The Efficacy of Dental Sealant Used with Bonding Agent on Occlusal Caries

Accepted Article (ICDAS 2-4): A 24-Month Randomized Clinical Trial

P. Kasemkhun, S. Nakornchai, A. Phonghanyudh and N. Srimaneekarn

Running Head: Bonding prior to sealant on occlusal caries

Corresponding Authors:
Siriruk Nakornchai (S.N.)
Department of Pediatric Dentistry, Mahidol University
No.6, Yothi road, Ratchathewi District, Bangkok 10400, Thailand
siriruk.nak@mahidol.ac.th
Tel. 662-200-7821 Fax. 662-200-7820

Authors:
Pornpailin Kasemkhun (P.K.)
Department of Pediatric Dentistry, Mahidol University
No.6, Yothi road, Ratchathewi District, Bangkok 10400, Thailand

Araya Phonghanyudh (A.P.)

Department of Pediatric Dentistry, Mahidol University
No.6, Yothi road, Ratchathewi District, Bangkok 10400, Thailand

This article has been accepted for publication and undergone full peer review but has not been
through the copyediting, typesetting, pagination and proofreading process, which may lead to
differences between this version and the Version of Record. Please cite this article as doi:
10.1111/IPD.12758
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 Natchalee Srimaneekarn (N.S.)
Accepted Article
Department of Anatomy, Mahidol University
No.6, Yothi road, Ratchathewi District, Bangkok 10400, Thailand

Author contribution
- S.N. conceived the idea and study design
- P.K. collected data
- N.S. analysed the data
- S.N., P.K., A.P. interpreted data and led the writing

Acknowledgement
The authors would like to thank Dr. Panyada Naksukpan, the dentist at Nakhon Pathom
Provincial Public Health Office for her cooperation and assistance throughout the
study.

Word count: 3,212 words

Authorship
Conflict of interest: The authors declare that we have no conflict of interest.
Funding: None
Ethical approval: This clinical study was performed in human participants. All

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 procedures were approved by Faculty of Dentistry/Faculty of Pharmacy, Mahidol
Accepted Article
University, Institutional Review Board (research code: MU-DT/PY-IRB 2017/DT114).
Trial Registration: Thai Clinical Trials Registry Identification number:
TCTR20190106003
Informed consent: Assent for children and informed consent from their parents were
obtained from all participants included in the study.

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Accepted Article
DR. SIRIRUK NAKORNCHAI (Orcid ID : 0000-0002-4685-607X)

Article type : Original Article

The Efficacy of Dental Sealant Used with Bonding Agent on Occlusal Caries (ICDAS 2-4):
A 24-Month Randomized Clinical Trial

Abstract
Background
Bonding before sealant application enhances retention on saliva-contaminated sound teeth; however, there are few
studies of bonding’s efficacy on sealant retention on occlusal caries.
Aim
To evaluate a bonding agent’s efficacy on sealant retention on occlusal caries and caries-transition.
Design
One hundred twenty pairs of first permanent molars with occlusal caries (ICDAS 2–4) from 98 children aged 7.3–
9.9 years were included. One molar was randomly selected to use bonding (Adper™ Single Bond 2, 3M ESPE)

applied before sealant application (Helioseal clear, Ivoclar Vivadent). Bonding was not used on the contralateral
tooth. Retention was determined using Simonsen’s criteria, caries-transition was evaluated using ICDAS scores,
DIAGNOdent values, and bitewings at baseline, 6-, 12-, and 24-months. Data were analyzed with McNemar’s and
Fisher’s exact tests.
Results
Bonding agent use significantly increased sealant retention rates (p<.001). Bonded (B) sealants had a higher
retention rate (83.3%) than nonbonded (NB) sealants (53.7%). The difference in the caries-transition rate was not
significant between the groups (p>.05). Three teeth (1.4%; NB:B=2:1) were restored due to radiographic dentin-
caries progression.
Conclusions
Using a bonding agent before applying sealant on permanent molar occlusal caries (ICDAS 2-4) significantly
enhanced sealant retention. Caries progression was rarely detected at the 24-month follow-up.

Keywords: bonding agent, clinical trial, dental caries, dental sealant, retention

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Accepted Article
INTRODUCTION
Applying a sealant on non-cavitated caries is a non-operative treatment based on the principle of minimal
intervention dentistry, which aims to preserve tooth structure by reversing or arresting carious lesions and
postponing placing a restoration.1 The sealant acts as a physical barrier preventing plaque accumulation on carious
lesions, protecting the lesions against a new acid attack, consequently inhibiting lesion progression.2 Studies have
demonstrated that sealant application was effective in arresting non-cavitated occlusal lesions.3,4 Currently, applying
a sealant on localized enamel breakdown or micro-cavitated occlusal lesions has been evaluated and increasingly
performed.5-7
Sealant retention is the main criterion for resin-based sealant effectiveness. A previous study revealed that
there was a 5–10% sealant loss per year in sound teeth,8 however, the lowest retention percentage and highest need
for retreatment were in patients at a moderate to high risk for caries and those with demineralized or cavitated
carious lesions.9 An in vitro study found that a sound surface could be sealed better than a carious surface10 and that
the annual rate of caries progression was lower for sealed carious lesions compared with unsealed lesions.11
Using a bonding agent as an intermediate sealant layer has been demonstrated to be effective in enhancing
sealant retention, reducing microleakage, and increasing resin flow into the fissures of sound teeth with or without
saliva contamination.12-15 However, there is only one in vitro study of carious lesions demonstrating that the use of
bonding significantly enhanced the bond strength of a sealant compared with not using bonding.16
To our knowledge, no clinical trial has reported the efficacy of using a bonding agent prior to sealant
application on occlusal carious lesions. Therefore, the aim of the present study was to evaluate the efficacy of a
bonding agent in enhancing the retention rate of a resin-based sealant placed over occlusal caries in permanent
molars and the effect on caries transition. We hypothesized that there is no difference in sealant retention rate and
caries transition between using and not using a bonding agent prior to sealant application at a 24-month follow-up.
MATERIALS AND METHODS
The participants comprised 98 children (age range 7.3–9.9 years) from Nakhon Pathom Province in
Thailand. The study protocols and consent forms were approved by the Faculty of Dentistry/Faculty of Pharmacy,
Mahidol University, Institutional Review Board (research code: MU-DT/PY-IRB 2017/DT114). The purposes and
procedures of this clinical study were explained to all participants and their parents. Written informed consent was
obtained from the parents whose children met the criteria and an assent was given by the children.
The sample size was based on McCafferty et al.,17 which compared sealant retention rates between using
and not using a bonding agent on sound teeth. The sample size was calculated using McNemar's test of equality of
paired proportions ( = 0.05, 1- = 0.9). A sample size of 96 pairs was required, and anticipating a 25% dropout
rate; the total sample size was 120 pairs.
A randomized, controlled, split-mouth, single-blind study design was used. The inclusion criteria were
healthy and cooperative children who had at least one pair of fully erupted first permanent molars with ICDAS
scores 2–4 in functional occlusion. The teeth had no previous treatment, and the bitewing radiographs showed
radiolucent involvement of the outer-third of the dentin or less. Children who had defective tooth enamel or known
allergies to acrylics were excluded.

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 The procedures were conducted using standard dental units at the Nakhon Pathom Provincial Public Health
Accepted Article
Office. Two pediatric dentists served as evaluators and were trained in and used a standardized evaluation of clinical
and radiographic dental caries according to the ICDAS criteria. At baseline, the teeth were cleaned by toothbrushing
and dried by an air syringe. The teeth were examined using a standard dental unit light, a mouth mirror and a blunt
No. 5 dental explorer to detect any remaining plaque or debris, microcavitation, or sealant. The caries level was
assessed and recorded based on the ICDAS criteria and the DIAGNOdent Pen caries detection aid (KaVo,
Germany) following the manufacturer’s instructions. In addition, the simplified oral hygiene index (OHI-S) and the
decayed, missing, filled teeth (dmft/DMFT) index measurements were recorded.
Bitewing radiographs were taken using the Nomad Pro2 (KaVo, USA) Handheld X-ray System (60 kV,
2.5 mA, 0.6 s) with Kodak Ultra Speed dental films, held by bitewing tags for the upper and lower dentition, to
confirm the lesion depth. The examiners classified carious lesions as having no radiolucency present, having a
radiolucency at the dentino-enamel junction (DEJ) levels, or having a radiolucency limited to the outer-third of the
dentin.
The sealing procedures were performed by two different pediatric dentists from the examiners, assisted by
two dental assistants using four-handed dentistry. The dentists received clinical sealant placement training before the
study began following the standard protocols. One of the teeth that met the inclusion criteria was randomly selected
for bonding prior to application of a sealant by drawing lots, and the contralateral tooth served as a control tooth.
After the teeth were cleaned with pumice using rubber cups in a slow-speed handpiece, moisture control
was maintained by cotton rolls and a saliva ejector. The pit and fissure surfaces of the teeth were air-dried for 5 sec
to ensure moisture control. All of the pit and fissure surfaces were etched with 37% phosphoric acid gel (3M
Scotchbond™ Multi-Purpose Etchant, USA) for 30 sec, following the manufacturer’s instructions and the teeth were
thoroughly rinsed with an air/water spray to remove the etchant. Air-drying was done until the etched surfaces
appeared chalky white. A bonding agent (Adper™ Single Bond 2, 3M ESPE, USA) was applied to all pit and fissure

surfaces with a microbrush, thinned out using an air syringe, and light-cured for 10 sec. A sealant (Helioseal clear,
Ivoclar Vivadent, USA) was applied with a disposable tip to all of the surfaces and light-cured for 20 sec using a
light-emitting diode (LED) light, 1 mm above the surface. The sealants were then examined with an explorer for
retention and any defects. The occlusion was evaluated using articulating paper and any interferences were adjusted
with a composite finishing bur. If contamination was found at any step, all procedures were repeated. The same
procedures were performed on the contralateral tooth; however, no bonding agent was used. Oral hygiene care
instructions were given and fluoride varnish was applied before the start of study and at the follow-up visits.
The children were scheduled for sealant retention rate evaluation as the primary outcome at 6-, 12-, and 24-
month follow-ups. Two blinded evaluators assessed sealant retention using Simonsen’s criteria18: complete
retention, partial retention, or total loss. Teeth with partial retention or total loss of the sealant were combined as the
retention loss group, and the sealant was not reapplied. Those with retention loss were not excluded, but were
included in all follow-up visit results. Caries transition as the secondary outcome was also evaluated using ICDAS
scores, DIAGNOdent values, and bitewing radiographs as no change, progression, or regression. The teeth that

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 demonstrated a clinical change to an ICDAS score ≥ 5 or progressed beyond the outer-third of the dentin were
Accepted Article
restored.
The difference in sealant retention rates between the teeth that received and those that did not receive a
bonding agent prior to sealing application were analyzed using the McNemar’s test and the relationship between
DIAGNOdent values and retention were analyzed with the Fisher’s exact test at a significance level of 0.05. The
intra- and inter-examiner reliability for the ICDAS scores and radiographic interpretations of the two evaluators was

calculated via the Cohen’s kappa statistics.

RESULTS
Ninety-eight children (age range 7.3–9.9 years) with 120 pairs of occlusal caries in first permanent molars
were examined as a baseline. One child dropped out at the 6-month follow-up and eight children dropped out in the
middle of the study due to moving to another school or province. Thus, 89 children with 108 pairs of teeth (10%
dropout rate) remained in the study at the 24-month follow-up. Seventy-six pairs (70.4%) had same ICDAS score
and 32 pairs (29.6%) had different ICDAS scores with one level of difference. The flow of the participants in the
trial is shown in Figure 1. The sex distribution of the children was 62 females (63.3%) and 36 males (36.7%). The
mean decayed, missing, filled teeth of the primary and permanent dentition (dmft/DMFT) was 6.8 and 3.3 teeth per
person, respectively. The overall level of oral hygiene was fair as measured by the mean simplified OHI-S at 1.29.
Based on the high dmft/DMFT values, overall fair oral hygiene, and risk assessment, the participants were classified
as having a high caries risk.
The sample distribution is shown in Table 1. There were no significant differences in ICDAS scores, dental
arch, radiographic evaluation, or DIAGNOdent values between the test and control group (p > .05). The intra- and
inter-examiner reliability of the baseline evaluation of the ICDAS scores of the two examiners was acceptable
(kappa values were 0.72 and 0.81 for the intra-examiner reliability and 0.81 for the inter-examiner reliability). The
intra- and inter-examiner reliability of the baseline evaluation of the DIAGNOdent values and the sealant retention
rates of the two examiners were in good agreement (kappa values were 0.81 and 0.81 for the intra-examiner
reliability and 0.80 for the inter-examiner reliability).
The sealant retention rate in each group is presented in Table 2. The sealant retention between the groups
was significantly different (p < .001). The complete retention rates in the nonbonding (NB) group was 86 (72.3%),
73 (61.3%), and 58 (53.7%) and in the bonding (B) group was 112 (94.1%), 105 (88.2%), and 90 (83.3%) at the 6-,
12-, and 24-month follow-ups, respectively.
At the 24-month follow-up, three teeth (1.4%; NB: B = 2:1) were restored due to caries transition from the
time of the radiographic examination; caries had progressed from the outer-third of the dentin to a deeper level, and
all of the teeth had retention loss. Only one tooth (0.46%) had clinically increased ICDAS score.
Caries transition based on the DIAGNOdent value results are presented in Table 3. There was no significant
difference in caries change between the two groups (p > .05) at all follow-up time points. In addition, there was no
significant association between sealant retention and caries transition in the NB and B groups (p > .05).
DISCUSSION

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 The present study evaluated the efficacy of bonding agent use in enhancing the retention rate of a resin-
Accepted Article
based sealant placed on occlusal caries in permanent molars. Our results indicated that using a bonding agent
significantly enhanced sealant retention rates compared with not using a bonding agent in occlusal carious lesions
(ICDAS 2-4). These results corresponded to an in vitro study by Kalra et al., which found that a bonding agent use
resulted in a significantly higher bond strength of resin-based sealants for incipient caries.16 Similar to sound teeth,
the split-mouth study by McCafferty et al. found that applying a bonding agent before resin-based sealant
application significantly increased the retention rate,17 and it was 9.8% higher compared with occlusal caries teeth in
the present study (98% vs. 88.2% respectively) at the 12-month follow-up. The complete retention rate of the NB
group was 53.7%, which was quite different from Soto-Rojas et al.19 and Fontana et al.,20 which had rates of 71.3%
and 78%, respectively, at the 24-month follow-up. The possible reasons were that the first study combined complete
retention and partial loss in the same group, and thus, the retention rate was rather high. The latter study had only a
small number of high ICDAS scores, and the ICDAS score of zero was included. 20 In contrast, the ICDAS scores in
the present study were mostly ICDAS 2 and 3. At the 24-month follow-up, the B group had a complete retention rate
that was 29.6% higher compared with the NB group rate, or an average retention loss rate per year that was
approximately three-fold higher in the NB group compared with the B group (23.2% vs. 8.4% respectively). These
results can be explained by the organic substances that are present in carious lesions and the lesions were moister
than the sound surfaces. This moisture causes more micro-leakage and insufficient sealant penetration depth,
resulting in reduced bond strength that was similar to saliva-contaminated teeth.21 Thus, it is possible that applying a
bonding agent prior to a sealant on carious surfaces enhanced the retention rate, which occurred on saliva-
contaminated surfaces12-15. This is because the volatility of the ethanol-based bonding agent provides deep flow into
the micro-spaces of the etched enamel and effectively displaces the trapped water in the moist enamel.17,22
In this study, none of the participants in the complete retention group had changes in their ICDAS score. In
contrast, only one tooth in the retention loss group showed lesion progression. These results corresponded with a
previous study that found that the annual rate of caries progression in sealed teeth was lower compared with
unsealed carious lesions.11 However, the reason for having only one tooth that progressed in the retention loss group
in the present study may be that the sealant slows down lesion progression while the sealant remains intact.
Moreover, our samples were from a group with a high caries risk, therefore we had to continuously emphasize oral
hygiene care and apply fluoride varnish, and these could have retarded lesion progression. These finding are similar
to Alves et al. that suggested that a sealant protected against caries progression despite the sealant being lost over
time.23 Radiographs revealed three teeth with caries progression; all had retention loss, and two had baseline lesions
in the outer-third of the dentin. These results suggest that close monitoring may be required, especially radiographic
monitoring, to prevent extensive caries progression in dentin lesions. None of the teeth showed radiographic caries
regression, including the complete retention group. These findings were contrary to Handelman et al. that found
caries regression in the radiographic assessments of intact sealant teeth.24 These results may imply that a longer
follow-up period is needed, similar to that in a previous study that found a case with no lesion regression, but
unchanged lesion depth, in sealed carious lesions after 6 years of follow-up.25 The small number of teeth with caries
progression suggests that non-operative treatment with a sealant is the treatment of choice for initial caries,

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 including micro-cavitated lesions, and better outcomes are attainable when integrated with effective routine
Accepted Article
prevention. Thus, we can minimize tooth structure destruction and postpone the placement of a restoration that will
provide increased long-term benefit compared with operative treatment.
The ICDAS 1 group was excluded because its characteristics are very similar to those of sound teeth and
may have affected the sealant retention rate in the carious teeth group in this study. We also found that it was
difficult to distinguish between ICDAS score 2 and 3 teeth after sealing. Although clear sealant was used to enhance
the visual examination in monitoring caries transition; it was still limited to performing a tactile evaluation using the
explorer along the intact sealant. However, it was usable in the sealant loss area. A limitation of using bitewing
radiographs is that they cannot detect enamel caries because they clearly show only dentin lesions. Because of those
limitations, the DIAGNOdent was used in this study as an adjunct method to monitor caries transition. This
diagnostic tool is based on laser fluorescence technology. It was suggested that the DIAGNOdent can monitor
occlusal caries that was sealed to a sealant, and could also predict the need for sealant repair based on higher
DIAGNOdent values during the follow-up period.20 However, our study found that 45 teeth (20.8%) from both groups

demonstrated lesion progression based on the DIAGNOdent values at the 24-month follow-up, with 31 teeth (69%)
that progressed into enamel and 14 teeth (31%) into dentin, however, only three teeth among these demonstrated
radiographic progression. This inconsistency between the DIAGNOdent values and radiographic change could be
the result of the aforementioned radiograph limitation that cannot not reveal the early stage of demineralization and
tend to underestimate the lesion stage.26 However, the DIAGNOdent has its own limitations when used with sealed
teeth; it was found that the intrinsic fluorescence of the sealant affected the reading capability of the instrument that
resulted in it not differentiating true carious lesions correctly.27 This is similar to a previous study that found
significantly increased DIAGNOdent values after clear sealant application. 28 These results are in accordance with
our study that found higher DIAGNOdent values in the complete retention group compared with the retention loss
group. Based on these findings and aforementioned limitations of both diagnostic tools, we decided to place a
restoration when the lesions progressed radiographically beyond the outer third of the dentin, and when the ICDAS
score progressed to ICDAS ≥ 5.
The limitation in this study was that it was quite difficult to recruit participants who had the same ICDAS
score for each tooth pair in their mouth; thus, some sample pairs had different ICDAS scores. Although the
difference was limited to only one level, we cannot conclude whether or not there are differences between each
ICDAS score due to the low power in each cluster. However, within this limitation, our results are sufficient as a
proof of principle of the efficacy of bonding agent use. Similarly, evaluating caries transition is also needed to be a
main focus in further studies. To determine that the bonding agent beneath a sealant will be effective over a long-
term period for treating carious lesions and that this can be a therapeutic goal of a dental sealant will require a longer
follow-up period. Based on the results of this randomized clinical controlled trial, it can be concluded that using a
bonding agent prior to applying a sealant significantly enhanced the sealant retention rates on occlusal caries
(ICDAS 2-4) in permanent molars at the 24-month follow-up. Caries progression was rarely detected at the 24-month

follow-up.

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Accepted Article
Why this paper is important to pediatric dentists

 The use of a bonding agent prior to sealant application for occlusal caries (ICDAS 2-4) enhances sealant
retention.
 Applying a sealant to occlusal caries (ICDAS 2–4) controls caries progression.

Trial Registration
Thai Clinical Trials Registry Identification number: TCTR20190106003
Funding

None

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Figure

Figure 1. Flow of the participants in the clinical trial

Table 1. Sample distribution at baseline

Variable Group p-value
No bonding used Bonding used
N (%) N (%)
ICADAS

2 57 (47.5) 51 (42.5) .117

3 49 (40.8) 50 (41.7)
4 14 (11.7) 19 (15.8)
Dental arch

.302
Upper 57 (47.5) 61 (50.8)
Lower 63 (52.5) 59 (49.2)
Radiographs

No radiolucency detected 101 (84.2) 100 (83.3) .967

DEJ level 1 (0.8) 1 (0.8)
≤ outer third of dentin 18 (15.0) 19 (15.9)
DIAGNOdent values

Enamel caries (14-20) 52 (43.3) 47 (39.2) .406

Deep enamel caries (21-29) 41 (34.2) 42 (35.0)
Dentin caries (≥30) 27 (22.5) 31 (25.8)
McNemar’s test.
DEJ = Dentinoenamel junction

Group 6-Month Follow-up 12-Month Follow-up 24-Month Follow-up

NB B p-value NB B p-value NB B p-value
N (%) N (%) N (%) N (%) N (%) N (%)
ICDAS RL CR RL CR RL CR RL CR RL CR RL CR

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 2 12 44 1 49 19 37 4 46 19 32 6 37
Accepted Article
3
(21.4)
17
(78.6)
32
(2)
4
(98)
46
(33.9)
22
(66.1)
27
(8)
7
(92)
43
(37.3)
22
(62.7)
21
(14)
6
(86)
40
(34.7) (65.3) (8) (92) (44.9) (55.1) (14) (86) (51.2) (48.8) (13) (87)
4 4 10 2 17 5 9 3 16 9 5 6 13
(28.6) (71.4) (10.5) (89.5) (35.7) (64.3) (15.8) (84.2) (64.3) (35.7) (31.6) (68.4)
Total 33 86 7 112 46 73 14 105 50 58 18 90
<.001 <.001 <.001
(27.7) (72.3) (5.9) (94.1) (38.7) (61.3) (11.8) (88.2) (46.3) (53.7) (16.7) (83.3)

Table 2. Sealant retention rate during follow-up

McNemar’s test.
B = bonding used; NB = no bonding used; CR = complete retention; RL = retention loss

Table 3 Caries transition using DIAGNOdent values

Group 6-Month Follow-up 12-Month Follow-up 24-Month Follow-up

NB B p-value NB B p-value NB B p-value
N (%) N (%) N (%) N (%) N (%) N (%)
Caries RL CR RL CR RL CR RL CR RL CR RL CR
Transition
Progression 4 13 1 16 12 13 2 15 11 13 2 19
(12.1) (15.1) (14.3) (14.3) (26.1) (17.8) (14.3) (14.3) (22) (22.4) (11.1) (21.1)
No change 23 60 5 72 .785 26 47 10 72 .697 32 33 14 57 .732
(69.7) (69.8) (71.4) (64.3) (56.5) (64.4) (71.4) (68.6) (64) (56.9) (77.8) (63.3)
Regression 6 13 1 24 8 13 2 18 7 12 2 14
(18.2) (15.1) (14.3) (21.4) (17.4) (17.8) (14.3) (17.1) (14) (20.7) (11.1) (15.6)
Total 33 86 7 112 46 73 14 105 50 58 18 90
p-value 0.772 1.000 0.939 1.000 0.867 0.714
Fisher’s exact test.
B = bonding used; NB = no bonding used; CR = complete retention; RL = retention loss

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Accepted Article
Figure

Assessed for eligibility

(N= 150 participants)
Not meet the inclusion criteria (N=27)
Declined to participate (N=25)
Baseline participants
(N= 98 participants, n=240 teeth)

Split mouth random allocation

Using of bonding agent Non-use of bonding agent

n = 120 teeth n = 120 teeth

6-month follow-up
(N= 97 participants, n=238 teeth)

12-month follow-up
(N= 97 participants, n=238 teeth)

24-month follow-up
(N= 89 participants, n=216 teeth)

Figure 1. Flow of participants in the trial

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