R E V I E W A RT I C L E

RM Davies The rational use of fluoride

RP Ellwood
GM Davies toothpaste

Authors’ affiliations: Abstract: Well-formulated fluoride toothpastes are clinically

RM Davies, RP Ellwood, Dental Health Unit, proven to prevent and control dental caries. They may also be a
Manchester, UK
risk factor in the aetiology of dental fluorosis. This review
GM Davies, Central Manchester Primary Care
Trust, Manchester, UK considers the available evidence to support the appropriate use
of fluoride toothpaste to maximise the benefit and minimise the
Correspondence to: risk. Three factors have an important influence on the anticaries
RM Davies
Dental Health Unit,
efficacy of fluoride toothpaste, namely concentration, frequency
Manchester Science Park, of brushing and postbrushing rinsing behaviour. The evidence
Lloyd Street North, suggests that low-fluoride (<600 ppm F) toothpastes provide
Manchester M15 6SH, UK
less caries protection than standard (1000 ppm F) or high
Tel.: þ44 161 232 4703
Fax: þ44 161 232 4700 (1500 ppm F) concentration formulations. However, low-fluoride
E-mail: robin.davies@man.ac.uk toothpastes are appropriate for very young children (under
7 years) at low caries risk, particularly if living in fluoridated
areas. For other young children, higher concentrations of
fluoride should be used. Brushing should be recommended
twice daily, whilst rinsing with large volumes of water should be
discouraged. Small amounts of toothpaste are comparable in
efficacy to large amounts. The risk of fluorosis is associated with
the ingestion of high doses of fluoride during tooth development
and consequently only young children are at risk. The variability
in the dose of fluoride ingested is mainly a function of the amount
used, less so its concentration. To minimise fluorosis risk,
parents should be advised to use only a pea-sized amount of
toothpaste and encourage spitting out of excess. It is concluded
that by using fluoride toothpastes appropriately, the benefits
can be maximised and the risks of fluorosis minimised.

Key words: fluoride toothpaste

Dates:
Accepted 12 November 2001
To cite this article:
Int J Dent Hygiene 1, 2003; 3–8
Davies RM, Ellwood RP, Davies GM:
Introduction
The rational use of fluoride toothpaste
Fluoride toothpaste plays an essential role in any programme
Copyright # Blackwell Munksgaard 2003 designed to prevent dental caries in populations, communities
ISSN 1601-5029 and individuals. From a global perspective, fluoride toothpaste is
Davies et al. Rational use of flouride toothpaste
considered to have had the most significant impact of any inter-
vention on the decline in dental caries (1), but there is evidence
that the swallowing of toothpaste by young children is associated
with an increased risk of dental fluorosis in both fluoridated and
non-fluoridated communities (2–10). Dental professionals are
frequently asked for advice regarding the choice and use of
fluoride toothpaste, and it is important that this should be based
on the best available evidence. This review will consider the
factors that increase the benefits and minimise the risks asso-
ciated with fluoride toothpaste.
Benefits
Numerous clinical trials have demonstrated that the use of
fluoride toothpaste reduced the caries increment by approximate-
ly 25% when compared with a non-fluoride toothpaste (11). How-
ever, most clinical trials are conducted over 2–3-year time periods,
and while such intervals are sufficient to establish product effi-
cacy, they may underestimate the true magnitude of long-term
compound benefits. Recently, it was calculated that an improve-
ment of just 5% in caries prevention efficacy against a positive
control product would, in fact, have 10-year benefits of up to 15%
and 20-year benefits of up to 28% (12). The efficacy of fluoride
toothpastes is potentially influenced by several factors, namely:
 Fluoride concentration;
 Frequency of use;
 Amount used;
 Rinsing behaviour.
Fluoride concentration
In the European Union, the maximum permissible concentration
of fluoride in a cosmetic dentifrice is 1500 ppm. Formulations
with higher concentrations can only be purchased in pharmacies
and in some countries, such as the UK, may only be available on
prescription. In the USA, most OTC dentifrices contain
1100 ppm F; formulations containing up to 1500 ppm F are
available, but the labelling must indicate that they are for children
over 6 years of age and adults living in non-fluoridated areas
considered to be at high caries risk. Dentifrices containing
fluoride concentrations higher than 1500 ppm F are prescrip-
tion-only medicines.
In most countries of the world, low-fluoride dentifrices, con-
taining less than 600 ppm F, are available for young children. A
notable exception is the USA where, despite widespread water
fluoridation, low-fluoride dentifrices are not marketed. The
results of clinical trials of fluoride toothpastes have been reviewed
extensively (11). Overall, the results support the conclusion that
4 | Int J Dent Hygiene 1, 2003; 3–8
fluoride concentration is an important factor affecting efficacy.
Within the range 1000–2500 ppm F, an increase of around
500 ppm F results in an additional 6% reduction in dental caries
(13, 14). The clinical benefit of increased fluoride concentration is
accompanied by an increase in plaque fluoride levels (15).
Low-fluoride toothpastes, containing less than 600 ppm F, are
available for young children in many countries. In the UK, for
example, where only 10% of the population receive fluoridated
water, 39% of 4–6-year-old children were reported to be using
such toothpastes (16). Few clinical trials of low-fluoride tooth-
pastes have been conducted in preschool children, the age group
for which they are intended, but it seems likely that they would
be less effective than dentifrices containing 1000–1500 ppm F. In
a recent community-based programme, children initially aged
12 months and living in deprived, non-fluoridated areas of the
north-west of England, received free toothpaste until they were
5 years of age. This study demonstrated that those children who
had received toothpaste containing 1450 ppm F had significantly
less caries experience at 5 years of age than either the group who
had received toothpaste containing 440 ppm F or the control
group who had received no toothpaste other than that which they
had purchased themselves (17). The mean dmft for the groups
were 2.18 (1450 ppm F), 2.55 (440 ppm F) and 2.60 (control).
Toothpastes containing concentrations of fluoride higher than
1500 ppm F have been shown to be significantly more effective in
reversing root caries lesions in adults and have a place in the
management of caries in the increasing, dentate elderly popula-
tion (18).
Frequency of toothbrushing
A number of clinical trials have reported an association between
reported brushing frequency and caries incidence. In 3-year
clinical trials, the caries increments in subjects who brushed once
a day were 20–30% more than those who brushed twice a day (14,
19, 20). This association between brushing frequency and caries
experience has also been reported in cross-sectional surveys of
populations (21). While these data need to be interpreted with
some caution because of the association between reported brush-
ing frequency and other health indicators such as social class and
sugar consumption, it seems appropriate to recommend to brush
twice daily. Such behaviour sustains elevated concentrations of
fluoride in plaque where it can inhibit dissolution of tooth mineral
by acid (22).
Whether brushing should take place before or after eating is a
debatable issue. Brushing before meals means that fluoride,
although present when eating takes place, is rapidly cleared by
saliva. If applied after eating, fluoride levels are sustained for

longer. There is no strong evidence to indicate which of these
routines is more beneficial.
Evidence supports the recommendation that fluoride tooth-
paste should be used prior to going to bed. Salivary flow rates
decrease during sleep and the resultant reduction in buffering
capacity increases the risk of caries. Recently, it was demon-
strated that after using a toothpaste containing 1500 ppm F last
thing at night, the concentrations of fluoride in saliva 12 h later
were comparable to those found 1–4 h after brushing during the
day (23).
Amount of toothpaste
Data concerning the effect that the amount of toothpaste has on
efficacy is sparse. One study demonstrated that the mean salivary
fluoride levels after brushing with 0.25 g of toothpaste was
approximately one-third that obtained after brushing with 1.0 g
of toothpaste (24). However, a clinical trial of dentifrices contain-
ing 1000, 1500 and 2500 ppm F demonstrated a correlation
between plaque fluoride and increasing fluoride concentration
of the dentifrices, but no correlation between plaque fluoride and
the amount of dentifrice used per application (25). These findings
were consistent with the caries increments observed and suggest
that the fluoride concentration of a dentifrice is more important
than the amount of fluoride applied in determining plaque
fluoride levels and efficacy.
Rinsing behaviour
An important determinant of efficacy is the rinsing behaviour
after brushing with a fluoride toothpaste. In clinical trials, indi-
viduals who rinsed with large volumes of water had higher caries
increments than those using smaller volumes (14, 19, 20). Whilst
it is important to remove any excess toothpaste slurry from the
mouths of young children to minimise swallowing, vigorous
rinsing with water should be discouraged. Recently, it has been
demonstrated that using the toothpaste slurry as a rinse after
brushing can enhance the efficacy of fluoride toothpaste. A 26%
reduction in caries incidence of approximal surfaces was claimed
for this method (26).
Risks
The prevalence of fluorosis is reported to have increased in both
fluoridated and non-fluoridated communities in North America
(27), but a review of available data in the UK failed to substantiate
this claim on a population basis (28). Nevertheless, the use of
fluoride toothpaste by very young children has been implicated as
Davies et al. Rational use of flouride toothpaste
a potential risk factor for fluorosis in a number of studies. The age
brushing commenced (2, 3, 7, 29), the frequency of brushing (5–7)
and the amount of toothpaste placed on the brush (7, 10, 30) have
all been implicated as fluorosis risk factors. All of these factors are
associated with the inability of very young children to spit out and
the inevitable swallowing of toothpaste placed in the mouth.
The ingestion of fluoride during the first 3 years of life appears
to be the most critical for fluorosis of the aesthetically important
maxillary central incisor teeth (31, 32). In Britain, 49% of children
aged 1.5–4.5 years were reported to have started toothbrushing
before the age of 1 year and another 40% had commenced the
year after (21). The risk of fluorosis is related to the dose of
fluoride ingested which is a function of both the amount of
toothpaste ingested and its fluoride concentration.
The threshold level of fluoride ingested beyond which fluorosis
may occur is not known accurately (33). The best data available
have been obtained from water fluoridation studies, which sug-
gest that children should consume no more than 0.10 mg F/kg
body weight (34), if an undesirable degree of fluorosis is to be
avoided. A lower threshold of 0.05–0.07 mg F/kg body weight has
also been suggested (35). These thresholds are the best available
but it should be noted that, whereas ingestion from fluoridated
water produces a continuous low exposure to fluoride, ingestion
from toothpaste or tablets occurs less frequently and thus may
result in higher peak plasma levels. Such peak levels may result in
a greater fluorosis risk for a given daily intake of fluoride.
In a recent cross-sectional study, an investigator asked 49
mothers of children aged 30 months to show how they normally
brushed their child’s teeth. Twenty-four used a toothpaste con-
taining 440 ppm F and the rest one containing 1450 ppm F (36).
The amount of toothpaste and fluoride retained in the mouth
were calculated. The mean weight of toothpaste placed on the
brush was 0.3 g (range 0.09–1.0 g), the proportion ingested ranged
from 27 to 96% (mean 72%) and the mean weight ranged from
0.04 to 0.83 g. The mean weight of fluoride ingested per brushing
using the 1450 ppm F toothpaste was 0.42 mg (range 0.05–
1.02 mg) compared with a mean of 0.10 mg (range 0.02–
0.33 mg) for those using the 440 ppm F toothpaste. The potential
daily dose of fluoride ingested was calculated using the mean
weight of the children and assuming that toothbrushing occurred
twice daily. For those using the 1450 ppm F toothpaste the mean
was 0.06 mg F/kg/day (range 0.007–0.14) compared with
0.01 mg F/kg/day (range 0.002–0.05) for those using the
440 ppm F toothpaste. Using the 440 ppm F toothpaste twice
daily, no child exceeded 0.05 mg F/kg body weight threshold.
However, 14 out of 25 average-weight children would have
exceeded this value using the 1450 ppm F toothpaste; 7 would
have exceeded 0.07 mg F/kg body weight and 4 would have
Int J Dent Hygiene 1, 2003; 3–8 | 5
Davies et al. Rational use of flouride toothpaste

exceeded 0.10 mg F/kg body weight. The study reaffirms that the completing a clinical trial, children, now aged 9 years but who had
amount of toothpaste applied is particularly important for young used toothpaste containing either 550 ppm F or 1000 ppm F from
children, as they tend not to be able to spit out and hence swallow 2 to 5 years of age, were examined for fluorosis and compared with
a large percentage of the toothpaste applied. Whilst the risk of a control group (43). Photographs of the maxillary incisor teeth
fluorosis is related to both the fluoride concentration and amount were scored for fluorosis using the TF index. Two hundred and
of toothpaste swallowed and absorbed, this study indicated that sixty-eight children (18%) and 825 (16%) of their teeth had a TF
the amount of toothpaste used has potentially a greater impact on index score of 1 or higher. Significantly more children and teeth in
fluorosis risk than concentration. both the 1000 ppm F toothpaste and control group had a TF score
Despite the fact that parents of young children are advised to 2 when compared with the group who had used the low-fluoride
supervise their children and apply a pea-sized amount of tooth- toothpaste. However, there was no significant difference between
paste, many fail to do so. In the UK, manufacturers of toothpaste the groups when the number of children or teeth with cosmeti-
have labelled their products with these instructions since 1990 cally unacceptable TF scores 3 were compared.
and yet 10% of children aged 1.5–4.5 were reported to have never
had their teeth brushed by an adult and 27% of 1.5–2.5-year-olds
Summary
brushed themselves (21). Furthermore, 58% of 1.5–2.5-year-olds
were reported to cover a small part of the brush with paste while An important attribute of fluoride is that its benefits can be
37% covered half or more. delivered in many ways. However, the versatility of fluoride is
Whilst the evidence indicates that early toothbrushing beha- also its Achilles heel since young children may be exposed to too
viour may be associated with an increased risk of fluorosis, its much fluoride which increases the risk of fluorosis. The available
impact on the prevalence of fluorosis in a population also depends evidence supports the following advice regarding the use of
on how frequently this risk factor occurs in that population. The fluoride toothpaste.
proportion of fluorosis observed in the population that can be  Young children should be supervised when toothbrushing.
attributed to a particular risk factor is called the ‘attributable risk’.  Parents should apply a smear or pea-sized amount (0.25 g) of
In a case/control study in a fluoridated community, it was esti- toothpaste for young children.
mated that 71% of mild-to-moderate cases of fluorosis could be  Teeth should be brushed twice a day, one occasion being last
attributed to having brushed more than once a day with more than thing at night.
a pea-sized amount of toothpaste throughout the first 8 years of  Excess paste should be spat out, not rinsed with a large volume
life (30). Brushing with no more than a pea-sized amount was not of water.
associated with any increased risk. This emphasises the impor- A professional decision concerning the appropriate concentra-
tance of parental supervision when dispensing toothpaste onto tion of fluoride to advise should be made after considering the age
the toothbrush. In a further study, approximately one-third of of the child or children, the degree of caries risk and possible
mild-to-moderate fluorosis cases in non-fluoridated areas and two- exposure to other fluoride sources. From the preceeding discus-
thirds in fluoridated areas could be attributed to habits associated sion of the appropriate use of fluoride toothpaste we would
with the early use of fluoride toothpaste (10). recommend the amount of toothpaste to be used depending
Although there is some evidence that the prevalence of fluoro- on the age category, caries risk and fluoridated or non-fluoridated
sis has increased, it is important to know to what extent this is water in Table 1.
perceived to be an aesthetic problem by those affected and their
Table 1. Suggested use of fluoride toothpaste for different age
parents. Several studies have addressed this issue (37–40) and
groups
there is general agreement that using the TF index (41), only
cases with scores of 3 or more may be of aesthetic concern. In a Toothpaste
Caries Water advised
recent study in the UK, the prevalence of fluorosis in a fluoridated
Age category risk fluoridated? (ppm F)
community was 54% compared with 23% in a non-fluoridated
6 years of age or younger
community (42). However, only 3% of subjects in the fluoridated Low Yes or no <600
area had a TF score 3 compared with 1% in the non-fluoridated Medium Yes or no 1000–1100
High Yes 1000 or 1100
area. The prevalence of moderate-to-severe fluorosis in the USA
High No 1450
was reported to be extremely low at 1.3% (27).
More than 6 years of age All levels – 1100 or 1450
Low-fluoride toothpastes have been specifically formulated for
Adults High – >1450
young children to reduce the risk of fluorosis. After previously

6 | Int J Dent Hygiene 1, 2003; 3–8


Acknowledgements
Robin Davies and Roger Ellwood are employees of the Colgate-
Palmolive Company.
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