DOI: 10.1111/ipd.

12096

Infiltration and sealing versus fluoride treatment of occlusal

caries lesions in primary molar teeth. 23 years results
AZAM BAKHSHANDEH & KIM EKSTRAND
Section for Cariology and Endodontics & Paedodontics and Clinical Genetics, Department of Odontology, Faculty of Health
and Medical Sciences, University of Copenhagen, Nrre Alle, Copenhagen N, Denmark

International Journal of Paediatric Dentistry 2015; 25: 4350

Background. Studies examining the efficacy of

sealing occlusal caries lesions in the primary dentition are limited, and no studies have so far
examined the efficacy of infiltrating occlusal
lesions on primary molar teeth.
Objectives. This study aimed to evaluate the efficacy of infiltrating, sealing, or fluoride varnishing
on the occlusal surfaces with initial caries lesions.
Design. Split-mouth design study was carried out
with 50 children aged between 5 and 8 years with
three occlusal lesions. After randomization, one
lesion was infiltrated with ICON and varnished
with Duraphat (I+F), one lesion was sealed with

Introduction

Even though the prevalence of caries lesions

in children and adolescents has dropped the
last 30 years1,2, caries is still a significant
problem for many children. In the permanent
dentition, for example, initial caries lesions
on occlusal surfaces are common during the
rather long-lasting eruption periods of molar
teeth35. Approximal caries in the primary
molar teeth is also a problem; thus, Ekstrand
showed in 2006 that about 50% of the
9-year-old Danish children had one or more
restorations on those surfaces2.
In the primary dentition, the progression
rate of lesions limited to enamel is 23 times
faster than in the permanent dentition6,7. In
addition, caries progression in dentin is 36
times faster than in enamel and that counts
for both dentitions69. Knowledge of the

Correspondence to:
Azam Bakhshandeh, Section for Cariology & Endodontics
and Paedodontics & Clinical Genetics, Department of
Odontology Faculty of Health and Medical Sciences,
University of Copenhagen, Nrre Alle 20, 2200
Copenhagen N, Denmark. E-mail: azamba@sund.ku.dk

Delton and varnished with Duraphat (S+F), and

one lesion only varnished with Duraphat (F).
Results. Lesion status could be followed on radiographs
on
47
children
after
23 years
(mean=22 months). Seven lesions in the I+F
group, 9 lesions in the S+F, and 17 lesions in the
F group showed radiographic progression. A significant difference in lesion progression was only
found between the I+F- and the F group of teeth
(P = 0.021).
Conclusions. Infiltration and sealing occlusal surfaces with initial caries lesions on primary molar
teeth showed a high efficacy in arresting caries
progression, significant for the I+F or borderline
significant for the S+F compared with the F
group.

progression rate has led to significant changes

in treatment interventions. Thus, the treatment choice has moved toward non-invasive
and minimally invasive approaches10,11. In
the case of no visible cavitation on the surface, non-invasive approaches are usually
used, attempting to arrest further lesion progression, to avoid cavitation and restorative
treatment. Clinical studies have shown that
progression of many initial approximal caries
lesions can be arrested by secondary prophylactic approaches such as sealing and infiltration in the primary dentition12 as well as in
the permanent dentition in young adults1315.
Furthermore, the efficacy of these treatments
is reported to be significantly higher than
when lesions are treated by Duraphat varnish. If approximal sealing and approximal
infiltration are interesting methods, it would
be of importance to study whether these
techniques are also useful in controlling caries
progression on the adjacent occlusal surface.
Thus, it can be beneficial for the clinician to
use the same material for the initial approximal and occlusal lesions.
Thus, we aimed in this study to evaluate
the efficacy of infiltration and sealing versus

2014 BSPD, IAPD and John Wiley & Sons A/S. Published by John Wiley & Sons Ltd

43

44

A. Bakhshandeh & K. Ekstrand

fluoride varnish application of initial occlusal

lesions in primary molar teeth. The study was
conducted in Greenland. The null hypothesis
was that no differences existed concerning
lesion progression, whether the lesion was
infiltrated, sealed, or only varnished by
Duraphat.
Material and methods

Sample
Sample size was based on the following premises: randomized clinical trial split mouth,
a=5%, 1b=80%, clinically relevant effect not
to be missed 30%. A sample size of about 40
patients at the end of the study was required,
using a formula for testing differences in proportions for the paired sample design.
The inclusion criteria were presence of at
least three primary molars with initial lesions
on three occlusal surfaces in each child. Children with systemic disease were excluded,
and children, who were known to have difficulties in cooperating, were also excluded.
One hundred and fifty children were examined in the public dental healthcare clinics in
Nuuk, the capital of Greenland during the
first half of 2009; 20 patients in January 2009
and an additional 30 patients in September
2009 fulfilled the inclusion criteria. The study
was approved by the Greenlandic ethics committee (no. 2009-1). Signed informed consent
from all parents/patients was obtained before
initiating the treatments. Whether the parents
allowed their child to participate in the study
or not, the child would receive normal standard examinations and treatments at a clinic
in the Public Dental Health care in Nuuk.

able indicated an arrested lesion, whereas the

latter indicated an active lesion. At least two
of the three criteria should be present for registration whether the lesion was active or not.
In this study, the localization of the lesion was
in the fossa, ipso facto, a plaque stagnation
area, and if the lesion appeared as a white
spot, the lesion was assessed as active. If the
lesion was scored as brown spot, but rough,
then the lesion was assessed as active. The
investigator (AB) had considerable experience
in using the ICDAS Scoring System and has
reached adequate reproducibility values17.
An experienced dental assistant took bitewing radiographs (BW), using a film holder
Kwik-Bite (Hawe-Neos, Switzerland). The
equipment used was a Secodent Philips X-ray
source (65 kV, 7.5 mA, exposure time 0.25 s)
using E-speed films (Eastman Kodak Co, New
York, NY, USA), and the films were automatically processed (XR 24 Pro; D
urr Dental AG,
Bietigheim-Bissingen, Germany). Radiographs
at baseline were assessed one at a time with
the individual radiograph located over a light
box and using a Mattsons magnifying glass
(Dental X-Ray, Copenhagen, Denmark). The
radiographs were scored according to the following criteria: sound, radiolucency in
enamel only, radiolucency extending to the
enamel dentine junction (EDJ), radiolucency
within the outer 1/3 of the dentin, radiolucency in 2/3 of the dentin, radiolucency
within the inner 1/3 of the dentin or BW not
readable18.
If a child had more than three occlusal initial lesions, only three lesions were selected
and treatments were allocated based on a
random number table19.
Risk assessment

Selection of the lesions and assessment

Teeth were pumiced and cleaned professionally, and caries was then scored clinically
using the ICDAS visual scoring system. The
activity of each lesion was also registered in
ICDAS by recording the following three variables: color (brownish/whitish), localization
(no plaque stagnation area/plaque stagnation
area), and the roughness (smooth/rough) of
the lesion16. The first criterion in each vari-

The individual caries risk level for each child

was assessed by means of the caries experience and measured by the d3ef-s (decayed,
extracted, and filled surfaces) index. The
patient was evaluated as low risk when the
d3ef-s was 0; moderate risk when the d3ef-s
varied between 1 and 4, and at high risk
when the d3ef-s was over 4. Occurrence of
plaque was scored as 0 = no visible plaque or
1 = visible plaque.

2014 BSPD, IAPD and John Wiley & Sons A/S. Published by John Wiley & Sons Ltd

Treatment of initial occlusal lesions in primary teeth

Clinical procedure
The three lesions were randomly allocated to
one of three groups blinded for the participants: 1 infiltration plus fluoride varnish
(I+F); 2 sealing plus fluoride varnish (S+F),
and 3 fluoride varnish (F). Infiltration of
the test lesion was made with ICON (DMG
Chemisch-Pharmazeutische Fabrik GmbH,
Hamburg, Germany), and sealing was made
with Delton (Dentslply DeTrey, Copenhagen, Denmark) on the second test lesion. The
treatment for the control group was fluoride
varnish application with Duraphat (2.26% F;
Woelm Pharma GmbH, Eschwege, Germany).
Infiltrated test lesion plus fluoride varnish
(I+F). The lesions in this group were treated
with ICON according to the following procedure. The surface was cleaned; 15% hydrochloric acid was placed on the lesion for
2 min.; surface was rinsed and dried for 20 s
and then dehydrated twice by treating with
95% ethanol and air-dried with a three-inone air syringe; infiltrant resin (ICON; DMG,
Hamburg, Germany) was applied to the lesion
for 3 min.; resin was polymerized after the
resin surplus was removed according to the
instructions of the manufacturer; the resin
was applied again for 30 s and polymerized.
Fluoride varnish (Duraphat) was applied to
the whole occlusal surface of the tooth, covering the infiltrant and the surrounding
enamel.
Sealed test lesion and fluoride varnish (S+F). The
surface was cleaned; 35% phosphoric acid
placed on the lesion for 60 s; the surface was
rinsed and dried for 20 s and then dehydrated
twice by treating with 95% ethanol and airdried with a three-in-one air syringe; Delton
was applied to the lesion for 20 s; the resin
was polymerized according to the instruction
of the manufacturer; and Duraphat was
applied to the whole occlusal surface of the
tooth, covering the sealing and the surrounding enamel.
Control lesion, fluoride varnish (F). The occlusal
surface was pumiced with toothpaste, rinsed
with water, and air-dried carefully. Duraphat

45

was then applied on the occlusal surface covering the lesion.

The children were informed not to eat or
drink for at least 2 h after fluoride application. All children followed the program
offered by the dental service, which includes
regular examinations and oral hygiene
instruction. All three selected occlusal lesions
received Duraphat varnish at baseline and
three times during the study period.
Reading of the bitewings
The baseline radiographs were collected during 2009, while the radiographs at the final
visit were collected in November 2011. The
baseline radiographs and the final radiographs
were initially analyzed alone and scored using
the scoring system shown above. For possible
caries progression analyses, the baseline and
the final radiographs were analyzed pairwise.
For reproducibility assessment, the examiner
read all the baseline and final radiographs a
second time, with one weeks interval. For all
comparisons, the examiner was blinded as to
whether the examined radiograph was from
baseline or final and as to whether the lesion
was allocated in the I+F, S+F, or F group.
Statistical analysis
The intra-examiner reliability for the pairwise
radiographic readings was assessed by unweighted kappa scores. Caries experience
(d3ef-s), individual caries risk levels, ICDAS
scores, radiographic scores, and progression
status of the lesions were reported descriptively. Freidman test was used for testing
whether the lesion severity on the radiographs differed within the three groups at the
baseline. The treatment was considered as a
failure in the presence of progression or restoration of the lesion. Cochrans Q-test was
used for testing differences in lesion progression between the three interventions. In the
case of significant differences between groups,
the McNemar change test for related groups
was conducted, and the 95% confidence
intervals were expressed. Finally, difference
in the proportions of lesion progression
between the I+F, S+F, and F (therapeutic

2014 BSPD, IAPD and John Wiley & Sons A/S. Published by John Wiley & Sons Ltd

46

A. Bakhshandeh & K. Ekstrand

effect) was calculated. P-values < 0.05 were

considered significant in all tests20.
Results

Baseline
Sample. At baseline, 50 children (boys:
n = 27; girls: n = 23) aged between 5 and
8 years old (mean=6.51 years) with 150 primary molar teeth were enrolled in the study.
Fifty-six first primary molars and 94 second
primary molars were included in the study.
Caries risk groups. The d3ef-s varied between 0
and 14 (mean=3.06  4.26). Twenty-five
patients (50%) were characterized as having
low risk, 12 patients (23%) had moderate,
and 13 patients (27%) were at high risk. Over
half the patients (58%) had no plaque, and
the majority were in the low caries risk group.
Clinical assessment. Fifty-four of the lesions
were scored as ICDAS code 1 (I+F = 34%,
S+F = 32%, and F = 42%), 91 lesions were
scored as ICDAS code 2 (I+F = 62%, S+F =
62%, F = 58%), and 5 lesions were scored as
ICDAS code 4 (I+F = 4%, S+F = 6%, F = 0%)
in all groups.
Radiographic assessment. Intra-examiner agreement for the radiographic readings was 0.81.
The radiographic penetration of the lesions at
baseline was distributed as shown in Table 1.
Only 1 unreadable BW in the I+F group was
Table 1. Distribution of the radiographic scoring of 150
lesions in 50 patients at baseline in the three treatment
groups.
Treatment
Radiographic scores at baseline

I+F

S+F

Sound
Radiolucency in enamel only
Radiolucency reaching the
enameldentin junction
Radiolucency reaching up to
outer 1/3 of the dentin
Total

6
0
19

3
0
18

13
1
21

22
1
58

25

29

15

68

50

50

50

150

I, infiltration; S, sealed; F, fluoride varnish.

Total

found. The lesion depth was scored as <1/3 in

the dentin where a clear penetration into the
dentin was visible on the radiograph. One
hundred and twenty-seven lesions of 150
(84%) had penetrated into the enameldentin
junction or in the outer third of the dentin.
As illustrated in Table 1, there were more
lesions with no or very superficial penetration
in dentin in the F group compared with the
other two groups. Statistical analyses showed
significant differences between the three
intervention groups in radiographic depth of
the lesions at baseline (P = 0.001). Further,
analyses between two treatment groups, I+F
and S+F, showed no significant differences in
lesion depth at baseline (P = 0.251).
Follow-up
Radiographic assessment. At the final follow-up,
47 of 50 children enrolled at baseline were
radiographically examined. In the infiltration
group, two of the 47 lesions in teeth were
exfoliated and were designated, conservatively, to have had no progression. The radiographic control period varied between 8 and
34 months (mean=22 months). Only one
patient had an observation period of
8 months, and three patients had at least
18 months observation period, 19 patients
had at least 24 months, and 24 patients had
over 24 months. As shown in Table 2, 40
lesions (85%) in the I+F group, 38 lesions
(81%) in the S+F group, and 30 lesions
(64%) in the F group did not progress, judged
from the radiographic examinations. Hence, 7
lesions (15%) in the I+F group, 9 lesions
(19%) in the S+F group, and 17 lesions
(36%) in the F group showed radiographic
progression (P = 0.026). Additionally, the significant differences in lesion progression were
only found between the I+F and F groups
(P = 0.021). The P-value for the I+F versus
the S+F was 0.774; and between the S+F and
the F was 0.096. The lesion progression in
relation to the jaws and the quadrants was
analyzed, and no significant influence was
found (P > 0.05). The difference in the clinical therapeutic effect between the I+F and
S+F was only 3%, compared with 20%

2014 BSPD, IAPD and John Wiley & Sons A/S. Published by John Wiley & Sons Ltd

Treatment of initial occlusal lesions in primary teeth

47

Table 2. Changes in lesion depth in the three intervention groups during the follow-up period in relation to radiographic
scores at baseline.
Treatment
I+F

Radiographic score at baseline

S+F

Progression

Sound
Radiolucency in enamel only
Radiolucency reaching the
enameldentin junction
Radiolucency reaching up to
outer 1 of 3 of the dentin
BW not readable
Total

No
progression

Progression

No
progression

Progression

No
progression

Total

2
3
1

3
0
14

0
0
1

2
0
17

6
0
5

5
1
16

18
4
55

22

19

64

0
7

1
40

0
9

0
38

0
17

0
30

1
139

I, infiltration; S, sealed; F, fluoride.

between the I+F and the F groups and 17%

between the S+F and the F groups.
Clinical assessment. When comparing the clinical ICDAS scores at baseline with the radiographical status at the end of the study, a
total of 20 of 83 lesions with ICDAS code 2,
11 of 51 lesions with ICDAS code 1 and 2 of
5 of the lesions with ICDAS code 4 showed
radiographic progression.
Risk assessment. The caries risk in relation to
caries progression was also examined and is
illustrated in Table 3. Approximately half of
the lesion progressions are registered in
patients with high caries risk in the S+F
group and the F group, whereas in the I+F
group, the highest number of progressions is
in patients with moderate caries risk. It is also
noticeable that lesion progression is also high
in patients with low caries risk in the F
group. The influence of caries risk group on
Table 3. The distribution of caries risk profile in relation to
lesions with progression at the last follow-up.
Radiographic progression
Caries risk profile

I+F

S+F

Low (n = 14)
Moderate (n = 4)
High (n = 15)
Lesions with progression (n = 33)

2
3
2
7

2
1
6
9

10
0
7
17

I, infiltration; S, sealed; F, fluoride.

(14%)
(75%)
(13%)
(21%)

(14%)
(25%)
(40%)
(27%)

(72%)
(0%)
(47%)
(52%)

lesion progression is statistically significant

(P = 0.02).
Discussion

Prevalence of occlusal caries is relatively high

in primary molar teeth in many countries;
hence, increased efforts in non-invasive/microinvasive approaches are highly needed2,21.
With this in mind, this study was initiated to
determine the efficacy of infiltration and sealing in arresting progression of the initial caries lesions on occlusal surfaces in comparison
with Duraphat treatment of occlusal initial
lesions.
Comparison of the efficacy of the three
treatments was possible, as the study was
designed as a split-mouth randomized clinical
trial. As all three lesions in each patient
received Duraphat varnish three times during
the study period, the carry-across effects were
believed to be under control. It was therefore
possible to distinguish which treatment was
more efficacious than the others. A random
number table was used for allocating the
treatments to the selected teeth, the child was
blinded to the given treatments, and those
who applied the F varnish to the teeth during
the study period were also blinded. Finally,
AB, who read the radiographs at baseline and
at the end of the study, was also blinded to
the treatment the teeth had received. These
precautions increase the internal validity of
the findings in this study. The results of the

2014 BSPD, IAPD and John Wiley & Sons A/S. Published by John Wiley & Sons Ltd

48

A. Bakhshandeh & K. Ekstrand

study would, however, be strengthened if

more than one examiner had been involved
in the study.
At the final examination, three patients
(6%) could not be recorded because the
patients had moved to other districts or settlements in Greenland. Therefore, a total of 47
lesions in each intervention group were
examined by radiographs; hence, the possible
negative influence when many participants
drop out of a study seems to be under control
in this study.
A total of 33 occlusal lesions (24%) showed
radiographic progression by the end of the
study. Over half of the lesion progressions
were registered in the control group (F),
which received Duraphat varnish only. At the
same time, over half of these progressions
were in patients with low caries risk. Infiltration (I+F) and sealing (S+F) of the initial
occlusal lesions were noticeably more efficacious in stabilizing lesion progression in all 3
caries risk group profiles.
Caries experience is reported to be a very
important predictor for caries risk assessment.
Seen from a Greenlandic point of view, selection bias is found in this study, because the
caries experience in the study group
(mean=3.06  4.26) was about half of that
for the population of Greenlandic 6-year-olds,
which in 2012 was 6.67  10.58 (KE, Frank
Senderovitz, Chief dental officer in Greenland, Personal communication). This difference in caries experience is in fact logical and
can be related to the inclusion criteria, where
the children in our sample should not have
occlusal fillings in at least three of eight molar
teeth, remembering that occlusal fillings very
often are made as an extension of an approximal filling. Thus, the caries progression rate
in our sample seems to be slower than the
general tendency among children in Greenland. On the other hand, the caries progression rate in our sample seems more to
resemble the caries progression rate among
children in the western society. According to
the registration of the mean d3ef-s in 2012,
the figures for 5- and 7-year-olds in Denmark
are 1 and 2, respectively.
The results of pairwise radiographic comparison of this study indicate that resin infiltra-

tion plus fluoride varnish of initial occlusal

lesions in the primary dentition is significantly
more efficacious after 2 years in arresting
lesion progression in comparison with fluoride
varnish alone. In addition, sealing plus fluoride varnish of the lesion had a borderline significant better effect in stabilizing the lesion
progression than fluoride application only.
The clinical therapeutic effects of the infiltration plus fluoride varnish and the sealing plus
fluoride varnish were superior to that of fluoride alone. It is worth noticing that the radiographic lesion depth at the baseline was not
equally distributed among the groups in this
study. Infiltrated and sealed lesions had deeper lesion depth on the radiographs than the
lesions treated with fluoride varnish only
(Table 1). Despite the diversity in the lesion
depth between the groups, infiltration and
sealing were more effective in arresting lesion
progression than fluoride varnish.
Lesion progression in infiltrated or sealed
lesions may occur in the case of deficient
penetration of the infiltrant/resin in the pores
present in active caries lesions. Phosphoric
acid 3537% is used for sealing whereas
hydrochloric acid 15% is recommended for
use in the infiltration technique. Normally,
the highly mineralized enamel superficial
layer is present in caries lesions and acts as a
barrier for the resin and infiltrant. The retention of sealing and infiltration materials is
adequate when the enamel surface is etched
and dehydrated by absolute alcohol (99.6%).
Moreover, it is shown in several studies that
the surface zone of the proximal lesion has to
be removed with, for instance, 15% HCl, thus
enabling the infiltrant material to adequately
penetrate the pores in the lesion2224. In a
recent in vitro study by Paris et al.24, it was
demonstrated that penetration depth of the
infiltrant in primary molars is statistically better than in permanent molars this could
explain the difference found between the
infiltration and the sealing methods in this
study, keeping in mind that the tooth type,
tooth side, and jaw type had no significant
influence on the results. On the other hand,
the etching was twice longer in the infiltration technique than it was with the sealing
method when two different acids were used.

2014 BSPD, IAPD and John Wiley & Sons A/S. Published by John Wiley & Sons Ltd

Treatment of initial occlusal lesions in primary teeth

In this study, the recommended procedures

by the manufacturers were used.
In the primary dentition, the lesions occur
most frequently at the approximal surfaces,
followed by the occlusal surfaces. Studies
have shown that progression of initial approximal lesions can be arrested by secondary
prophylactic approaches such as sealing and
infiltration.
In conclusion, the infiltration technique
plus fluoride varnish showed a high and significant effect in arresting caries progression
of the initial occlusal caries lesions in primary
molar teeth, whereas sealing plus fluoride
varnish has a superior effect to fluoride application alone. The null hypothesis is, therefore, accepted regarding the I+F group
compared with the F group but rejected for
the S+F compared with F group. Infiltration
plus fluoride varnish may be used as a treatment of initial occlusal caries lesions in children with moderate to high caries risk. When
an approximal surface is chosen to be treated
with infiltration, the same material can be
used on the occlusal surface as primary or
secondary prevention. This also applies to the
sealing technique.

Why this article is important to pediatric dentists?

Infiltration, sealing, and fluoride varnish are commonly used approaches for the treatment of approximal lesions.
Infiltration and sealing combined with fluoride varnish are efficacious in arresting progression of occlusal
caries lesions in primary molars.
It will be beneficial for clinicians to use the same
material for treatment of initial approximal and occlusal lesions.

Acknowledgements

The author wish to acknowledge DMG

(Chemisch-Pharmazeutische Fabrik GmbH,
Hamburg, Germany) for the financial support
and the sponsored material used in this study.
Conflict of interest

The authors declare that they have no conflict

of interest.

49

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