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A randomised controlled trial of the effectiveness of providing free fluoride

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 Community Dental Health (2002) 19, 131-136 @ BASCD 2002
Received 21 June 2001; Accepted 16 November 2001

A randomised controlled trial of the effectiveness of providing

free fluoride toothpaste from the age of 12 months on reducing
caries in 5-6- year old children
G.M. Davies1, H.V. Worthington2, R.P. Ellwood3, E.M. Bentley3, A.S. Blinkhorn2,
G.O. Taylor and R.M. Davies3
ICentral Manchester Primary Care Trust, Manchester, UK; 2University of Manchester Dental School, Manchester, UK; 3Dental
Health Unit, Manchester, UK; 4West Pennine Health Authority, UK

Objective To assess the impact of regularly supplying f~ee fluoride toothpaste regularly to children, initially aged 12 months, and
living in deprived areas of the north west of England on the levei of caries in the deciduous dentition at 5-6 years of age. A further
aim was to compare the effectiveness of a programme using a toothpaste containing 440 ppmF (Colgate 0-6 Gel) with one containing
1450 ppmF (Colgate Great Regular Flavour) in reducing caries. Design Randomised controlled parallel group clinical tria!. Clinical
data were collected from test and control groups when the children were 5-6 years old. Setting A programme of posting toothpaste
with dental health messages to the homes of children initially aged 12 months. Clinical examinations took place in primary schools.
Participants 7,422 children bom in 3-month birth cohorts living in high caries areas in nine health districts in north west England.
Within each district children were randomly assigned to test or control groups. Interventions Toothpaste, containing either 440 ppmF
or 1450 ppmF, and dental health literature posted at three monthly intervals to children in test groups until they were aged 5-
6 years. Main outcome measures The dmft index, missing teeth and the prevalence of caries experience. Results An analysis of
3,731 children who were examined and remained in the programme showed the mean dmft to be 2.15 for the group who had received
1450 ppmF toothpaste and 2.49 for the 440 ppmF group. The mean dmft for the control group was 2.57. This 16% reduction
between the 1450 ppmF and control group was statistically significant (P<0.05). The difference between the 440 ppmF group and
control was not significant. Further analyses to estimate the population effect of the programme also confirmed this relationship.
Conc/usion This study demonstrates that a programme distributing free toothpaste containing 1450 ppmF provides a significant
clinical benefit for high caries risk children living in deprived, non-fluoridated districts.

Key words: caries reduction, fluoride toothpaste, health promotion, pre-school children, RCT

Introduction enviranment. Water fluoridation has been shown to

There have been dramatic impravements in the dental
health of children in England during the past 30 years but
marked inequalities persist between and within different
regions of the country. Since 1985 biennial national
surveys of 5-year-old children, coordinated by the British
Association for the Study of Community Dentistry
(BASCD), have demonstrated that children in this age
graup and living in the north west of England have the
highest levels of caries in the country (Nugent and Pitts,
1997). In 1993/4 the mean dmft for 5-year-old children
living in England was 1.74 with 57% having no caries
experience whereas in the north west region the compa-
rable values were 2.83 and 42% respectively (Pitts and
Palmer, 1995). Such inequalities are strangly associated
with deprivation and their reduction is central to the
govemment's recently outlined health policy (Department
ofHealth, 1998)and dental strategy (DepartmentofHealth,
2000).
Undoubtedly the most important reason for the
general decline in the prevalence of dental caries has
been the increased availability of fluoride in the oral
reduce the mean dmft in 5-year-old children and to reduce
the inequalities in dental health between the social classes
(Jones et aI., 1997; NHS Centre for Reviews and Dissemi-
nation, 2000; Riley et aI., 1999). However, despite
requests fram many health authorities to implement water
fluoridation in the north west the water company has
failed to do so (Taylor, 1995).
It is generally accepted that the widespread availabil-
ity and regular use of fluoride toothpaste has been the
main reason for the decline in dental caries during the last
three decades in most industrialised countries (Bratthall
et aI., 1996). The use of fluoride toothpaste varies
between different regions of England. In 1994 the amount
spent on toothpaste per person per year varied fram
f5.1O in the more affluent south of the country to f2.80
in the more deprived north west; the volumes of tooth-
paste purchased ranged fram 360ml per person in the
south to 200ml in the north west (Davies and Hawley,
1995). A high praportion of pre-school children in the
north west are fram socially deprived backgraunds and
are more likely to commence toothbrushing later in life
and to brush less frequently than children fram more

Correspondence to: Df. G.M. Davies, Dental Department, Central Manchester Primary Care Trust, Mauldeth House, Mauldeth
Road West, Manchester, M21 7RL, UK.
 affluent backgrounds (Hinds and Gregory, 1995). Since
there is a strong body of evidence to support the efficacy
of fluoride toothpastes in reducing dental caries (Clarkson
et ai., 1993)and such health-related behaviours are estab-
lished early in life (Blinkhom, 1978) one approach to
reducing inequalities in dental health would be to encour-
age toothbrushing by young children in deprived areas
by supplying them with free fluoride toothpaste.
Clinical trials of fluoride toothpaste have demonstrated
that their efficacy is strongly associated with fluoride
concentration. It has been calculated that for every
additional 500 pprnF there is a further 6% reduction in
dental caries (Stephen et aI., 1988). However, there are
concems that very young children may swalIow signifi-
cant amounts of fluoride from toothpaste and that this
rnight be a risk factor for dental fluorosis (Bentley et aI.,
1999). Consequently some authorities have recommended
that young children, at low caries risk, should use low
fluoride toothpaste during their first six years of life
(British Society of Paediatric Dentistry, 1996).
This randomised controlIed trial assessed the effect
of supplying free fluoride toothpaste regularly to children
from the age of 12 months to 5V2years, living in deprived
areas of north west England, on the leveI of caries at
5-6 years of age. A further aim was to compare the
effectiveness of a programme using a toothpaste contain-
ing 440 pprnF (Colgate 0-6 Gel) with one containing 1450
pprnF (Colgate Great Regular Flavour) in reducing caries.
Method
The study was a randornised controlIed paralIel group
clinical triaI. Dental examinations were conducted under
blind conditions but as 'off the shelf' toothpaste (with-
out over wrapping or repackaging) was delivered to the
participants, subjects and their families were aware of
which toothpaste they were using. The potential partici-
pants were children bom in nine health districts in the
north west of England with high levels of dental caries.
These districts were identified using the results of the
BASCD co-ordinated survey of 5-year-old children in
1993/94 (Pitts and Palmer op. cit.). The mean dmft and
percentage of 5-year-old children with caries experience
in the nine selected districts were as folIows: Bolton
(3.36,64%), Tameside (2.89, 58%), Oldham (2.49, 53%),
Salford (2.89, 58%), Wigan (3.17, 66%), Bumley (3.23,
64%), Blackbum (3.06, 61%), Skelmersdale (3.07, 59%)
and South Sefton (2.48, 55%).
Participantswere enrolIed in two phases. In five health
districts the children bom between 1 October and 31
December 1993 were recruited, and in the remaining four
those bom between I April and 30 June 1994. Names and
addresses of children bom within the specified three-
month periods were obtained from the appropriate health
authorities. Ethical approval for the study was obtained
from the local research ethics committees in the selected
districts.
For this three group study, it was estimated that a
final sample size of approximately 1,250 in each group
would have 95% power to detect a difference in means
of 15% between any of the three possible pair wise
comparisons using a t-test with a 0.05 two-sided signi-
ficance leveI and applying a Bonferroni correction
132
(assuming coefficient of variation is unity). In addition, it
was anticipated that 50% of children, initialIy identified,
would be lost to folIow-up over the 5-year period and
therefore 2,500 were recruited in each study group.
Within each of the nine districts children were given
an identity number and centralIy alIocated to either one
of the two test groups or a control group using random
number tables. Children in the test groups were sent
either a children's toothpaste containing 440 ppmF
(Colgate 0-6 Gel) or one containing 1450 pprnF (Colgate
Great Regular Flavour).
When the potential participants were 12 months old
a letter was sent to approximately 5,000 parents of chil-
dren who had been alIocated to the test groups seeking
passive consent for their children to participate. Reply
paid cards were included with these letters for parents to
retum if they did not want their child to participate. Free
toothpaste was then sent to alI test children every 12
weeks and a toothbrush was sent annualIy. Leaflets
encouraged parents to use a pea-sized amount of the
toothpaste sent to them and to brush their child's teeth
twice daily. Toothpaste was supplied to participants in
the two test groups until they were 5V2years old. Chil-
dren were withdrawn from test and control groups if
toothpaste or questionnaires were retumed by the post
office as undeliverable.
Children were exarnined clinicalIy when they were 5-
6 years old. Passive consent for this examination was
sought from all test and control children by means of a
letter posted to children' s homes and supplemented by
a second letter sent by local examining teams when
required. Every effort was made to locate the children
involved with the study within the schools they attended.
In each district the clinical examinations were undertaken
by trained, standardised and calibrated examiners accord-
ing to the standards set by BASCD (Mitropoulos et aI.,
1992). Children were examined lying supine and a Daray
lamp provided illumination. Teeth were dried using
cotton wool rolIs and alI diagnoses were by visual means
only. Probes were used only to remove debris and caries
was scored at the dentinal leveI.
The mean dmft (primary outcome) of the three groups
was compared at the end of the study using an ANOVA
F ratio test folIowed by pairwise comparisons between
groups with the Bonferroni adjustment to the P value,
reported in the tables. Chi square tests were used to
compare differences in proportions between the three
groups. The overalI a levei of significance was set at
0.05.
The first analysis was performed on children remain-
ing in the study at its conclusion. This provided informa-
tion on the effectiveness of the programme for children
who received toothpaste during the study, but it cannot
be known whether they used it. However, health authori-
ties need to know how effective such a strategy would
be across the whole district. It is, therefore, important to
attempt to estimate the effectiveness or 'true' benefit of
this type of programme to the community. Such an 'intent
to treat' approach (HolIis and CampbelI, 1999) implies that
the analysis should include alI subjects initially
randomised to the three groups and which would require
complete folIow-up of alI subjects for alI outcomes. Whilst
in practice this is very difficult to achieve in most studies,
 Eligible children
7,422

1450 ppm F 440 ppm F Contro I

Randomised to study groups n=2,488 n=2,472 n=2,462

Children remaining in study

+ + +

Children withdrawn from study I n=51O I I n=501 I I n=286 I

Figure 1. Chart describing the number of children allocated to study groups and examined at 5 years of age

Table 1. Number of children: eligible, allocated to study groups, withdrawing and examined.

1450 ppmF 440 ppmF Control Total

toothpaste toothpaste

1ncluded in study - allocated to group 2488 2472 2462 7422

Withdrawals
Did not want to take part 334 307 O 641
Moved out of area, emigrated 449 474 509 1432
Dentist advised against taking part in study 1 O O 1
Product related 4 O O 4
Total 788 781 509 2078
Clinically examined including withdrawals 1696 1677 1655 5028
(Percent of children initially included) (68) (68) (67) (68)
Clinically examined and still in study 1186 1176 1369 3731
(Percent of children initially included) (48) (48) (56) (50)

a further two analyses were performed for the primary
outcome dmft to try to estimate the population effect.
The first included data fram all children who were clini-
cally examined and were originally part of the study
population but included those who did not complete the
study. The second also included subjects initially
randomised but not examined clinically by imputing the
means and standard deviations fram the contraI graup.
Results
The health authorities pravided a list of 7,458 names and
addresses. Due to duplications, changes of address and
death, 7,422 were randomly allocated to the three study
graups (Figure 1 and Table 1). Reply paid cards were
returned by the parents of 641 test children, indicating
that they did not wish their children to participate and
during the five years of the study 1,432 children moved
away fram the area. Five children withdrew fram the 1450
ppmF toothpaste group, one because the dentist advised
this, three because of concerns about fluorasis and one
because of an allergy to the toothpaste.
Clinical examinations were completed for 5,028 chil-
dren, 68% of those who were initially recruited to the
study. The first analysis involved the 3,731 children who
had been examined and had remained in the study. They
represented 50% of the children originally allocated to
study graups. There were significant differences in the
mean dmft values for the three graups (Table 2). The
,
children in the graup who had received the 1450 ppmF
toothpaste had a statistically significantly lower mean
dmft than both those who had received the 440 ppmF
toothpaste and those in the contraI graup (16% reduc-
tion compared with control) (P<0.05). There was no
statistically significant difference between the mean dmft
values for the 440 ppmF toothpaste group and the
contraI graup (p::l).
Further analyses of the 3,731 children considered the
prevalence of caries experience (dmft>O) and teeth miss-
ing due to caries (mt). There was a statistically significant
difference between the graups for caries prevalence rang-
ing fram 50% in the 1450 ppmF graup to 58% in the 440
ppmF graup and 58% in the control graup (P<O.OOl)
(Table 3). A statistically significant difference was also
found for the proportion of children who had teeth
extracted (Table 4) because of caries (mt) which ranged
fram 12% in the 1450 ppmF graup, to 14% in the 440
ppmF graup, and up to 17% in the control graup (P=0.002).

133
 --
Table 2. Comparison of mean dmft between graups
for subjects examined excluding subjects who were
withdrawn fram the study

Group Number Mean Standard

deviation

1450 ppmF toothpaste 1186 2.15 2.96

440 ppmF toothpaste 1176 2.49 3.16
Control 1369 2.57 3.16
Total 3731 2.41 3.10
ANOVA F Ratio 2,3728=6.5, P=0.002
Comparison between 1450 ppmF toothpaste versus
contrai P=0.002; between 1450 ppmF and 440 ppmF
toothpastes P=0.020; between 450 ppmF and contrai
Pd.O.

Table 3. Comparison of caries experience between graups at final

examination for all subjects examined (excluding subjects who were
withdrawn from study) (column percentages in parenthesis).

1450 ppmF 440 ppmF Contral Total

toothpaste toothpaste
n (%) n (%) n (%) n (%)

dmft=O 588 (50) 498 (42) 580 (42) 1666 (45)

dmft>O 598 (50) 678 (58) 789 (58) 2065 (55)
Total 1186(100) 1176(100) 1369(100) 3731(100)

Chi square value (2 df) =17, P-value<O.OOl

Table 4. Comparison of mt between graups at final examination for

all subjects examined (excluding subjects who were withdrawn from
study).

1450 ppmF 440 ppmF Contral Total

toothpaste toothpaste
n (%) n (%) n (%) n (%)

mt=O 1042 (88) 1011 (86) 1137 (83) 3190 (86)

mt>O 144 (12) 165 (14) 232 (17) 541 (15)
Total 1186(100) 1176(100) 1369(100) 3731(100)

Chi square value (2 df) =12, P-value=O.002

Table 5. Comparison of mean dmft between groups for all children examined
and imputing mean and standard deviation from control group for children not
exarnined.

Ali children examined 1mputing mean and standard

deviation fram contral graup
for children not examined
Graup Number Mean Standard Number Mean Standard
deviation deviation

1450 ppmF 1696 2.21 2.99 2488 2.33 3.06

440 ppmF 1677 2.47 3.18 2472 2.51 3.19
Contrai 1655 2.60 3.20 2462 2.60 3.20
Total 5028 2.43 3.12 7422 2.48 3.15
Ali children examined
ANOVA F Ratio 2,5025=6.7, P=O.OOI
Comparison between 1450 toothpaste versus control P=O.OOI;between 1450
and 440 toothpastes P=0.049; between 450 and contrai P=0.71.
Imputed data
ANOVA F Ratio 2,7419=4.7, P=0.009
Comparison between 1450 toothpaste versus control P=0.009; between 1450
and 440 toothpastes P=O.13; between 450 and contrai P=0.96.

134

The dmft data were further analysed in an attempt
to estimate the population effect of the programme using
an intent-to-treat approach (Table 5). One analysis simply
compared all 5,028 children who were initially allocated
to study groups and received a c1inical examination.
Statisticallysignificant differences in mean dmft were still
found between the group allocated to use 1450 ppmF
toothpaste and the control, and between the 1450 ppmF
and 440 ppmF toothpaste groups (P<0.05). Once again
there was no significant difference between the 440
ppmF toothpaste and the control group. A further analy-
sis imputed the control group mean (2.60) and standard
deviation (3.20) for the children lost from the study and
not examined. The results of this analysis also demon-
strated a statistically significant difference in mean dmft
between the 1450 ppmF toothpaste and control group,
but no differences between 1450 pprnF and the 440 ppmF
groups, nor between the 440ppmF and control group.
Discussion
The inequalities in the levels of dental caries amongst
pre-school children in different regions and districts of
the United Kingdom will be reduced only by the implemen-
tation of effective preventive measures. The efficacy of
fluoride toothpastes has been demonstrated in numerous
clinical trials (Clarkson et aI., op. cit) but children in
deprived areas commence toothbrushing later in life, use
fluoride toothpaste less frequently and have higher
levels of dental caries than those in more affluent areas
(Hinds and Gregory, op. cit).
The aim of this randomised controlled c1inical trial
was to assess whether the regular provision of free
fluoride toothpaste and leaflets encouraging twice daily
brushing with a pea-sized amount of toothpaste could
reduce the high levels of dental caries in young children
living in deprived areas of the north west of England. The
study was designed primarily to evaluate the effective-
ness of the programme rather than the efficacy of the
products per se and consequently its design differed
from that of a conventional c1inical tria!. All children in
the three study groups had access to fluoride tooth-
pastes but for the two test groups free toothpaste and
information was supplied whereas the control group had
to purchase their own. All the analyses of effectiveness
demonstrated that the provision of free toothpaste
containing 1450 ppmF significantly reduced mean dmft
when compared with the control group. When the analy-
sis was restricted to data from children who had been
supplied with toothpaste throughout the study those
who had received the 1450 pprnF toothpaste had signifi-
cantly less caries than those receiving the 440 ppmF
toothpaste.
Toothpastes containing low concentrations of fluo-
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