d e n t a l m a t e r i a l s 3 2 ( 2 0 1 6 ) 323333

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Are uoride releasing dental materials clinically

effective on caries control?

Jaime Aparecido Cury a, , Branca Heloisa de Oliveira b ,

Ana Paula Pires dos Santos b , Livia Maria Andal Tenuta a
a Piracicaba Dental School, UNICAMP, Piracicaba, SP, Brazil
b Dental School, UERJ, Rio de Janeiro, RJ, Brazil

a r t i c l e i n f o a b s t r a c t

Keywords: Objectives. (1) To describe caries lesions development and the role of uoride in controlling
Dental caries disease progression; (2) to evaluate whether the use of uoride-releasing pit and ssure
Fluorides sealants, bonding orthodontic agents and restorative materials, in comparison to a non-
Dental materials uoride releasing material, reduces caries incidence in children or adults, and (3) to discuss
how the anti-caries properties of these materials have been evaluated in vitro and in situ.
Methods. The search was performed on the Cochrane Database of Systematic Reviews and
on Medline via Pubmed.
Results. Caries is a biolm-sugar dependent disease and as such it provokes progressive
destruction of mineral structure of any dental surface intact, sealed or restored where
biolm remains accumulated and is regularly exposed to sugar. The mechanism of action
of uoride released from dental materials on caries is similar to that of uoride found in
dentifrices or other vehicles of uoride delivery. Fluoride-releasing materials are unable to
interfere with the formation of biolm on dental surfaces adjacent to them or to inhibit acid
production by dental biolms. However, the uoride released slows down the progression
of caries lesions in tooth surfaces adjacent to dental materials. This effect has been clearly
shown by in vitro and in situ studies but not in randomized clinical trials.
Signicance. The anti-caries effect of uoride releasing materials is still not based on clinical
evidence, and, in addition, it can be overwhelmed by uoride delivered from dentifrices.
2015 Academy of Dental Materials. Published by Elsevier Ltd. All rights reserved.

functional again and esthetically appealing to the patient.

1. Introduction
Dental materials are used in Dentistry for many clinical pur-
poses. If the material is used to rebuild the tooth and does
not have properties that may help to control caries adjacent
to the lling, the role of this material is only to make the tooth
However, when dental materials have the ability to release
uoride, it is expected that, besides restoring function and
esthetics, they may control the recurrence of caries on den-
tal structure adjacent to the lling and/or even contribute to
reduce caries incidence in the entire dentition.

This paper was originally intended for publication with the set of papers from the Academy of Dental Materials Annual Meeting,
710 October 2015, Hawaii, USA; published in DENTAL 32/1 (2016).

Corresponding author. Tel.: +55 19 21065303.
E-mail addresses: jcury@unicamp.br (J.A. Cury), branca.oliveira@gmail.com (B.H. de Oliveira), ana.paulapires@uol.com.br
(A.P.P. dos Santos), litenuta@unicamp.br (L.M.A. Tenuta).
http://dx.doi.org/10.1016/j.dental.2015.12.002
0109-5641/ 2015 Academy of Dental Materials. Published by Elsevier Ltd. All rights reserved.
324 d e n t a l m a t e r i a l s 3 2 ( 2 0 1 6 ) 323333
In addition, uoride-releasing materials are also used as
sealants to prevent caries in pits and ssures and as mate-
rials for bonding and/or cementing orthodontic brackets and
bands. In this case, it is also expected that the uoride released
by these materials will work reducing the progression of
enamel caries around them.
The development of caries on dental surfaces adjacent to
dental materials should not be considered different from that
occurring on intact (natural) dental surfaces. Also, the mech-
anism of action of uoride on caries control adjacent to these
materials may be considered the same as that reported for
other ways or vehicles of uoride delivery, such as uoride
dentifrices (toothpastes). These concepts are discussed in Sec-
tions 2 and 3 of this paper.
2. Dental caries
Caries lesions develop on dental surfaces in which biolms are
formed, allowed to accumulate and retained for long periods of
time (e.g., occlusal surfaces, interproximal areas, along gingi-
val margins and on enamel-cementum junction) [1]. Although
necessary for caries lesion progression, biolm accumulation
alone is not enough. Sugars are the pivotal, negative fac-
tor, responsible for caries lesion progression [2]. The acid pH
produced from the fermentation of dietary sugars not only
provokes dissolution of the underlying dental minerals, but
also selects in the biolm formed the most cariogenic bacteria
[3].
Therefore, caries is a biolm-sugar dependent disease [1]
and, among the dietary sugars, sucrose is the most cariogenic
because besides being easily fermented into acids, it is the only
carbohydrate that change the matrix of the biolm formed,
making the biolm more cariogenic [4].
Thus, biolm accumulation is the necessary factor and
sugar exposure the negative determinant factor for caries
progression in any dental surface, intact or restored (Fig. 1).
The only difference between caries progression on enamel or
dentin adjacent to a lling, in comparison with a natural intact
surface, is the possibility of biolm accumulation in the gap
between the wall of the cavity and the lling material [5,6].
Every time sugar is ingested, biolm bacteria produce acids
and, consequently, the pH drops in the biolm uid. Thus,
pH is the driving force governing the loss or gain of Ca and
Pi from the mineral structure of the teeth. While pH remains
below around 6.5 for dentin and 5.5 for enamel, the miner-
als of these tissues are dissolved (demineralization) (Fig. 1a).
After around 2030 min, the pH rises again and, above 5.5 for
enamel and 6.5 for dentin, saliva tries to repair Ca and Pi loss
(remineralization) (Fig. 1b). However, saliva alone is not 100%
effective to repair all Ca and Pi minerals lost during the dem-
ineralizing process. The balance toward demineralization or
remineralization will be dependent on the daily frequency of
dietary sugars ingestion.
Thus, caries lesions progression on dental surfaces,
restored or not, is provoked by the same factors, biolm accu-
mulation and sugar exposure. Also, the process (chemical
events) of caries lesions development is the same in any dental
surface (Fig. 1a and b).
Table 1 Approaches for uoride use and vehicles for its
delivery in the oral environment.
Approaches for uoride use Vehicles (examples)
Community level Water uoridation
Individual level Fluoride dentifrice,
mouthrinse
Professionally applied Fluoride-releasing dental
materials, topical uoride
application (gel, varnish)
Combinations Fluoride
dentifrice + uoride-
releasing dental
materials
Therefore, dental caries as a disease is, by nature, primary,
and its control, either in intact dental surfaces or adjacent to
dental materials (secondary caries), is achieved by biolm
mechanical disruption and sugar restriction.
Also, caries is not the result of uoride deciency [7] but
this ion is the only therapeutic agent known to effectively con-
trol caries progression, and uoride-releasing materials may
be considered a way or vehicle of uoride delivery (Table 1).
3. Fluoride effect
The old concept that uoride strengthens the teeth, making
them more resistant to caries, is still prevalent. However, u-
oride is not able to prevent caries lesion development because
it does not avoid the formation of biolm in any dental sur-
face, either intact or adjacent to uoride-releasing materials.
Furthermore, the in vivo effect of uoride inhibiting acid pro-
duction from sugars in the biom is negligible [7].
In fact, uoride interferes with the caries process, reducing
demineralization and enhancing remineralization of enamel
and dentin [8]. This physico-chemical mechanism occurs
every time sugar is ingested and the pH falls in biolm uid; if
uoride is present, the amount of mineral dissolved is reduced
because part of Ca and Pi lost as hydroxyapatite returns to the
tooth as uorapatite (reduction of demineralization) (Fig. 2a).
When the ingestion of sugar ceases and the pH rises again,
uoride present in the oral uids enhances the natural phe-
nomenon of remineralization (Fig. 2b). As a consequence, the
progression of caries lesions is slowed down [7]. Also, follow-
ing the exchange of minerals between the biolm uid and
enamel or dentin in the presence of uoride, an enrichment
of uoride concentration in enamel or dentin surfaces occurs
a consequence of the effect of uoride on the caries process,
and not the cause of caries lesions reduction [9].
The anti-caries effect of uoride can be obtained by the
same mode of action irrespective of the ways or vehicles of
uoride use. Among them, toothbrushing with uoride den-
tifrices is the only one whose results on caries reduction
are strongly based on scientic evidence [10]. Besides their
effectiveness to control the incidence of caries in originally
intact dental surfaces, uoride dentifrices can also interfere
with caries lesion progression adjacent to dental materials
because during toothbrushing uoride is spread throughout
the mouth, and enriches remainings of biolm not perfectly
removed [11].
 d e n t a l m a t e r i a l s 3 2 ( 2 0 1 6 ) 323333 325

Fig. 1 Enamel demineralization as a function of sugar metabolism by dental biolm. Every time sugar is ingested, a low
pH, below the critical level for the dissolution of tooth mineral (hydroxyapatite), is achieved. Tooth mineral from an intact
surface, or adjacent to a restoration, will dissolve (a). Enamel remineralization following a demineralization event. As saliva
clears out sugar and acid from the biolm, its pH increases above the critical for dissolution of tooth mineral
(hydroxyapatite). Remineralization will occur in the surfaces previously demineralized (b).

Fluoride-releasing materials should also be considered a
way to maintain uoride constantly in the mouth (Table 1).
For instance, glass ionomer cements, in addition to releasing
uoride for a long time, can also be recharged with the ion
from other sources, such as uoride dentifrice [12].
Furthermore, uoride-releasing materials should be con-
sidered a unique way of uoride use because the ion is
maintained constant in the right place (the biolm), is avail-
able at the right time (whenever sugar is ingested), and in
enough concentration (low levels) to reduce de- and enhance
remineralization (Fig. 2a and b).
Another advantage of uoride-releasing dental materials
in comparison with dentifrice is that the effect of uoride
does not depend on patient compliance. Fluoride from dental
materials works passively.
However, considering that they all work by the same mode
of action, a synergistic effect of the combination of ways
of uoride use would not be expected. In fact, there is no
evidence of a synergistic or additive effect when uoride den-
tifrices, rinses and gels or varnishes are used in combination
[10,13]. Thus, no signicant additive effect would be expected
if uoride-releasing dental materials are used in a patient who
brushes his/her teeth at least twice/day with dentifrice con-
taining at least 1000 ppm F [5].
In fact, the anti-caries potential of uoride-releasing mate-
rials has been extensively studied since the silicate cement
era but most evaluations are based on in vitro and in situ
studies [14]. Therefore, there is a bulk of data recommending
these materials to improve oral health in terms of lower-
ing caries levels. However, these data accrue from studies
with a low level of evidence to inform clinical practice. Cur-
rently, it is acknowledged that health interventions should
be based on the best available evidence, and the only way
to know if they work in real life is by conducting random-
ized clinical trials. The current available evidence from clinical
studies on uoride-releasing pit and ssure sealants, bonding
orthodontic agents and restorative materials for caries control
is presented below.
4. Clinical effects of uoride-releasing
dental materials on the development of caries
lesions
The question we sought to answer in this section of the arti-
cle was whether the use of uoride-releasing pit and ssure
sealants, bonding orthodontic agents or restorative materials,
in comparison to a non-uoride releasing material, reduces
caries incidence in children or adults.
In order to gather the best, currently available evidence on
the clinical effects of uoride-releasing materials on caries
control, we searched for published systematic reviews of
326 d e n t a l m a t e r i a l s 3 2 ( 2 0 1 6 ) 323333

Fig. 2 The mode of action of uoride on the inhibition of demineralization. The same event described in Fig. 1a is
counteracted by a simultaneous precipitation of uoride containing minerals (uorapatite) in tooth enamel if uoride is
delivered to the biolm from any source. Here, uoride from dentifrice (on the left) or from restorative materials (on the
right) are described as uoride sources for the biolm (a). The effect of uoride on the enhancement of enamel
remineralization (b). Remineralization from saliva described in Fig. 1b is boosted by uoride made available to the biolm by
uoride dentifrice or uoride-releasing materials (b).

randomized controlled trials (RCTs). The search was per-
formed on the Cochrane Database of Systematic Reviews and
on Medline via Pubmed, using the tool Clinical Queries and
the option Systematic Reviews. Searches for published RCTs
were also performed in order to seek more recent studies
published after the date of the end of the search performed
in the systematic reviews that we had identied and read.
The search for RCTs was performed on Medline via Pubmed
using the tool Clinical Queries and the clinical study cate-
gory Therapy within the narrowed scope. We used different
combinations of Mesh terms and free vocabulary: dental
caries [mh], tooth demineralization [mh], orthodontics [mh],
dental atraumatic restorative material [mh], uorides [mh],
dental materials [mh], pit and ssure sealants [mh], compos-
ite resins [mh], dental cements [mh], glass-ionomer cements
[mh], compomers [mh], resin-modied glass-ionomer, giomer,
nano-ionomer, and dental sealants. Commentaries on sys-
tematic reviews and RCTs were also searched for in the
Database of Abstracts of Reviews of Effects (DARE) and in the
secondary publications Evidence-based Dentistry and Journal
of Evidence-based Dental Practice. All searches were per-
formed in May 2015.
Cochrane systematic reviews are considered the high-
est standard in evidence-based health care and most of
the Cochrane Oral Health Group reviews focus on the
prevention of dental caries [15]. Thus, higher priority was
given to the results of Cochrane reviews whenever they
could provide information on topics that were relevant to our
research question.
4.1. Pit and ssure sealants
Sealing pit and ssures of occlusal surfaces with a thin layer
of resin was introduced as a caries preventive method in
the late 1960s. Resin dental materials used for this purpose
evolved from ultraviolet to visible-light cured sealants, with
the newest materials having uoride incorporated into the
resin [16]. There is evidence to suggest that resin-based ssure
sealants are effective in preventing occlusal caries in perma-
nent molars of children and adolescents when compared to no
sealants, but it is still not known whether uoride-releasing
resin-based sealants provide any additional benet [17].
The potential of glass-ionomer cements (GIC) to form a
chemical bond to enamel thus reducing the importance of
maintaining a dry operating eld during application, and their
ability to release uoride to provide a possible cariostatic
effect, were strong motivations for their use as pit and s-
sure sealing materials, especially in very young children and
in partially-erupted posterior permanent teeth [18]. However,
available evidence does not allow a denitive conclusion as
 d e n t a l m a t e r i a l s 3 2 ( 2 0 1 6 ) 323333
to whether glass-ionomer or resin-modied glass-ionomer
sealants are equally effective or superior to resin-based dental
sealants in preventing occlusal dental caries in permanent or
primary teeth [17,19].
A recent mapping of systematic reviews undertaken
for topics considered clinically relevant for the practice of
Pediatric Dentistry concluded that there is high to moderate-
quality evidence of a caries preventive effect of ssure sealing
with resin-based materials. This study also noted that there is
still uncertainty concerning the effectiveness of ssure seal-
ing with other materials [20]. The Cochrane review on dental
sealants for caries prevention that was updated and published
in 2013 encourages conducting good quality primary studies
that compare the caries protective effect of different types of
sealants [17].
A Medline search via Pubmed using the Clinical Query
option identied six clinical trials that evaluated the caries
preventive effect of different dental sealing materials and
were published after the date of the end of the search per-
formed in the Cochrane review. These studies tested and
compared the caries preventive effect of high-viscosity glass-
ionomer cements, uoride-releasing resin-based sealants, a
owable composite resin, glass carbomer sealants and an
ormocer sealant [2126]. Most of them had a split-mouth
design and only two found that one material performed better
than the other; the results of one study favored a high-
viscosity glass-ionomer sealant over an ormocer sealant and
those of another study favored a high-viscosity glass-ionomer
cement over a glass carbomer sealant. There is still a clear
need for more clinical trials on this topic and studies aiming at
investigating the possible benets of local release of uoride
from sealants should not use a split-mouth design because
it has been shown that the cariostatic effect of a uoride-
releasing dental sealant can be exerted beyond the pits and
ssures of the sealed tooth; for example, on the distal surfaces
of second primary molars adjacent to a tooth sealed with GIC
[27].
4.2. Bonding orthodontic materials
The presence of orthodontic appliances increases the num-
ber of retentive sites in the dentition and also may cause
pain and discomfort [28]. This makes it more difcult for indi-
viduals to properly clean their teeth, which increases biolm
accumulation. Thus, orthodontic treatment carries the risk of
caries lesion development. Initial enamel lesions may develop
around orthodontic appliances as early as six months after
bonding [29,30].
An alternative to compensate for the increased caries
risk would be to enhance uoride availability using uoride-
releasing orthodontic adhesives or cements. These materials
would act as uoride reservoirs and could potentially increase
uoride levels in saliva, biolm and dental hard tissues.
One Cochrane systematic review we found aimed to eval-
uate the effects of uoride in reducing the incidence of white
spot lesions during orthodontic treatment [28]. In the updated
version of this review, three studies, among which only one
had low risk of bias, met the inclusion criteria but none of
them were RCTs testing materials containing uoride that is
released during treatment (e.g., uoride-releasing composite
327
resin-bonding materials, glass-ionomer cements, compomers
and resin-modied glass-ionomers for bonding or banding).
It should be noted that an earlier version of this review had
less strict inclusion criteria and therefore included a higher
number of studies. The updated review made substantial
changes to the protocol regarding inclusion criteria, which
resulted in the exclusion of all studies included previously.
For example, quasi-randomized studies were excluded. Also,
split-mouth trials were no longer accepted as they may lead
to biased treatment efcacy estimates due to carry-across
effects [31]. The changes in the inclusion criteria resulted in
changes in the conclusions; while the rst version concluded
that uoride-releasing bonding materials during orthodontic
treatment could reduce the occurrence and severity of white
spot lesions, the updated version could not draw any conclu-
sion regarding the effects of such materials due to the absence
of studies meeting the inclusion criteria.
Other Cochrane reviews have evaluated the effectiveness
of adhesives used to attach bands or bonded molar tubes dur-
ing xed appliance treatment on dental caries in the banded
or bonded teeth. First permanent molars where bands had
been cemented with glass-ionomer developed fewer white
spot lesions than those where bands had been cemented with
zinc phosphate. However, this evidence is considered weak
as it comes from only two trials that did not perform any
statistical analysis [32]. Regarding the comparison between
adhesives used to attach bonded molar tubes and adhesives
used to attach bands, one trial found that participants whose
rst permanent molars had tubes bonded with light-cured
composite developed more white spot lesions compared to
patients whose rst permanent molars had bands cemented
with glass-ionomer, although enamel changes were consid-
ered minor as they could not be seen in wet teeth [33].
One non-Cochrane review concluded that uoride-
releasing bonding materials appear to have no signicant
effect on the prevention of white spot lesions development
[34] and another revealed weak evidence that glass-ionomer
cements might be more effective than composite resins in pre-
venting white spot lesions development in xed orthodontic
patients [35].
Finally, a search for recent RCTs in Medline via Pubmed
failed to nd any parallel RCT addressing the question of
interest. Taken together, the evidence accrued from the sys-
tematic reviews described above makes it impossible to
provide any evidence-based recommendation regarding the
effectiveness of using uoride-releasing material to bond or
cement orthodontic appliances on white lesion spots devel-
opment. There is a need to design high quality clinical trials
on this subject. Researchers should prioritize RCTs with a par-
allel design and use standardized methods of caries diagnosis,
including the assessment of white spot lesions as well as cav-
itated lesions at both enamel and dentin levels. Also, studies
should cover longer follow-up periods in order to assess the
impact of white spot lesions on patients esthetic perception
and satisfaction.
4.3. Restorative materials
Fluoride-releasing restorative materials are seen as very
attractive to the clinician because they could serve a
328 d e n t a l m a t e r i a l s 3 2 ( 2 0 1 6 ) 323333
double purpose; besides repairing carious or defective teeth,
they could help prevent the development of new carious
lesions. However, very few systematic reviews and clinical
trials have considered the anti-caries effect of these dental
materials as their outcome measure.
In 2006, Wiegand et al. [14] reviewed existing evidence
on the cariostatic effect of uoride-releasing dental restora-
tives. They found few clinical longitudinal studies with an
observation period of three years or more that evaluated
the inuence of uoride-releasing dental materials on den-
tal caries development and noted that these studies showed
conicting results as to whether or not these materials con-
tribute to reduction of the risk of developing new dental caries
lesions.
A Cochrane review [36] compared survival and caries devel-
opment for restorative materials used to treat dental caries
lesions in childrens primary dentition. Of the three stud-
ies included, two compared a uoride-releasing material to a
non-uoride releasing material. One split-mouth study com-
pared a resin-modied glass-ionomer with an amalgam over
a 36-month period, and another tested a compomer versus an
amalgam. Only the 12-month data of the former and the 24-
month data of the latter were useable. At 12 months no caries
lesion was recorded and at 24 months there was no differ-
ence between compomer and amalgam restorations in terms
of secondary caries.
A systematic review published in 2009 [37] compared the
absence of caries lesions at the margins of glass-ionomer
cement (GIC) and amalgam restorations in primary and
permanent posterior teeth. A meta-analysis combining the
results of a parallel and a split-mouth study with a follow-
up of 6 years showed an odds ratio (OR) of 2.64 (95% CI 1.39,
5.03) in favor of single-surface GIC restorations in permanent
teeth. No other statistically signicant differences were found.
This systematic review has been updated; ve new trials were
included and one trial that was accepted in the original review
was excluded [38]. All of the included trials appear to be sub-
jected to the risk of selection and detection/performance bias.
Although new estimates of effect were produced, the original
conclusions did not change and it was found that the margins
of single-surface GIC restorations in permanent teeth had a
65% lower chance of developing carious lesions after 6 years
than did similar teeth restored with amalgam (RR 0.35; 95% CI
0.19, 0.65).
Another systematic review sought to verify whether
resin-modied glass-ionomer cements (RM-GIC) offer a more
signicant caries-preventive effect than composite resins (CR)
[39]. Four studies addressing dental restorations in children
or in adult patients who had received radiation therapy to
the head and neck were included. There was substantial
heterogeneity among the studies and no meta-analysis was
performed. Most of the comparisons made provided no sta-
tistically signicant differences in terms of caries protection
between the two materials. Moreover, all studies presented
methodological problems that could compromise their inter-
nal validity. Therefore, no conclusion regarding the review
question could be drawn.
The search for parallel RCTs in Medline via Pubmed iden-
tied one study that investigated the longevity of amalgam
and compomer restorations in primary molars of 610 year old
children [40]. Placement of all restorations was preceded by the
application of a bonding agent with a uoride-release charac-
teristic and children in the two treatment groups also received
uoride-releasing dental sealants. After a mean follow-up
period of 1.4 years, an exploratory sub-analysis of the data
showed that the frequency of restoration replacement due to
caries in posterior primary teeth was signicantly higher in
teeth restored with compomer (3.0%) than in teeth restored
with amalgam (0.5%). Additional analysis of data from the
same trial [41] assessed whether the occurrence of new caries
on teeth other than the tooth where the restoration was placed
varied by type of restorative material over a 5-year follow-
up period. A very small, but statistically signicant effect of
dental material on new caries formed in different teeth was
found in favor of amalgam restorations; caries lesions on other
teeth appeared sooner after the placement of compomer than
after the placement of amalgam. In contrast, among restora-
tions with a full 5 years of follow-up, the mean number of
new caries lesions on other teeth or on other surfaces of the
same tooth was slightly lower in children who received com-
pomer restorations than in children who received amalgam
restorations. Overall, it was not possible to conclude whether
one material was more successful than the other in preventing
dental caries.
Glass-ionomer cements (GIC) have also been used in the
atraumatic restorative treatment (ART). This technique, origi-
nally designed for non-dental settings, has now been included
in dental curriculums and is used by private practitioners [42].
The outcome measure in all systematic reviews we iden-
tied comparing ART with conventional restorations was
restoration survival, that is, tooth or restoration fracture or
loss. One of these reviews also assessed the caries-preventive
effect of ART sealants, but not of ART restorations [43]. Survival
rates of ART and conventional restorations appear to be simi-
lar [4347]. However, these similar survival rates do not answer
the question whether the use of a uoride-releasing material
reduces the risk of new caries lesions. Most studies compared
ART to amalgam restorations and these differ not only in the
restorative material employed, but also in the amount of car-
ious tissue removed, the instruments used to remove it and
the preservation of remaining tooth structure.
A recent parallel RCT comparing amalgam restorations
and ART with a high-viscosity GIC in primary molars showed
that few restorations (5.4%) failed due to dentin caries along-
side the restoration. After three years, both materials showed
higher survival rates when used in single-surface restorations
and no signicant difference was found between the cumula-
tive survival rates of amalgam and ART restorations. It should
be noted that the high-viscosity GIC was used with a higher
than usual powder-to-liquid ratio [48].
Besides the lack of assessment of caries as an out-
come measure, the systematic reviews mentioned above
have other limitations: the rst studies of ART used low or
medium-viscosity GIC, whereas more recent ones have used
high-viscosity GIC, which has been the type of GIC required
with ART since the mid-1990s; there are few long-term studies
available; most studies focused on primary teeth, which have
a shorter lifespan; there is a high risk of bias in the included
studies, especially due to the inclusion of uncontrolled lon-
gitudinal clinical studies or RCTs with unclear randomized
 d e n t a l m a t e r i a l s 3 2 ( 2 0 1 6 ) 323333 329

Table 2 Summary of clinical studies about uoride-releasing materials.

Type of dental material
Pit and ssure sealants
Systematic reviews RCT Conclusions
Mejare et al., 2003 Chen and Liu, 2013 Fissure sealing with resin-based
Chadwick et al., 2005 Guler and Yilmaz, 2013 materials has a caries preventive
Ahovuo-Saloranta et al., 2013 Erdemir et al., 2014 effect. It is still not known whether
Mejare et al., 2015 Gorset et al., 2014 F-releasing resin-based sealants
Liu et al., 2014 provide any additional benet. There
Zhang et al., 2014 is still uncertainty concerning the
effectiveness of ssure sealing with
other materials.

Bonding orthodontic materials
Derks et al., 2004 None The evidence on the effectiveness of
Millet et al., 2007 using F-releasing material to bond or
Rogers et al., 2010 cement orthodontic appliances on
Millet et al., 2011 white lesion spots development is still
Benson et al., 2013 inconclusive.

Restorative materials
Frencken et al., 2004
Vant Hof et al., 2006
Wiegand et al., 2007
Yengopal et al., 2009
Mickenaustsch et al., 2009
Mickenaustsch et al., 2010
Mickenaustsch and Yengopal, 2011
Yengopal and Mickenaustsch, 2011
Mickenaustsch and Yengopal, 2012
Socini et al., 2007 It is still not known whether
Trachtenberg et al., 2009 F-releasing restoratives reduce caries
Hilgert et al., 2014 risk in comparison to non F-releasing
restoratives. There is weak evidence
that GIC confers greater caries
protection than amalgam in
single-surface restorations in
permanent teeth.

sequence allocation and/or allocation concealment; and pub-
lication bias cannot be ruled out due to language and database
searching restrictions.
These shortcomings may be addressed in a planned
Cochrane review that aims to assess the effects of ART for
the treatment of decayed primary and permanent teeth in
children and adults. In the published protocol, the authors
stated that non-randomized studies will be excluded; other
outcomes, in addition to restoration failure, such as caries, will
be considered; all included trials will be evaluated regarding
the potential of bias; and a comprehensive search will be per-
formed [49].
In conclusion, it is still not known whether uoride-
releasing restoratives reduce caries risk in comparison to
non uoride-releasing restoratives and there is only weak
evidence that GIC confers greater caries protection than amal-
gam in single-surface restorations in permanent teeth. It
seems that there is an urgent need for well-designed, random-
ized controlled trials to investigate the anti-caries benet of
uoride-releasing lling materials. In order to provide results
that can be used to positively inuence clinical practice, future
trials should adhere to the CONSORT guidelines [50], adopt
a parallel group design [38] and report on outcomes that are
important to both clinicians and patients.
In summary (Table 2), if uoride releasing materials are
clinically effective on caries control is still a dogma but based
on large numbers of in vitro and in situ studies made, they
should work; this will be discussed in the next section of this
paper.
5. Anti-caries potential of uoride
releasing materials in vitro and in situ studies
No result from in vitro or in situ studies can be directly extrap-
olated to the clinical situation without further testing, but
sometimes they are the best available evidence [51,52]. In fact,
in order to minimize potential differences between the results
of a clinical trial and those obtained from in vitro and in situ
studies, models have been developed and validated aiming
to simulate what occurs in real life. Nevertheless, models are
only models and we have to be careful to choose the one(s)
that best mimics clinical performance.
5.1. Evaluation of uoride release from dental
materials
When testing uoride-releasing dental materials, our mod-
els should simulate the caries process as closely as possible
to correctly estimate the anti-caries potential of those mate-
rials. Even the simplest test, such as the one that assesses
the ability of a material to release uoride, should simulate
the caries process, because uoride controls caries lesions
progression by reducing demineralization when the pH drops
and by enhancing remineralization when the pH rises again
[5355]. An incorrect simulation of uoride release, ignoring
how uoride works on caries control, has implications not only
to estimate the anti-caries potential of the material but also to
compare different commercial products, as shown in Table 3.
Thus, if water is used to estimate the release, the best product
is the rst of the table, but if the caries process is simulated
by cycling the specimens in de- and remineralizing solutions,
the best product would be the second one. Moreover, data on
cumulative release are not relevant to control caries, since it
is a chronic disease and the process of caries lesions progres-
sion occurs every day, every time. Thus, uoride should be
constantly available in the mouth to interfere with the caries
process. Consequently, the release should be evaluated for
long periods because uoride does not work as a vaccine and,
therefore, it does not strengthen the tooth. Fluoride release
should be evaluated in real time.
330 d e n t a l m a t e r i a l s 3 2 ( 2 0 1 6 ) 323333
Table 3 Fluoride released (g F/cm2 ) from dental materials to different media. Carvalho and Cury, 1999.
Materials
H2 O
CHE 7.62 0.73 A
VIT 5.91 0.79 B
VAR 2.71 0.25 C
DYR 1.50 0.17 D
TET 0.14 0.02 E
Materials followed by distinct letter differ from each other.
5.2. Evaluating the effect of the uoride released
in vitro pH-cycling chemical model
Fluoride works interfering with the dynamics of the caries pro-
cess and therefore the effect of uoride-releasing materials
should be tested using models that mimic the caries process
[56]. If the material releases only uoride, its effect can be
evaluated using simple pH-cycling chemical models because
the antimicrobial effect of uoride on caries is not relevant.
Fluoride only has an effect on the metabolism of bacteria at
concentrations of 10 ppm or higher [57], and no way or vehi-
cle of uoride use is able to sustain this concentration in
biolm [5,9,13,5860]. However, if the uoride-releasing mate-
rial releases any antibacterial substance, its synergistic or
additive effect with uoride should be evaluated using in vitro
biolm models [61] or an in situ protocol [5,62].pH-cycling
chemical models are the ones most used to test dental mate-
rials and they are useful to compare the effect of a restorative
or bonding uoride-releasing material with that of a negative
control material that does not release uoride. The effect of
uoride-releasing materials on the reduction of demineral-
ization on enamel or dentin adjacent to llings and bondings
tested in a pH-cycling model can be assessed qualitatively (e.g.
visual inspection of the nal aspects of restored slabs) and
quantied using validated methods to estimate mineral loss
[56].
However, in vitro pH-cycling models should not be used
to compare different uoride-releasing materials because
there is no pH-cycling model validated to differentiate their
doseresponse effect. Indeed, the effect of uoride-releasing
materials has been evaluated using models that have been
developed to evaluate uoride dentifrice and very few of them
were validated in terms of dose-response [63,64].
Moreover, since uoride works interfering with the de-
remineralization process and not by making tooth minerals
more resistant to acids, there is no reason to assess uoride
uptake by enamel or dentin as an important outcome mea-
sure to explain the mode of action of uoride-releasing dental
materials [65]. This outcome represents only the consequence
of caries progression reduction by uoride availability. In fact,
the higher concentration of uoride found in enamel adjacent
to an ionomeric lling in comparison with resin is not due to a
chemical reaction between uoride released and enamel, but
to the effect of uoride on the caries process (Fig. 2a and b).
Media
Articial saliva pH-cycling
deremineralizing
solutions
1.26 0.08 B 8.35 0.51 B
3.13 0.36 A 12.27 1.16A
0.80 0.10 C 6.17 0.24 D
1.20 0.05 B 7.82 0.65 C
0.07 0.003 D 0.28 0.02 E
5.3. Evaluating in situ the effect of uoride-releasing
materials
In situ models can be used to evaluate the physicochemical
effect of uoride on caries process and also some antibac-
terial effect of the material, if present [5,65]. The necessary
biolm accumulation is provided and the biolms are exposed
to sugar several times a day, simulating a high cariogenic chal-
lenge.
The main outcome in this kind of study is the reduction
of demineralization [65]. Fluoride uptake by enamel or dentin
can be determined to give support to the demineralization
ndings found and to explain how uoride works reducing
caries lesion progression adjacent to the lling or any dental
surface.
When the potential antibacterial effect of a given dental
material is to be tested, in situ models or biolm models can
be used. Although the antibacterial effect of uoride is not
clinically relevant, it could be enhanced by other ions simulta-
neously released from the material, such as aluminum. Using
an in vitro biolm model, we found promising results on the
combined effect of F and Al [61]. However, this evaluation was
done using a closed in vitro model and our mouth is an open
sink that does not concentrate the cumulative effect of ions
released from dental materials. In two other in situ studies
aiming to check the promising results found in vitro for the
combined effect of F and Al [62,66], enamel blocks restored
with a composite resin as negative control, with a material
that releases mainly uoride (Ketac Fil ), or with one that
releases high amounts of Al and F (Vitremer ) were submit-
ted to cariogenic challenges to test the anti-caries effect of
the materials. In the short term in situ study [62], restored
enamel slabs were placed in contact with a culture of Strepto-
coccus mutans in palatal appliances worn by volunteers. They
rinsed with a 20% sucrose solution for 1 min as a cariogenic
challenge and the effect of the restorative material was evalu-
ated by microhardness change in enamel. The results showed
that both uoride-releasing materials reduced demineraliza-
tion around the llings in comparison with resin, but we could
not nd differences between the two uoride-releasing mate-
rials being evaluated.
Fluoride concentration in biolm and in enamel adjacent to
the llings was tested, indicating that the materials released
uoride to the biolm, which was then taken up by enamel
 d e n t a l m a t e r i a l s 3 2 ( 2 0 1 6 ) 323333 331

Fig. 3 Fluoride concentration (M) in the uid of biolm

formed on to cervical enamel/dentin slabs restored with
composite resin or glass-ionomer cement (GIC), under
non-F or F dentifrice use. Fluoride present on the biolm
formed on glass ionomer cement restorations (around
5 M = 0.1 ppm F) represent 1/100 of the necessary
concentration to present antibacterial activity, Cenci et al.
[5].

during the cariogenic challenge, with no difference between

the two materials [62].
In a subsequent long-term in situ study to test the same
materials, the effect of uoride was conrmed, but not the
additive effect of aluminum [66].
5.4. Combined effect of uoride from dental materials
and dentifrice in situ
In situ studies can also be used to estimate the combined effect
of uoride released by a lling and that delivered by dentifrice.
An in situ study to test the effect of this combination [67] found
that a uoride releasing material could be dispensable if uo-
ride dentifrice was being used. However, appropriate controls
are mandatory and the study lacked a control group testing
a negative control lling material (composite resin), under
non-uoride dentifrice use. A following study [5] designed to
overcome this limitation tested the effect of glass-ionomer
cement restorations (against an appropriate negative control
using composite resin) on the inhibition of mineral loss adja-
cent to enamel or dentin, under the use of uoride dentifrice
(against an appropriate negative control using non uoride
dentifrice). The biolms formed on the restored slabs were
analyzed for biochemical and microbiological composition,
and demineralization adjacent to the cervical restoration was
assessed on the enamel and dentin margins using transverse
microradiography.
Biolm uid was separated from the solids and for the rst
time uoride released by dental material was quantied in
biolm uid; the right place where uoride should be present
to interfere with the caries process. The results showed that
uoride concentration is 100 times lower than that needed for
the uoride-releasing material to present antibacterial action
(Fig. 3).
Regarding demineralization, the results clearly showed
that in the absence of uoride from dentifrice, the dental
Fig. 4 Area of mineral loss (vol.% mineral m) on the
enamel (a) or dentin (b) margins of composite or
glass-ionomer restorations exposed to a high cariogenic
challenge in situ, under the use of non-F or F dentifrice,
Cenci et al. [5].
material itself has the property to release uoride at a concen-
tration effective to control caries, either in enamel or in dentin
(Fig. 4). However, no additive or synergistic effect was observed
when uoride dentifrice was concomitantly used 3/day.
Unfortunately, the data of this crossover in situ study
cannot be validated by a clinical trial, because no ethical
committee would approve a non-uoride dentifrice group.
Therefore, it will remain as the best evidence available to rec-
ommend the use of uoride-releasing restorative materials in
patients with low adherence to uoride dentifrice use, but at
the same time to make them unnecessary in patients who use
uoride dentifrice regularly.
6. Conclusions
In summary, dental caries is not a result of uoride deciency
but uoride frequently available in the oral environment can
effectively slow down the rate of lesion progression in every
dental surface where biolm is accumulated and regularly
exposed to dietary sugars.
Since caries is a biolm-sugar dependent disease, daily
oral hygiene, preferably with uoride dentifrice, and the
332 d e n t a l m a t e r i a l s 3 2 ( 2 0 1 6 ) 323333
restriction of the intake of dietary carbohydrates are manda-
tory to achieve maximum caries control.
Fluoride-releasing dental materials present the necessary
properties to be effective on caries control. However, their
effectiveness to control caries is not still proved. Also, the
effect of uoride released by dental materials on caries can
be substituted by uoride delivered from dentifrice.
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