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Guidelines on the use of fluoride in children: an EAPD policy document.

1. Background considerations

The European Academy of Paediatric Dentistry (EAPD), in collaboration with the Hellenic Division of EAPD, organised a workshop in Athens, Greece (June, 1997), aiming at drawing up guidelines for future use of fluorides among European children. The first draft of these guidelines was published in the EAPD newsletter, and members were invited to make comments and suggestions. The revised first draft was then presented at the biannual EAPD Congress in Sardinia (1998), where it was discussed in great detail, so that members' viewpoints were taken into consideration. The major concepts of the proposed guidelines were approved, and a working group, consisting of the authors of the original paper, was authorised to finalise and publish the recommendations [Oulis et al., 2000]. In November 2008 the EAPD organised another workshop, again in Athens, Greece, to update the original fluoride guidelines. These updated fluoride guidelines employed the evidence-based SIGN (Scottish Intercollegiate Guidelines Network) methodology for ranking the levels of evidence and the grades of recommendations [SIGN 83, 2005; SIGN 50, 2008].

2. Introduction

Evidence suggests that the cariostatic effect of fluoride is mostly exerted by its topical rather than systemic effect [Featherstone, 1999]. This effect might be even greater when combined with good oral hygiene, such as when practised as comprehensive tooth brushing with a fluoride toothpaste [Rolla et al., 1991]. Concern about the prevalence of dental fluorosis in some children has mostly been related to the use of fluoride supplements, especially during the first 6 years of life [Ismail and Bandekar, 1999]. However, it has also been shown that early exposure to fluoride toothpaste might be a risk factor [Levy et al., 1995; Mascarenhas and Burt, 1998]. Studies that have summarised the risks for dental fluorosis have concluded that the risk is highest when the exposure takes place in both the secretory and the maturation phases of enamel formation [DenBesten, 1999; Evans and Stamm, 1991]. Therefore, three age groups can be considered in terms of having a risk for enamel mottling, namely:

0-4 years

Babies and infants under the age of 4 years of age are considered to be at risk of dental fluorosis of permanent incisors and first molars because the calcification and maturation of these teeth occurs during this period of life. More specifically, the period spanning from 15 to 30 months of age is called the "susceptibility window" as this has been estimated as the highest risk period [Evans and Stamm, 1991]. It is during this period when the use of fluorides must be carefully monitored and balanced with the need to prevent the occurrence of early childhood caries. Special attention should be given to the use of topically applied fluorides during this period of life, because of the inadequate control of the swallowing reflex.

4-6 years

The posterior teeth (premolars and second molars) are calcifying and maturing during this period and at risk of dental fluorosis. Nevertheless, when this occurs it represents less of an aesthetic problem, which needs to be weighed against the marked benefit of caries prevention brought about by the use of fluoride.

6 years and above

The risk for enamel mottling during this period is negligible, with the exception of third molars.

3. Guidelines

The following guidelines are recommended as an integral part of preventive programs for children. It must be emphasised, however, that any dentist supervising a child's oral care must address individual needs.

I. Water Fluoridation

Water fluoridation is the controlled adjustment of the natural fluoride concentration in drinking water to that recommended for optimal dental health. Water fluoridation is effective at reducing caries [McDonagh et al., 2000; Griffin et al., 2007, National Health and Medical Research Council, 2007] and has been hailed as one of the 10 greatest achievements in public health in the 20th century [Centers for Disease Control and Prevention, 1999a,b]. It is socially equitable, in that it is available to all social groups and ages. With the exception of dental fluorosis, no association between adverse effects and water fluoridation has been established [McDonagh et al., 2000; National Health and Medical Research Council, 2007]. The development of dental fluorosis is influenced by the total fluoride ingestion from all sources, including toothpaste, during tooth development.

In recent years, the use of bottled drinking waters has become more extensive. These bottled waters, when containing optimal fluoride levels, may play a role in caries prevention. However, further research on the role of fluoride-containing bottled waters, dental caries and fluorosis is needed.

The EAPD reaffirms its support for the use of water fluoridation as a community-based intervention to prevent dental caries.

II. Fluoride Tablets & Drops, Fluoridated Milk and Fluoridated Salt

Fluoride tablets and fluoride drops (traditionally termed fluoride supplements), fluoridated milk and fluoridated salt have been available for decades. Initially their use intended to mimic the consumption of fluoride from naturally fluoridated water in areas without fluoride in drinking water. Now the common view is that it is through the topical effect on tooth surfaces that fluorides have a caries preventive action [Hellwig and Lennon, 2004] and the term "supplements" should be avoided. Use of fluoride-containing toothpastes is almost universal, but other fluoride sources may have an additional effect when the caries challenge is considerable according to an individual's caries-risk assessment. As the systemic effect of fluoride plays a more minor role in caries inhibition it may be argued that fluorides should be applied locally and not given systemically. However, the efficacy and safety of water fluoridation [Yeung, 2008] indicate that systemic distribution of fluoride might be acceptable when this form seems to be the most convenient approach. One Cochrane review which aimed to examine the effect of additional topical fluoride compared with toothpaste alone, found a modest reduction in caries compared with toothpaste only [Marinho et al., 2004]. Some individuals experience an increased caries challenge and are often termed to be "patients at risk". In general, newly erupted teeth are more prone to caries [Arrow, 2007] and thus specific ages also might be considered being a "risk" age. Among preschool children many do develop caries before the age of 3 years , especially in underprivileged groups, and there might be reason to consider an early start of a preventive program [Wendt et al., 2001; Scottish Intercollegiate Guidelines Network, 2005; Skeie et al., 2005]. On the other hand, dental fluorosis is more likely to occur the earlier the supplement is introduced [Wang et al., 1997]. Studies indicate that mild to moderate dental fluorosis is a significant side effect of fluoride supplements [Ismail and Hasson, 2008]. Another problem with alternative fluoride sources to toothpaste, is the compliance within targeted groups [Horowitz, 2000].

The use of fluoridated toothpaste is the basic caries prevention recommended for all and this should be promoted towards all individuals and caregivers. In cases when tooth brushing is not carried out according to recommendations [Alm, 2008] or the caries-risk is increased for other reasons, then additional sources of fluoride could be useful. However, according to recent evidencebased reports on fluoridated milk, fluoridated salt, fluoride tablets and fluoride drops there is lack of evidence to make good recommendations [ Swedish Council on Technology Assessment in Health Care, 2002; Yeung et al., 2005; National Health and Medical Research Council, 2007;] and many of the studies "are highly biased" [Ismail and Hasson, 2008]. Lack of good studies or evidence does not necessarily mean that these methods do not work. There is a general need for well-designed studies which addresses these matters. But the time when negative controls can be defended is definitely gone, so it is now more complicated to obtain the research answers needed.

Fluoridated milk

Two evidence-based reviews [Yeung et al., 2005; National Health and Medical Research Council, 2007] indicate that there is limited support that fluoridated milk has a caries-preventive effect. However, there is only one randomised controlled trial (RCT) rated 1+ [Maslak et al., 2004] in a recent review [Espelid, 2008]. The assignment system is according to the level of evidence defined in SIGN50 [Scottish Intercollegiate Guidelines Network, 2008]. This study by Maslak et al., [2004] had a low attrition of participants during the 3 year study period. The results indicated a caries preventive effect of fluoridated milk. Six-year-old children using fluoridated milk since the age of 3 years, had 76.4 % (p<0.05) lower DMFT (first permanent molars) compared with the control group. For primary teeth a significant caries reduction was also demonstrated (31.3 %, p<0.05). Typically fluoridated milk is used in limited groups of children in kindergartens, but there are insufficient studies of good quality examining the effects of fluoridated milk in preventing dental caries [Yeung et al., 2005]. The fluoride concentration in milk is usually in the range 2.5-5.0 mg F/L.

Fluoridated salt

Fluoridated salt is widely used in Germany, France and Switzerland with 30-80% of the marketed salt for domestic use being fluoridated [Marthaler and Petersen, 2005]. More than 30 other countries worldwide use fluoridated salt and this type of fluoride delivery is highly recommended by WHO. Salt is most commonly fluoridated at 250 mg of fluoride per kg [Gillespie et al., 2005]. There is no RCT conducted on this topic according to recent reviews [ Swedish Council on Technology Assessment in Health Care, 2002; National Health and Medical Research Council, 2007; Espelid, 2008;]. Some cross-sectional studies and controlled clinical trials do indicate a caries preventive effect of salt, but fluoridated salt is probably less effective among small children due to the low salt diet now recommended for this age group.

Fluoride tablets/lozenges and fluoride drops

One well-designed, double blinded RCT indicates that supervised administration of fluoride tablets may be an effective preventive measure among children with high caries-risk [Stephen and Campbell, 1978]. This paper was graded 1+ and had a small drop-out rate [Espelid, 2008]. Another well-designed study graded 1+ could not demonstrate an additional effect of fluoride tablets compared with a positive control (fluoride rinse) [Poulsen et al., 1981]. Some additional RCTs report contradictory findings [ Swedish Council on Technology Assessment in Health Care, 2002; Espelid, 2008]. These studies might be more or less biased because they are rated as low quality studies.

If the level of fluoride in drinking water is between 0.3-0.6 mg F/L there should not be any additional fluoride use other than F-toothpaste in the 2-3 years of age group. In the older groups the daily tablet dose should then be reduced to 0.25 mg F/day.

Fluoride for local use has been delivered in drops and in combinations with vitamins. Some caries preventive effect has been reported [Espelid, 2008]. A comparison of fluoride tablets and fluoride drops with a negative control in a RCT showed a significant effect of both methods, after 2 years in a preschool population [Lin and Tsai, 2000]. The best caries preventive effect according to this study was obtained using fluoride drops twice a day compared with the daily sucking of a fluoride tablet (0.25 mg NaF).


Fluoridated milk and fluoridated salt could be a public health measure in target groups with high caries prevalence and low compliance for tooth brushing in areas without water fluoridation. Fluoride tablets and fluoride drops could be considered on an individual basis for children at high risk of caries (Grade of recommendation: C).

III. Fluoride Gels, Rinses and Varnishes

General comment: Topical fluorides should be used in children assessed as being at increased risk for caries development, including children with special oral health care needs. The evidence, recommendations and good practice points for fluoride gels, rinses and varnishes are shown in Table 2.

IV. Fluoride Toothpastes

Clinical effectiveness--The extensive use of fluoridated toothpastes has probably been one of the major reasons for the dramatic reduction in dental caries recorded over the past 30 years. Tooth brushing with fluoridated toothpaste is close to an ideal public health method in that its use is convenient, inexpensive, culturally approved and widespread [Burt, 1998]. The use of fluoride toothpaste in children and adolescents has been subjected to several systematic reviews during the recent decade [Marinho et al., 2003a; Twetman et al., 2003; Ammari et al., 2003, Marinho, 2008] and the caries-preventive effectiveness, expressed as prevented fraction, is summarized in Table 3.

Potential harm--One problem with young children's use of toothpaste is that they often swallow considerable amounts with a subsequent risk for dental fluorosis [Mascarenhas and Burt, 1998]. Fluoride toothpaste may be responsible for up to 80% of the daily fluoride intake [de Almeida et al., 2007] and the first 3 years of life seem to be the most critical. Therefore, parents should be strongly advised to use only a pea-size of toothpaste for very young children and assist or supervise tooth brushing until at least 7 years of age. A children's toothpaste with a lower concentration of fluoride may be indicated although the evidence for a caries-preventive effect of formulas with less than 500 ppm F are insufficient [Twetman et al., 2003; Steiner et al., 2004].

Evidence based statements--Based on the conclusions of narratives [Davies et al., 2003; Twetman, 2009] and systematic reviews [Marinho et al., 2003a; Twetman et al., 2003; Ammari et al., 2003], the following evidence-based statements can be formulated as shown in Table 4:

Tooth brushing behaviour--The duration of tooth brushing should exceed one minute on each occasion and children should be encouraged to spit out excess toothpaste and avoid rinsing with water. There is no firm evidence to suggest the ideal timing of tooth brushing but a common recommendation is that children's teeth should be brushed last thing at night before bedtime and on at least one other occasion. Eating directly after brushing should be avoided. Children's teeth can be brushed with either manual or powered toothbrushes with a soft small head.

Clinical recommendations

The EAPD recommendations for the use of fluoride toothpaste in children are summarized in Table 5. The daily use of fluoride toothpaste, in combination with oral hygiene instructions, is recommended as the basic part of a caries-preventive program in addition to other caries-preventive methods, such as diet counselling, topical use of fluorides and fissure sealants, which are also important. There is good evidence for outreach programs (school- or home-based) targeted at vulnerable high caries-risk groups as well as ethnic minorities [Twetman, 2009]. Where fluoride toothpaste is used in conjunction with other fluoride vehicles, the cumulative effect of fluoride must be taken into account for children less than 6 years of age. Care must be taken to ensure that a balance is maintained between maximising the protective effect against dental caries and minimising the risk of dental fluorosis. Furthermore, "best available evidence" must be balanced with the practitioner's expertise and the family's preferences. The background fluoride exposure as well as the socio-economic level of the community may also influence the above-mentioned recommendations.


The European Academy of Paediatric Dentistry wishes to thank Professor Jack Toumba (Workshop and Report Coordinator), Dr Nick Lygidakis (EAPD President) and Associate Professor Constantine Oulis (Workshop Coordinator) for organizing the Fluoride Workshop that has enabled the updating of the EAPD Fluoride Guidelines. Special thanks should be attributed to those who took part in the Workshop, and especially to the speakers in the scientific sessions beforehand, who contributed their valuable knowledge that significantly contributed to these guidelines. Finally, thanks to the Workshop group moderators and participants as follows:

I. Water Fluoridation: Moderators: Carmel Parnell (Ireland) & Martin Curzon (UK). Participants: Cheryl Butz (Germany), Katarzyna Emerich (Poland), Miguel Hernandez (Spain), Betul Kargul (Turkey), Haroula Koletsi-Kounari (Greece), Adam Maxim (Romania), Ilija Skrinjaric (Croatia), Vassiliki Topitsoglou (Greece), Annie-Maria Vierrou (Greece), Alexia Vlotoma (Cyprus).

II. Tablets & Drops/Milk/Salt: Moderators: Ivar Espelid (Norway) & Constantine Oulis (Greece). Participants: Kostas Arapostathis (Greece), Dimitris Emanouil (Greece), Padraig Fleming (Ireland), Sotirios Kalfas (Greece), Rok Kosem (Slovenia), Teresa Leisebach (Switzerland), Cor van Loveren (Netherlands), Argy Polychronopoulou (Greece), Colin Robinson (UK), Nikolai Sharkov (Bulgaria), Ulrich Schiffner (Germany), Karin Ziskind (Israel).

III. Gels/Rinses/Varnishes: Moderators: Sven Poulsen (Denmark) & Lisa Papagiannoulis (Greece). Participants: Ivana Bagic (Croatia), Verena Buerkle (Austria), Monty Duggal (UK), Sotiria Gizani (Greece), Nikos Kotsanos (Greece), Valeria Marinho (UK), Elsa Paiva (Portugal), William Papaioannou (Greece), Laura Strohmenger (Italy), George Vadiakas (Greece), Vesna Zivojinovic (Serbia).

IV. Toothpastes: Moderators: Svante Twetman (Denmark) & Richard Welbury (UK). Participants: Dominique Declerck (Belgium), Roger Ellwood (UK), Guy Goffin (Switzerland) Sara Karjalainen (Finland), Katerina Kavvadia (Greece), Gunilla Klingberg (Sweden), Goran Koch (Sweden), Kostas Louloudiadis (Greece), Nick Lygidakis (Greece), Helen Mamai-Homata (Greece), JeanLouis Sixou (France), Christian Splieth (Germany), Jack Toumba (UK), Ferranti Wong (UK).


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Table. 1 Recommended dosage schedule (as-
sumption is <0.3 mg F/L in drinking water)

Age               Recommendation

0-24 month             none
2-6 years          0.25 mg F/day
7-18 years         0.50 mg F/day

Table 2. The evidence, recommendations and good practice points for
fluoride gels, rinses and varnishes

Modality               Evidence               Recommendation

                       Evidence of            Level according
                       efficacy               to
                                              [SIGN 50,

Gels (profes-          Primary teeth:         1++
sional use;            Two trials included
5,000-12,500           in a Cochrane
ppm F)                 review [Marinho
                       et al., 2002a], but
                       effect in primary
                       teeth uncertain
                       [Poulsen, 2009]

                       Permanent              1++
                       teeth: Efficacious
                       in preventing
                       caries [Marinho
                       et al., 2002a;
                       Poulsen, 2009]

Rinses (home           Primary teeth:         --
use or at              No data available
schools; daily:        [Poulsen, 2009;
0.05% NaF              Marinho et al.,
(225ppm F);            2003b]
weekly: 0.2%
NaF (900 ppm

                       Permanent              1++
                       teeth: Efficacious
                       in preventing
                       caries [Poulsen,
                       2009; Marinho et
                       al., 2003b]

* Varnishes            Efficacious in         1++
(professional          preventing caries
use; 1,000-            in both primary
56,300 ppm F)          and permanent
                       teeth [Poulsen,
                       2009; Marinho et
                       al., 2002b]

Modality               Good Practice

                       Recommendation         Grade
                                              [SIGN 50,

Gels (profes-          Do not use in          D
sional use;            children < 6
5,000-12,500           yrs of age, as
ppm F)                 risk:benefit ratio
                       is in favour of
                       risk due to danger
                       of swallowing
                       the gel

                       Use for caries         A
                       prevention in
                       permanent teeth

Rinses (home           Do not use in          D
use or at              children < 6 yrs
schools; daily:        of age, as risk:
0.05% NaF              benefit ratio is
(225ppm F);            in favour of risk
weekly: 0.2%           due to danger of
NaF (900 ppm           swallowing the
F)                     rinse

                       Use for prevention     A
                       of caries in
                       permanent teeth

* Varnishes            Should be used         A
(professional          for prevention
use; 1,000-            of caries in both
56,300 ppm F)          primary and
                       permanent teeth


Gels (profes-          Use 2-4 times per year
sional use;            Obvious deposits of dental
5,000-12,500           plaque should be removed
ppm F)                 prior to application.
                       In order not to exceed PTD
                       clinicians should [Whitford,

                       Use appropriate size trays, and
                       suction devices during and
                       after treatment.

                       Patient should sit in upright
                       position and not swallow
                       Allow child to expectorate
                       Teeth should be wiped at the
                       end of the session with gauze
                       Instruct child not to eat or drink
                       for 20-30 min after application

Rinses (home           Supervised use more efficacious
use or at              than unsupervised
schools; daily:        10 ml of the solution is swished
0.05% NaF              around the mouth for 1 minute
(225ppm F);            Instruct child not to eat or drink
weekly: 0.2%           20-30 mins after application
NaF (900 ppm

* Varnishes            Use 2-4 times per year
(professional          Obvious deposits of dental
use; 1,000-            plaque should be removed
56,300 ppm F)          prior to application
                       In order not to exceed PTD
                       clinicians should take the same
                       precautions as for gels (see

                       A thin film using minimal
                       amount should be used
                       Amount could be kept at a
                       minimum by limiting application
                       to surfaces at risk
                       Instruct child not to eat or drink
                       for 20-30 mins after application

Table 3. Factors influencing the caries-preventive
effect of fluoride toothpaste as displayed in
systematic reviews. Prevented fraction
(PF %) with confidence intervals.

Intervention               vs. control         (95% CI)

Fluoride                     placebo              24
toothpaste                                      (21-28)

Supervised                non-supervised          11
brushing                     brushing           (4-18)

Brushing                   once per day           14
twice per day                                   (6-22)

1,450-1,500             1,000-1,100 ppm F          8
ppm F                                           (1-16)

F-toothpaste              F- toothpaste           10
+ other                                         (2-17)
sources *

* water fluoridation, fluoride varnish, fluoride gel, or fluoride

Table 4. Statements with level of evidence
according to the Scottish Intercollegiate
Guidelines Network [2008]

Statement SIGN                              Level of Evidence

Brushing with fluoride                             1++
toothpaste daily prevents caries,

Increasing the frequency of                        1+
brushing with fluoride toothpaste
improves caries prevention,

Adult assistance/supervision of                    2+
tooth brushing in children improves
caries prevention,

Toothpastes containing higher
concentrations of fluoride are more                1++
effective than those with lower levels
of fluoride in preventing caries,

Commencement of tooth brushing                      3
prior to 1 year of age reduces the
probability of developing caries,

Ingestion of fluoridated                           2-
toothpaste by young children is
associated with an
increased risk of dental fluorosis.

Table 5. Recommended use of fluoride
toothpaste in children

Age group              Fluoride               Amount to
                       concentration          be used
                                              Daily use

6 months-<2            500 ppm                twice
years                                         pea-size

2-<6 years             1000 (+) ppm           twice

6 years                1450 ppm               twice
and over                                      1-2 cm

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Publication:European Archives of Paediatric Dentistry
Article Type:Report
Geographic Code:4EUGR
Date:Sep 1, 2009
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