision

2023

Fluoride Therapy

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.

Abstract

This best practice provides information for practitioners regarding the use of ﬂuoride as an aid in preventing and controlling dental caries in

pediatric dental patients. These recommendations address systemic ﬂuoride (water ﬂuoridation, dietary ﬂuoride supplements), topical ﬂuo-

ride delivery via professional application (acidulated phosphate ﬂuoride gel or foam, sodium ﬂuoride varnish, silver diamine ﬂuoride), and

home-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 tooth-

paste, and caries risk. The speciﬁc needs of each patient determine the appropriate use of systemic and topical ﬂuoride products, whether

delivered 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 best

practice 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

BEST PRACTICES: FLUORIDE THERAPY

THE REFERENCE MANUAL OF PEDIATRIC DENTISTRY 353

the U.S. Department of Health and Human Services revised

these recommendations in 2015 to a standardized level of 0.7

ppm F to balance the benets of preventing dental caries while

reducing the chance of uorosis.

Community water uoridation has been associated with the

decline in caries prevalence in U.S. adolescents, from 90 per-

cent 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 children

. Additionally,

a Cochrane review found that water uoridation led to a 15

percent increase in caries-free children in primary dentition and

14 percent increase in caries-free children with permanent

dentition.

Consuming fluoridated drinking water is both safe and

effective in preventing and controlling dental caries. Al-

though adverse health eects (e.g., decreased cognitive ability,

endocrine disruption, cancer) have been ascribed to the use of

uoride over the years, the preponderance of evidence from

large cohort studies and systematic reviews does not support an

association of such health issues and consumption of uoridated

water at the recommended concentration.

Regarding cognitive

ability, a recent study of mothers’ urinary uoride levels and

their child’s intelligence quotient (IQ) levels suggested an

association with exposure levels much greater than those rec-

ommended in the U.S. for water uoridation.

Also utilizing

maternal urinary fluoride levels, a multicenter prospective

cohort study

followed children born in Canada between

2008 and 2012. Forty-one percent of followed patients lived in

uoridated communities. is study assessed IQ at ages three

and four years using the Wechsler Preschool and Primary Scale

of Intelligence with Full Scale Intelligence Quotient (FSIQ) as

the primary outcome.

Results indicated that a one mg increase

in daily uoride intake (e.g., an extra six cups of optimally-

uoridated water each day) during pregnancy was associated

with a 4.49 point lower FSIQ score in boys but did not sig-

nicantly impact girls.

e study results suggested maternal

exposure to high uoride levels was associated with lower IQ

scores in boys and girls; however, it overlooked confounding

variables that did not adjust for dierences in socioeconomic

status or maternal IQ, and there was no IQ dierence when

evaluating the full population.

Moreover, a prospective study

in New Zealand did not support an association between uori-

dated water and IQ measurements

, and a national sample in

Sweden found no relationship between uoride levels in water

supplies and cognitive ability, noncognitive ability, and educa-

tion

. e current evidence does not support that consuming

water fluoridated at the level 0.7 ppm F is associated with

reductions in IQ.

Repeated consumption of fluoride at levels higher than

those recommended in this document during enamel devel-

opment, however, can cause dental uorosis (children 15-30

months of age being most susceptible for fluorosis of the

permanent incisors).

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 uorosis.

Very mild and mild levels of uorosis

are associated with decreased caries experience and presents

clinically as an increase in diuse or lacy appearing white opaci-

ties of the enamel and generally are not considered an esthetic

problem.

21,22

e Iowa Fluoride Study was a longitudinal study

that gathered data on fluoride intake from multiple sources

(water, beverages, foods, uoride supplements, and dentifrices)

on subjects from birth to 36 months.

Those subjects were

examined at about age nine to assess permanent incisors and

rst molars for uorosis using the Fluorosis Risk Index.

is

study found the prevalence of mild uorosis was 13 percent

among those children with average uoride 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.

When uo-

ride intakes average 0.06 mg/kg or more per day, mild uorosis

prevalence was 38 percent.

A more recent study found mild

uorosis levels increased to over 60 percentfor adolescents ages

16 and 17 in 2011-2012 compared to 29.4 percent in 2001-

2002; this is a greater than 31 percent increase.

Fluoride uoridation, supplements, and infant formula

Fluoride supplements are eective in reducing prevalence of

dental caries and may be considered for children at high caries

risk who drink fluoride-deficient (less than 0.6 ppm F) wa-

ter

(see Table). Fluoride supplementation schedules were last

revised in the early 1990s

and have not been adjusted since

1) uoride concentration in municipal water was standardized

and 2) recommendations to use fluoridated toothpaste with

the eruption of the rst tooth were promulgated.

Before prescribing supplements, determination of dietary

uoride intake from all sources can help reduce intake of ex-

cess uoride. Sources of dietary uoride may include drinking

water from home, day care, and school; beverages such as

soda

, juice

, and infant formula

; prepared food

; and

toothpaste. Concentrated infant formulas requiring reconsti-

tution with water have raised concerns regarding an increased

risk of uorosis.

Infants may be particularly susceptible be-

cause of the large consumption of such liquid while the body

weight is relatively low

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 mg 0 0

3 to 6 years 0.50 mg 0.25 mg 0

6 to at least 16 years 1.00 mg 0.50 mg 0

Note: 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 supplements

for patients with ﬂuoride-deﬁcit community water.

BEST PRACTICES: FLUORIDE THERAPY

354 THE REFERENCE MANUAL OF PEDIATRIC DENTISTRY

infant formula can be associated with an increased risk of mild

uorosis but recommended the continued use of uoridated

water.

One study has shown that dental uorosis levels do

not vary in fluoridated areas regardless of premixed versus

reconstituted formula.

Nevertheless, over-supplementation of

uoride, even for patients residing in areas with unuoridated

water, can cause uorosis.

Since standardization of the optimal

uoride levels in drinking water to 0.7 ppm F in 2015, dental

uorosis is less likely to occur. However, caution is indicated

when considering the use of uoride supplements for children

under age six due to their continued dental development and

consumption of uoride from a variety of sources.

Professionally-applied uoride varnish, gel, and foam

Professionally-applied topical uoride treatments are ecacious

in reducing prevalence of dental caries. e most commonly

used agents for professionally-applied uoride treatments are

five percent sodium fluoride varnish ([NaFV]; 2.26 percent

uoride [F], 22,600 ppm F) and acidulated phosphate uoride

([APF]; 1.23 percent F, 12,300 ppm F). Meta-analyses of 23

clinical trials, most with twice yearly application, favors the use

of uoride varnish in primary and permanent teeth to prevent

decay.

Fluoride varnish appears to be eective at preventing

caries in higher-risk children younger than ve years of age.

Unit doses of ve percent uoride varnish are the only pro-

fessional topical fluoride agent recommended for children

younger than age six for safety reasons.

Meta-analyses of

placebo-controlled trials show that fluoride gels, applied at

three-months to one-year intervals, also are ecacious in re-

ducing caries in permanent teeth.

38,39

Some topical uoride 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.

Evidence that topical uoride foams are ecacious in

children is limited.

Children at risk for caries should receive

a professional uoride treatment at least every six months.

2014, the U.S. Preventive Services Task Force recommended

a schedule for uoride varnish application specically by non-

dental 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

uoride can reverse incipient/white spot caries lesions

43-45

but,

due to heterogeneity of studies included in the systematic

review coupled with home use of uoride dentifrices by research

subjects, a valid conclusion could not be made

. Yet another

study has shown that incipient enamel lesions (International

Caries Detection and Assessment System Code 2) can be

arrested with semiannual applications of ve percent NaFV.

Silver diamine uoride

irty-eight percent silver diamine uoride ([SDF]; ve percent

F, 44,800 ppm F) has been cleared by the U.S. Food and Drug

Administration as a dentin desensitizer in adults.

It currently

is used frequently to arrest cavitated caries lesions. SDF is

thought to arrest caries by the antibacterial eect of silver and

remineralization of enamel and dentin by fluoride.

Silver

ions have an antimicrobial eect mainly in the treated carious

dentin

, and the combination of silver and uoride in an alka-

line solution have a synergistic eect that creates an unfavorable

environment for collagen enzyme activation, thereby reducing

dentin degradation.

Clinical trials show caries arrest rates

ranging from 35 to 80 percent

, but such studies have a high

risk of bias and a high heterogeneity between them, leading to

conditional recommendations for its use.

Numerous clinical

trials conclude that biannual application of SDF results in

higher caries arrest in dentin caries lesions as compared to uoride

varnish.

47.53

us, SDF is an important adjunct therapy in the

individualized comprehensive care plan for children and adoles-

cents for whom access to denitive dental restorative care may

be limited for a variety of reasons or preferentially postponed.

As the product is highly concentrated, less than a drop is

needed to treat several caries lesions, making it cost-eective.

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 in

accordance with dosing and application criteria.

While current

data on the systemic eects of silver is limited

, data supports

a cytotoxic eect to the dental pulp cells when applied directly

on pulp tissue

57-59

. SDF solution, when applied to deep caries

lesions (0.25-0.5 millimeters dentin thickness remaining), can

be rapidly absorbed into dentin and produce a mild inam-

mation.

Whether tertiary dentin formation is a response to

cariogenic bacteria or to the SDF remains undetermined.

Two investigations

61,62

have evaluated SDF as an indirect pulp

therapy medicament. One study

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-modied glass ionomer) at preventing secondary caries.

e absence of postoperative pain and maintenance of tooth

vitality indicated that SDF did not adversely aect the pulp

when applied as an indirect pulp therapy agent.

e other

reported side eects of SDF are that caries lesions stain black

after treatment and skin and gingiva temporarily stain with

contact.

Home-use uoride products

The goal of home-use fluoride products for children is to

maximize the time uoride is in direct contact with the tooth

surface, in lower-dose higher-frequency approaches.

In chil-

dren having higher baseline levels of caries, utilizing higher

concentrations of fluoride in the toothpaste, brushing with

greater frequency, and having supervision of brushing were

ecacious in reducing the prevalence of dental caries in perma-

nent teeth.

64,65

A meta-analysis of eight clinical trials on caries

increment in preschool children also shows that toothbrushing

with uoridated toothpaste signicantly reduces dental caries

prevalence in the primary dentition.

Using no more than a

BEST PRACTICES: FLUORIDE THERAPY

THE REFERENCE MANUAL OF PEDIATRIC DENTISTRY 355

smear or rice-sized amount (0.1 mg F) of uoridated toothpaste

for children less than three years of age may decrease risk of

uorosis. Using no more than a pea-sized amount (0.25 mg F)

of uoridated toothpaste is appropriate for children aged three

to six

67.68

(see Figure). To maximize the beneficial effect of

fluoride in the toothpaste, supervised toothbrushing should

be done twice a day, and rinsing after brushing should be kept

to a minimum or avoided altogether.

Other topical uoride

products (e.g., prescription-strength home-use 0.5 percent F

gels and pastes; prescription-strength home-use 0.09 percent

F mouthrinse) have benet in reducing dental caries in those

patients at higher risk, such as adolescents, adolescents with

special health care needs, or patients with xed orthodontic

appliances; these products are recommended for use in chil-

dren six years or older.

Having children spit after brushing

and parents supervise the amounts administered to children

will help avoid over-ingestion. Over-ingestion of uoridated

toothpaste combined with other dietary uoride sources may

lead to daily intake greater than the recommended amount

and could lead to development of dental uorosis.

Over 20,000 reports per year regarding uoride ingestion

are received at poison control centers

, and over 80 percent of

suspected cases occur in the under-six-years age group

. e

probably-toxic dose for uoride is ve mg/kg body weight.

Lower dosage may result in gastrointestinal disturbances with

higher doses producing central nervous system side eects such

as seizures or tetany.

Fifteen mg/kg body weight of uoride

likely could be fatal for a small child.

Over-the-counter

toothpastes approved by the American Dental Association con-

tain at least 1000 ppm F and less than 1500 ppm F.

Currently

available prescription strength toothpastes may contain 5000

ppm F

or 605 mg F per 100 milliliters

. Parental dispensing

of toothpaste for use by children under the age of three,

supervised toothbrushing for all children unable to expectorate,

and keeping prescription uoride supplements and/or home-

use fluoride products out of reach of young children can

prevent unintended ingestion which has acute (toxicity) as

well as chronic (uorosis) implications.

Recommendations

e AAPD recommends:

1. the use of uoride for the prevention and control of

caries as it is both safe and highly eective in reducing

dental caries prevalence.

2. consumption of optimally-fluoridated community

water as a cost-eective method to prevent and control

caries at the population level.

3. toothbrushing at least twice daily with an age-

appropriate amount of over-the-counter fluoride-

containing toothpaste to prevent caries as rst line for

caries prevention.

4. professionally-applied topical uoride treatments such

as ve percent NaFV or 1.23 percent F gel preparations

at least twice per year to reduce incidence of dental caries.

5. 38 percent SDF be used to arrest cavitated caries le-

sions in primary teeth and permanent teeth as part of a

comprehensive caries management program.

6. prescription-strength home-use 0.5 percent F gels and

pastes 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 uoride be

based on the unique needs of each patient, including

the risks and benets (e.g., risk of mild or moderate

uorosis versus the benets of decreasing caries incre-

ment and, in some cases, preventing devastating dental

disease).

8. uoride dietary supplements be cautiously considered

for children at caries risk who drink less than optimally-

fluoridated water as supplementation, in the face of

all other sources of uoride, could exceed the recom-

mended amount of daily uoride intake.

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