1-httpfluoridealert.orgresearchersstateskentucky2-.docx

1-http://fluoridealert.org/researchers/states/kentucky/
2-
3-School fluoridation studies in Elk Lake, Pennsylvania, and
Pike County, Kentucky--results after eight years.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1229128/?page
=1
4-American Association for Dental Research Policy Statement
on Community Water Fluoridation
http://journals.sagepub.com/doi/abs/10.1177/0022034518797274
5- Ground-Water Quality in Kentucky: Fluoride - University of
Kentucky
http://www.uky.edu/KGS/pdf/ic12_01.pdf
6-Kentucky Oral Health Program Brochure - Cabinet for Health.
https://chfs.ky.gov/agencies/dph/dmch/cfhib/Oral%20Health%2
0Program/beigebrochureoralhealth80107.pdf
7-
8-
9-
PIIS00028177146263
98.pdf
746 JADA, Vol. 131, June 2000

Enamel fluorosis is a hypomineralization of the
enamel caused by the ingestion of an amount of
fluoride that is above optimal levels during
enamel formation.1,2 Clinically, the appearance of
enamel fluorosis can vary. In its mildest form, it
appears as faint white lines or streaks visible
only to trained examiners under controlled exam-
ination conditions. In its pronounced form, fluo-
rosis manifests as white mottling of the teeth in
which noticeable white lines or streaks often
have coalesced into larger opaque areas.2,3 Brown
staining or pitting of the enamel also may be
present.2,3 In its most severe form, actual break-
down of the enamel may occur.2,3
In recent years, there has been an increase in
the prevalence of children seen with enamel fluo-
A B S T R A C T
Background. Few studies have evaluated the
impact of specific fluoride sources on the prevalence of
enamel fluorosis in the population. The author con-
ducted research to determine attributable risk percent
estimates for mild-to-moderate enamel fluorosis in two
populations of middle-school–aged children.
Methods. The author recruited two groups of
children 10 to 14 years of age. One group of 429 had
grown up in nonfluoridated communities; the other
group of 234 had grown up in optimally fluoridated
communities. Trained examiners measured enamel
fluorosis using the Fluorosis Risk Index and meas-
ured early childhood fluoride exposure using a ques-
tionnaire completed by the parent. The author then
calculated attributable risk percent estimates, or the

proportion of cases of mild-to-moderate enamel fluo-
rosis associated with exposure to specific early fluo-
ride sources, based on logistic regression models.
Results. In the nonfluoridated study sample,
sixty-five percent of the enamel fluorosis cases were
attributed to fluoride supplementation under the pre-
1994 protocol. An additional 34 percent were
explained by the children having brushed more than
once per day during the first two years of life. In the
optimally fluoridated study sample, 68 percent of the
enamel fluorosis cases were explained by the children
using more than a pea-sized amount of toothpaste
during the first year of life, 13 percent by having
been inappropriately given a fluoride supplement,
and 9 percent by the use of infant formula in the
form of a powdered concentrate.
Conclusions. Enamel fluorosis in the non-
fluoridated study sample was attributed to fluoride
supplementation under the pre-1994 protocol and
early toothbrushing behaviors. Enamel fluorosis in
the optimally fluoridated study sample was attrib-
uted to early toothbrushing behaviors, inappropriate
fluoride supplementation and the use of infant for-
mula in the form of a powdered concentrate.
Clinical Implications. By advising
parents about the best early use of fluoride agents,
health professionals play an important role in reduc-
ing the prevalence of clinically noticeable enamel
fluorosis.
RISK OF ENAMEL FLUOROSIS IN NONFLUORIDATED
AND OPTIMALLY FLUORIDATED POPULATIONS:
CONSIDERATIONS FOR THE DENTAL PROFESSIONAL
DAVID G. PENDRYS, D.D.S., PH.D.

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ARTICLE 1
Copyright ©1998-2001 American Dental Association. All rights
reserved.

for enamel fluorosis.17,25 The use
of infant formula in various
forms, before the infant formula
industry’s voluntary reduction
in the fluoride content of its
products, also has been associ-
ated with enamel fluorosis.12,17,33
Findings from two recent stud-
ies suggest that while the risk
of enamel fluorosis associated
with infant formula use may no
longer exist for children living
in nonfluoridated communities,
the use of formula in the pow-
dered concentrate form pre-
pared with optimally fluoridated
water may continue to be an
enamel fluorosis risk factor.21,25
While an increasing number
of studies have reported esti-
mates of the relative risk or the
increased likelihood of enamel
fluorosis associated with specif-
ic early fluoride exposures, rel-
atively few investigations have
evaluated the impact of a spe-
cific fluoride-containing agent
on the prevalence of enamel
fluorosis in the population.12,15,34
This impact is a function of
both the relative risk associated
with a specific fluoride-contain-
ing agent, as well as the preva-

lence of exposure to that agent
within the population. It is
thought to be best measured via
estimation of the attributable
risk percent,35 or the percentage
of all fluorosis cases that can be
explained by exposure to a spe-
cific fluoride-containing agent.
The attributable risk, therefore,
becomes an estimate of the
potential reduction in cases
that would occur were the asso-
ciated exposure modified or
eliminated. Because children
may be exposed to several dif-
ferent fluoride-containing
agents during the tooth-devel-
opment period, the most accu-
rate attributable risk percent
estimate for a specific fluoride-
rosis in both optimally fluoridat-
ed and nonfluoridated areas of
the United States.4,5 The great-
est relative increase in fluorosis
prevalence has occurred in non-
fluoridated areas.4 Dentists and
hygienists need to understand
the most likely reasons for this
increase. This will allow them to
advise parents about the most
appropriate use of fluoride to
prevent caries in their children
while minimizing the risk of
their children developing enamel
fluorosis.

Dating back to the classic
research of H. Trendley Dean,
it has been well-known that a
concentration of approximately
1 part per million fluoride in
the drinking water imparts sub-
stantial caries protection with
the absence of noticeable enam-
el fluorosis.6-8
Since the advent of optimal
water fluoridation, other pre-
ventive fluoride agents have
been introduced. They include
ingestible fluoride supplements
and fluoride toothpaste, which
may be ingested by young chil-
dren, although it is intended for
topical use.9-11
Studies suggest that behav-
iors associated with the early
use of fluoride toothpaste—such
as the amount of toothpaste
usually used when brushing—
are associated with enamel fluo-
rosis in both optimally fluori-
dated and nonfluoridated popu-
lations in the United States and
elsewhere.12-25 Studies further
suggest that early fluoride sup-
plements use by children living
in nonfluoridated areas have
been an important risk factor
for enamel fluorosis.21,26-32 Not

unexpectedly, the inappropriate
use of fluoride supplements by
children living in optimally
fluoridated areas has been
shown to be a strong risk factor
containing agent should be
adjusted for exposure to any
other fluoride-containing
agents.4,35 To date, only two
investigations have reported
adjusted attributable risk per-
cent estimates15,34; and only one
of these investigations has
reported these estimates along
with adjusted confidence inter-
vals, which gives the reader the
best sense of the statistical sig-
nificance of those estimates.34
That study also was the only
one to have reported findings
from the investigation of a U.S.
population.34
A study of Canadian children
who were current residents of
an optimally fluoridated area
reported that 72 percent of the
fluorosis cases could be attrib-
uted to beginning to brush teeth
with fluoride toothpaste during
the first two years of life.12 In
this same study, 22 percent of
the cases were attributed to the
use of infant formula.

A study of Australian chil-
dren who also resided in an opti-
mally fluoridated area reported
that 47 percent of the fluorosis
cases could be explained by a
history of swallowing toothpaste
at a young age, while 55 percent
of the fluorosis cases seen in this
study could be explained by the
early cessation of breast-feeding,
with the implication that these
infants were switched to the use
of infant formula.15
A study of children in
Connecticut who grew up in
optimally fluoridated communi-
ties reported that 71 percent of
the cases could be attributed to
“usually” brushing more than
once a day and “usually” using
more than a pea-sized amount
of toothpaste during the first
eight years.34 Twenty-five per-
cent of these cases were attrib-
utable to children having been
JADA, Vol. 131, June 2000 747
RESEARCH
reserved.

inappropriately given a fluoride
supplement during the first
eight years of their lives.34
Understanding attributable
risk information reported in
the literature is important;
dentists and hygienists need to
be able to provide the parents
of young children with appro-
priate advice regarding the
early use of fluoride toothpaste
and fluoride supplements. In
this article, I report on results
of research I performed to
determine attributable risk
percent estimates for mild-to-
moderate enamel fluorosis in
two populations of middle-
school–aged children born after
the 1978 fluoride supplement
dosage revision36,37 and after
the decision by U.S. infant for-
mula manufacturers to reduce
and control the fluoride content
of their products38,39 (effective
for those born in 1980 and
after). Because comprehensive,
surface-specific analyses of the
relative risk percent estimates
associated with enamel fluoro-
sis in these two populations
have been previously report-
ed,21,25 key findings from those
reports will be only briefly

reviewed in this article.
MATERIALS AND
METHODS
Detailed descriptions of the
methods used in my previous
investigations are published
elsewhere21,25; therefore, only a
brief summary follows. All
study procedures involving
human subjects were approved
by the University of
Connecticut Health Center
Institutional Review Board. The
study subjects consisted of mid-
dle-school–aged children who
had grown up in either six non-
fluoridated Massachusetts and
Connecticut communities or
five optimally fluoridated
Connecticut communities.
Among the subjects who grew
up in nonfluoridated areas of
Massachusetts and Connecticut,
it was found that children who
were reported to have begun
brushing with fluoridated tooth-
paste during the first two years
of life and who reported they
usually brushed more than once
per day had an approximately
three- to fourfold increase in the
risk of enamel fluorosis, depend-

ing on the specific enamel sur-
faces affected.21 In this same
population, children who were
reported to have used a fluoride
supplement throughout the sec-
ond through eighth years of life
had an approximately two- to
eightfold increase in the risk of
enamel fluorosis, again depend-
ing on the specific enamel sur-
faces affected.21
The subjects in the second
population grew up in optimally
fluoridated areas in Connecti-
cut.25 These areas had begun
fluoridation many years before
these children were born, and
when the water departments
were contacted, they indicated
that episodes of below-optimum
fluoridation were rare and brief
over the lifetimes of the sub-
jects. In this population, it was
found that children who were
reported to have usually
brushed with more than a pea-
size amount of toothpaste and
who were reported to have usu-
ally brushed more than once
per day had a six- to eightfold
increase in the risk of enamel
fluorosis, depending on the spe-
cific surfaces affected.25
Children in these optimally

fluoridated areas who inappro-
priately were given fluoride
supplements had an approxi-
mately six- to 10-fold increase
in the risk of enamel fluorosis,
again depending on the specific
enamel surfaces affected.25 In
this population, the reported
use of infant formula in the
form of a powdered concentrate
produced an approximately
four- to 10-fold increase in the
risk of enamel fluorosis, once
again depending on the specific
surfaces affected.25
Two trained examiners
measured enamel fluorosis
using the Fluorosis Risk
Index.40 For the attributable
risk analyses presented in this
article, I included a subject as a
fluorosis case if he or she had
mild-to-moderate enamel fluo-
rosis as defined by Møller41 that
was characterized by the pres-
ence of paper-white streaking,
coalescence of opacities or both
on more than 50 percent of two
or more enamel surface zones,
anywhere throughout the denti-
tion.41 A fluorosis control was
defined as any subject who was
fluorosis-free throughout the
dentition.

Two examiners conducted
random, blind inter- and
intraexaminer reliability exami-
nations daily throughout the
data collection period. There
were few cases (approximately
2 percent) of subjects showing
signs of more severe fluorosis,
which was characterized by the
presence of brown staining or
pitting. Therefore, I included
these few subjects in the analy-
ses with the rest of the cases.
I retrospectively obtained fluo-
ride exposure history via a self-
administered, closed-ended
questionnaire that was mailed
to the parents of all case and
control subjects. Parents were
offered $20 for return of the com-
pleted questionnaire. This ques-
tionnaire had been pretested and
used in two fluorosis risk investi-
gations.17,27 The subject’s name
748 JADA, Vol. 131, June 2000
RESEARCH
reserved.

was handwritten on the cover of
the questionnaire and into each
of the questions within the ques-
tionnaire. This was done to help
keep parents with several chil-
dren mindful of the specific child
we were asking about.
For each quarter of the first
year of life—birth through 3
months, 4 through 6 months,
and so on—parents were asked
to indicate, by checking the
appropriate box, whether the
subject’s main source of food
was breast milk, ready-to-feed
infant formula, formula in the
form of liquid concentrate, for-
mula in the form of powdered
concentrate, cow’s milk or solid
food. They also were asked to
do this for the second year of
the children’s lives as a whole.
Then they were asked to write
in the usual brand of infant for-
mula used, which allowed me to
determine whether the formula
was milk- or soy-based. For
each of the first eight years,
parents were asked to write in
the city and state (country if
not the United States) where
the subject lived for each year.
Also for each of the first eight
years, parents were asked to
indicate by checking the appro-

priate box whether the subject
was given plain vitamins with-
out fluoride, a vitamin drop
with fluoride, a vitamin tablet
with fluoride, a fluoride drop
alone, a fluoride tablet alone or
nothing. Parents were asked to
indicate by circling the best
choice whether the subject usu-
ally did not brush, usually
brushed once a day or usually
brushed more than once a day
during the first eight years, and
by circling the best drawing to
indicate whether the subject
usually placed a pea-sized
amount or more of toothpaste
on his or her toothbrush when
brushing during the first eight
years. Parents were asked to
indicate by circling the appro-
priate age at which the subjects
began to brush and at what
ages they helped the subjects
brush their teeth. For each of
the first eight years, parents
were asked to write in the sub-
jects’ places of residence.
Parents also were asked to indi-
cate whether they used bottled
water or a tap water filter for
more than two of the first eight
years. Finally, they were asked
to indicate their relationship to
the subjects and to indicate by

circling the appropriate ages
during which of the subjects’
first eight years they had lived
with them.
I included for analysis only
subjects whose questionnaires
were completed by parents who
had resided with the subjects
for the entire eight-year survey
period. I assessed questionnaire
reliability by having a random-
ly drawn sample of respondents
complete a second question-
naire that was mailed at least
one month after the completion
of the first.
I included in the nonfluori-
dated group analysis only data
from subjects born after 1979
who were residents of a non-
fluoridated community for the
entire eight-year survey period.
For the optimally fluoridated
group analysis, I included only
data from subjects born after
1979 who were residents of an
optimally fluoridated commu-
nity for the entire eight-year
survey period. I determined the
fluoridation status of prior resi-
dences other than in the survey
communities using the
Fluoridation Census.42

I derived adjusted attribut-
able risk percent estimates and
adjusted 95 percent confidence
intervals, or CIs, individually
for early fluoride exposures
found to be associated with an
increased risk of mild-to-
moderate enamel fluorosis,
based on logistic regression
analyses.43,44 I derived these
attributable risk percent esti-
mates separately for the nonflu-
oridated study sample and for
the optimally fluoridated study
sample. I included variables
found to have been either
important predictors of enamel
fluorosis or important covari-
ates in the relative risk analy-
ses21,25 in each of the attributa-
ble risk analyses.
RESULTS
A total of 1,091 subjects (94
percent of those enrolled and
15 percent of those eligible to
enroll) were examined for fluo-
rosis in the nonfluoridated
study sample. A total of 867
subjects (95 percent of those
enrolled and 14 percent of
those eligible to enroll) were
examined for fluorosis in the
optimally fluoridated study

sample. Intra- and interexam-
iner agreement on case vs. con-
trol status was 98.9 percent
and 93.8 percent, respectively
(κ = 0.93 and 0.73, respective-
ly), in the nonfluoridated sam-
ple and 100 percent and 86 per-
cent, respectively (κ = 1.0 and
0.70, respectively), in the opti-
mally fluoridated sample. The
prevalence of mild-to-moderate
enamel fluorosis was 39 per-
cent in the nonfluoridated sam-
ple and 34 percent in the opti-
mally fluoridated sample.
Eighty-four percent of the cases
from the nonfluoridated com-
munities and 74 percent of
cases from the optimally fluori-
dated communities involved the
maxillary anterior teeth.
The questionnaire return
JADA, Vol. 131, June 2000 749
RESEARCH
reserved.
rate was 90 percent in the non-
fluoridated sample and 91
percent in the optimally fluori-

dated sample. A 12 percent
reliability sample in the nonflu-
oridated sample and a 16
percent reliability sample in
fluoridated revealed an average
agreement between the second
and first questionnaire respons-
es of 87 percent for both study
samples.
A total of 250 subjects with
rosis and 179 fluorosis-free con-
trols were available in the non-
fluoridated study sample for
analysis, after exclusions based
on year of birth, fluoridation
history or completion of the
questionnaire by someone other
than parents who had lived
with their children throughout
the entire eight-year survey
period. These subjects ranged
in age from 10 to 13 years of
age (mean = 12.5 years), and 57
percent were girls. Eighty-six
percent of these subjects were
lifelong residents of their cur-
rent communities.
A total of 180 subjects with
mild-to-moderate fluorosis and
54 fluorosis-free control sub-
jects were available in the
fluoridated study sample for

analysis, again after exclusions
based on year of birth, fluorida-
tion history or completion of the
questionnaire by someone other
than parents who had lived
with their children throughout
the entire eight-year survey
period. These subjects ranged
in age from 10 to 14 years of
age (mean = 12.9 years), and 56
percent were girls.
Tables 1 and 2 show the mul-
tiple logistic-regression–
derived, adjusted attributable
risk percent estimates for these
two study samples. Individual
attributable risk percents do
not add to 100 percent, since
the variables studied in both
samples were not mutually
exclusive exposures.43
For the nonfluoridated study
sample, Table 1 shows that an
estimated 65 percent of the
cases could be attributed to or
explained by exposure to fluo-
ride supplements during the
second through eighth year of
life. Thirty-four percent of the
cases in this sample could be
explained by a history of having
begun to brush with toothpaste
during the first two years and

having usually brushed more
than once per day. The logistic-
regression–derived test for
750 JADA, Vol. 131, June 2000
RESEARCH
TABLE 1
29
65
34
8
6
45
* Estimate of cases attributable to each specific fluoride source
based on logistic regression modeling.21 Note that individual
attributable risk
percents do not add up to 100 percent, as fluoride
supplementation and toothbrushing history are not mutually
exclusive exposures.43
† CI: Confidence interval.
‡ Reference group: no supplementation during each of the
identified periods.
§ Reference group: began after year 2; brushed once per day.
FLUORIDATION SOURCE

Supplementation History‡
ATTRIBUTABLE RISK PERCENT ESTIMATES*
ATTRIBUTABLE RISK
95 PERCENT CI†
ESTIMATED PERCENTAGE OF ENAMEL FLUOROSIS
CASES ATTRIBUTABLE TO
SPECIFIC FLUORIDE SOURCES IN A NONFLUORIDATED
POPULATION.
Supplemented Year 1
Supplemented Years 2
Through 8
Toothbrushing History§
Began During Years 1
and 2; Brushed More
Than Once per Day
Began During Years 1
and 2; Brushed Once
per Day
Began After Year 2;
Brushed More Than
Once per Day
Used More Than a
Pea-sized Amount of
Toothpaste
−6-52

34-81
18-47
−2-17
−4-14
−7-72
reserved.
trend across the three tooth-
brushing exposure categories
was statistically significant,
suggesting a dose response
effect; however, the negative CI
limits for two of the toothbrush-
ing exposure categories indicate
that the analysis cannot say
with 95 percent certainty that
cases could be attributed to
these two exposure histories.
While not statistically signifi-
cant, the findings suggested
that perhaps 45 percent of the
observed cases could be attrib-
uted to the usual early use of
greater than a pea-sized
amount of toothpaste when
brushing.
For the study subjects who

grew up in optimally fluoridat-
ed communities, Table 2 shows
that an estimated 13 percent of
the cases could be explained by
the inappropriate use of fluo-
first two years of life. Forty-six
percent of the cases could be
usually used more than a pea-
sized amount of toothpaste
when brushing and usually
having brushed more than once
per day. The test for trend
across the three toothbrushing
exposure categories was statis-
tically significant, again sup-
porting the presence of a dose-
response effect. A clear associa-
tion with age when brushing
began was not observed in this
study sample, when adjusted
for usual toothbrushing fre-
quency and amount of tooth-
paste used.
Table 2 also shows that 9
percent of the cases could be
used infant formula in the form
of a powdered concentrate as
the main source of food, espe-
cially during the last quarter of
the first year. There was no

suggestion of an association
with ready-to-feed infant for-
mula and no significant associa-
tion was observed with liquid
concentrate formula. The
reported use of either bottled
water or a tap water filter was
not statistically significantly
associated with fluorosis in the
analyses from either nonfluori-
dated or optimally fluoridated
populations.
DISCUSSION
Attributable risk percent esti-
mates associated with enamel
fluorosis are useful in assessing
the public health impact of par-
ticular fluoride exposures.
JADA, Vol. 131, June 2000 751
RESEARCH
6-20
25-61
8-35
−6-10
3-15
TABLE 2

13
46
22
2
9
* Estimate of cases attributable to each specific fluoride source
based on logistic regression modeling.24 Note that individual
attributable risk
percents do not add up to 100 percent, as fluoride
supplementation, toothbrushing history and infant formula use
are not mutually exclusive
exposures.43
† CI: Confidence interval.
‡ Reference group: no fluoride supplementation years 1 through
2.
§ Reference group: pea-sized amount of toothpaste, once per
day.
** At 10 to 12 months of age. Referent group: no infant formula
used.
FLUORIDATION SOURCE ATTRIBUTABLE RISK PERCENT
ESTIMATE* ATTRIBUTABLE RISK
95 PERCENT CI†
ESTIMATED PERCENTAGE OF ENAMEL FLUOROSIS
CASES ATTRIBUTABLE TO
SPECIFIC FLUORIDE SOURCES IN AN OPTIMALLY
FLUORIDATED POPULATION.

Supplemented Years
1 Through 2
Toothbrushing History§
More Than a Pea-sized
Amount of Toothpaste,
More Than Once per
Day
More Than a Pea-sized
Amount of Toothpaste,
Once per Day
Pea-sized Amount of
Toothpaste, More Than
Once per Day
Formula as Powdered
Concentrate**
Supplementation History‡
reserved.
Children in the United States
today are exposed to a variety
of fluoride sources during early
childhood. Some sources, such
as fluoride supplements, are
intended to be ingested.
Others, such as fluoride tooth-
paste, are intended for topical

use but are nevertheless
ingested by preschool-aged chil-
dren who typically have not
begun to expectorate any or
enough of the toothpaste with
which they brush.45,46 It is
important when estimating the
attributable risk percent specif-
ic to a particular fluoride expo-
sure that this estimate be
adjusted for the effects of the
other exposures. In this way,
the estimate of the effect of a
particular exposure is not
biased by the other exposures.
It also is important to recognize
that the effect of exposure to a
specific fluoride source within a
population is always in the con-
text of exposure to that source
along with exposure to the
other fluoride sources within
that population. In this way,
the fluorosis impact of one fluo-
ride source among several can
be estimated, and appropriate
professional and public health
action can be taken.
In this study, approximately
two-thirds of mild-to-moderate
enamel fluorosis cases observed
in optimally fluoridated areas
and at least one-third of mild-
to-moderate enamel fluorosis
cases observed in nonfluoridat-

ed areas could be attributed to
or explained by habits related
to the early use of fluoride
toothpaste. Three potentially
important behaviors associated
with early toothbrushing are
when toothbrushing began, the
usual daily frequency of tooth-
brushing and the usual amount
of toothpaste used during
brushing. All three of these
behaviors are indicators of the
overall fluoride ingestion associ-
ated with early toothbrushing.
In the nonfluoridated study
population, the age at which
toothbrushing began and the
usual frequency of toothbrush-
ing were most significantly
sis. While not statistically sig-
nificant, these findings suggest
that as much as 45 percent of
the enamel fluorosis cases could
be explained by a history of
having usually used more than
a pea-sized amount of tooth-
paste when brushing.
In the optimally fluoridated
study population, the usual
amount of toothpaste used
when brushing and the usual
daily frequency of toothbrush-

ing were most significantly
sis. The statistically significant
trends observed with early
toothpaste use in both study
samples suggests a dose-
response relationship.
A previous investigation of a
Connecticut study population
who grew up in optimally
fluoridated communities esti-
mated that approximately 70
percent of enamel fluorosis
cases could be attributed to
early toothbrushing behav-
iors.34 Findings from Canadian
and Australian studies of chil-
dren who were current resi-
dents of optimally fluoridated
areas suggested that many of
the enamel fluorosis cases seen
in those investigations also
could be attributed to early
toothbrushing habits.12,15 This
study’s findings from the opti-
mally fluoridated study sample
are consistent with those past
reports. Importantly, this
study’s findings from the non-
fluoridated study sample sug-
gest that early toothpaste use
behaviors may affect the
prevalence of enamel fluorosis,
regardless of whether the com-

munity is optimally fluoridated.
These findings reinforce the
important opportunity and need
for dentists and hygienists to
guide the parents of preschool-
aged children in proper fluoride
toothpaste use. Specifically,
dental professionals should
advise parents to supervise
their preschool-aged children
during toothbrushing and be
sure that the children use only
a small pea-sized amount of
toothpastes when brushing.
This advice should be given and
followed regardless of whether
the children live in an optimally
fluoridated or nonfluoridated
area. Parents should encourage
their children to expectorate
the toothpaste at the earliest
possible age rather than swal-
low it, avoid toothpastes with
flavors that would encourage
young children to wish to eat
the toothpaste, and keep tooth-
paste and all other fluoride-
containing products out of the
reach of preschool-aged chil-
dren. These findings further
support the call for a lower-
fluoride-concentration tooth-
paste, specifically for use by pre-
school-aged children.34,47-49

The findings of this study
indicate that nearly two-thirds
of the cases of mild-to-moderate
enamel fluorosis observed in
nonfluoridated areas could be
attributed to or explained by
the early use of fluoride supple-
ment. Subjects in this investi-
gation would have been given
fluoride supplements under the
pre-1994 protocol; these find-
ings strongly support the new,
lower dosage fluoride supple-
mentation protocol, which has
been accepted by both the
752 JADA, Vol. 131, June 2000
RESEARCH
reserved.
American Dental Association
and the American Academy of
Pediatrics (Table 3).50,51
The ADA Guide to Dental
Therapeutics50 is a good
resource on the use of fluoride
supplements, as well as other
fluoride-containing compounds.
Dentists and hygienists should
evaluate the fluoride content of

a child’s drinking water, while
keeping in mind that the child
may have access to more than
one drinking water source dur-
ing the day, both at home and
in a child-care setting, for
example. If the child’s drinking
water is not from a municipal
water supply of known fluoride
concentration, the drinking
water sources must be tested
for their fluoride content. Then,
a proper decision regarding
what fluoride supplementation,
if any, is appropriate can be
made based on the protocol in
Table 3. By doing this, dentists
can avoid inappropriately pre-
scribing fluoride supplements to
children who already are drink-
ing adequately fluoridated
water. It also is important to
determine whether children are
receiving a fluoride supplement
as part of a multiple vitamin
prescribed by a physician.
Dentists should ask parents to
bring to the office any vitamin
preparations their children are
taking so the vitamins can be
evaluated directly. Dentists also
should ask parents to inform
them if the children’s drinking
water sources change.

The use of bottled drinking
water complicates the process,
as bottled water’s fluoride con-
tent can vary markedly, and
manufacturers are not required
to list the fluoride content.52 A
one-time test of the fluoride
content of bottled water may
not be sufficient to prescribe a
fluoride supplement, as a
child’s family might change the
brand of bottled water it drinks
or the fluoride concentration
could change.
My current findings indicate
that 13 percent of the cases of
rosis observed in optimally
fluoridated areas could be
attributed to or explained by
the inappropriate use of fluo-
first two years of children’s
lives while they lived in these
optimally fluoridated areas.
This is not surprising. The use
of fluoride supplements by chil-
dren living in optimally fluori-
dated areas has never been
recommended by any profes-
sional organization, given
the likelihood of causing an
above-optimal ingestion of fluo-
ride.50, 51,53-55 Fortunately, the

percentage of cases attributa-
ble to inappropriate fluoride
supplementation was relatively
low in this study population
and was approximately one-
half that reported in the only
previously published report of
the attributable risk associated
with enamel fluorosis and
inappropriate fluoride supple-
mentation.34 Nevertheless, this
finding illustrates the need for
dentists and hygienists to
serve as a source of guidance
to parents as to the proper use
of fluoride supplements.
The findings of this investi-
gation suggest that nearly 10
percent of the enamel fluorosis
cases in optimally fluoridated
areas could be explained by
having used infant formula in
the form of a powdered concen-
trate during the first year. I
observed no suggestion of an
association between enamel
fluorosis and infant formula—
in any form—in the nonfluori-
dated population. These find-
ings support the continued con-
JADA, Vol. 131, June 2000 753
RESEARCH

None
None
None
None
TABLE 3
None
None
0.25 mg/day
0.50 mg/day
None
0.25 milligrams
per day‡
0.50 mg/day
1.00 mg/day
* Revised schedule accepted by the American Dental
Association,50 the American Academy of Pediatric Dentistry
and the American
Academy of Pediatrics.
† ppm: Parts per million.
‡ 2.2 mg sodium fluoride contain 1 mg fluoride ion.
AGE

Less Than 0.3 ppm† 0.3 to 0.6 ppm More Than 0.6 ppm
FLUORIDE CONCENTRATION IN THE DRINKING WATER
REVISED FLUORIDE SUPPLEMENTATION SCHEDULE.*
Birth to 6 Months
6 Months to 3 Years
3 to 6 Years
6 to 16 Years
reserved.
cern that the use of powdered
concentrate formula mixed
with optimally fluoridated
water still may have an impact
on the prevalence of enamel flu-
orosis in optimally fluoridated
areas.55,56
To my knowledge, this is the
first investigation reporting
attributable risk percent esti-
mates associated with infant
formula use after the U.S. for-
mula manufacturers’ voluntary
decision in 1979 to reduce the
fluoride in their products.

Therefore, other studies will
need to be conducted to confirm
these findings. In the interim,
however, it may be prudent to
recommend to parents living in
optimally fluoridated areas who
are feeding formula to their
infants, that they either use a
ready-to-feed formula or pre-
pare formula from concentrate
using bottled water with a
known low-fluoride concentra-
tion. Care should be taken,
however, to explain to the par-
ent that drinking optimally
fluoridated water by itself is not
a risk factor for noticeable
enamel fluorosis,6,7 and that
drinking optimally fluoridated
water has proven important
caries preventive benefits.7
The questionnaire used in
these investigations originally
was judged to possess content
validity (that is, adequacy of the
questions to measure what the
questionnaire is suppose to
measure)57,58 by me, my col-
leagues, nondental–trained
pretesters and a National
Institutes of Health scientific
review panel. Throughout its use
in five separate investigations of
several thousand subjects, there
have been few questions raised

by respondents relative to the
meaning of questions. Beyond
this, questions in this question-
naire have shown considerable
predictive validity57,58 as used in
the specific investigation report-
ed in this article, as well as in
previous investigations in which
it has been used. For example,
as hypothesized in previous
toothpaste ingestion studies,47
adjusted multivariate analyses
have consistently shown specific
early toothpaste-use variables to
be associated with enamel fluo-
rosis diagnosed by examiners
blind to the children’s fluoride
exposure histories. This supports
the likelihood that the question-
naire has measured what it
intended to measure.
In this type of study (case-
controlled), guessing on the
part of questionnaire respon-
dents always diminishes the
observed association between
fluoride exposure and fluorosis
or hides it entirely.59 In con-
trast, if responses were biased
such that a history of exposure
to one fluoride source really
reflected a true exposure to a
different fluoride source, then

the potential for an observed
spurious association would
exist. In this situation, howev-
er, adjustment for the true risk
factor by use of a multivariate
analyses would reveal a true
lack of association between the
spurious factor and fluorosis.
Therefore, the use of fully
adjusted, multivariate analyses
in this investigation lends fur-
ther support to the validity of
observed associations.
CONCLUSIONS
The findings reported in this
article suggest that early tooth-
brushing habits have an impor-
tant impact on the prevalence
of mild-to-moderate enamel fluo-
rosis in both nonfluoridated and
optimally fluoridated areas. At
least one-third of the fluorosis
cases in nonfluoridated areas
and two-thirds of the cases in
optimally fluoridated areas
could be explained by specific
patterns of early fluoride tooth-
paste use.
Approximately two-thirds of
mild-to-moderate enamel fluoro-
sis cases in nonfluoridated areas
could be explained by the use of

fluoride supplements under the
pre-1994 supplementation pro-
tocol. Inappropriate use of fluo-
ride supplements explained 13
percent of fluorosis cases in
optimally fluoridated areas. An
additional 9 percent of fluorosis
cases in optimally fluoridated
areas were explained by the use
of infant formula in the form of
a powdered concentrate. This
relationship with infant formula
use was not seen in nonfluori-
dated areas.
These findings reinforce the
important role that health pro-
fessionals can have in reducing
the prevalence of enamel fluoro-
sis in U.S. children today and
suggest that much of the clini-
cally noticeable enamel fluoro-
sis seen today could be prevent-
ed by specific changes in early
childhood behaviors. In particu-
lar, providing the parent of a
young child with appropriate
advice regarding the early use
of fluoride toothpaste and fluo-
ride supplements may have a
significant impact on the preva-
lence of enamel fluorosis in
both nonfluoridated and opti-
mally fluoridated populations. �
Dr. Pendrys is an associate professor,

Department of Behavioral Sciences and
Community Health, School of Dental
Medicine, University of Connecticut Health
Center, 263 Farmington Ave., Farmington,
Conn. 06030-3910. Address reprint requests
to Dr. Pendrys.
This study was supported by National
Institute of Dental and Craniofacial Research
grants DE08939 and DE9400110592.
The author thanks Drs. Ralph V. Katz and
754 JADA, Vol. 131, June 2000
RESEARCH
reserved.
Douglas E. Morse, coexaminers in these inves-
tigations, as well as Ms. Laura Byrne-Maraj
for her assistance with data management.
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JADA, Vol. 131, June 2000 755
RESEARCH
reserved.
RISK OF ENAMEL FLUOROSIS IN NONFLUORIDATEDAND
OPTIMALLY FLUORIDATED POPULATIONS:
CONSIDERATIONS FOR THE DENTAL
PROFESSIONALMATERIALS AND
METHODSRESULTSDISCUSSIONCONCLUSIONS
FluorideSupplemen
tation.docxFLUORIDE SUPPLEMENT PROGRAM
GUIDELINES

1. The program is primarily for pre-school children (6 months–6
years), but may be provided up to age 16 (targeting children
who do not attend a school with fluoridated water), who are not
presently receiving fluoridated drinking water, other fluoride
supplements, or vitamins with fluoride.
2. Whether or not a child is receiving fluoride can be
determined by the answers to questions on the questionnaire and
consent form (OH-9). A copy of the form is included in this
section.
3. When bottled water is being used as the primary source of
drinking water, the fluoride content of the water should be
determined. If the child’s legal representative is unaware of the
fluoride content of the bottled water, there are several sources
of information, which can be helpful in learning the fluoride
content of different brands of bottled water. Generally, bottled
water has a toll-free phone number printed on the label, or a
product web site, which can be accessed to learn the fluoride
content of the bottled water. Additional sources for learning the
fluoride content of bottled water can be found at International
Bottled Water Association (IBWA) Information Hotline: 1-800-
WATER-11 or the International Bottled Water Association
Website http://www.bottledwater.org/default.htm. Do not
submit a sample of bottled water for testing, without first
attempting to determine the fluoride content of the bottled
water.
4. If the child is not receiving fluoride in the water supply, an
analysis of the natural fluoride content of the home water
supply must be performed prior to prescribing fluoride
supplementation. Instructions for taking and submitting a water
sample are provided on the reverse side of “Information for
Parents or Guardians”.

5. The maximum amount of fluoride a child under six should
receive is 0.5 mg. fluoride ion per day.
6. Fluoride drops (8 drops–1 mg. fluoride ion) are packaged in
plastic bottles containing one ounce liquid with about 500 drops
(62.5 mg. fluoride ion) per bottle.
7. Fluoride chewable tablets (0.5 mg. fluoride ion) are packaged
in plastic bottles containing 120 tablets (60 mg. fluoride ion)
per bottle.
8. Dosage levels of fluoride drops or tablets depend on the age
of the child and the amount of fluoride in the drinking water
(from fluoride water sample tests). The dosage schedule for
fluoride drops or tablets is included in the fluoride supplement
protocols. For patients with abnormal fluoride test results of
water samples submitted to the State Lab, issuing of fluoride
supplements (drops or tablets) and follow-up should be followed
per protocol.
9.
If the test results from the water sample are:
· Equal to or greater than 2.00 ppm fluoride concentration,
submit another sample of the water source to the State Lab for
confirmation testing.
· If both water samples are equal to or greater than 2.00 ppm up
to 4.00 ppm fluoride concentration, recommend to the parent or
guardian that children equal to or less than 8 years of age
should consume another source of water.
· Equal to or greater than 4.00 ppm fluoride concentration,
recommend that both children and adults should consume
another source of water.
· The Environmental Protection Agency classifies water with
equal to or greater than 2.00 ppm fluoride concentration as the
Secondary Containment Level and water with equal to or greater
than 4.00 ppm fluoride concentration as the Maximum

Containment Level for fluoride in water.
· When both water samples are equal to or greater than 4.00
ppm fluoride concentration, the nurse working with the Fluoride
Supplement Program in the local health department should
contact the local health department environmentalists and
request an investigation of the water source.
· If the second water samples, comes back less than 2.00 ppm,
submit a third water sample to the State Lab for testing.
· If fluoride concentration in two of the three samples is less
than 2.00 ppm, follow the Fluoride Supplements Protocols for
water samples with fluoride concentrations less than 2.00 ppm.
If the fluoride concentration in two of the three samples is equal
to or greater than 2.00 ppm, follow Fluoride Supplement
Protocols for water samples with fluoride concentrations equal
to or greater than 2.00 ppm.
· For further clarifications and directions, call the Oral Health
Program at 502-564-3246, extension 4421.
10. Orders for fluoride supplement drops or tablets must be
signed by the health officer, another physician, a dentist, or
another health professional with prescriptive authority.
Protocols may be used—one copy will cover all children in the
program. A sample copy is included in this section. If
prescription blanks are used, a signed prescription for fluoride
must be in each child’s folder.
11. Parents or guardians must be advised concerning the
importance of giving their child no more than the prescribed
amounts of fluoride. It should be called to the attention of the
parent or guardian that excessive amounts (i.e., more than 2 mg.
per day) over an extended period of time (two or three months)
may cause tooth discoloration during their development; with
white spots appearing on the child’s permanent teeth. In
addition, they need to be told of the potentially toxic nature of
fluoride when ingested in large doses at a single time.

If, for example, a 22 pound child takes 264 mg. of sodium
fluoride
(120 mg. fluoride ion) at any single time, symptoms of acute
toxicity
can occur (stomach upset, vomiting). The minimum lethal dose
for a
22-pound child is 480 mg. of sodium fluoride.
12. If it is determined that a child will participate in a
preventive dental program, a questionnaire and consent form,
the fluoride analysis of home water supply report, and a record
of the amount of fluoride to be provided, if needed, shall be
made a part of the child’s permanent health record. (Each
participating child in the family must have a signed
questionnaire and consent form and a record of the amount of
fluoride to be taken.)
13. If more than one child in a family is to receive the fluoride
supplement, written instructions for each child must be given to
the parent.
14. A 3-month supply of supplements may be provided for each
child in a family. Empty containers should be returned before
providing a replacement. At this time, a determination should
be made whether circumstances affecting the amount of fluoride
supplement to be provided have changed, such as change in
address, change in water source or the ‘aging out’ of the
impacted children. Questions to Ask Parents
a. Have you moved?
b. Have you changed your water supply? (Hint: even redrilling
a well may impact the fluoride intake of the family.)
c. Has the child been placed on a vitamin supplement with
fluoride?
Fluoride Supplementation Recommendations are based on the

current guidelines of the American Dental Association,
http://www.ada.org/2684.aspx#dosschedule
For additional information, please call the Oral Health
Administrator at 502-564-3246, ext 4421.
Water Samples Tested for Fluoride Concentration
Results of Initial Water Sample Test
Fluoride Concentration
Equal to or greater than 2.00 ppm
Submit another sample of the water source to the State Lab for
testing
Less than 2.00 ppm
Follow Fluoride Supplement Protocols

Less than 2.00 ppm
Submit another sample of the water source to the State Lab for
testing
Equal to or greater than 4.00 ppm
Recommend children and adults consume another source of
water
RN/RDH responsible for Fluoride Supplement Program at LHD
should contact LHD environmentalist and request an
investigation of the water source
Equal or greater than 2.00 ppm to 4.00 ppm
Recommend children 8 years of age and younger consume
another source of water
2 water samples equal to or greater than 2.00 ppm
Follow chart for readings equal to or greater than 2.00 ppm
2 water samples less than 2.00 ppm

Follow Fluoride Supplement Protocols
For further information or directions, contact
the Oral Health Program
502-564-3246 x 4421
FLUORIDE SUPPLEMENT PROTOCOL
Infants and preschool children who are not drinking fluoridated
water or who are not taking vitamins with fluoride should be
given this essential nutrient. A laboratory test done on a sample
of the drinking water supply will tell how much fluoride is in
the water and the amount of the supplement that may be needed.
Call the Oral Health Program at 502-564-3246 to order forms,
fluoride supplements, water sample, and collection kits or if
further information is needed.
HEALTH RISK OR CONDITION
TREATMENT/ INTERVENTION
EDUCATION/ COUNSELING
FOLLOW-UP
Unfluoridated drinking water source may be:
· Well
· Cistern
· Bottled
· Spring
Distribute one (1) bottle of fluoride drops and/or one (1) bottle
of fluoride tablets to each child with individualized doses as
follows:
NaFrinse Drops – 1 bottle has about 500 drops fluoride.
NaFrinse Tablets – 1 bottle contains 120 tablets.
Children under 3 are not issued tablets. Dosage depends on age
of child and amount of fluoride in drinking water.
At each preventive visit ask:
1. Have you moved?

2. Has the source of your child’s drinking water changed?
3. Is child taking vitamin with fluoride supplement?
Yes response to #1 and 2—assess new water supply, if indicated
Yes response to #3—discontinue fluoride supplementDOSAGE
Age of child
Fluoride in water
0 to 0.3 ppm
Fluoride in water
0.3 to 0.6 ppm
Fluoride in water
0.6 ppm and above
Age birth – 6 months
None
None
None
Age 6 months – 3 yrs
2 drops – .25 mg 1 time per day
(8 month supply)
None
None
Age 3 – 6 yrs
(4 month supply)
or
1 tablet – .50 mg 1 time per day
(About a 4 month supply)
(8 month supply)
Must give drops. There are no .25 mg tablets.
None
Age 6 – 16 yrs *
*Children who do not attend school with a fluoridated water
supply may continue in the program.
8 drops – 1.0 mg 1 time per day

(2 month supply)
or
2 tablets – .50 mg 1 time per day (2 month supply)
(4 month supply)
or
1 tablet – .50 mg 1 time per day
(4 month supply)
None
Dispose of unused drops or tablets by:
· Returning any unused liquid or tablets to LHD
· Flushing unused liquid or tablet down toilet
· Placing unused liquid or tablets in disposable trash container
Source: American Dental Association’s Council on Scientific
Affairs: Fluoride Supplement Dosage Schedule: 2010
_____________________________________________________
_____
Physician, Dentist, Other
Date
PIIS00028177146282
69.pdf
C O M M E N T A R Y G U E S T E D I T O R I A L
628 JADA, Vol. 140 http://jada.ada.org June 2009
Editorials represent the opinions of the authors
and not those of the American Dental Association.

Fluoridated toothpaste
and the prevention of early
childhood caries
A failure to meet the needs
of our young
I
n the United States, dental caries is on the rise in children, es-
pecially among the very young and the poor.1 The cause is not
fully understood but likely is related to the consumption of in-
creasingly available, inexpensive foods containing excess sug-
ars, as well as to the now-ubiquitous habit of snacking and
drinking sweetened drinks throughout the day.2,3
Dental services for low-income children in the United States,
cov-
ered through the Early Periodic Screening, Diagnosis and
Treatment
(EPSDT) Program—Medicaid’s child health insurance
program—
have achieved limited success in reducing dental caries. Access
to
dentists accepting Medicaid payment remains a major obstacle
for
these children.4 As a consequence, in some states, public health
offi-
cials have encouraged medical care providers to screen children
from
birth to 24 months of age for dental care needs and to apply
sodium
fluoride varnish during primary care visits.5 Researchers are
investi-
gating other strategies, such as combining povidone-iodine and
fluo-

ride varnish or xylitol syrups and confections.6,7
A more accessible and less costly strategy to prevent caries
among
young children is the regular use of fluoridated toothpaste. Con-
cerned about the rising rates of early childhood caries (ECC), an
ex-
pert panel convened in 2007 by the U.S. government
recommended
that children younger than 2 years who are at high risk of
experienc-
ing caries brush twice per day with a “smear” of regular U.S.
fluo-
ride toothpaste (typically containing about 1,100 parts per
million
fluoride) and that children aged 2 to 6 years brush twice daily
with
no more than a pea-sized amount of U.S. fluoridated
toothpaste.8
Regular toothpaste typically contains about 1,100 parts per
million
fluoride.
However, there is resistance among dentists, physicians and
par-
ents in the United States to using regular fluoridated toothpaste
with very young children; the U.S. Food and Drug
Administration
(FDA) Drug Facts label discourages its use in this population.
Fluoridated toothpaste is packaged with the mandatory warning:
“Keep out of reach of children under 6 years of age. If more
than
used for brushing is accidentally swallowed, get medical help or
con-

It is time for the dental
profession, the dental
industry and the
government to
reconsider instructions
to parents regarding
the use of fluoridated
toothpaste for children
younger than 2 years.
Peter M. Milgrom, DDS;
Colleen E. Huebner, PhD,
MPH; Kiet A. Ly, MD, MPH
G U E S T E D I T O R I A L
Copyright © 2009 American Dental Association. All rights
reserved. Reprinted by permission.
tact a Poison Control Center
right away.”9
The intention behind the
choice of the terms “smear” and
“pea-sized” in the expert report
was to limit children’s excess
exposure to fluoride. However,
without evidence of the benefits
and risks associated with fluo-
ride use, the expert panel rec-

ommendation will have little
impact, particularly while the
FDA limits the directions for
use to “adults and children
2 years of age and older.”9
The concentration of fluoride
in toothpaste varies from coun-
try to country in accord with
government regulations, which
makes it difficult to compare
study results. The FDA allows
dentifrices containing 850 to
1,150 ppm total fluoride for use
by children 2 years and older
and 1,500 ppm fluoride for use
by those 6 years and older.
However, consumers and health
care providers often do not un-
derstand the distinction. The la-
beling is confusing because of
the different forms of fluoride
used and the use of percent
weight/volume measures; un-
derstanding these technical
terms requires health literacy
beyond that of many Americans.
It is time for the dental pro-
fession, the dental industry and
the government to reconsider
instructions to parents regard-
ing the use of fluoridated tooth-
paste for children younger than
2 years. Unfortunately, the lit-
erature concerning toothpaste

use in the very young is scant.
Fluoridated toothpaste is highly
effective in preventing caries in
children’s permanent denti-
tion,10 but only one study has
demonstrated its efficacy in
doing so in the primary denti-
tion of very young children.
Described by its authors as an
effectiveness study of a program
for parents with low incomes,
not a trial of toothpaste’s effica-
cy, it nonetheless provided a
comparison of the use of fluori-
dated toothpaste—either
440 ppm (monosodium fluoride
0.304 percent weight/volume) or
1,450 ppm (sodium fluoride 0.32
percent weight/volume)—with
no use of fluoridated tooth-
paste.11 The investigators as-
signed families to receive tooth-
paste and educational materials
regularly by mail while their
children were aged 1 to 51/2
years. Clinical examinations
conducted when the children
were 5 to 6 years old found an
advantage for children in the
1,450-ppm fluoride group rela-
tive to those in the 440-ppm
group and to those in the un-
treated control group. Overall,
they found that the 440-ppm

fluoride intervention had no ad-
vantage relative to the control.
In a study of 1,100-ppm fluoride
toothpaste used by preschool
children in China, You and col-
leagues12 reported equivocal
findings. This latter study does
not meet FDA scientific stand-
ards for a randomized clinical
trial of a regulated drug, but its
results suggest that further in-
vestigation of fluoridated tooth-
paste in very young children is
warranted.
The benefit identified by
Davies and colleagues11 of use of
the 1,450-ppm toothpaste was
not without associated risk. A
follow-up study found that those
who received the 1,450-ppm flu-
oride toothpaste had significant-
ly more fluorosis—some with
fluorosis scores in the range con-
sidered esthetically objection-
able according to standardized
measures used in public
health—than did those who re-
ceived the 440-ppm fluoride
toothpaste.13 Scores observed in
the objectionable range were
among children who lived in rel-
atively less deprived communi-
ties, suggesting an association
between better adherence to

home hygiene goals (that is,
brushing begun at an early age)
and greater risk of developing
fluorosis. Data from Bentley and
colleagues14 suggested the same.
Instructing parents to use a
smear or a pea-sized amount of
fluoride toothpaste with their
young children is not universal-
ly effective in reducing the
amount applied to the tooth-
brush. Also, it may be possible
to apply too little toothpaste.
Itthagarun and colleagues15 con-
cluded, “Reduction of the
amount of fluoride toothpaste to
less than a pea-size in order to
minimize the risk of fluorosis
should be undertaken with cau-
tion because it may compromise
the cariostatic effects of the
toothpaste, as shown by in vitro
studies.” Other researchers had
reached a similar conclusion in
an earlier study involving sali-
vary fluoride analyses.16 Thus,
the amounts of U.S. 1,100-ppm
fluoride toothpaste being recom-
mended for use by our youngest
children may be ineffective.
In the United States, in con-
trast to some other countries
(such as England and
Australia), no fluoridated tooth-

paste has been formulated for
use by infants and toddlers, and
none has been tested.10,17
Furthermore, using no tooth-
paste or using only nonfluori-
dated toothpaste (such as Baby
Orajel Tooth and Gum Cleanser
[Church and Dwight, Princeton,
N.J.]) is regarded as the stand-
ard of care for children of this
age. There is nothing in the
portfolio of research supported
by the National Institute of
630 JADA, Vol. 140 http://jada.ada.org June 2009
Dental and Craniofacial
Research or sponsored by the
Centers for Disease Control and
Prevention on this topic; we do
not know what investigations, if
any, manufacturers are
sponsoring.
Formally testing the benefits
and secondary effects of the use
of 1,100-ppm fluoridated tooth-
paste with infants and toddlers

in the United States who are at
high risk of developing caries—
and changing instructions for
use on toothpaste labels, if ap-
propriate—can benefit many
children at little cost relative to
current investments in dental
research and profits from oral
care products. Parents and pro-
fessionals in poor and minority
communities in the United
States have told us in the
course of our research that they
would support a randomized
placebo-controlled study of a
special fluoridated toothpaste
for infants and toddlers. Thus,
we conclude on the basis of ex-
isting science and the rising lev-
els of dental caries that clinical
trials of fluoridated toothpaste
for very young children in the
United States are overdue. ■
Dr. Milgrom is a professor, Department of
Dental Public Health Sciences, and director,
Northwest Center to Reduce Oral Health
Disparities, University of Washington, Box
357475, Seattle, Wash. 98195-7475, e-mail
“[email protected]”. Address reprint re-
quests to Dr. Milgrom.
Dr. Huebner is an associate professor,
Department of Health Services, University of
Washington, Seattle, and the director, gradu-

ate program in Maternal and Child Health
Public Health Leadership, University of
Washington, Seattle.
Dr. Ly is an acting assistant professor,
Department of Dental Public Health Sciences,
University of Washington, Seattle.
Disclosure. None of the authors reported
any disclosures.
The development of this article was sup-
ported in part by grant U54DE019346 from
the National Institute of Dental and
Craniofacial Research, National Institutes of
Health, Bethesda, Md.
1. U.S. Department of Health and Human
Services. Figure 21-1: Progress quotient chart
for focus area 21—oral health. In: Healthy
People 2010 Midcourse Review. Modified
April 9, 2007. “www.healthypeople.gov/Data/
midcourse/html/tables/pq/PQ-21.htm”.
Accessed April 16, 2009.
2. Ismail AI, Lim S, Sohn W, Willem JM.
Determinants of early childhood caries in low-
income African American young children.
Pediatr Dent 2008;30(4):289-296.
3. Thitasomakul S, Piwat S, Thearmontree
A, Chankanka O, Pithpornchaiyakul W,
Madyusoh S. Risks for early childhood caries
analyzed by negative binomial models. J Dent
Res 2009;88(2):137-141.

4. Milgrom P, Weinstein P, Huebner C,
Graves J, Tut O. Empowering Head Start to
improve access to good oral health for chil-
dren from low income families (published on-
line ahead of print Feb. 2, 2008). Matern
Child Health J.
5. dela Cruz GG, Rozier RG, Slade G.
Dental screening and referral of young chil-
dren by pediatric primary care providers.
Pediatrics 2004;114(5):e642-e652.
6. Berkowitz RJ, Koo H, McDermott MP, et
al. Adjunctive chemotherapeutic suppression
of mutans streptococci in the setting of severe
early childhood caries: an exploratory study. J
Public Health Dent (in press).
7. Milgrom P, Ly KA, Tut OK, et al. Xylitol
pediatric topical oral syrup to prevent dental
caries: a double blind, randomized clinical
trial of efficacy. Arch Pediatr Adolesc Med (in
press).
8. Health Resources and Services
Administration, Maternal and Child Health
Bureau. Appendix A: Decision support ma-
trix—topical fluoride recommendations. In:
Topical Fluoride Recommendations for High-
Risk Children: Development of Decision
Support Matrix, Recommendations from
Maternal and Child Health Bureau Expert
Panel. Washington: Altarum Institute; 2009.
“mohealthysmiles.typepad.com/
Topical%20fl%20recommendations%20for%20
hi%20risk%20children.pdf”. Accessed April

16, 2009.
9. Anticaries drug products for over-the-
counter human use, 21 CFR 355;2006.
10. Marinho VC, Higgins JP, Sheiham A,
Logan S. Fluoride toothpastes for preventing
dental caries in children and adolescents.
Cochrane Database Syst Rev 2003;(1):
CD002278.
11. Davies GM, Worthington HV, Ellwood
RP, et al. A randomised controlled trial of the
effectiveness of providing free fluoride tooth-
paste from the age of 12 months on reducing
caries in 5-6 year old children. Community
Dent Health 2002;19(3):131-136.
12. You BJ, Jian WW, Sheng RW, et al.
Caries prevention in Chinese children with
sodium fluoride dentifrice delivered through a
kindergarten-based oral health program in
China. J Clin Dent 2002;13(4):179-184.
13. Tavener JA, Davies GM, Davies RM,
Ellwood RP. The prevalence and severity of
fluorosis in children who received toothpaste
containing either 440 or 1,450 ppm F from the
age of 12 months in deprived and less de-
prived communities. Caries Res 2006;
40(1):66-72.
14. Bentley EM, Ellwood R, Davies RM.
Fluoride ingestion from toothpaste by young
children. Br Dent J 1999;186(9):460-462.

15. Itthagarun A, King NM, Rana R. Effects
of child formula dentifrices on artificial caries
like lesions using in vitro pH-cycling: prelimi-
nary results. Int Dent J 2007;57(5):307-313.
16. DenBesten P, Ko HS. Fluoride levels in
whole saliva of preschool children after brush-
ing with 0.25 g (pea-sized) as compared to 1.0
g (full-brush) of a fluoride dentifrice. Pediatr
Dent 1996;18(4):277-280.
17. Twetman S, Axelsson S, Dahlgren H, et
al. Caries-preventive effect of fluoride tooth-
paste: a systematic review. Acta Odontol
Scand 2003;61(6):347-355.
JADA, Vol. 140 http://jada.ada.org June 2009 631
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L E T T E R S
Fluoridated toothpaste and the prevention of early childhood
caries: A failure to meet the needs
of our youngDisclosureREFERENCE
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Also include a brief abstract (≤ 150 words summarizing the lab
objectives, importance, results, and conclusions).
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Results and Discussion
This section should represent the bulk of your report. It should

include a presentation of pertinent results, using figures and
tables as appropriate, and a discussion of the meaning and
relevance of the results. The discussion is your opportunity to
demonstrate your understanding of the laboratory technique,
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Conclusions
The objective(s) of the laboratory should be reiterated and
specific conclusions should be listed using bullet points.
Questions
The questions from the laboratory handout should be included
in a numbered list. Complete, concise answers to the questions
should be provided.
References
Include appropriate citations for all material referenced in the
report.
* Note that there is no Materials and Methods section. There is
no need to repeat the information provided in the laboratory
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Each laboratory report is worth 100 points. The grade
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Questions – 20
RESEARCH ARTICLE
Oral Health–Promoting School Environments and Dental Caries

in Québec Children
Anu Edasseri, MSc,1 Tracie A. Barnett, PhD,2 Khady Kâ,
PhD,3 Mélanie Henderson, PhD,4 Belinda Nicolau, PhD1
Introduction: Dental caries are highly prevalent among children
and have negative health consequences. Their occurrence may
depend in part on school-based environmental or policy- related
factors, but few researchers have explored this subject. This
study aimed to identify oral health promoting school
environment types and estimate their relation with 2-year dental
caries incidence among Québec children aged 8–10 years.
Methods: This study used data from two visits (completed in
2008 and 2011) of the QUALITY (Québec Adipose Lifestyle
Investigation in Youth) cohort, which recruited white children
at risk of obesity and their families from Greater Montreal
schools. Measures included school and neighborhood
characteristics, and Decayed, Missing, Filled-Surfaces index
scores. Principal component and cluster analyses, and
generalized estimating equations were conducted.
Results: Data were available for 330 children attending 200
schools. Based on a series of statistical analyses conducted in
2016, the authors identified three distinct school environment
types. Type 1 and 2 schools had strong healthy eating programs,
whereas Type 3 had weak programs. Type 1 schools had
favorable neighborhood food environments, whereas Type 2 and
3 had unfavorable ones. Adjusting for potential confounders,
children attending Type 1 and 2 schools had 21% (incidence
rate ratio1⁄40.79, 95% CI1⁄40.68, 0.90) and 6% (incidence rate
ratio1⁄40.94, 95% CI1⁄40.83, 1.07) lower 2-year incidence of
dental caries, respectively, compared with Type 3 schools.
Conclusions: School-based oral health promotion programs
combined with a favorable neighborhood can lower dental
caries incidence in school children.
Am J Prev Med 2017;53(5):697–704. & 2017 American Journal
of Preventive Medicine. Published by Elsevier Inc. All rights
reserved.

INTRODUCTION
Despite improved detection and treatment
modalities, dental caries remain the most com-
mon chronic oral disease among children and a
major public health concern affecting 60%−90% of
school-aged children worldwide.1 Oral conditions
(untreated caries, severe periodontitis, and tooth loss)
affect nearly 3.9 billion people worldwide; untreated
decay in permanent teeth is the most prevalent condition,
affecting 35% of the population and ranking 80th among
the top 100 causes of disability-adjusted life years.2 North
American children have the second highest lifetime
caries experience measured by the Decayed, Missing,
and Filled-Teeth index (Decayed Missing Filled-
3
youth have experienced dental caries, with a higher prevalence
and severity found among youth from a low socioeconomic
background.4 Moreover, oral health is a determinant of general
health and plays an important role in quality of life.5 Finally,
oral disease is the fourth
From the 1Division of Oral Health and Society, Faculty of
Dentistry, McGill University, Montreal, Québec, Canada;
2Epidemiology and Biostatistics Unit, Institut National de la
Recherche Scientifique−Institut Armand Frappier, Laval,
Québec, Canada; 3University of Montreal Hospital Research
Centre, Montreal, Québec, Canada; and 4Department of Pedia-
trics, Université de Montréal, Centre Hospitalier Universitaire
Sainte- Justine, Montreal, Québec, Canada
Address correspondence to: Belinda Nicolau, PhD, Faculty of
Dentistry, McGill University, 2001 McGill College Avenue,
Suite 527, Montreal, QC Canada, H3A 1G1. E-mail:
[email protected]
0749-3797/$36.00
https://doi.org/10.1016/j.amepre.2017.07.005
Teeth1⁄42.08) worldwide. More than half of Canadian

& 2017 American Journal of Preventive Medicine. Published by
Elsevier Inc. All rights Am J Prev Med 2017;53(5):697–704 697
reserved.
698 Edasseri et al / Am J Prev Med 2017;53(5):697–704
most expensive condition to treat and is therefore a major
economic burden to both society and individuals.1 Fortunately,
dental caries are mostly preventable, and even reversible, if
detected in early stages and if effective intervention is
available. However, the effectiveness of oral health education
and clinical preventive programs in improving oral health
outcomes is questionable.6,7 Dental health education may
increase knowledge, but whether it translates into better oral
health behaviors is still a matter of debate.6–8 In fact,
information giving alone may be ineffective and may even
increase health inequity because people with the highest need
are frequently less educated, with fewer economic resources to
make healthier choices.9,10 Also, focusing on clinical
prevention, such as sealants and topical fluorides, alone is
palliative7 and not
cost effective.11
Health promotion strategies that go beyond the
individual level to integrate elements of policy development
and social and physical environmental factors may be more
effective for disease prevention than isolated behavior-specific
interventions.7,12 The WHO’s concept of health promoting
schools highlights the importance of the environment, and
advocates for a comprehensive approach in transforming
schools as healthy settings.13 Considering oral health
promotion as an integral component of health promoting
schools, WHO has proposed guidelines for oral health
promoting schools.14 Schools worldwide have attempted to
adapt and implement school-based oral health promotion
programs according to these guidelines.
These initiatives generally had a favorable impact on reduction
of dental caries in children,15–17 however, instances of failure
were also reported.18,19 Although the Québec government

responsible for schools in the current study published guidelines
for school health promotion in 2005,20 the authors did not find
any studies evaluating its effect on oral health outcomes.
Other school-related variables may play important roles in
determining children’s health and health behaviors, notably
neighborhood disadvantage. For example, favorable school
socioeconomic environment is inversely related to dental caries
in Québec school children.21 In addition, school SES, based on
average percentage of low- income families in the school
neighborhood, appears to modify the association between oral
health promotion and dental caries reduction, the effect being
stronger among low SES schools,15 where the need is the
greatest.
Disadvantaged neighborhoods may also have more nutritionally
poor food sources; hence, children attending schools located
in disadvantaged neighborhoods may be more likely to adopt
poor dietary habits. Some evidence suggests an adverse effect
of an unhealthy food environment around schools on pediatric
obesity.22
A previous study published by the QUALITY (Québec Adipose
Lifestyle Investigation in Youth) cohort group found that a
higher number of “unhealthful” compared with “healthful” food
stores in the proximity of schools had undesirable effects on
children’s dietary habits.23 However, studies on the
surrounding food environment and children’s dietary habits
provide inconsistent findings and are mostly cross-
sectional22; there is a need for additional longitudinal
studies.22
Despite major criticism of traditional preventive and behavioral
approaches, many interventions targeting isolated behaviors
persist. Few studies have looked at comprehensive programs in
schools that incorporated policy elements and participatory
approaches15,16,18; a literature search identified only one such
study from Canada15 and none from Québec. In addition, fewer
studies have considered school neighborhood disadvant-
age,15,16 and the authors identified none that included the

surrounding food environment in their assessment of the oral
health promoting school environment. Therefore, the aims are to
identify distinct school environments based on oral health
promoting and neighborhood environmental factors, and to
estimate the relation between school environment types and 2-
year dental caries incidence among Québec children aged 8–10
years.
METHODS
Study Sample
Data were from an ongoing prospective study, the QUALITY
cohort, which investigates the natural history of metabolic risk
in youth. A full description of this study can be found
elsewhere.24 Briefly, the QUALITY cohort recruited 630 white
children aged 8–10 years at baseline from schools located
within 75 km of three major urban centers in the province of
Québec. Both biological parents had to be available and at least
one of them had to be obese (BMI ≥30 or waist circumference
4102 cm in men and 488 cm in women) for inclusion in the
study. An ancillary study included a formal evaluation of the
schools attended by QUALITY participants and the
neighborhood for children attending schools in the Montreal
Census Metropolitan Area (home to 480% of QUAL- ITY
participants). Among the 296 schools (attended by 506 children
of the QUALITY study) in the Montreal Census Metropolitan
Area, 247 schools (attended by 430 children) agreed to
participate in the study. The current study uses data collected in
Visit 1 (baseline, aged 8–10 years) and Visit 2 (children aged
10–12 years), which were completed in 2008 and 2011,
respectively.
The QUALITY cohort study obtained ethics approval from
several IRBs, including the Centre Hospitalier Universitaire
Sainte- Justine and McGill University. Parents and school
principals signed consent forms and children provided assent.
Measures
Trained dentists performed the clinical oral health examination
in a dental office during the hospital visit. This study used the

Child Dental Health Survey of England, Wales, and Northern
Ireland
www.ajpmonline.org
diagnostic criteria to record dental caries.25 Two-year dental
caries incidence was measured as the difference in the Decayed,
Missing, Filled-Surfaces (DMF-S) index between Visits 1 and 2.
Surfaces that were not examined in either visit were excluded
from the DMF-S index calculation. Five observations had
negative DMF-S incremental values. In each of these cases,
some of the initial caries lesions in Visit 1 were replaced by
sealants in Visit 2 and thus were not counted in Visit 2, leading
to negative differences. As this is equivalent to a difference of
0, the 2-year dental caries incidence in all these cases was also
recorded as 0.
Data on age, sex, and parental SES were collected using
structured questionnaires administered to parents at Visit 1.
Parental SES was measured using two variables: parental
education and parental income. Parental education, collected as
a seven- category variable, was later combined for both parents
and categorized into (1) one or two parents with high school or
less; (2) one or two parents with collège d'enseignement général
et professionnel/vocational or trade school; and (3) one or two
parents with university degree. The annual household income
before taxes was collected as 12 categories ranging from
o$10,000 to ≥$140,000 Canadian dollars. This variable was
later adjusted for the number of people living in the house26
and further grouped into quartiles.
Trained research assistants collected school environment data
by interviewing school principals with the aid of structured
questionnaires. Questions related to healthy eating promotion
policies in schools were derived from recognized guidelines for
Québec schools, including the Institute of Medicine Recommen-
dations for Schools to Address Childhood Obesity,27 the School
Health Index,28 the School Health Policy and Programs
Survey,29 and the Coalition for School Nutrition.30
School neighborhood disadvantage information was obtained

from the 2006 Canadian Census. The authors constructed a
material deprivation index of the area within 1,000 m of street
network around each school. The index comprises “the
proportion of individuals without a high school diploma, the
employment population ratio and the average personal income”
for people aged ≥15 years in census dissemination areas, with a
higher value representing lower deprivation.31 This variable
was classified into tertiles ranging from high (0) to low (2)
deprivation. The numbers of convenience and fast-food stores
within 500 m around each school were calculated using the GIS
from the Montreal Epide- miological and Geographic Analysis
of Population Health Out- comes and Neighbourhood Effect
database that contains information until May 2005.32 These
variables were then dicho- tomized into at least one store within
500 m (unfavorable) versus none within 500 m (favorable).
Statistical Analysis
The analyses for this paper were conducted in 2016. Principal
component analysis (PCA) with a polychoric correlation matrix
was used to group variables measuring schools’ healthy eating
promotion policies. Oblimin oblique rotation was applied to
differentiate the components and those with eigen values 41
were retained.
Subsequently, the authors performed a hierarchical agglomer-
ative average linkage cluster analysis using the components
identified by PCA, along with variables that measured presence
of dental health/hygiene programs and formal healthy eating
promotion initiatives, school’s surrounding food environment
and SES, to identify distinct types of school environments.
Cluster stop rules (Calinski−Harabasz pseudo-F index, and
Duda−Hart and Je [2]/Je [1] indices) were used to select the
optimal number of clusters.33
After preliminary descriptive and exploratory analyses, the
authors used generalized estimating equations with a binomial
link function, exchangeable correlation matrix, and school as
the grouping variable, to model the association between school
environment types and 2-year dental caries incidence in

children, adjusting for potential confounders. All analyses were
preformed using Stata/SE, version 12.
RESULTS
Out of the 430 children (attending 247 schools) for whom
school data were available, 357 had data on dental caries for
both visits. The authors further excluded 27 children because of
missing data for other covariates. The mean age for the final
sample of 330 children was 9.2 years (SD1⁄40.9 years) at
baseline. The mean DMF-S for Visits 1 and 2 were 0.6
(SD1⁄41.4) and 2.0 (SD1⁄42.9), respectively (Table 3).
PCA and cluster analyses were performed in 226 schools (21
schools were excluded because of missing values). PCA
included ten variables, which loaded on three components
(Table 1 and Appendix Table 1, available online). Three distinct
types of school environments were identified based on cluster
analysis and the school types were defined by examining the
mean or proportion of each variable within each cluster (Table
2). Type 1 included schools located in neighborhoods with high
SES, favorable surrounding food environments, strong healthy
eating promotion, and weak dental care programs (50.9% of all
schools). Type 2 included schools located in neighborhoods
with low SES, unfavorable surrounding food environments,
strong healthy eating promotion and strong dental care programs
(36.1%). Type 3 comprised schools located in neighborhoods
with average SES, unfavorable surrounding food environ-
ments, weak healthy eating promotion, and average dental care
programs (13.0%).
Finally, the authors used generalized estimating equa- tion to
model the association between the three variables representing
school environment types and 2-year dental caries incidence.
Using Type 3 school as a reference, children attending Type 1
and 2 schools had 21% (incidence rate ratio1⁄40.79, 95%
CI1⁄40.68, 0.90) and 6% (incidence rate ratio1⁄40.94, 95%
CI1⁄40.83, 1.07) lower 2- year incidence of dental caries,
respectively, after adjusting for age, sex, parental SES, and
baseline DMF-S index (Table 4).

November 2017
Edasseri et al / Am J Prev Med 2017;53(5):697–704 699
700 Edasseri et al / Am J Prev Med 2017;53(5):697–704 Table
1. Variable Loading Pattern in Principal Component Analysis
Component
Variable 1 2 3 variance
Unexplained
Willingness to participate in healthy eating promotion of:
School management 0.4876 — — 0.1524
Teachers 0.4423 — — 0.2016
Daycare managers 0.4740 — — 0.1964
Community 0.4478 — — 0.2851
Agreement with community to promote healthy eating within
school 0.3448 — — 0.5884
School makes room for families to engage in volunteer
activities — 0.5879 — 0.5096
Frequently informs parents about health promotion activities in
schools — 0.5509 — 0.4839
Educates teachers on the importance of promoting healthy living
— 0.5655 — 0.4078
Strict rule for approval of catering service menu by a
nutritionist — — 0.6770 0.3284
School sells drinks and snacks in accordance with principles of
healthy eating — — 0.6909 0.3417 during fundraising programs
DISCUSSION
This study aimed to identify school environment profiles based
on oral health promoting and neighborhood environmental
factors and estimate their impact on
2-year dental caries incidence. The study identified three
distinct school environment types and the results suggest that a
favorable school environment can lower the incidence of dental
caries in children. These findings are in agreement with
previous cross-sectional studies
Table 2. Description of the School Environment Types Based on
the Variables Used in the Cluster Analysis

Cluster
Variables used in cluster analysis 1 (n1⁄499)a 2 (n1⁄475)a 3
(n1⁄426)a
School Material Deprivation Index
M (SD) 1.22 (0.80) 0.67 (0.72) 0.92 (0.84)
Range 0 to 2 0 to 2 0 to 2
Presence of a convenience store or a fast-food store within 500
m around the school (yes1⁄41/no1⁄40)
Yes, n (%) 0 (0) 75 (100) 26 (100)
Formal school initiatives to promote healthy eating
(yes1⁄41/no1⁄40)b
Yes, n (%) 83 (84) 75 (100) 0 (0)
Component 1: Willingness of school to promote healthy eating
within school and involvement of community partnersb
M (SD) 5.34 (0.73) 5.38 (0.85) 5.05 (1.12)
Range 2.99 to 6.33 1.71 to 6.45 1.07 to 6.31
Component 2: Encouraging teachers and parents to promote
healthy lifestyles in childrenb
M (SD) 3.36 (0.55) 3.26 (0.55) 2.97 (0.63)
Range 1.34 to 3.89 1.88 to 3.88 1.98 to 3.82
Component 3: Great attention to providing healthy food within
schoolb
M (SD) 0.83 (0.54) 0.68 (0.56) 0.42 (0.49)
Range −0.24 to 1.59 −0.31 to 1.56 −0.24 to 1.52
Visit by any dental health professional at school
(yes1⁄41/no1⁄40)c
Yes, n (%) 88 (89) 71 (95) 24 (92)
Programs providing dental hygiene education (yes1⁄41/no1⁄40) c
Yes, n (%) 79 (80) 65 (87) 22 (85)
Programs other than the provision of dental hygiene education
(yes1⁄41/no1⁄40)c
Yes, n (%) 46 (47) 28 (37) 14 (54)
aTotal 200 schools included in the complete case analysis.
bThe types of schools were graded as strong/average/weak in
healthy eating promotion, based the on the distribution of these

variables in three
clusters.
cThe types of schools were graded as strong/average/weak in
dental care programs, based the on the distribution of these
variables in three clusters.
www.ajpmonline.org
Edasseri et al / Am J Prev Med 2017;53(5):697–704 701 Table
3. Distribution of Sociodemographic Characteristics and Mean
DMF-S in Children Within Each School Environment
Cluster
Type
Total (n1⁄4330 1 (n1⁄4168 2 (n1⁄4119 3 (n1⁄443 Variable
[100%]) [50.9%]) [36.1%]) [13.0%])
Age, years, M (SD) 9.2 (0.9) 9.2 (0.9) 9.3 (0.9) 9.0 (0.9)
Sex, n (%)
Boys 191 (57.9) 93 (55.4) 73 (61.3) 25 (58.1)
Girls 139 (42.1) 75 (44.6) 46 (38.7) 18 (41.9)
Household income, n (%)
o$29,070 78 (23.6) 38 (22.6) 33 (27.7) 7 (16.3)
$29,070–$42,579 79 (23.9) 40 (23.8) 30 (25.2) 9 (20.9)
$42,580–$56,271 85 (25.8) 33 (19.6) 38 (31.9) 14 (32.6)
4$56,271 88 (26.7) 57 (33.9) 18 (15.1) 13 (30.2)
Parental education, n (%)
One or both parents hold a high school degree or 25 (7.6) 15
(8.9) 10 (8.4) 0 less
One or both parents completed CEGEP/vocational 121 (36.7) 67
(39.9) 39 (32.8) 15 (34.9) or trade school
One or both parents hold a university degree 184 (55.8) 86
(51.2) 70 (58.8) 28 (65.1)
DMF-S Index, M (SD)
Baseline DMF-S 0.6 (1.4) 0.5 (1.2) 0.7 (1.6) 0.8 (1.5)
DMF-S Visit 2 2.0 (2.9) 1.6 (2.3) 2.3 (3.3) 3.0 (3.5)
CEGEP, collège d'enseignement général et professionnel; DMF-
S, Decayed, Missing, Filled-Surfaces.
investigating the impact of comprehensive oral health

promotion approaches.15,16 In contrast, a school-based study
using a participatory approach to reduce sugar intake of
children failed to bring about any change in diet
behaviors or reduction of dental caries. This failure may have
been attributable to the narrow scope of the policy, which
restricted children’s food intake to fruits and milk during school
breaks rather than focusing on overall diet
Table 4. Association Between School Environment Types and 2-
year Dental Caries Incidence (GEE, n1⁄4330)
Variables in the model Change in DMF-S over 2 years, M (SD)
IRRa (95% CI)
School environment
Type 1 1.1 (1.7) 0.79 (0.68–0.90)
Type 2 1.7 (2.6) 0.94 (0.83–1.07)
Type 3 2.3 (2.7) 1
Age — 1.06 (1.00–1.12)
Sex
Male 1.4 (2.2) 1
Female 1.5 (2.2) 1.06 (0.96–1.18)
Household income
o$29,070 2.1 (2.7) 1
$29,070–$42,579 1.5 (1.8) 0.97 (0.85–1.10)
$42,580–$56,271 1.3 (2. 4) 0.98 (0.84–1.15)
4$56,271 1.0 (1.8) 0.95 (0.78–1.15)
Parental education
One or both parents hold a high school degree or less 3.0 (3.2) 1
One or both parents completed CEGEP/vocational or trade
school 1.6 (2.1) 0.77 (0.67–0.87)
One or both parents hold a university degree 1.2 (2.1) 0.71
(0.62–0.82)
Baseline DMF-Sa — 1.08 (1.05–1.10)
aBaseline DMF-S was separately included in the model to better
capture the variations in the baseline caries risk of children,
which may not be captured by the difference in DMF-S indices
over 2 years.
CEGEP, collège d'enseignement général et professionnel; DMF-

S, Decayed, Missing, Filled-Surfaces; IRR, incidence rate ratio.
November 2017
702 Edasseri et al / Am J Prev Med 2017;53(5):697–704
behaviors. Moreover, the program did not include measures to
raise the awareness of teachers, children, or parents regarding a
healthy diet18 and did not consider the broader built and social
environments around the schools, which could potentially
influence children’s food habits.
In this study, Type 1 schools, which showed the strongest
protective association with dental caries, had strong healthy
eating environments inside the schools as well as favorable food
environments around the schools. This finding suggests that an
environment promoting healthy eating, that also incorporates
the socioenviron- mental and policy aspects of health
promotion, may be particularly effective in reducing dental
caries. This observation aligns with the common risk factor
approach to oral health promotion, which advocates for an
integrated strategy, targeting risk factors (e.g., high sugar diet)
that are common to multiple chronic diseases, and their
underlying determinants.9
Moreover, this study’s results highlight the importance of
school neighborhood disadvantage factors on dental caries
incidence in schoolchildren. Type 1 schools were located in the
highest SES neighborhood and had favorable surrounding food
environments, whereas Type 2 and 3 schools, located in
neighborhoods with relatively low SES, had unfavorable
surrounding food environments. The additional protective
influence of Type 1 schools may be attributable to the reduced
access to nutritionally poor food sources in the school
neighborhoods. A previous study in QUALITY cohort children
reported that unhealthful stores around schools may have a
negative influence on the dietary choices of children attending
that school,23 which provides insight on the potential mediating
pathway.
It is also notable that despite scoring the lowest in dental
health-specific programs, Type 1 schools were associated with

the greatest reduction in dental caries. However, this reduction
was lower among schools with comparatively stronger dental
health programs, possibly because these were isolated programs,
which were not integrated with other initiatives (e.g., healthy
eating initiatives) and did not have strong involvement of
parents, teachers, and communities; additionally, these schools
had unfavorable surrounding food environments. The results
are in line with previous studies concluding that dental care
programs may play a role in lowering dental caries incidence;
however, a more prominent role could be attributed to social
and environmental factors.34,35 Moreover, a comprehensive
and integrated effort toward oral health promotion, rather than a
single focus on dental-specific preventive measures and
education, may be more effective.9
Limitations
There are some limitations to this study. The general- izability
of the results may be limited due the study’s selection criteria,
which included only white children with a family history of
obesity. A comparison with the general population at baseline
showed that the study population came from a relatively higher
socioeconomic sector of society.24 Thus, study participants may
already be at a lower risk for dental caries. Despite this, the
study identified a significant decrease in dental caries incidence
after adjusting for individual SES. It could be reasonably
assumed that, if this study had included a more representative
population of children from Montreal with a relatively lower
SES, the protective association would have been higher than or
at least as strong as the one observed. Moreover, the sample
included substantial variation in terms of the range of the
neighborhoods represented. However, potential selection bias
due to voluntary entry into the study cannot be ruled out, as is
the case with most studies. Another limitation is the relatively
short follow-up period. However, future studies are planned on
the same cohort of children with a longer follow-up period to
confirm and expand the findings.
Another potential limitation is the possibility of bias due to a

relatively high percentage of missing values, which may not be
distributed completely at random (Appendix Table 2, available
online). The authors performed a sensitivity analysis by
imputing missing values through multiple imputation using
chained equations. There was no significant difference in
point estimates for Type 1 school environments, where the
greatest reduction in dental caries was observed. How- ever, the
point estimate for Type 2 school environments, associated with
moderate reduction in caries incidence, moved away from the
null, possibly suggesting a selection bias; the effect measure
remained non-significant (Appendix Table 3, available online).
Additionally, some of the information on the school
environment was reported by school principals, which may have
resulted in over-reporting of positive attributes because of
social desirability. Nonetheless, the chance that this would
introduce bias is low, as over-reporting would occur in all the
schools included in the study non- differentially. The study used
multiple factors to classify school environments and these
factors could not have been manually assigned to different
clusters. Therefore, there is a possibility for mis-specification
of clusters. However, given the complexity inherent to such a
classification, this limitation may be inevitable.
One of the main strengths of this study is the use of a
prospective design, providing a stronger basis for causal
inference. The authors also carried out a comprehensive
assessment of the school environment, which allows to
www.ajpmonline.org
disentangle, to an extent, the effects of environments within and
outside the school and of SES on dental caries incidence.
CONCLUSIONS
Findings from this study indicate that school environments
with a comprehensive, integrated, and participatory approach
to oral health promotion may be most effective in lowering
dental caries incidence in children. Interestingly, favorable food
environments seem to be a strategic component of oral health
action, rather than dental care programs. The results do not

suggest that dental care programs are unnecessary, but that such
programs are less effective in isolation.
More favorable neighborhood characteristics around schools
seem to have a strong influence in lowering dental caries
incidence. Although socioeconomic aspects may not be directly
modifiable, environmental-level policies can be implemented to
modify built environments around the schools, which in turn
may buffer some of the socioeconomic inequalities. Although
this study was not designed to directly recommend policy
changes, the results add evidence in support of it.
Furthermore, the results provide policymakers with evidence-
based data. The Québec government has been encouraging
schools to promote healthy food, mostly to deal with the obesity
crisis.36 An evaluation study from Québec concluded that,
despite an improvement observed over the last years, the goal of
providing only healthy food in schools was inadequately met.37
The authors call policymakers’ attention to the fact that
promoting a healthy eating environment in Québec’s schools
may have effects beyond obesity reduction, benefitting
children’s oral health. Rather than focusing only on dental
programs for caries reduction, they could re-allocate some
resources to strategies including common risk factor and
participatory approaches, with a special emphasis on
disadvantaged neighborhoods.
Future studies could target a more representative sample
including a higher proportion of participants from lower
socioeconomic sectors to confirm the findings.
ACKNOWLEDGMENTS
Dr. Marie Lambert (July 1952–February 2012), pediatric geneti-
cist and researcher, initiated the QUALITY cohort. Her leader-
ship and devotion to QUALITY will always be remembered and
appreciated. We are also grateful to all the families that
participate in the QUALITY cohort.
This study was supported by the Canadian Institutes of Health
Research (Institute of Musculoskeletal Health and Arthritis and
Institute of Genetics), the Heart & Stroke Founda- tion of

Canada, the Fonds de Recherche du Québec−Santé, and
the Fonds de Recherche du Québec– Réseau de Recherche en
santé buccodentaire et osseuse.
A. Edasseri was the recipient of a Graduate Excellence
fellowship from the McGill University Faculty of Dentistry. K.
Kâ was recipient of a PhD fellowship from the Canadian
Institutes of Health Research−Strategic Training in Applied
Oral Health Research. T.A. Barnett (Junior 2) and M.
Henderson (Junior 1) are Fonds de recherche du Québec−Santé
research scholars. B. Nicolau holds a Canada Research Chair
(Tier 2) in Life Course Oral Epidemiology.
The QUALITY cohort study obtained ethics approval from
several IRBs, including the Centre Hospitalier Universitaire
Sainte-Justine (IRB Study Number: 2040) and McGill
University (IRB Study Number: A02-M08-16A).
A. Edasseri conceived the hypothesis, conducted the data
analysis, and led the writing. K. Kâ assisted with analysis; M.
Henderson assisted with the study and edited the manu- script;
and T.A. Barnett and B. Nicolau conceived and super- vised the
study, including data analysis, and assisted with the writing.
No financial disclosures were reported by the authors of this
paper.
SUPPLEMENTAL MATERIAL
Supplemental materials associated with this article can be found
in the online version at https://doi.org/10.1016/j.
amepre.2017.07.005.
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