Copyright C Munksgaard 2001

Community Dent Oral Epidemiol 2001; 29: 43542

Printed in Denmark . All rights reserved

ISSN 0301-5661

A community trial of fluoridated

powdered milk in Chile

Rodrigo Marino1, Alberto Villa2 and

Sonia Guerrero2
1
School of Health, University of New
England, Armidale, NSW, Australia;
2
Department of Public Nutrition, Institute of
Nutrition and Food Technology, (INTA),
University of Chile, Santiago, Chile

Marino R, Villa A, Guerrero S. A community trial of fluoridated powdered milk

in Chile. Community Dent Oral Epidemiol 2001; 29: 43542. C Munksgaard, 2001
Abstract Objective: To demonstrate the effectiveness of a dental caries prevention program on the primary dentition of Chilean rural children, using fluoridated
powdered milk and milk derivatives. Methods: Fluoridated milk and milk-cereal
was given to about 1000 preschool children in Codegua, a rural community located
in the 6th Region of Chile, using the standard National Complementary Feeding
Program (PNAC). The daily fluoride dose from fluoridated powdered milk was
estimated at 0.25 mg for infants (02 years old), 0.5 mg for children aged 23
years and 0.75 for children aged 36 years. Cross-sectional samples of children
aged 36 years were taken from Codegua (study community) from 1994 to 1999
and from La Punta (control community) from 1997 and 1999. Results: Significant
reductions (72%) were observed in the dmfs indices in the 36-year-old groups
in Codegua, when comparing 1999 with 1994 data. In 1999, children in the study
community showed significantly lower dmfs than children in the control community (41%). The proportion of caries-free children in the study community
increased after 4 years of program implementation (from 22.0% to 48.4%). Conclusion: Under Chilean rural conditions, fluoridation of powdered milk distributed
through the PNAC is an effective caries prevention alternative for areas where
water fluoridation might not be feasible.

The value of milk as an alternative vehicle for the

administration of fluorides for caries prevention in
humans has been reported since the early 1950s.
Ziegler found a significant reduction in dental caries for both primary and permanent dentition (1).
He also established that optimal results could be
achieved when fluoridated milk ingestion starts
early in childhood. Stephen et al. (2), reporting on
a 5-year double-blind study, found significant reductions in the DMFS index (from 6.61 to 3.76;
43.1% reduction) and the DMFT index (from 3.11
to 2.14; 31.2% reduction) of permanent teeth in the
test group compared to the control group. After 5
years of fluoridated milk consumption, there was a
75% reduction in the DMFS index for interproximal
surfaces of first molars (2).
Banoczy et al. (3, 4) studied the caries preventive
effect of fluoridated milk in 269 25-year-old institutionalized children in Hungary. After 10 years
of consumption of fluoridated milk the compari-

Key words: dental caries prevention; milk

fluoridation; Chile; rural populations
Rodrigo Marino CD, MPH, PhD, School of
Health, University of New England,
Armidale, NSW 2351, Australia
e-mail: rmarino/metz.une.edu.au
Submitted 2 February 2000;
accepted 30 November 2000

sons between the test and control groups showed

statistically significant reductions for the DMFT
and DMFS, 60% and 67%, respectively.
A community trial in Bulgaria (5, 6) included approximately 3000 children aged 310 years, who
regularly drank fluoridated milk for 5 years. After
5 years, reductions in the dmft and DMFT values
of 44% and 77%, respectively, were observed in the
study group when compared to baseline data (6).
In Chile, the National Complementary Feeding
Program (PNAC) is a 40-year-old government public program (7). Under PNAC, every Chilean child
is entitled to receive, at no charge, 2 kg of powdered cows milk (PuritaTM) per month, from birth
until 2 years of age. Thereafter and until the child
reaches 6 years of age, he/she is entitled to 1 kg of
a milk derivative (Purita CerealTM) per month. The
national coverage of PNAC is about 90% (7). Based
on the wide coverage of the PNAC, the Institute
of Nutrition and Food Technology (INTA) of the

435

Marino et al.

University of Chile decided to assess the feasibility

of using PNAC products as a F vehicle for caries
prevention. The program used disodium monofluorophosphate (MFP) instead of sodium fluoride
(NaF) to circumvent problems associated with Carich vehicles such as milk (812). Analytical methods for measuring low levels of MFP-fluoride in
milk (10, 13) and other biological fluids were developed (13). The bioavailability and absorption of F
from MFP in milk was also assessed (11, 14, 15).
In 1994, INTA commenced a community trial to
test the feasibility and effectiveness of using powdered milk as the vehicle for delivering fluoride to
a rural community with low F concentration in its
drinking water. The program aim was to prevent
dental caries in the primary dentition of children
36 years of age. This paper reports on the results
of the trial, after 4 years of program implementation.

Material and methods

The Ethics Committee of INTA, University of
Chile, approved this studys protocol. Letters were
sent to the parents and guardians of each child in
the two communities, requesting their consent for
receiving fluoridated milk and dental examinations.
Two communities from the Chilean 6th region
were selected following a matching scheme based
on geographic proximity, community size and similarity with regard to the prevalence of the outcome
under study (16). Codegua, the test community, is
an inland municipality, some 100 km to the south
of Santiago, the Chilean capital city. It is located
at approximately 600 m above sea level and had a
population of 10 567 in 1994. La Punta, the control
community, is located some 10 km north of Codegua. Children from Codegua and La Punta have
to go to the Regional capital (Rancagua) for dental
treatments, other than emergencies. These communities were also similar in other oral health-related
environmental variables such as media exposure
(TV, radio, print) laws and regulations (17).

tially evaporated whole milk prior to the final drying process and concurrently with the
incorporation of other additives such as vitamins
and minerals. Disodium monofluorophosphate
used throughout this study was pharmacopoeia
grade, imported from Albright & Wilson, England.
The control community (La Punta) consumed the
same type of products, but without MFP addition.
Analyses of the distribution logs at the community
health centers were done throughout the study, to
evaluate whether the fluoridated milk was delivered constantly to the test community during the
scheme period.
Following the 1984 dietary fluoride supplementation (18, 19), the average daily F ingestion from
fluoridated milk products was estimated at 0.25 mg
F/day among children 023 months old; 0.5 mg F/
day for children 23 years old; and 0.75 mg F/day
for children 36 years old.
Batches of the fluoridated products were prepared every 6 months. The F concentrations in
these products were controlled (12) at INTAs laboratory before each batch was delivered to Codegua.
In addition, random samples of the fluoridated
products were also taken at the municipal storehouse and analyzed for quality control. Concentrations of F in the samples of fluoridated powdered
milk products were found to be within7% relative to their target values throughout the entire
period of this study.
The powdered milk products delivered through
PNAC are prepared using a 1:10 dilution with
boiled tap water. The fluoridated milk was delivered in March 1995. The target concentrations of
MFP were set at the following values: powdered
milk (2 kg/month) provided to infants (02 years
old) 28.5 mg MFP/kg; Purita cereal (1 kg/month)
given to children aged 23 years 114 mg MFP/
kg; Purita cereal given to children 36 years old
172 mg MFP/kg. The two cereal packages had similar presentation (vacuum-sealed plastic bags inside cardboard containers), but were different
colors.

Monitoring
Milk products and fluoride dosage
Milk distribution is the responsibility of the nutritionists at the local community health centers, as
part of normal PNAC procedures. Fluoridated
powdered milk and milk-cereal were prepared for
distribution in the test community by Loncoleche
S.A., a dairy company under contract to the Regional Health Authority, by adding MFP to par-

436

Fluoride exposure from water, food and F dietary

supplements were examined before the fluoridated
milk scheme began. The natural fluoride concentrations of the water supplies were in the range 0.06
0.09 ppm, a value consistent with existing records
for the last 7 years. Families mobility was very low
in both communities (20). The fluoride content in
food was assessed through a 24-h recall diary and

Trial of fluoridated powdered milk in Chile

regarded as very low. Fluoride supplements were

not used in these communities (20).
Toothpaste containing fluoride accounts for almost 100% of the toothpaste sales in Chile. Beside
any home use, in both communities toothbrushing
is done twice a day in all day care centers dependent on the Ministry of Education (20).
The ratio of F to creatinine concentration of midmorning urine spot samples from participating
children was used as an estimator of daily fluoride
urinary excretion and daily F intake (2123). A
baseline value was obtained for 30 children from
each community, before the start of the fluoridated
milk distribution. This procedure was repeated on
20 children every 3 months to measure compliance
in the test community and to assure that the control
community was not receiving additional fluoride
from milk or any other source beside the original
and low water level. One laboratory technician
who used standard analytical procedures according to the guidelines described previously (21) did
these laboratory analyses.
Data obtained in urine samples showed an estimated average daily F dose of 0.068 mg F/kg body
weight for children in the test community, and
0.034 mg F/kg body weight in the control community. When the distribution of daily F-dose was
examined, some 15% of the participating children
from Codegua (test community) presented daily Fdose values lower than 0.04 mg F/kg body weight.
The determinations of fluoride concentration in
MFP-fluoridated milk and in urine samples were
carried out using a fluoride ion selective electrode
(Orion model 9609) connected to an Orion model
940 digital pH/mV meter. Creatinine was measured spectrophotometrically (10, 11, 24).

who were examined at home. Thus, after 4 years,

there would be children totally exposed to the
milk-fluoridation scheme (3 and 4 years old) and
partially exposed to the program (5 and 6 years
old). The study used repeated cross-sectional samples, which consisted of a fresh sample of individuals from each community taken at each of the examinations (17).

Dental clinical examinations

Baseline clinical examinations in the test community were carried out in October 1994 and follow-up examinations every consecutive year. Clinical examinations usually took place at the
beginning of the academic year mid-March to
mid-April. However, administrative and logistical
problems prevented the collection of data in the
control community (La Punta) until March 1997.
After that, follow-ups were conducted in both communities.
Two examiners (S.G., R.M.) collected clinical
data. In 1994, as well as in 1999, the levels of interexaminer reproducibility achieved in the duplicate
examinations of 25 children were higher than 0.90
(26). Intraexaminer reliability, assessed by the repetition of exams in 25 children, showed kappa statistics higher than 0.90.
Oral examinations were conducted using natural
light, dental mirrors and sickle probes. Clinical
data were recorded following the usual WHO criteria and recommendations (27) on standard WHO
forms (SUP/92/33580). Radiographic examination
was not performed and teeth were not dried before
scoring. Dental status experience was assessed
using the dmfs index for primary dentition. Examinations were not conducted blind with respect to
the area of residence.

Sample
The sample size was determined using Cohens criteria (25) to obtain an effect size of five-tenths (0.5)
[(raw control group mean raw test group mean)/
standard deviation] at the significance criterion of
0.05, and a power of 0.80. Following these criteria,
the minimum sample size was 50 participants in
both the control and test groups, for each age
group (25). This number represented about one
quarter of the population in each age group and
community.
Convenience samples of children in Codegua
and La Punta in each age group, between 3 and 6
years, were examined from those attending the
public kindergartens and primary schools. The exception was some children in the 3-year-old group

Statistical analysis
The results will be presented in four ways using agespecific estimates. Firstly, dmfs data in the test community and those from the control community were
compared at baseline. As no baseline data were
available for the control community, data collected
in 1997 were considered baseline data for this locality. Additionally, data collected between 1997 and
1999 were compared in the control group. Secondly,
data from 1994 and 1999 were compared in the test
community. The 1994 and 1999 samples were considered independent samples (28). This design corresponds to a one-group pretest-post-test design
with a non-equivalent control group (28, 29). A third
cross-sectional comparison was made between the

437

Marino et al.
Table 1. Age-specific mean number of decayed, missing and filled tooth surfaces (dmfs) and standard deviations in 36-yearold children living in Codegua and La Punta (Rural Chile) by year of data collection

Codegua

Age

1994

1996

1997

1998

1999

3.11 (5.07)
(n27)
5.40 (8.10)
(n42)
13.75 (16.12)
(n55)
19.21 (12.94)
(n53)

3.47 (5.10)
(n43)
6.91 (6.64)
(n35)
6.07 (7.54)
(n41)
9.84 (9.15)
(n45)

0.67 (1.73)
(n45)
3.94 (5.60)
(n48)
5.62 (6.77)
(n78)
8.03 (9.82)
(n69)

1.62 (4.06)
(n48)
2.33 (4.87)
(n51)
5.73 (7.47)
(n45)
7.58 (6.93)
(n50)

1.52 (2.48)
(n60)
3.18 (7.27)
(n64)
3.03 (4.83)
(n66)
5.63 (6.23)
(n62)

2.25 (3.05)
(n40)
2.78 (3.58)
(n36)
7.44 (8.36)
(n52)
8.67 (8.57)
(n61)

2.89 (4.58)
(n46)
5.17 (4.95)
(n41)
6.95 (8.18)
(n63)
7.41 (9.03)
(n51)

3.85 (5.67)
(n59)
4.22 (5.00)
(n60)
5.61 (7.05)
(n59)
8.79 (8.89)
(n62)

4
5
6
La Punta

3
4
5
6

1999 data from the test community and from the

control community. This design corresponds to a
separate sample post-test only (29). Differences in
the dmfs indices were analyzed using the MannWhitney U-test. Two-tailed tests were performed to
test differences in dental caries indices. Finally, the
proportion of participants free from caries was compared between 1994 and 1999 in Codegua; between
1997 and 1999 in La Punta; and between 1997 in La
Punta and 1994 in Codegua. Analyses of differences
were done using the chi-square test (c2). Level of significance was set at 0.05. Data were analyzed using
SPSS-PC V5.1 (30).

Results
In 1994, during baseline, 177 children, aged 36
years were examined in Codegua. In 1997, the first
year in which data could be collected from the control community, 189 children aged 36 years were
examined in that locality. Table 1 shows the sample
sizes for each group in each of the communities.
The age-specific mean number of decayed, filled
and missing primary surfaces in children from Codegua and La Punta by year are shown in Table 1.
Although there was some variation in the mean
dmfs values at the different measurement points, in
the control community, these differences were not
statistically significant between 1997 and 1999. Data
from 1994 in the study community were not statistically different to the 1997 values in the control community, with the exception of the 6-year-old group
(P0.001).

438

The age-specific percentage reduction between

1994 and 1999 in Codegua is shown in Table 2.
Mean dmfs values were lower in 1999 than in 1994
for all age groups. Percentage reductions ranged
from 41% (4-year-olds) to 78% (5-year-olds). Table
3 compares the dmfs in La Punta, the control community, and Codegua, the test community, in 1999.
Mean dmfs values were lower in the test community for all age groups. Percentage reductions
ranged from 25% (4-year-olds) to 61% (3-year-olds).
Table 4 shows the proportion of children free
from dental caries experience (dmf0) between
1994 and 1999 in Codegua, between 1997 and 1999
in La Punta and at and between Codegua and La
Punta in 1999. For Codegua, the study community,
these comparisons show statistically significant increases in the proportion of children free from caries experience. On the other hand, the proportion
of caries-free children in the control community be-

Table 2. Age-specific mean number of decayed, missing and

filled primary tooth surfaces (dmfs) and standard deviations
in 36-year-old children living in Codegua (Central Chile) by
year of data collection
Age
(years)
3
4
5
6
36
a

1994
3.11 (5.07)
5.40 (8.10)
13.75 (16.12)
19.21 (12.94)
11.78 (13.69)

1999
1.52
3.18
3.03
5.63
3.35

(2.48)
(7.27)
(4.83)
(6.23)
(5.68)

Percentage changes in indices.

Reductiona

Pb

51%
41%
78%
71%
72%

0.06
0.05
0.01
0.01
0.01

Mann-Whitney test.

Trial of fluoridated powdered milk in Chile

Table 3. Age-specific mean number of decayed, missing and
filled primary tooth surfaces (dmfs) and standard deviations
in 36-year-old children living in Codegua and La Punta
(Central Chile), 1999
Age
(years)

La Punta

Codegua

3
4
5
6
36

3.85
4.22
5.61
8.79
5.65

1.52
3.18
3.03
5.63
3.35

(5.67)
(5.00)
(7.05)
(8.89)
(7.08)

(2.48)
(7.27)
(4.83)
(6.23)
(5.68)

Percentage changes in indices.

Reductiona

Pb

61 %
25 %
46 %
36 %
41%

0.01
0.01
0.05
0.05
0.01

Mann-Whitney test.

tween 1997 and 1999 did not show statistically

significant differences. The proportions of cariesfree children in 1999 were higher in Codegua than
in La Punta, reaching a statistically significant difference for ages 3 and 4 years. In the 3-year-old
group, children from Codegua are about 3 times
less likely to have dental caries (OR0.35; 95% CI:
0.150.77). Similarly, the likelihood of having dental caries in the 4-year-old group is 2.5 times less
in Codegua (OR0.41; 95% CI: 0.180.91).

Discussion
Results obtained after 4 years of milk fluoridation
indicate that it is possible to reduce the prevalence
and severity of childrens dental caries in their primary dentition. This is especially true for those
children either born after the start of this program,
or aged around 1 year when it started. The latter
group includes those children who were truly free
from caries when they started receiving fluoridated
milk. Data obtained in clinical examinations of 3
6-year-old children in Codegua showed that the
decrease in the mean number of tooth surfaces af-

fected by dental caries ranged from 41% to 78%.

On the other hand, in children in the control community who did not participate in the milk fluoridation program, very similar patterns of dental caries experience were maintained throughout the
study. In the same way, children in the control community had higher dental caries indices than the
children in the test community at the end of the
study. The relevance of these findings lies in the
fact that these results were reached without any
modification to the normal technical operation of
the milk fluoridation program.
These findings are consistent with earlier milk
fluoridation studies that reported a 4077% reduction of caries experience in the primary dentition
(26). The present findings also support the advantages for dental caries prevention of commencing
fluoridated milk exposure as early as possible in
life (2). The present results are similar to those obtained after 9 years of water fluoridation in Valparaso, Chile, for the same age groups (31, 32). This
supports the contention that it is possible to obtain
at least comparable results in caries prevention in
the primary dentition using either milk or water as
vehicles for fluorides.
The daily fluoride dosages administered to children within the different age groups were established following the accepted international guidelines for fluoride supplementation at the time the
Ethics Committee of the University of Chile and
other local and international health authorities approved the experimental protocol of this study (33,
34). Later, such dosages were adjusted downward
to reduce risk of fluorosis (35). However, our original dosages were maintained because the fluoride
concentration in the drinking water of the test community was low (0.08 mg/l) and because it
would have been difficult to interpret the clinical

Table 4. Percentage of children free from dental caries history by age: comparisons between 1994 and 1999 of the trial in the
study community (Codegua); between 1997 and 1999 of the trial in the control community (La Punta) and between the study
community and the control community in (1999)
Codegua

La Punta
b

La Punta Codegua

Age (years)

1994
(%)

1999
(%)

Pa

1997
(%)

1999
(%)

Pa

1999
(%)

1999
(%)

Pa

3
4
5
6
36

40.7
33.3
21.8
3.8
22.0

63.3
53.1
50.0
27.4
48.4

0.05
0.05
0.01
0.01
0.01

42.5
38.9
23.1
16.4
28.0

37.3
31.7
33.9
16.1
29.6

NSc
NSc
NSc
NSc
NSc

37.3
31.7
33.9
16.1
29.6

63.3
53.1
50.0
27.4
48.4

0.01
0.05
NSc
NSc
0.01

Chi square test (c2).

March 1997. c Non-significant.

439

Marino et al.

outcome of this study if the daily dosages had been

changed in the middle of the trial period.
The present scheme was organized as a 5-year
study. Therefore, distribution of fluoridated milk
did not continue after 1999. Nevertheless, additional clinical examinations will be carried out in 2001
and 2002 to compare the prevalence and severity
of enamel fluorosis in the permanent anterior teeth
and first molars of children aged 68 years who
took part in the current community trial. Comparison of these results with the baseline data will allow any necessary adjustments of daily fluoride
dosages to be made that would be more adequate
in future expansions of milk fluoridation programs
under Chilean conditions.
Randomization was not attempted in the present
study because in each of the communities there is
only one school and one day care center. The issue
of random allocation by school does not have
much meaning once communities have been selected as the control or the study community. Communities were also not blind to fluoride exposure,
with parents carefully instructed about what was
involved in participating in the study. In particular,
the need to avoid exposing the children to other
systemic sources of fluoride was emphasized in the
test community. This might have introduced differences in parental feelings in each of the two communities. However, in the present case, it was assumed that communities usual ingestion and
compliance with the PNAC would not be affected
by the parents awareness of the addition of fluoride to the milk products.
No attempt was made to correct for fluoride exposure; irregular participants in the PNAC program or participants with low compliance with
milk products were kept in the test group. This information was available by cross checking with the
log of milk distribution from the study community
and from urinary excretion analysis. Any correction of this kind would have improved the already
positive results, but the elimination of these cases
would have provided misleading results, and
would not have answered our research question,
which aimed to assess whether the PNAC is an effective vehicle for fluoride in this type of community.
Epidemiological surveillance was implemented
in this study by means of baseline and periodical
follow-up fluoride urinary excretion studies in
both communities. Mid-morning spot urine samples were collected and the daily fluoride urinary
excretion was estimated assessing their fluoride/

440

creatinine ratio following the previously described

technique (21). Admittedly, this technique might
present positive or negative bias depending on the
time of sample collection compared to the fluoridated product intake. In the present study, fluoridated milk was usually ingested at breakfast. Thus,
mid-morning spot samples would lead to an overestimation of the daily fluoride renal excretion.
Consequently, the estimated average daily fluoride
doses represent an upper limit, adding confidence
to the safety of F delivery. Another recent publication (36) summarizes several alternative methods
of urinary sample collection in order to monitor renal fluoride excretion more accurately during community preventive programs on oral health. It is
suggested that either time-controlled or 24-h urinary collection of preschool children will have to
be used in the future to ensure the safety of fluoride preventive programs (36).
The major limitation of this study was that no
data were collected for the control community concurrently with baseline data collection in the test
community in 1994. In this study we have used
three comparisons to circumvent this difficulty.
However, we can not be sure that the test and control groups were equal before the commencement
of milk fluoridation distribution at the beginning of
1995, as it is still possible that some external factor
affecting dental caries may have been present between October 1994 and March 1997 in the control
community. However, we regard this alternative as
unlikely.
Additional data sources could be used to support
this studys results (28): representative data among
same age group children from the 6th Chilean region tend to be consistent with our findings at
baseline in the study community and the control
community in 1997, 1998 and 1999 (37).
At baseline, the test community showed unusually high dmfs scores for 5- and 6-year-olds. It
must be remembered that the present approach
was one of repeated single measurements at different times. This was because there was more interest in establishing community-wide changes
then individual changes (17). Repeated cross-sectional samples are better suited for this purpose
than longitudinal samples. Thus, different samples
were used each year. Data from La Punta at 1997
and 1999, which is also supported by the archival
data (37), would represent the mean of dmfs trend
in non-fluoridated rural communities of central
Chile, rather than a cohort effect operating in these
communities. The use of convenience samples may

Trial of fluoridated powdered milk in Chile

have been biased and therefore the degree of the

effect overestimated in the test community when
compared to the control community. However,
even though such a degree of difference (4070%)
could have been affected by sampling to some degree, the effect would never be so great as to make
these differences negligible.
These results have shown that a communitybased program using fluoridated milk is effective
in reducing dental caries prevalence in the primary
dentition of rural preschool children without being
an additional burden on an already existing distribution program of milk and milk derivatives. In
conclusion, it seems reasonable to suggest that
fluoridated milk could be successfully extended to
many other rural or semi-rural areas in Chile.

Acknowledgments
This study was funded by a grant received from the Borrow
Dental Milk Foundation (BDMF), and done under the sponsorship and technical and administrative assistance of the
World Health Organization (WHO), and the Oral Health Department of the Chilean Ministry of Health. The authors
would like to acknowledge the support and cooperation received from the Regional Health Service (6th Region), and
Dr. Olaya Fernandez, Chief Dental Officer, Ministry of
Health, Chile. In particular, we would like to acknowledge
the Community Health Center and the Municipality of Codegua, the staff of the day care centers and schools involved in
this project for their assistance during the collection of the
data. We are also indebted to the educational authorities of
the Municipalities of Codegua and San Francisco de Mostazal. Finally, thanks to the anonymous reviewers for their suggestions and comments.

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