Journal of Dentistry 74 (2018) 49–55

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Journal of Dentistry
journal homepage: www.elsevier.com/locate/jdent

Efficacy of sealing occlusal caries with a flowable composite in primary T

molars: A 2-year randomized controlled clinical trial
Kairon Ribeiro Diasa, Carolina Barbosa de Andradea, Taíssa Tomaz Waitb, Raiane Chamonb,e,
Michelle Mickael Ammaric, Vera Mendes Sovierod,f, Leandro Lobob, Aline de Almeida Nevesa,
⁎
Lucianne Cople Maiaa, Andréa Fonseca-Gonçalvesa,
a
Department of Pediatric Dentistry and Orthodontics, School of Dentistry, Universidade Federal do Rio de Janeiro, Rio de Janeiro, RJ, Brazil
b
Department of Medical Microbiology, Professor Paulo de Góes Institute, Universidade Federal do Rio de Janeiro, RJ, Brazil
c
Department of Specific Training, School of Dentistry, Universidade Federal Fluminense, Nova Friburgo, RJ, Brazil
d
Department of Preventive and Community Dentistry, School of Dentistry, Universidade do Estado do Rio de Janeiro, Rio de Janeiro, RJ, Brazil
e
Department of Pathology, School of Medicine, Universidade Federal Fluminense, Niterói, RJ, Brazil
f
School of Dentistry, Faculdade Arthur Sá Earp Neto (FASE), Petropólis, RJ, Brazil

A R T I C LE I N FO A B S T R A C T

Keywords: Objectives: This randomized controlled clinical trial evaluated the efficacy of sealing carious dentin in control-
Pit and fissure sealants ling the progression of lesions in primary molars for 2-year follow-up.
Dental caries Materials and methods: Children (6.79 ± 1.81 years, n = 28) presenting primary molars with occlusal caries in
Primary teeth the outer half of dentine were randomized and allocated into 2 groups: test (sealing caries with a flowable resin –
Caries lesion
SC) and control (partial removal of caries followed by restoration – PRC). The primary outcomes were: the
Partially excavation
clinical success of restorations evaluated by USPHS criteria and the radiographic analysis of caries progression.
Flowable resin
The children anxiety was evaluated by a Facial Image Scale; and the time required to perform the treatments was
registered.
Results: In 21 patients evaluated after 2 years, 48 primary molars were analyzed. Clinically, there was no dif-
ference between the groups. There was no difference between treatments (p = 0.848) considering lesion pro-
gression. The anxiety level did not change after the two interventions (p = 0.650). The treatment time of SC
(9.03 ± 1.91 min) was lower (p = 0.002) than the PRC time (17.13 ± 5.26 min).
Conclusion: Sealing carious dentin may be used in dentistry since it did not alter the children anxiety, reduced
the chair time and demonstrated clinical success rate and no radiographic difference in relation to the partial
caries removal followed by restoration.

1. Introduction There is scientific evidence for the benefits of sealing caries as a

Studies have shown that the conventional restorative technique
where carious dentine is totally removed, should be replaced by a more
conservative removal of decayed tissue followed by the restoration
[1,2]. Moreover, there is a growing demand, especially in children, for
even less invasive techniques [3], due to difficulties in the management
of children’s behavior during restorative dental appointments [4]. Thus,
a restorative treatment that requires less time during its clinical pro-
cedure would become interesting for these patients. Some clinical stu-
dies [3–6] have already investigated less invasive treatments of carious
deciduous teeth. Among them, sealing of caries [4,7] is a technique that
recommends covering the carious tissue extending up to the outer half
of dentin with resin-based sealants [8].
preventive approach [9–11]. However, when indicated as a therapeutic
treatment [4,7,8], more clinical studies are need. In a recent clinical
trial [4], the authors observed the efficacy of a pit and fissure resin-
based sealant in arresting dentinal caries lesions compared to partial
excavation (control) and restorative treatment in primary molars.
However, although they stated that no caries progression was registered
on the radiographic evaluations of teeth that have their caries sealed,
the control group showed significantly better clinical survival rate after
18 months of follow-up. Truly, while the sealant remains adhered to the
tooth surface, the lesion is arrested [4].
According to Feigal and Donly [12] there is a failure rate of sealants
range from 5% to 10% each year. Without appropriate clinical follow-
up, previously sealed surfaces will be equally susceptible to caries as

⁎
Corresponding author at: Rua Rodolpho Paulo Rocco, 325, CEP: 21941-91, Brazil.
E-mail address: andrea.goncalves@odonto.ufrj.br (A. Fonseca-Gonçalves).

https://doi.org/10.1016/j.jdent.2018.05.014
Received 12 November 2017; Received in revised form 16 May 2018; Accepted 21 May 2018
0300-5712/ © 2018 Elsevier Ltd. All rights reserved.
K.R. Dias et al.
surfaces that were never sealed [12,13]. Thus, a more resistant sealant
to masticatory wear would benefit the sealing caries treatment. Re-
cently, Shinkai et al. [14] affirmed that flowable are resin materials
indicated as cavity liners, fissure sealants and restorative material for
small cavities. According to a recent study [14], flowable resin is
equivalent to universal resin composites in resistance to tooth wear.
Therefore, the aim of this study was to investigate the efficacy of sealing
dentin caries with a flowable resin by comparison with partial caries
removal followed by composite restoration in primary molars. The null
hypotheses of this study were that the clinical and radiographic success
of sealing caries with a flowable resin would not be different from
partial caries removal followed by restoration in children with dentin
caries lesion in deciduous molars.
2. Materials and methods
2.1. Ethics
The Research Ethics Committee of the Clementino Fraga Filho
Hospital of the Federal University of Rio de Janeiro gave the approval
of the present study (protocol #244-14; trial registration no.
NCT02584218). Parents gave also written consent for children to par-
ticipate after being informed of the aims of the study.
2.2. Study design
This controlled randomized clinical trial was conducted in the pe-
diatric dental unit of the Federal University of Rio de Janeiro (UFRJ).
Between September 2014 and June 2015, one trained examiner re-
cruited 28 children (3–8 years old) with primary molars (n = 57)
showing occlusal caries extending up to the outer half of dentin tissue,
confirmed by interproximal radiograph exam. Children were rando-
mized by a block design using a coin tossing system, with allocation
concealment (through a sequentially numbered, white, sealed envel-
opes) into 2 arms: the test group (children who received the sealing
caries treatment with a flowable resin), and the control group (children
where partial caries removal was followed by composite restoration and
flowable resin). When more than one tooth per child fulfilled the in-
clusion criteria, all of them received the same treatment, keeping the
parallel design of the study. This trial followed the CONSORT re-
commendations [15]. Moreover, this is an interim study with a 24
months follow-up. Details of primary and secondary outcomes criteria
are presented in Table 1.
2.3. Participants and recruitment
Children aged 3 to 8 years, who sought the first time dental care at
the Pediatric Dental Unit of UFRJ, were selected after a complete
anamnesis, clinical and radiographic examination by one operator
(KRD), who was trained and calibrated for the caries assessment ac-
cording to dmft/DMFT indexes [16] (inter examiner Kappa
value = 0.91). Examinations were performed after a complete profes-
sional cleaning of the children’s teeth. Inclusion criteria for the tooth
were: opening of the occlusal cavity limited to 1.5 mm diameter mea-
sured with a millimeter probe, and lesion limited radiographically to
the outer half of the dentin. Exclusion criteria at the tooth level were
the presence of cavities or restorations in other surfaces. Children were
also excluded if they had carious lesions affecting other teeth than the
deciduous molars; signs or symptoms of pulpal or perirradicular pa-
thology (including pain) in any tooth; or if they were unable to co-
operate during the clinical appointments.
2.4. Sample size
Sample size was calculated based on the difference in the proportion
of clinical success (one of the main outcome) observed in the only one
50
Journal of Dentistry 74 (2018) 49–55
previous similar study [4], since no caries progression (main outcome)
was verified by these authors after 18-months follow-up. Assuming a
difference of proportions of 35% between test and control groups, based
on a two-sided test, considering a power of 80% and α = 0.05%, a
sample size of 17 tooth allocated into each group of treatment was
required to complete the study. With the estimative of 20% of drop out,
at least 21 teeth for each group should be selected.
2.5. Baseline assessments
The selected children received a professionally tooth cleaning with
pumice and rotating brushes, and air-dried before assessment of their
caries status. The caries risk was performed by one trained and cali-
brated examiner (KRD), using the form based on Cariogram® software
[17]. Thus, the patient’s risk was classified as low, moderate, and high
risk of caries [18], considering the following variables of assessment:
dmft/DMFT index [16] (kappa inter value = 0.91); visible plaque index
[19] (Kappa inter value = 0.73); dietary habits; and exposition to
fluoride. The same examiner (KRD) interviewed the parents to assess
the remaining data of the caries risk form.
Routinely, every child who presented clinically detected carious
lesions was referred to radiographic examination. Radiographs were
taken with individualized film-holders (Silicon bite registers) by a
single operator using Express™ digital x-ray system (Instrumentarium,
Finland) and Spectro 70× Seletronic equipment (Dabi Atlante, Brazil).
After processing, the digital radiographic images were stored using
CliniView™ software (Version 9.3.0).In this study, from 190 potentially
eligible children aged 3–9 years diagnosed with occlusal caries that
would be possibly included in the research, 152 were excluded because
they did not meet the inclusion criteria (95 caries lesions presented the
opening of occlusal cavity bigger than 1.5 mm; and 57 had cavities or
restorations in other surfaces, which most of them were detected after
the radiograph examination), 3 because their parents declined to par-
ticipate, and 7 were excluded because they would not cooperate during
the clinical appointments.
2.6. Randomization and intervention
In order to balance test (sealing) and control (partial caries re-
moval + composite restoration) groups, patients were first stratified in
two clusters paired by caries risk. Secondly, each cluster was allocated
into test or control group using a coin tossing system. The allocation
concealment was guaranteed by a sequentially numbered, white and
sealed envelopes distributed by a third investigator (AL) not involved
with the clinical assessment or with data analysis.
Children from both test and control groups and their parents were
periodically (every three month) instructed regarding oral health care
including dental floss usage, low sugar intake, and tooth brushing with
fluoridated toothpaste after meals.
Patients from the test group had their teeth sealed according to the
following protocol: (a) cleaning occlusal surface with pumice; (b) local
anesthesia; (c) application of rubber dam; (d) 37% phosphoric acid
application on the occlusal surface for 15 s; (e) rinsing and drying the
surface; (f) application of adhesive system (Adper Single Bond 2, 3 M
ESPE, Saint Paul, USA), following the manufacturer’s instructions
which was light cured for 20 s; (g) resin Filtek Flow (3 M ESPE, Saint
Paul, USA) was applied on the whole occlusal surface and cured for
20 s; (h) occlusion checked and adjusted when necessary.
Patients from the control group had their teeth restored according to
the following protocol: (a) cleaning occlusal surface with pumice; (b)
local anesthesia; (c) application of rubber dam; (d) cavity was opened
in enamel with a diamond bur in high speed (when it was necessary);
then caries lesion was completely removed at the enamel/dentin
junction, and dentin caries lesion was partially removed with hand
instruments until the dentin started to become ‘firm and leathery’ [4];
(e) 37% phosphoric acid was applied in the cavity for 15 s; (f) rinsing
K.R. Dias et al.
Table 1
Outcome criteria for all procedures: assessments in the 2 treatment arms (sealing caries and partial caries removal followed by restoration).
and drying the surface; (g) application of adhesive system (Adper Single
Bond 2, 3 M ESPE, Saint Paul, USA), following the manufacturer’s in-
structions which was light cured for 20 s; (h) restoration with composite
resin (Z250, 3 M ESPE, Saint Paul, USA), using the incremental tech-
nique until cavity was filled and light cured of each increment for 20 s;
(i) resin Filtek Flow (3 M ESPE, Saint Paul, USA) was applied on the
whole occlusal surface and cured for 20 s; (h) occlusion checked and
adjusted when necessary.
2.7. Outcomes and follow-up
Recall examinations were performed with 3-6-12-24 month inter-
vals. The primary outcomes were the clinical success and the proportion
of radiographic caries progression in the test group in comparison with
the control group. Clinical evaluation of the teeth was performed using
the USPHS criteria [20] (Table 2). This exam was conducted by an
experienced examiner (LCM) who was blinded in relation to the treat-
ment.
Digital radiographs were taken at baseline and repeated after 6,12
and 24 months. Pair-wise reading of radiographs was assessed by two
trained and calibrated evaluators (AFG, MMA), who were trained by a
“gold standard” examiner (VMS), (kappa interexaminer value = 0.90).
The outcome variable was the caries progression status (absence or
presence of caries progression), regarding chronological order of the
radiographs. The examiners were also blinded in relation to the studied
groups. No digital filters were used at this stage.
A facial image scale [21] was the first secondary outcome evaluated
before and after each treatment. The scale was presented for all chil-
dren by the examiner (KRD) and the child was asked to point his/her
feeling at that moment (immediately before treatment): very happy;
happy; neutral; unhappy; and very unhappy). Directly after treatment,
the child pointed again which figure more resembled what he/she was
feeling. The treatment time between the two techniques was also as-
sessed by a digital timer and the timer was triggered after the dental
element was properly isolated with rubber dam and locked after the
rubber dam was removed.
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Journal of Dentistry 74 (2018) 49–55
2.8. Statistical analysis
All data were analyzed in SPSS 20.0 (SPSS Inc, IL, USA). Chi-square
test was used to verify the distribution of characteristics variables of the
sample among the groups. Fisher exact test was used to analyze the
statistical differences between the groups considering the following
outcomes: clinical assessment and the change in children’s anxiety.
Since more than one tooth could be chosen from one child, the gen-
eralized estimated equations (GEE) approach was used to adjust for the
clustering effect of the radiographic progression of caries. Therefore,
the child was handled as their own cluster for the correlation (clus-
tering) between observations of multiple teeth. Change in the child’s
anxiety was measured using Chi-square test by evaluating the feeling
variation (before and after the treatment) as: positive change; no
change; or a negative change. The comparison of treatment time was
evaluated by the use of the Student-t test. The level of significance
considered for all tests was 5%.
3. Results
Of the 28 children (mean age = 6.79 ± 1.81) allocated into the
groups, 15 were male (53.6%) and 13 were female (46.4%). The overall
baseline dmft/DMFT value was 5.56 ± 2.51 and children had 54.4% of
their teeth with visible plaque. A total of 57 caries lesions were treated,
thus all treatments were completed as designed; 29 (50.9%) of them
received the test treatment (caries sealing) and 28 (49.1%) received the
control treatment. Considering all teeth, 10 (17.5%) were first primary
molars and 47 (82.5%) were second primary molars; 25 (43.9%) were
placed in the upper jaw and 32 (56.1%) in the lower jaw. No difference
(p = 0.453) was observed between the number of lower or upper mo-
lars in the test and control group (Table 3).
One child from the test group with 2 teeth and six children (7 teeth)
from control group represented the drop-out of the study. Of the pa-
tients (n = 21) that completed 24-month follow-up, 48 teeth were
evaluated. A flow diagram (Fig. 1) shows: number of children, number
of teeth allocated to the test and control groups, number of drop-outs
patients at the four evaluation times.
Clinically, all evaluated teeth received score Alfa or Bravo after 3, 6
K.R. Dias et al. Journal of Dentistry 74 (2018) 49–55

Table 2
United States Public Health Service (USPHS) Ryge Criteria for Direct Clinical Evaluation of Restoration.

Scores USPHS criteria

Color Match
Alfa (A) There is no mismatch in color, shade, and/or translucency between restoration and the adjacent teeth structure
There is a mismatch between restoration and adjacent tooth structure, but not outside the normal range of tooth color ,
Bravo (B)
shade and/or translucency
There is a mismatch between restoration and adjacent tooth structure outside the normal range of tooth color , shade
Charlie (C)
and/or translucency
Cavo Surface Marginal Discoloration
Alfa (A) No discoloration anywhere on the margin between the restoration and the tooth structure
Bravo (B) Presence of discoloration that does not penetrate along the margin of the restorative material in a pulp direction
Charlie (C) Presence of discoloration that penetrates along the margin of the restorative material in a pulp direction
Anatomic form
Alfa (A) The restoration is not under-contoured (i.e. The restorative material in not discontinuous with existing anatomic form)
Restoration in discontinuity with the original anatomical shape (missed material), but the dentin or base material are not
Bravo (B)
exposed
Charlie (C) Restoration in discontinuity with the original anatomical shape (missed material), with exposure of dentin or base material
Marginal adaptation
Alfa (A) Absence of visible cracks in the restoration margins where the explorer can penetrate
Bravo (B) Presence of visible cracks in the restoration margins where the explorer penetrates, but the dentin / base are not exposed
Presence of visible cracks in the restoration margins where the explorer can penetrate, but the restoration has no mobility,
Charlie (C)
fracture or partial loss
Delta (D) The restoration is mobile, fractured or missed in part or in total
Secondary Caries
Absence of caries in the margins of restorations (The restoration is a continuation of existing anatomic form adjacent to the
Alfa (A)
restoration)
Presence of caries in the margins of restorations (There is evidence of dark keep discoloration adjacent to the restoration -
Bravo (B)
but not directly associated with cavosurface margins)

and 12-months follow-up for “color match”, “cavo surface marginal
discoloration”, “anatomic form”, and “marginal adaptation” criteria.
Clinical success was also observed after 24-month follow-up in relation
to all USPHS criteria. After 24-months follow-up, only three teeth (2
from test group and 1 from the control group; p = 0.595) were scored
as Charlie for “anatomic form” and for “marginal adaptation”, 2 teeth
from the test group were classified as Charlie and 1 as Delta in the
control group (p = 0.595). No difference between groups was also ob-
served after 24 months for “Secundary caries criterium” (p = 0.689)
(Table 4).
Radiographically, at 24 month, progression of lesions in children
that received the test treatment was not different compared with those
that received the control treatment (odds ratio [OR], 1.29; 95% con-
fidence interval [CI], 0.09–18.93; p = 0.848). Only two lesions pro-
gressed to the half of dentin tissue, after 24 months, one from test group
and other from control group.
According to the Facial Image Scale [21] analyses, no difference
between treatments was observed (p = 0.650). “No change” of the child
anxiety was detected in the majority of children after both treatments
(14 sealing caries/14 controls). A positive change was verified after 6
treatments of sealing caries, and also after 4 control treatments. The
“negative change” of the child anxiety was perceived after 26.9% of
treatments, (9 sealing caries/5 controls). Furthermore, the mean time
required for the sealing procedure was 9.03 ± 1.91 min; whereas
17.13 ± 5.26 min was the mean time to treat the lesions by partial
caries removal followed by restoration (p = 0.002).
4. Discussion
The previous study on the efficacy of sealants to arrest occlusal
caries in dentin has been conducted with the use of a resin-based
fluoride-releasing pit and fissure sealants in children or adults [4],
while studies in which flowable resins were used as a sealant of carious
dentin in primary molars were not found. In the present study, a more
resistant material against masticatory wear was used to seal occlusal
dentin caries. In fact, it has recently been proposed [14] that flowable
resin composites would be equivalent to universal resin composites in
resistance to tooth wear. Thus, in the present study the authors adopted
a flowable resin in the test group.
In consideration of the fluoride release of dental material, a fluoride-
releasing pit and fissure sealant could be considered better than a flow-
able resin in the prevention of caries. However, despite of the advantage
of fluoride release, a synergistic effect of the combination of fluoride
vehicles would not be expected [26]. In fact, there is no evidence of a
synergistic or additive effect when fluoride vehicles are used in combi-
nation [27]. Thus, no significant additive effect would be expected if
fluoride-releasing dental materials are used in a subject who brushes his/
her teeth at least twice/day with dentifrice containing fluoride [26].
Moreover, in the present clinical trial, the authors used adhesive
system and resin composite to restore just experimental/control molars,
with all the occlusal surfaces sealed with a flowable resin. According to
Bakhshandeh et al. [8] this procedure is perfectly indicated to increase
the sealant longevity, since microleakage may occurs more frequently

Table 3
Distribution of the included children (whole sample), with their respective molars and archs, according to the treatment groups.
Age (mean ± SD) Gender%(n) Molar %(n) Arch%(n) Arch side%(n)

female Male first second upper lower right left

a a a a a a a a
Main Group (sealing of caries) 7.15 ± 1.95 64.3(9) 35.7(5) 6.9(2) 93.1(27) 58.6(17) 41.4(12) 44.8(13) 55.2(16)a
Control Group (partial removal of caries followed by restoration) 6.73 ± 1.48a 42.9(6)a 57.1(8)a 28.6(8)b 71.4(20)a 46.4(13)a 53.6(15)a 50.0(14)a 50.0(14)a

Note: Different letters in the same column represent statistically significant results.

52
K.R. Dias et al. Journal of Dentistry 74 (2018) 49–55

Fig 1. Consort flow diagram of the trial.

Table 4
Clinical results of caries sealing (test group) and partial removal of caries followed by restoration (control group) after 3, 6, 12 and 24-months follow-up.
USPHS criteria Outcome Score 3 months 6 months 12 months 24 months p value*
assessment
Test group Control group Test group Control Test group Control Test group Control
(n = 29) (n = 23) (n = 29) group (n = 29) group (n = 27) group
(n = 23) (n = 23) (n = 21)

Color Match Success Alfa 26 23 26 23 26 23 25 21 –

Bravo 3 0 3 0 3 0 2 0
Insuccess Charlie 0 0 0 0 0 0 0 0

Cavo Surface Marginal Success Alfa 27 23 27 20 27 20 26 20 –

Discoloration Bravo 2 0 2 3 2 3 1 1
Insuccess Charlie 0 0 0 0 0 0 0 0

Anatomic form Success Alfa 29 23 29 23 27 22 25 20 0.595

Bravo 0 0 0 0 2 1 0 0
Insuccess Charlie 0 0 0 0 0 0 2 1

Marginal adaptation Success Alfa 29 23 29 23 27 22 25 20 0.595

Bravo 0 0 0 0 2 1 0 0
Insuccess Charlie 0 0 0 0 0 0 2 0
Delta 0 0 0 0 0 0 0 1

Secondary Caries Success Alfa 29 23 29 23 29 23 26 20 0.689

Insuccess Bravo 0 0 0 0 0 0 1 1

Note: USPHS – United States Public Health Service Criteria [Cvar and Ryge, 2005].
* P value < 0.05 represent differences between the groups considering 24-month time point; since no cases of insuccess were detected for all criteria before 24
months.

around sealed carious lesions than sealed sound surfaces. Thus, the After 18-month follow-up, Hesse et al. [4] found a significant clin-
authors of this study opted to seal the entire occlusal surface. Moreover, ical failure of molars that were sealed compared to those included in the
only lesions smaller than 1.5 mm of diameter were included. control group (partial removal of caries followed by restoration). In our

53
K.R. Dias et al.
study, we observed a clinical and radiographic success of the sealing
caries treatment after 24-months follow-up. However, the authors have
full awareness that patient should be monitored for a long period, to
assert that the clinical success and no progression of caries were
achieved. In addition, Poulsen et al. [28] affirmed that re-treatments of
sealants were more frequent on second molars than first molars; exactly
as in the present study, since 91.3% of the teeth included in the test
group were second molars. Thus, it reinforces a continued follow-up.
In the present study, pair-wise reading of radiographs after 24-
months revealed that one caries lesion (3.7%) progressed in the test
group and other (4.8%) in the control group. This result was different
from a similar study [4], since no caries progression was observed by
these authors even after 18-month follow-up. However, a previous trial
[8] also showed a radiographic progression of lesions (7.5%) that were
considered with a perfect retention. Although a cavitation was not
observed clinically, the present authors indicated the partial caries re-
moval followed by restoration in the seal case and a new restoration in
the control group. In addition, more studies are needed to elucidate this
issue.
A Facial Image Scale [21] was used to compare, in both groups, a
possible change in the child anxiety over the employed treatments. This
instrument is indicated for children who lack the ability either to re-
cognize or interpret manifestations of anxiety or to answer ques-
tionnaires [29]. The authors observed no difference between the test
and control group, considering this outcome. Actually, in 68.9% of
sealing treatment, and 64.3% of partial caries removal followed by
restoration, the children showed no change or a positive change of their
feelings. De Menezes et al. [29] also observed similar results when
compared the dental anxiety of children, by the use of the same scale,
submitted to 3 different treatments: atraumatic restorative treatment,
ultraconservative treatment (partial caries removal without anesthesia,
drill and rubber dam) and conventional treatment (total caries removal
with drill, but without rubber dam and not all the cases were performed
under anesthesia). We did not find in the literature any clinical trial that
assessed the child anxiety when their dentin caries lesions were sealed.
However, no difference between the groups was expected, since in both
groups, children were anesthetized, and the rubber dam isolation was
performed, which were considered the most likely managements that
would adversely affect children's attitude about the treatment.
A considerable difference was found among the groups regarding
the time required to treat. Taking in mind that the chair time of a child
is a variable that influence his/her behavior, the present results should
be highlighted, since the mean time in test group was lower than in the
control group. The mean time for sealing caries in a previous study was
similar to our study [30].
Although the present study is registered at the Clinical Trials web-
site with a follow-up of 36 months, it is important to emphasize that
this research is an interim analysis with 24 months follow-up.
According to Stephens et al. [33], there are specific circumstances
where releasing interim results will enable challenging trials to be
completed successfully, such as: 1) short-term interventions are used,
meaning that disclosure of interim results would not impact on the
treatment of current patients, and trial comparisons; 2) a sufficient
number of reliable outcomes are available in order to make compar-
isons. The present study performed a short-term intervention and the
primary outcomes were similar to other published trials [4,8].
It is still important to mention that at 80% power, if we had found
difference in the main outcomes, the sample size would be sufficient.
However, we did not have the 35% difference as initially suspected. So,
hypothetically, if such a difference existed, it might even be smaller, but
imprecision is a fact. We have much less power to detect any difference
between groups. However, we must highlight that the present result
will be extremely useful for the elaboration of future meta-analyzes.
54
Journal of Dentistry 74 (2018) 49–55
5. Conclusions
The results demonstrated that caries sealing technique performed on
the outer half of carious dentin may be used in dentistry since in this
study this treatment did not alter the children anxiety, reduced chair
time and demonstrated clinical success rate and no radiographic pro-
gression of caries compared to the partial caries removal followed by
restoration.
Clinical relevance
This study shows that sealing caries with a flowable composite is
effective to arrest dentin caries lesion and did not alter the children
anxiety. In addition, sealing carious dentin may be used in dentistry
since it reduced the chair time and demonstrated clinical success rate.
Acknowledgement
The authors thank 3M-ESPE to provide the composite resins.
References
[1] D.N. Ricketts, E.A. Kidd, N. Innes, J. Clarkson, Complete or ultraconservative re-
moval of decayed tissue in unfilled teeth, Cochrane Database Syst. Rev. 3 (2008)
CD003808.
[2] D. Ricketts, T. Lamont, N.P. Innes, E. Kidd, J.E. Clarkson, Operative caries man-
agement in adults and children, Cochrane Database Syst. Rev. 3 (2013) CD003808.
[3] R.M. Santamaria, N.P. Innes, V. Machiulskiene, D.J. Evans, C.H. Splieth, Caries
management strategies for primary molars: 1-yr randomized control trial results, J.
Dent. Res. 93 (2014) 1062–1069.
[4] D. Hesse, C.C. Bonifacio, F.M. Mendes, M.M. Braga, J.C.P. Imparato, D.P. Raggio,
Sealing versus partial caries removal in primary molars: a randomized clinical trial,
BMC Oral Health 14 (2014) 58.
[5] A.C. Hyde, H.J. Rogers, H.A. Batley, A.G. Morgan, C. Deery, An overview of pre-
formed metal crowns. part 2: the hall technique, Dent. Update 42 (2015) 939–942.
[6] M. Mijan, R.G. de Amorim, S.C. Leal, J. Mulder, L. Oliveira, N.H. Creugers,
J.E. Frencken, The 3.5-year survival rates of primary molars treated according to
three treatment protocols: a controlled clinical trial, Clin. Oral Investig. 18 (2014)
1061–1069.
[7] B.C. Borges, J. de Souza Borges, R. Braz, M.A. Montes, I.V. de Assunção Pinheiro,
Arrest of non-cavitated dentinal occlusal caries by sealing pits and fissures: a 36-
month: randomised controlled clinical trial, Int. Dent. J. 62 (2012) 251–255.
[8] A. Bakhshandeh, V. Qvist, K.R. Ekstrand, Sealing occlusal caries lesions in adults
referred for restorative tratment: 2–3 years of follow-up, Clin. Oral Invest. 16
(2012) 521–529.
[9] J. Hou, Y. Gu, L. Zhu, Y. Hu, M. Sun, H. Xue, Systemic review of the prevention of
pit and fissure caries of permanent molars by resin sealants in children in China, J.
Investig. Clin. Dent. 8 (2017), http://dx.doi.org/10.1111/jicd.12183.
[10] A. Azarpazhooh, P.A. Main, Pit and fissure sealants in the prevention of dental
caries in children and adolescents: a systematic review, J. Can. Dent. Assoc. 74
(2008) 171–177.
[11] J. Beauchamp, P.W. Caufield, J.J. Crall, K. Donly, R. Feigal, B. Gooch, A. Ismail,
W. Kohn, M. Siegal, R. Simonsen, Evidence-based clinical recommendations for the
use of pit-and-fissure sealants: a report of the American Dental Association Council
on Scientific Affairs, J. Am. Dent. Assoc. 53 (2009) 131–147.
[12] R.J. Feigal, K.J. Donly, The use of pit and fissure sealants, Pediatr. Dent. 28 (2006)
143–150.
[13] G. Botton, C.S. Morgental, M.M. Scherer, T.L. Lenzi, A.F. Montagner, R.O. Rocha,
Are self-etch adhesive systems effective in the retention of occlusal sealants? A
systematic review and meta-analysis, Int. J. Paediatr. Dent. 26 (2016) 402–411.
[14] K. Shinkai, Y. Taira, S. Suzuki, M. Suzuki, In vitro wear of flowable resin composite
for posterior restorations, Dent. Mater. J. 35 (2016) 37–44.
[15] D. Moher, K.F. Schulz, D.G. Altman, CONSORT Group (Consolidated Standards of
Reporting Trials), The CONSORT statement: revised recommendations for im-
proving the quality of reports of parallel-group randomized trials, J. Am. Pediatr.
Med. Assoc. 91 (2001) 437–442.
[16] World Health Organization (WHO), Oral Health Surveys. Basic Methods, World
Health Organization, Geneva, 1997.
[17] S. Paris, R. Haak, H. Meyer-Lueckel, Diagnostics, treatment decision and doc-
umentation, in: H. Meyer-Lueckel, S. Paris, K. Ekstrand (Eds.), Caries management:
science and clinical practice, 1st ed., Thieme, New York, 2013(P. 332).
[18] K.R. Dias, C.B. Andrade, T.T.A. Wait, R.C. Chamon, K.R.N. Dos Santos,
V.M. Soviero, L.C. Maia, A. Fonseca-Gonçalves, Influence of the microbiological
component of Cariogram(®) for evaluating the risk of caries in children, Acta
Odontol. Scand. 6 (2017) 1–7.
[19] A. Ribeiro ADE, M. Portela, I.P. Souza, Relation between biofilm, caries activity and
gingivitis in HIV+ children, Pesqui. Odontol. Bras. 16 (2002) 144–150.
[20] J.F. Cvar, G. Ryge, Reprint of criteria for the clinical evaluation of dental restorative
materials. 1971, Clin. Oral Investig. 9 (2005) 215–232.
K.R. Dias et al.
[21] H. Buchanan, N. Niven, Validation of a Facial Image Scale to assess child dental
anxiety, Int. J. Paediatr. Dent. 12 (2002) 147–152.
[26] J.A. Cury, B.H. de Oliveira, A.P. Dos Santos, L.M. Tenuta, Are fluoride releasing
dental materials clinically effective on caries control? Dent. Mater. 32 (2016)
323–333.
[27] V.C. Marinho, J.P. Higgins, A. Sheiham, S. Logan, Combinations of topical fluoride
(toothpastes, mouthrinses, gels,varnishes) versus single topical fluoride for pre-
venting dental caries in children and adolescents, Cochrane Database Syst. Rev. 1
(2004) CD002781.
[28] S. Poulsen, L. Laurberg, M. Vaeth, U. Jensen, D. Haubek, A field trial of resin-based
and glass-ionomer fissure sealants: clinical and radiographic assessment of caries,
55
Journal of Dentistry 74 (2018) 49–55
Commun. Dent. Oral Epidemiol. 34 (2006) 36–40.
[29] D.M. De Menezes Abreu, S.C. Leal, J. Mulder, J.E. Frencken, Dental anxiety in 6–7-
year-old children treated in accordance with conventional restorative treatment,
ART and ultra-conservative treatment protocols, Acta Odontol. Scand. 69 (2011)
410–416.
[30] A.S. Goldman, X. Chen, M. Fan, J.E. Frencken, Methods and preliminary findings of
a cost-effectiveness study of glass-ionomer-based and composite resin sealant ma-
terials after 2 yr, Eur. J. Oral Sci. 122 (2014) 230–237.
[33] R.J. Stephens, R.E. Langley, P. Mulvenna, M. Nankivell, A. Vail, M.K. Parmar,
Interim results in clinical trials: do we need to keep all interim randomised clinical
trial results confidential? Lung Cancer 85 (2014) 116–118.