The Journal of EVIDENCE-BASED DENTAL PRACTICE

REVIEW ARTICLE

EFFECTIVENESS OF PIT AND FISSURE

SEALANTS FOR PREVENTING AND
ARRESTING OCCLUSAL CARIES IN
PRIMARY MOLARS: A SYSTEMATIC
REVIEW AND META-ANALYSIS

PHOEBE P.Y. LAM, BDSa, DIVESH SARDANA, BDSa,

MANIKANDAN EKAMBARAM, BDS, MDS, PhD, FDS, RCSEd, MPaed Dent, RCSEd,
MRACDS(Paed)b,
GILLIAN H.M. LEE, BDS, MDS, Adv Dip Paed Dent HK, PhD, M Paed Dent RCS, MRACDS
(Paed), FHKAM, FCDSHK, FDS RCSEda, AND
CYNTHIA K.Y. YIU, BDS, MDS, PhD, FHKAM (Dental Surgery), FCDSHK (Paediatric
Dentistry)a
a
Paediatric Dentistry, Faculty of Dentistry, The University of Hong Kong, Pokfulam, Hong Kong SAR, Hong Kong
b
Paediatric Dentistry, Faculty of Dentistry, University of Otago, Dunedin, New Zealand

CORRESPONDING AUTHOR:
ABSTRACT Cynthia K.Y. Yiu, Paediatric Dentistry
Objective and Orthodontics, 2nd Floor, Prince
The use of pit and fissure sealants have been well supported in permanent teeth, Philip Dental Hospital, 34-Hospital
but no concrete evidence is available to support this procedure in primary molars. Road, Sai Ying Pun, Hong Kong
This review aims to systematically assess randomized controlled trials and sum- (SAR), China.
marize the evidence on the effectiveness of different sealants in prevention and E-mail: ckyyiu@hkucc.hku.hk
arrest of the pit and fissure occlusal caries in primary molars of children.
Materials and methods KEYWORDS
Four electronic databases were searched from inception to March 2018. Seven Pit and fissure sealants, Occlusal
studies were included in the qualitative and quantitative syntheses. Two reviewers caries, Prevention, Arrest, Primary
independently selected studies, extracted data, assessed risk of bias using the molars, Review
revised Cochrane risk of bias tool, and evaluated the certainty in the evidence
Conflict of Interest: The authors have
adopting the Grading of Recommendations Assessment Development and
no actual or potential conflicts of
Evaluation approach. Odds ratio and retention rate of different sealants were
interest.
recalculated and analyzed.
Source of Funding: There is no
Results funding received.
This review identified no significant difference in the overall caries incidence and
Received 28 October 2018; revised
progression when evaluated over 24 months between (1) resin-based sealant
12 September 2019; accepted 25
(RBS) and glass ionomer sealants (GIS) or resin-modified GIS; (2) conventional and
October 2019
newly developed RBS; (3) autopolymerized and light-polymerized RBS; (4) RBS
with topical fluoride application and topical fluoride alone; and (5) RBS with J Evid Base Dent Pract 2020: [101404]
topical fluoride application and resin infiltration with topical fluoride application. 1532-3382/$36.00
The pooled estimates of the mean retention rates of RBS and GIS on primary ª 2020 Elsevier Inc.
molars over an 18-months period were 85.94% and 23.18%, respectively. The All rights reserved.
doi: https://doi.org/10.1016/
j.jebdp.2020.101404

June 2020 1
 The Journal of EVIDENCE-BASED DENTAL PRACTICE
certainty in the evidence of each outcome was determined
as low or very low mainly because of high risk of overall bias
and imprecision.
Conclusion
There are currently insufficient well-controlled randomized
controlled clinical trials to determine whether sealants are
beneficial in preventing or arresting noncavitated occlusal
caries in the primary molars.
INTRODUCTION
D ental caries is a significant global public health prob-
lem with substantial negative impacts. Untreated caries
among children can lead to disturbed eating and sleeping
habits, possible hospitalization, diminished growth, and
reduced weight gain,1–5 thus severely undermining their
general health and quality of life.2,4,5
Pit and fissure sealants have been a recommended procedure
in preventing the development of pit and fissure caries in
permanent molars.6 Pit and fissure sealants serve as a physical
barrier between enamel and the oral environment, reducing
the accumulation of food debris and plaque.7 With the
increased popularity of minimal intervention dentistry,
sealants have also been introduced to treat active initial
fissure caries and even to arrest noncavitated fissure
caries.8–10 There is evidence suggesting that the
progression of caries in permanent dentition or in both
primary and permanent dentitions could be arrested and
controlled by intact sealants, regardless of the caries
severity.2,10–12 However, the effectiveness of sealants in
preventing or arresting noncavitated caries lesions in
primary molars still requires further investigations.13,14 Other
factors such as less prominent occlusal fissure morphology
of primary molars15 and uncooperative behavior displayed
by young pediatric patients toward dental interventions16
may also affect the success of the treatment.
There are many options of sealant materials commercially
available, with the most widely used ones being resin-based
sealants (RBS) and glass ionomer sealants (GIS). Each type of
sealant carries its own merits, contributing to its clinical
performances and efficacies in caries prevention.
The effectiveness of RBS in preventing occlusal caries in
permanent molars has been well recognized, and the evi-
dence in favor of RBS has been graded to be of moderate
quality.6 Benefits of RBS can last for a long duration after
placement. For instance, Bravo et al.17 showed that RBS
could reduce more than 60% of occlusal caries at 9-year
follow-up after placement of sealant compared with un-
sealed molars. Its effectiveness has been greatly contributed
by its longevity of clinical survival.18 Clinical trials reported
more than 80% complete retention of sealant after 2 years
and 70% after 3 years in permanent molars.6
2 Volume 20, Number 2
However, the retention rate and effectiveness of RBS in caries
prevention in primary molars is still under investigation.
Application of RBS required more than 15 minutes,19 which in
very young children can be a technique-sensitive procedure.
Moisture control is also of paramount importance for the
retention and success of RBS,20 but it may be difficult among
young preschool children or in outreach settings.
Results regarding the benefits of GIS on permanent molars
are inconsistent6 because many studies reported poor
retention rates and did not find significant differences
between GIS and the control groups.6,9,21,22
However, GIS may be more advantageous to use in very
young patients because it can chemically bond to enamel
and is more tolerable to inadequate moisture control.23 As
its application requires less clinical steps, GIS is
comparatively more acceptable to younger patients.
Poulsen24 reported 75% retention rate of GIS placed on
primary second molars under clinical settings over 1 year.
However, further investigation of its clinical efficacy of
caries prevention compared with no or other interventions
in primary molars is still required.
The use of fluoride to treat incipient carious lesions via
remineralization has proven effective.25 Fluoride facilitates
adsorption of calcium ions to demineralized enamel
surface, as well as substitutes hydroxyl ions (OH-) to form
fluorapatite, which has strong acid resistance against
demineralization.26 Professionally applied topical fluoride
agents such as varnishes and gels have proven to be
effective in preventing caries among children and
adolescents.27,28 Currently, there is still insufficient
evidence to determine the superiority of resin or glass
ionomer fissure sealants over topical fluoride varnishes for
occlusal caries prevention because of the lack of reliable
results and low quality of evidence.29
Sealants containing fluoride, amorphous calcium phosphate
(ACP), prereacted glass ionomers, and other formulations
have been manufactured and marketed. The manufacturers
claim that these newly formulated sealants have greater abil-
ities to prevent caries. They also claim additional benefits from
these sealants, for instance, continuous release of fluoride and
other ions essentially for remineralization, reduction of the
pathogenicity of cariogenic plaque, increasing the pH favor-
able for the formation of apatite crystals, and so forth.30,31
Despite several proposed potential mechanisms, the clinical
evidence of these sealants on both permanent and primary
dentition is still insufficient.
A considerable amount of literature has been published on
the use of pit and fissure sealants in permanent molars;
however, the use of pit and fissure sealants in primary molars
is still debatable. Therefore, a systematic review was carried
out with the aim of answering the following question: What

is the effectiveness of different types of pit and fissure
sealants, in preventing and arresting occlusal caries in pri-
mary molars, as compared with no treatment or other
preventive measures among children and adolescents?
MATERIALS AND METHODS
This systematic review was conducted and reported
following the guidelines proposed by the Cochrane Hand-
book for Systematic Reviews of Interventions32 and Preferred
Reporting Items for Systematic Reviews and Meta-Analyses
(PRISMA) statement,33 respectively.
The following PICO(S) statement was proposed:
Types of Participants (P)
Children and adolescents from the general population
younger than 18 years, as defined by the United Nations,34
whose primary molars included were either sound, having
incipient occlusal carious lesions, or noncavitated carious
lesions (ie, International Caries Detection and Assessment
System [ICDAS] code 0-4) were included.35 Studies
involving the placement of sealants on cavitated lesions
(ICDAS code 5-6) were excluded.
Types of Intervention (I)
The review included studies in which any type of pit and
fissure sealants have been placed on any primary molars.
Types of Control/Comparison (C)
The control teeth or control groups were those that did not
receive sealant or received professional topical fluoride
application alone. RBS group was considered as control
when comparing the efficacy of RBS with that of the other
sealant types. On the other hand, when making a compar-
ison between conventional sealants and new types of seal-
ants or caries-preventive or caries arrest measures, the
conventional types of sealants were used as a control group.
Any studies including operative procedures as comparison
groups were excluded.
Types of Outcome Measures (O)
As the primary outcome, this review evaluated any caries
increment on the occlusal surface of primary molars,
including caries incidence and caries progression. Caries
incidence was defined as the diagnosis of new carious
lesions established from sound occlusal surfaces leading to
localized enamel breakdown on the occlusal surface (ICDAS
code 3). Caries progression was considered as any increase
in the extent of caries, for instance, from localized enamel
breakdown to progression to dentine (ICDAS code 3 to 4) or
from noncavitated dentine lesion to cavitated lesion with
the exposure of dentine (ICDAS code 4 to 5-6). Studies
measuring the change in decay, missing, and filled teeth or
The Journal of EVIDENCE-BASED DENTAL PRACTICE
surfaces (dmft or dmfs) index in primary molars were also
included and considered as caries incidence.
As the secondary outcome, this review assessed only the
clinical retention rate of sealants in trials, measuring the
complete and partial loss of sealant materials from the pits
and fissures of the occlusal surfaces.
Types of studies (S)
Randomized or quasi-randomized controlled trials of at least
6-months follow-ups, with either parallel or split-mouth
designs, were included.
Information Sources and Literature Search
Systematic searches for relevant randomized controlled
trials and quasi-randomized controlled clinical trials were
conducted from 4 electronic databases (Cochrane Central
Register of Controlled Trials [CENTRAL]; Ovid Embase; Ovid
MEDLINE; Web of Science) using the broad keywords and
Medical Subject Headings terms from inception to March
2018 (Appendix A). A hand search was performed, and
reference lists of the included studies and relevant
previous systematic reviews were screened to ensure no
relevant studies were omitted. Only studies with full text
available in English were included.
Study Selection
Two authors of this review (P.P.Y.L. and D.S.) independently
assessed the articles retrieved from the databases based on
their titles, keywords, and abstracts, followed by the deter-
mination of the potential eligibility of each article. Agree-
ments between reviewers were determined using Cohen’s
kappa coefficient (k). An opinion from the third reviewer
(C.K.Y.Y.) was sought to adjudicate on the final eligibility, if
required.
Data Collection and Measurement of Treatment
Effect
Data were extracted independently by the 2 reviewers
(P.P.Y.L. and D.S.) using standardized data extraction forms.
Data including study characteristics (trial design, beginning
year, and duration), participants (location, inclusion and
exclusion criteria, gender, age, baseline caries, and the
number of participants randomly assigned and evaluated),
intervention (number of groups and treatment arms), as well
as primary (incidence or progression of occlusal caries) and
secondary outcomes (retention of each sealant) were input.
When evaluating the primary outcome, categorical data of
caries increment in both intervention and control groups,
regarding caries incidence and caries progression, were
extracted in all included reports. A 2 3 2 table was con-
structed to conduct meta-analyses and report the results for
each outcome.
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 The Journal of EVIDENCE-BASED DENTAL PRACTICE
When evaluating the secondary outcome, the total number
of fully retained and partially retained events was grouped
as 1 variable and compared with the total number of seal-
ants placed. The pooled retention rate of each sealant was
calculated in the meta-analysis.
Risk of Bias in Individual Trials
Risks of bias of each included study were assessed based on
the 5 domains and the signaling questions mentioned in the
revised Cochrane risk of bias tool for randomized trials (RoB
2.0).36 Each trial report was evaluated in 5 domains of bias
with signaling questions used to formulate the judgment
regarding the risk of bias. The five domains include (I) Bias
arising from the randomization process, (II) Bias due to
deviation from intended interventions, (III) Bias due to
missing outcome data, (IV) Bias in the measurement of
outcome and (V) Bias in selection of reported result. As
recommended by RoB 2.0, for split-mouth studies, (Ib)
Bias arising from the timing of identification and recruitment
of individual participants were evaluated as a subdomain
under domain (I).
Data Synthesis and Analyses
Studies comparing the effectiveness of sealants with that of
other interventions to prevent or arrest carious lesions were
included for data synthesis and analysis.
In trials using split-mouth design, both intervention and
control measures are performed on different teeth inside
the mouth of the same subject. As the chance of carryover
of results is minimal for sealants, findings from split-mouth
studies that compared sealant versus nonsealant, or
sealant versus another type of sealants, were used as a
single effect estimate.
Stata, version 13.1, (StataCorp, College Station, TX, 2013)
was used to perform the meta-analysis. Meta-analysis with
fewer than 5 studies was handled with a fixed-effects model,
while the random-effects model was adopted for analysis
with more studies.37,38
Subgroup Analyses
Subgroup analyses were conducted to evaluate the treat-
ment effects for sealants placed on sound occlusal surfaces
(ICDAS code 0), incipient occlusal carious lesions (ICDAS
code 1-2), occlusal surfaces with localized enamel break-
down and without clinical signs of dentinal involvement
(ICDAS code 3), and noncavitated occlusal carious lesion
progressed to the outer one-third of the dentine (ICDAS
code 4), if available.
Assessment of Heterogeneity
Assessment of heterogeneity was conducted based on the
guidelines mentioned in the Cochrane Handbook for Sys-
tematic Reviews of Intervention.39 Amount of heterogeneity
4 Volume 20, Number 2
among studies was quantified using I2 statistics; at the same
time, the level of significance of the statistical heterogeneity
was set at P , .05 and calculated using a Chi-square test.
Heterogeneity were determined as substantial when
I2 . 60% and P , .05.39
Assessment of Publication Bias
As recommended by the Cochrane Handbook for System-
atic Reviews of Intervention,40 the assessment of the risk of
bias across studies in relation to publication bias was
planned to be assessed using tests for funnel plot
asymmetry when more than 10 studies were included in a
particular outcome.
Assessment of Certainty in the Evidence
Two reviewers (P.P.Y.L. and D.S.) independently graded
the certainty in the evidence (or quality of the evidence) for
each outcome, adopting the Grading of Recommendations
Assessment Development and Evaluation (GRADE)
approach.41 Although, at baseline, the evidence of each
primary outcome began as high certainty as only
randomized controlled trials were included, the certainty in
the evidence was diminished in the presence of serious
issues in relations to the risk of bias, imprecision,
inconsistency, indirectness, or publication bias.41
Because the data of the retention rate were extracted from
the sealant/intervention group without comparing retention
rate to any control groups or different sealant group, these
observational data were not considered to have been ran-
domized by the study authors. Baseline rating of the certainty
in the evidence of retention rate was determined as low
because only observational data were included (Appendix E).
RESULTS
Study Selection
A systematic literature search identified 1678 records, and
979 remained for screening after removal of duplicates.
After screening for titles and abstracts, 98 were retrieved for
full-text reading (Kappa k: 0.928), but only 7 studies42–48
were included for final qualitative and quantitative synthe-
sis (Kappa k: 1). An overview of the PRISMA flowchart33 of
study identification, screening determination of eligibility
and final inclusion along with the reasons for exclusion is
presented in Figure 1 and Appendix B.
Study Characteristics
The characteristics of the randomized controlled trials
included in the present systematic review are summarized
in Table 1 and Appendix C. The 7 included studies
represented 980 participants from 4 European43,45,47,48
and 3 Asian countries,42,44,46 with 3526 molars with sound
occlusal surfaces, incipient active or noncavitated occlusal
 The Journal of EVIDENCE-BASED DENTAL PRACTICE

Figure 1. Flowchart of the screening process.

Identification Ovid Medline Embase Cochrane Web of Science Hand searching

(n= 554) (n=371) (n= 517) (n= 236) (n= 0)

Criteria for Inclusion

Participants (P): Primary molars in children and adolescents below 18
Intervention (I): Pit and fissure sealants on occlusal surfaces
Comparison (C): Any caries preventive or arrest measures
Outcome (O): 1. Caries increment in primary molars 2. Sealant retention rate
Screening

Records after removal of Records excluded (n= 881)

duplicates Irrelevant articles Review articles/ summary of trials
(n= 979) Laboratory studies RCTs on permanent molars

= 0.928 Records excluded (n= 91)

Permanent molars (n=50) Duplications (n=5)
Eligibility

Full text articles assessed Observational studies (n=10) Operative treatment as comparison (n=2)
for eligibility Cavitated lesions or proximal Default in study design (n=2)
caries (n=8) Irrelevant (n=2)
(n= 98)
Review article (n=6) Laboratory studies (n=1)
No English full text (n=5)
=1
Included

Studies included in quantitative and qualitative synthesis

(n= 7)

carious lesions. Three of the 7 studies included in this review
were published before the year 2010,45–47 whereas the
remaining 4 studies were published recently from 2011 to
2015.42–44,48 Two of the studies were conducted in
outreach settings,42,44 wherein the participants were
examined and treated at their respective schools, while
the examination and treatments in the remaining 5 studies
were performed in well-equipped clinical settings after the
subjects were enrolled from their schools or public-oriented
dental clinics.43,45–48 The age of the children recruited in the
included studies ranged from 18 months to 8 years.
Only 2 studies clearly diagnosed the carious status of all
their included primary molars to be of ICDAS code 0 to
code 4;42,48 however, other 5 studies indicated they only
recruited primary molars with sound occlusal surfaces or
with no signs of caries or cavitation.43–47 All the studies
mainly used visual-tactile diagnostic methods to evaluate
the occlusal caries status at baseline and during follow-up
assessment. One study48 additionally used bitewing
radiographs to determine the extent of carious lesions.
Sealants were placed only on primary
second molars42,43,46,48 or only on primary first molars,45 or
a combination thereof.44,47 Data comparing the
effectiveness of sealants versus control with no sealants,45
with topical fluoride varnishes,42,48 with another type of
sealants on primary molars,43,44,46,47 or with resin
infiltration were reported.48 Six42–45,47,48 and 5 studies43–47
reported the outcomes of caries incidence and sealant
retention rate, respectively, in formats from which data
could be extracted. For caries progression, only 2 studies
specifically evaluated the outcome in the ICDAS system so
that subgroup analysis of caries arrest could be
compared.42,48 The follow-up period in the included
studies ranged from 6 months to 3 years.
Results of Individual Studies and Data Synthesis
The review focused on 2 predefined outcomes: the primary
outcome of caries prevention and arrest in terms of caries
incidence and caries progression, respectively, and the
secondary outcome of sealant retention. Recalculated odds
ratios and level of significance of these relevant outcomes
are summarized in Table 2.
Risks of Bias of Included Studies
An exhaustive assessment of the risk of bias could not be
performed because of incomplete reporting of the included
studies. However, using the revised Cochrane risk of bias
tool,36 all 7 studies were assessed as having a high risk
of overall bias due to the fact that all studies had at least
1 domain being rated as of high risk of bias. Blinding
could not be achieved because outcome assessors can

June 2020 5
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Volume 20, Number 2

The Journal of EVIDENCE-BASED DENTAL PRACTICE

Table 1. Characteristics of included studies.

N Patient
(% M); N Primary
Study (year, RCT design, Age range, molar Baseline Diagnostic Evaluation time
No. countrya) setting years (mean) (E %)b caries riskc methodd Intervention point (months) Outcome

1 Bakhshandeh & Split-mouth, 47 (48.9); 141 (100) (L) 50% VT, BW (1) Infiltration (ICON! 8-34 (1) Caries
Ekstrand48 (2015, Dental clinic 5-8 (6.5) (M) 23%
GRL) (H) 27%
[DMG Chemisch- progression
Pharmazeutische Fabrik (ICDAS)
GmbH, Hamburg,
Germany])
plus fluoride varnish
(Duraphat [Woelm
Pharma GmbH,
Eschwege, Germany])

(2) Sealing (Delton!

[Dentslply DeTrey,
Copenhagen,
Denmark])plus fluoride
varnish (Duraphat)

(3) Fluoride varnish

(Duraphat)

2 Honkala et al.42 Split-mouth, 147 (51.7); 534 (100) (L) 40% VT (1) Light-cured Clin 12 (1) Caries
(2015; KWT) School 4-5 (4.1) (H) 60%
proTM (3M ESPE) prevalence
Helioseal (Ivoclar or progression
Vivadent, Liechtenstein, (ICDAS)
Germany)
(2) Sealant
retention
(2) Fluoride varnish
DuraShield!
(Sultan Healthcare)
containing 5%
sodium fluoride
 3 Ünal et al.43 Split-mouth, 75 (52); 150 (100) NR VT (1) Aegis (Bosworth 1, 3, 6, 12, (1) Caries
(2015, TUR) Dental clinic 4-7 (4.88) 18, 24
Co, Illusiana) incidence

(2) Helioseal (Ivoclar (2) Retention

Vivadent, Liechtenstein, rate
Germany) (3) Marginal
discoloration
(3) Helioseal F (Ivoclar
Viva- dent, (4) Marginal
Liechtenstein, Germany) adaptation

4 Ren et al.44 Split-mouth, 89 (NR); 356 (NR) NR VT (1) Fluororesin sealant 6, 18 (1) Caries
(2011, CHN) School 3 (NR)
(Clinpro TM sealant, 3M incidence
ESPE, light-cure)
(2) Retention
rate
(2) Glass ionomer
sealant (Fuji GP,
Chemosetting, Japan)

5 Ganesh & Split-mouth, 100 (NR); 200 (100) (L) 0% VT (1) Fuji VII (glass ionomer 6, 12, 24 (1) Caries
Tandon46 Dental clinic 3-5 (NR) (H)100%
(2006, IND)
pink sealant, GC incidence
Corporation,
(2) Retention
Tokyo, Japan)
rate

The Journal of EVIDENCE-BASED DENTAL PRACTICE

(2) Concise (unfilled
white resin
sealant, 3M ESPE Dental
Products,
St.Paul, Minn)

6 Chadwick et al.45 Parallel group, 508 (49.4); 2032 (0) (L) 2.6% VT (1) First primary molars 12-30 (1) Caries
(2005, GBR) Health clinic 1.0-2.7 (2.02) (H) 97.4%
sealed with glass incidence
ionomer & dental
health education
(2) Overall
(2) Dental health caries
education only prevalence
June 2020

(continued )
7
 The Journal of EVIDENCE-BASED DENTAL PRACTICE

easily identify subjects from sealant groups with visual

examination, while different types of sealants can be
differentiated by the investigators via tactile speculation.

(2) Retention
incidence
Outcome Therefore, 6 of 7 studies that only used visual and tactile

(1) Caries
examinations were rated as of high risk of bias in domain

rate
(IV) Bias in measurement of the outcome.42–47 The only
study which also used bitewings as an adjunct to outcome
assessment was rated as of low risk of bias in domain (IV);
however, it was considered as of high risk in domain
Evaluation time
point (months)

(I) Bias arising from the randomization process because of

24-40

considerable imbalanced distribution of caries severity

between the treatment arms.48 Two studies were being
rated as of high risk of bias in additional domains, either
in domain (II) Bias owing to deviations from intended
intervention as sealants were found in the control group45
or domain (III) Bias owing to missing outcome data which
(1) Light-polymerized

considerable uneven attrition of subjects between the 2

sealant (Delton!)
(2) Autopolymerized
(Prisma-Shield!)
Intervention

groups44,45, or a combination thereof (Figure 2 and

fssure sealant

Appendix D). Risk of bias across studies in terms of

publication bias could not be assessed because of a
limited number of studies found in all outcomes.

Evaluation of Primary Outcome and Certainty in the

Evidence
Resin-Based Sealant Versus No Use of Sealants
Diagnostic
methodd

Percentage of primary second molar (E) compared with that of all primary first and second molars included.

No study was found comparing the use of RBS with no

VT

sealant in caries increment in primary teeth.

Baseline caries risk proportion: low caries risk (L); moderate caries risk (M); high caries risk (H).
caries riskc

Glass ionomer sealant/resin-modified glass ionomer

Baseline

sealant versus no use of sealant

NR

Only 1 study with the parallel design45 contributed the data

Diagnostic method: Bitewing radiograph (BW); visual and tactile examination (VT).

comparing the efficacy of GIS versus no sealant in occlusal

102 (94.1)
N Primary

caries prevention (508 participants; 2032 teeth) after 12-

(E %)b
molar

30 months. Investigators identified no significant

difference in a number of carious occlusal surfaces
between the 2 groups (odds ratio [OR], 0.79; 95%
years (mean)

confidence interval [CI], 0.50-1.25, P 5 .310).45 Because

2.9-4.9 (NR)
Age range,
N Patient

52 (51.9);
(% M);

the study included caries-free molars only,45 comparison

regarding outcomes of caries arrest between the 2 groups
could not be performed.
Dental clinic
RCT design,

The evidence comparing GIS versus no sealant was based

Split-mouth,
setting

on only 1 randomized clinical trial and was assessed as

having very low certainty45 in accordance with GRADE
assessment criteria (Table 3). Other than bias in the
ISO alpha-3 codes of countries.

measurement of the outcome, the severe diversity in

Hotuman et al.47

follow-up dropout rates between the test group and con-

Table 1. (continued)

(1998, DNK)
Study (year,
countrya)

trol group, as well as the presence of sealants in the control

group, also suggested high risks of attrition and perfor-
mance bias, respectively.45 The evidence was downgraded
by 2 levels because of high risks of overall bias and 1
level because of indirectness because only primary first
No.

molars of very young children younger than 30 months

7

d
a

were recruited.45

8 Volume 20, Number 2

 Table 2. Summary of results table for the primary outcome (caries prevention and arrest).

Evaluation Level of
Intervention Comparison N time N subjects, Odds ratio significance
Outcome group group Outcome studies (months) N teeth (OR) (95% CI) (P value) Results

Caries prevention and arrest of sealants on primary molars

RBS versus no RBS No sealant (No outcome data available)

use of sealants

GIS/RMGIS GIS/RMGIS No sealant Caries incidence 1 12 508, 2032 0.79 .310 No significant difference
versus no (0.50, 1.25)
use of sealant

New types of New FS No sealant (No outcome data available)

fissure sealants
versus no use
of sealant

RBS versus GIS RBS GIS Caries incidence 1 6 89, 356 3.90 .041a GIS is more effective than
(1.06, 14.4)a RBS at 6 months but no
difference at 18 months
after placement

Caries incidence 1 18 89, 356 1.92 .216

(0.68, 5.40)

RBS versus other RBS F-RBS Caries incidence 1 24 75, 150 12.2 .093 No significant difference

The Journal of EVIDENCE-BASED DENTAL PRACTICE

new sealants (0.65, 226.97)

Autopolymerized AP-RBS LP-RBS Caries incidence 1 24 52, 102 0.58 .466 No significant difference
RBS (AP-RBS) versus (0.13, 2.55)
light-polymerized
RBS (LP-RBS)

Fissure sealants RBS 1 TFV TFV alone Overall caries incidence 1 12 147, 534 0.65 .095 No significant difference
with topical fluoride & progression (0.39, 1.08)
application versus
topical fluoride
application alone

1 24 47, 94 0.42 .069 No significant difference

June 2020

(0.16, 1.07)

(continued )
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Table 2. (continued)

Evaluation Level of
Intervention Comparison N time N subjects, Odds ratio significance
Outcome group group Outcome studies (months) N teeth (OR) (95% CI) (P value) Results

Fissure sealants RBS 1 TFV Resin infiltration Overall caries incidence 1 24 47, 94 1.35 .584 No significant difference
compared with other (RI) 1 TFV & progression (0.46, 4.00)
types of caries-preventive
and caries arrest
measures

Caries incidence 1 47, 94 3.57 (0.11, .469 No significant difference

111.71)

Subgroup analysis

Fissure sealants with RBS 1 TFV TFV alone Caries incidence 1 12 147, 529 0.52 .034a RBS 1 TFV was more
topical fluoride (Baseline caries ICDAS 0, (0.29, 0.96)a effective in caries
application versus topical 1, 2) prevention than TFV
fluoride application alone alone at 12 months

1 24 47, 25 0.54 (0.02, 12.78) .702 No significant difference

Caries progression 1 12 147, 10 0.01 .022a RBS 1 TFV was more

(Baseline caries ICDAS 3- (0.02, 0.50)a effective in caries arrest
4) than TFV alone at
12 months

1 24 47, 80 0.55 (0.20, 1.52) .245 No significant

difference

Fissure sealants RBS 1 TFV Resin infiltration Caries incidence 1 24 47, 8 0.127 .224 No significant difference
compared with other (RI)1 TFV (Baseline caries ICDAS 0, (0.00, 3.52)
types of caries-preventive 1, 2)
and caries arrest
measures

Caries progression 1 24 47, 33 0.82 .894 No significant difference

(Baseline caries ICDAS 3) (0.05, 14.39)

Caries progression 1 24 47, 42 9.26 .044a RBS 1 TFV was less

(Baseline caries ICDAS 4) (1.06, 80.94)a effective than RI 1 TFV in
caries arrest at 24 months

CI, confidence interval; GIS, glass ionomer selant; RBS, resin-based sealant; RMGIS, resin-modified glass ionomer sealant; TFV, topical fluoride varnish; FS, fissure sealant.
a
Significant difference found.

Figure 2. Assessment of risks of bias using revised Cochrane risk of bias tool for randomized trials (RoB 2.0).
(I) (Ib)
New Types of Fissure Sealants Versus No Use of Sealant
No trials have studied the comparison between new seal-
ants, for instance, amorphous calcium phosphate (ACP)–
containing resin-based sealant (ACP-RBS) and fluoride-
containing sealants (F-RBS), and controls with no sealant
placed. Hence, no outcome could be assessed.
Resin-Based Sealant Versus Glass Ionomer Sealant
Two studies44,46 were included comparing RBS with GIS/
resin-modified glass ionomer sealant (RMGIS) in terms of
caries incidence; however, only the results of 1 study44 were
used to rate the evidence because the result of the other
study46 prevented the reviewers to extract data comparing
new caries incidence between RBS and GIS.
Ren et al. 44 (89 participants; 356 teeth) reported
significantly lower caries incidence rate in the GIS/RMGIS
group at 6 months (OR, 3.90; 95% CI, 1.06-14.4, P 5
.041), but no difference between both groups at
18 months (OR, 1.92; 95% CI, 0.68-5.40; P 5 .216).
However, the risk of the overall bias of this study was very
high because of the bias arising from the randomization
process, bias due to missing outcome data, and bias in
the measurement of the outcome.44 A low rating was
given to the certainty in the evidence comparing RBS and
GIS in primary molars. The evidence was downgraded by
The Journal of EVIDENCE-BASED DENTAL PRACTICE
(II) (III) (IV) (V)
2 levels because of the very high risk of overall bias
(Table 3).
Resin-Based Sealant Versus Other New Sealants
One study43 (75 participants; 150 teeth) compared
conventional RBS with 2 other newly developed sealants,
including ACP-RBS and F-RBS. No statistically significant
difference was found between RBS and F-RBS regarding
caries incidence (OR, 12.2; 95% CI, 0.65-226.97, P 5.093).43
No caries developed at 24 months in both the groups
comparing RBS with ACP-RBS and F-RBS with ACP-RBS;
therefore, no difference was found between these 2 com-
parisons. No information was provided on caries arrest
because all molars included were free of caries. The body of
evidence was thus downgraded to low by 2 levels because
of (1) high risk of overall bias and (2) imprecision (single
studies with participants number fewer than 100) (Table 3).
Autopolymerized Resin-Based Sealant Versus Light-Curing
Resin-Based Sealant
Another split-mouth study conducted in the late 1990s
compared autopolymerized chemical-curing RBS with light-
curing RBS (52 participants; 102 teeth).47 The study found
no significant difference in caries incidence between the 2
sealants (OR, 0.58; 95% CI, 0.13-2.55, P 5 .466).47 The
authors only diagnosed caries at the cavitation level and
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Table 3. GRADE summary of findings table for the primary outcome (caries prevention and arrest).

N Patient Inconsistencyc
(% M);
Age N Primary Heterogenicity Certainty in the
range molar N Risk of I2 c2 test Publication evidence (quality of
Comparison Results (year) (E %)a Studies biasb (%) (P value) Indirectnessd Imprecisione biasf the evidence) (GRADE)

GI/RMGIS No significant 508 (49.4); 2032 (0) 1 Very N/A N/A Serious Not serious N/A 4OOO very low due to
vs no difference at 1.0-2.5 serious – – Y – – overall very high risk of
sealant 12 months YY bias and indirectness

RBS vs GIS GIS is more effective 89 (NR); 356 (NR) 1 Very N/A N/A Not serious Not serious N/A 44OO low due to
than RBS at 6 months 3.0 serious – – – – – overall high very
but no difference at YY risk of bias
18 months

RBS vs No significant 75 (52); 150 (100) 1 Serious N/A N/A Not serious Serious N/A 44OO low due to
F-RBS difference at 4.0-7.0 Y – – Y – overall high risk of bias
24 months and imprecision

AP-RBS vs No significant 52 (51.9); 102 (94.1) 1 Serious N/A N/A Not serious Serious N/A 44OO low due to
LC-RBS difference at 2.9-4.9 Y – – Y – overall high risk of bias
24 months and imprecision

RBS + TFV No significant 194 (51.0); 628 (100) 2 Serious N/A N/A Not serious Serious N/A 44OO low due to
vs TFV difference at 12 & 4.0-8.0 Y – – Y – overall high risk of bias
alone 24 months and imprecision

RBS + TFV No significant 47(48.9) 94 (100) 1 Serious N/A N/A Serious Serious N/A 4OOO very low due to
vs RI + TFV difference at 5.0-8.0 Y – Y Y – overall high risk of bias,
24 months indirectness and
imprecision

GRADE, Grading of Recommendations Assessment Development and Evaluation; AP-RBS, autopolymerized resin-based sealant; F-RBS, fluoride-containing sealant; GIS, glass ionomer sealant; RBS, resin-
based sealant; LC-RBS, light-curing resin-based sealant; RMGIS, resin-modified glass ionomer sealant; RI, resin infiltration; CI, confidence interval; GI, glass ionomer.
a
Percentage of primary second molar (E) compared with that of all primary first and second molars included.
b
Risk of bias: Considered as serious if overall half of the studies included were of serious risk of overall bias.
c
Inconsistency: Considered as serious when I2 statistics $70% (*) and P-value of c2 test ,.05 (**).
d
Indirectness: Considered as serious when applicability of findings were restricted in terms of population, intervention, comparator, and outcomes.
e
Imprecision: Considered as serious when the total number of events was below 300 for dichotomous outcomes or 400 for continuous outcomes (#) or when the upper and lower limits of 95% CI include
both meaningful benefits and harm.
f
Publications bias: Considered as serious if P-value of Begg’s funnel plot ,.05. Not applicable (N/A) if funnel plot could not be constricted, given limited numbers of study. Publication bias was difficult to
detect, and thus, no downgrading was performed.Y: Downgrade by 1 level in quality of evidence;YY: Downgrade by 2 levels in quality of evidence; –: No change in quality of evidence

mentioned all molars included were sound. Therefore, there
were no data provided regarding the effects of sealants on
caries progression. The body of evidence was rated “low”
because the certainty in the evidence was reduced by 2
levels owing to (1) high risk of overall bias and (2)
imprecision (52 participants)47 (Table 3).
Fissure Sealants With Topical Fluoride Application Versus
Topical Fluoride Application Alone
Two split-mouth studies42,48 provided the results for the
comparison between RBS and application of 5% sodium
fluoride varnish versus fluoride varnish alone. Both studies
included primary molars with sound occlusal surfaces,
incipient lesions, localized enamel lesions, and
noncavitated carious lesion ranging from ICDAS score of
0 to 4; however, there were no coincident time points at
which the study results could be pooled for analysis. As
reported in Table 2, both studies42,48 found no significant
differences in overall effects in caries prevention and arrest
between the 2 groups (1 year: OR, 0.646; 95% CI, 0.386-
1.079; P 5 .095; 2 years: OR, 0.42; 95% CI, 0.16-1.07;
P 5 .069).42,48
In subgroup analyses (Table 2), significantly lower caries
incidence rate was found in the sealant group than in the
varnish group during 1-year follow-up (529 teeth). Signifi-
cantly fewer primary molars with sound occlusal surfaces or
incipient carious lesions (ICDAS code 0-2) had progressed
to ICDAS code 3 or above after 1 year (OR, 0.52; 95% CI,
0.29-0.96; P 5 .035).42,48 Although no significant difference
in caries incidence between the 2 groups was found at
2 years (OR, 0.54; 95% CI, 0.23-12.78; P 5 .702),42,48 the
small sample size included (25 teeth) had placed the
precision of the estimate uncertain.
When evaluating caries arrest in studies which placed seal-
ants on ICDAS code 3-4 lesions at baseline, significantly
fewer carious lesions were found to have progressed at 1-
year follow-up with increased ICDAS coding (OR, 0.01;
95% CI, 0.02-0.50; P 5 .022),42,48 although no difference
was found at 2-year follow-up (OR, 0.055; 95% CI, 0.20-
1.52; P 5 .245).42,48 Again, the authors of this review found
the evidence was of low certainty because of limited sample
sizes in both the comparisons (1 year: 10 teeth; 2 years: 80
teeth).
The body of evidence at 1 year was determined to be low in
accordance with GRADE assessment criteria. Despite the
fact that the study was somehow well conducted, the lack of
blinding in the assessment of caries prevention and mini-
mum sample size raised some concerns regarding the cer-
tainty and precision of the results.42 At 2-3 years, the
certainty in the evidence was also assessed as low. It was
downgraded twice because of high risk of overall bias and
imprecision (47 analyzed participants)48 (Table 3).
The Journal of EVIDENCE-BASED DENTAL PRACTICE
Fissure Sealants Compared With Other Types of Caries-
Preventive and Caries Arrest Measures
There was no study identified that performed a head-to-
head comparison of resin infiltration with sealant in
preventing occlusal caries. However, 1 split-mouth study48
was found to provide data indirectly for the comparison.
The study design contained 3 treatment arms: resin
infiltration and topical fluoride varnish, RBS and fluoride
varnish, and topical fluoride varnish alone. No difference
was found in the overall effectiveness of caries prevention
and arrest between the sealants plus fluoride varnish
group when compared with the resin infiltration with
fluoride varnish group (OR, 1.35; 95% CI, 0.46-4.00;
P 5 .584)48 (Table 2).
When conducting subgroup analyses, resin infiltration with
topical fluoride varnish was found to be significantly more
effective in arresting noncavitated dentinal caries of ICDAS
code 4 than RBS with topical fluoride varnish (OR, 9.26; 95%
CI, 1.06-80.94; P 5 .044; 42 teeth), while no difference was
found in caries prevention or arrest when the baseline caries
level was of ICDAS code 3 (OR, 0.82; 95% CI, 0.05-14.39;
P 5 .469; 33 teeth)48 or below (OR, 0.127; 95% CI, 0.00-
3.52; P 5 .22; 8 teeth).48
As the evidence was contributed by 1 small-scaled split-
mouth study with topical fluoride varnish applied in all
groups, the evidence was considered as having very low
certainty because of (1) high risk of overall bias—high risk of
bias in the domain of bias arising from randomization pro-
cess, (2) indirectness—there was no direct head-to-head
comparison of resin infiltration and sealant due to the po-
tential interference of topical fluoride, and (3) imprecision—
the total number of events is less than 10048 (Table 3).
Evaluation of Secondary Outcome and Certainty in
the Evidence
Direct Head-to-Head Comparison of Sealant Retention
Rate
Two studies performed direct head-to-head comparisons
between the retention rates RBS and GIS (189 partici-
pants).44,46 GIS significantly outweighed RBS in retention at
6 months after placement (OR, 0.29; 95% CI, 0.17-0.53; P ,
.001), but at 18 months, the situation was reversed, with
significantly more retained RBS than GIS (OR, 1.49; 95%
CI, 1.04-2.12; P 5 .026).44,46 No significant difference in
retention rate was found among RBS, F-RBS,43 ACP-RBS43
on retention, as well as between autopolymerized RBS
and light-cured RBS47 (Table 4).
Resn-Based Sealant Pooled Retention Rate
The overall retention rates of RBS and GIS were calculated
by extracting and analyzing observational data from all
included studies. Six studies involved treatment arms of RBS
or RBS with fluoride, but only 5 articles provided the data for
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The Journal of EVIDENCE-BASED DENTAL PRACTICE

Table 4. Summary of results table for the secondary outcome (direct head-to-head comparison of retention rate).

Evaluation N Level of
Intervention Comparison N time subjects, Odds ratio significance
Outcome group group Outcome studies (months) N teeth (OR) (95% CI) (P value) Results

Retention rate
of
sealants on
primary molars

RBS versus GIS RBS GIS Retained 2 6 189, 556 0.29 (0.17, ,.001a GIS is more retentive
sealants 18 189, 556 0.53)a .026a than RBS at 6 months
1.49 (1.04, but less retentive at
2.12)a 18 months
after placement

RBS versus RBS F-RBS Retained 1 12 50, 100 0.49 (0.04, 5.58) .565 No significant difference
other sealants 24 50, 100 1.23 (0.35, 4.32) .750 between RBS, F-RBS,
new sealants RBS F-RBS 1 12 50, 100 0.19 (0.01, 4.10) .291 and ACP-RBS
Retained 24 50, 100 0.38 (0.07, 2.03) .255
F-RBS ACP-RBS sealants 1 12 50, 100 0.33 (0.01, 8.22) .497
24 50, 100 0.31 (0.06, 1.60) .159
Retained
sealants

AP-RBS vs Autopolymerized Light-curing Retained 1 24 51, 102 0.74 (0.31, 1.79) .501 No significant difference
LC-RBS RBS RBS sealants between autopolymerized
RBS and light-curing RBS

AP-RBS, autopolymerized resin-based sealant; ACP-RBS, amorphous calcium phosphate–containing resin-based sealant; CI, confidence interval; F-RBS, fluoride-containing sealant; GIS, glass ionomer
sealant.
a
Significant difference found.

Figure 3. Retention rate of RBS over 6, 12, and 18 months. CI, confidence interval; RBS, resin-based sealant.
calculation of retention rate of RBS.42–44,46,47 The number of
participants included and evaluated were 422. The pooled
retention rates of RBS were calculated to be 89.79% (95%
CI, 86.14%-92.97%) at 6 months,43,44,46 86.81% (95% CI,
83.62%- 89.70%) at 12 months,42,43,46 and 85.94% (95%
CI, 82.13%-89.38%) at 18 months43,44,46,47 (Figure 3 and
Table 5).
However, owing to the nature of the observational data
included, high risk of overall bias of all reports included, and
considerable heterogeneity associated (6 month: I2 5
94.29%, P , .00143,44,46; 12 month: I2 5 87.49%, P 5
.06042,43,46; 18 month: I2 5 90.72%, P , .00143,44,46,47),
the certainty in the evidence was judged to be very low
(Table 5).
Glass Ionomer Sealants Pooled Retention Rate
Three studies reported the retention rate of GIS, with a total
of 697 participants, of whom 644 were evaluated.44–46 The
overall retention rate of GIS at 6 months was 94.85% (95%
CI, 94.15-96.00%).44,46 However, the retention rate dropped
considerably to 20.18% (95% CI, 17.91-22.54%)44–46 when
evaluated at 18 months. The certainty in evidence was
graded as very low because of the inclusion of
observational data, high risk of overall bias, and
substantial heterogeneity (6 month: I2 5 72.50%, P 5
The Journal of EVIDENCE-BASED DENTAL PRACTICE
.05744,46; 18 month: I2 5 78.61%, P 5 .01044–46) (Figure 4
and Table 5).
DISCUSSION
Strengths and Limitations
The methodology adopted in this review was based on the
guidelines and recommendations suggested by the
Cochrane Handbook for Systematic Reviews of In-
terventions36 and the PRISMA guidelines,33 such that
potential bias in the review process can be minimized.
Independent screening and assessment for eligibility and
risk of bias, data synthesi, and evidence evaluation
adopting the GRADE approach41 are all strengths of the
study. The current review also adopted the newly revised
Cochrane risk of bias tools for randomized trials (RoB 2.0)
published in 2016, which allows an objective judgment of
the risks of bias associated in each domain under a
comprehensive framework.36
One of the limitations includes the exclusion of non-English
trial reports. Several studies were excluded because there
were no translated English reports available. However, the
inclusion of non-English trials had been reported to have
minimal influence when summarizing treatment effect esti-
mates.49,50 The effect size estimates can still be robust in
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The Journal of EVIDENCE-BASED DENTAL PRACTICE

Table 5. GRADE summary of findings table for the secondary outcome (sealant retention).

N Patient Inconsistencyc
(% M); N Certainty in the
Evaluation Age Primary evidence (quality
Retention time range molar Retention Risk of Heterogenicity Publication of the evidence)
rate (month) (year) (% E)a rate (95% CI) biasb I2 (%) (P value) Indirectnessd Imprecisione biasf (GRADE)

RBS 6 508(49.4); 2032 (0) 89.79 (86.14, 92.97) Serious 94.29 ,.001 Not serious Not serious N/A 4OOO very low
1.0-2.5 due to
12 89 (NR); 356 (NR) 86.81 (83.62, 89.70) Serious 87.49 .060 Not serious Not serious N/A observational
3.0 data, overall high
18 75 (52) 150 (100) 85.94 (82.13, 89.38) Serious 90.72 ,.001 Not serious Serious N/A risk of bias,
4.0 -7.0 substantial
GRADE Y Y – Y – inconsistency &
imprecision

GIS 6 508 2032 (0) 94.85 (91.92, 97.19) Serious 72.50 .057 Not serious Not serious N/A 4OOO very low
(49.4%) due to
1-2.5 observational
18 89 356 (NR) 20.18 (17.91, 22.54) Serious 78.61 .010 Not serious Not serious N/A data, overall high
[NR, 3 yrs] risk of bias,
GRADE Y Y Y substantial
inconsistency &
imprecision

GRADE, Grading of Recommendations Assessment Development and Evaluation; CI, confidence interval; RBS, resin-based sealant; GIS, glass ionomer sealant.
a
Percentage of primary second molar (E) compared with that of all primary first and second molars included.
b
Risk of bias: (1) Bias arising from the randomization process (1b) Bias arising from the timing of identification and recruitment of individual participants (for split-mouth study only) (2) Bias due to deviations
from intended interventions (3) Bias due to missing outcome data (4) Bias in measurement of the outcome (5) Bias in selection of the reported results. Downgraded by 1 level if 1 domain was determined as
having high risk of bias; 2 level if more than 1 domains were rated as having high risk of bias.
c
Inconsistency: Downgraded when I2 statistics . 50% and P-value of c2 test ,.05.
d
Indirectness: Downgraded when applicability of findings was restricted in terms of population, intervention, comparator, and outcomes.
e
Imprecision: Downgraded when the total number of events was below 300 for dichotomous outcome or when the upper and lower limits of 95% CI include both meaningful benefits and harm.
f
Publications bias: Not applicable as funnel plot could not be constricted, given limited numbers of study. Publication bias was difficult to detect, and thus, no downgrading was performed.

both language-restricted and language-inclusive meta-
analyses.49,50
Publication bias also could not be evaluated with the use of
funnel plots as planned because the number of studies
available for each outcome was limited. As nearly half of the
studies were published more than 10 years ago, it was
difficult to contact primary authors for obtaining raw data or
assessing the risk of bias. Many studies used a short follow-
up time, thereby limiting the long-term validity of our
findings.
The number of appropriately designed and well-conducted
trials available for analysis was scarce. Majority of outcomes
were downgraded for high risks of overall bias and impre-
cision because of insufficient sample size.41 Most of the
results could not be pooled for data synthesis and meta-
analysis in multiple outcomes because of limited relevant
studies identified, as well as heterogeneity of the study
design, participants, clinical settings, treatment modalities
for comparison, and evaluation time points.
Therefore, the level of evidence available for data synthesis
is severely constrained because of the limited quantity and
quality of the relevant studies available. Other confounders
that might have influenced the magnitude of preventive and
arrest fraction of sealants were not clearly identified and
analyzed in many of the included studies. For instance,
factors such as local fluoridation, dietary habits, baseline
caries experience, and oral hygiene status of individual
participants may affect the overall caries risk and effective-
ness of sealants in caries prevention and arrest.51,52
Variables such as age and cooperativeness of subjects,
clinical setting, and equipment might also affect the ability
of the operators to achieve good moisture control,
thereby improving the retention of sealants.53
The results are also fundamentally dependent on an accu-
rate diagnosis of the occlusal caries status at the baseline
and follow-up assessment. Only 2 included studies incor-
porated the ICDAS II system to describe the caries
severity,42,48 while most studies only identified caries at the
cavitation level43–47 and might have considered other
incipient enamel lesions as sound; hence, the difficulty in
stratification of caries progression in further analyses
increases. Visual-tactile detection was used in all studies,
which is well supported as of adequate accuracy and overall
good performance.54,55 The use of radiographic
examination in addition to visual-tactile inspection in 1
study48 might have improved the diagnostic performance
and reduce the bias with respective to outcome
assessment. However, no new diagnostic tools such as
laser fluorescence, transillumination, electrical current, or
ultrasound were used to detect the progression of occlusal
caries in any study. These new diagnostic methods might
have been even more sensitive in the identification of
The Journal of EVIDENCE-BASED DENTAL PRACTICE
initial or dentinal occlusal caries,56–60 as well as providing
a more objective means to minimize the outcome
assessment bias when used as an adjunct in assessing
caries increment.57,58 Nonetheless, diagnosing the
progression of occlusal caries underneath a sealed surface
is still considered difficult no matter what type of
diagnostic method is used;61 thus, the validity of the
results generated would still have been compromised.
Comparison With Other Reviews
Pit and fissure sealants have been evaluated in a number of
systematic reviews, however, predominately on first per-
manent molars. The results of these reviews suggested that
RBS is effective in the prevention of occlusal caries when
compared with no active treatments.29 Sealants were also
found to be effective and hence recommended to reduce
the risk of progression of caries in occlusal noncavitated
lesions.10,62 Unfortunately, no outcomes were sought or
could be assessed for RBS compared with no sealants in
primary molars. One possible explanation was due to
ethical dilemma faced by most researchers of having
negative controls, especially when there is strong
established evidence suggesting RBS is significantly more
effective in preventing occlusal caries in permanent
molars, with its effectiveness lasting from 24 months to
9 years.6
The retention rates of RBS on primary molars found in this
review were similar to the retention rate on permanent
molars. Retention rates of RBS at 24-month follow-up were
found to be more than 80% for both permanent and primary
molars.6 The result of the GIS retention rates on permanent
molars was found to be inconsistent,6 but significantly
inferior to RBS.6,21 This review also identified conflicting
results for direct head-to-head comparisons of the reten-
tion rate between RBS and GIS in primary molars.
Despite significant superiority of RBS when compared with
GIS in terms of retention rate identified in the current review
and other systematic reviews on permanent molars,6,21
caries development in permanent teeth did not vary
significantly between the 2 materials.6,21,22 Inconsistent
low-quality results were found in this current review when
comparing the effectiveness of these 2 sealants in primary
molars.
The Cochrane Collaboration has recently launched an
intervention protocol on sealants for preventing dental
caries in primary teeth.63 However, the ongoing review
focusses primarily on caries prevention, including only
studies that placed sealants on sound or incipient carious
lesions on the occlusal surfaces of primary molars with
ICDAS code 0, 1, and 2 only. Despite similarities of the
participants and comparing interventions, this review also
evaluates the outcomes of sealants to arrest noncavitated
June 2020 17
 The Journal of EVIDENCE-BASED DENTAL PRACTICE

Figure 4. Retention rate of GIS over 6 and 18 months. CI, confidence interval; GIS, glass ionomer sealant.

occlusal carious lesion of ICDAS coding 3 and 4 in primary development of caries,6,10,21 it diminishes the cost of
molars. invasive operative treatments,69–72 especially among
children and adolescents with high caries risk.73 However,
Complete sealant retention has been previously proposed
these recommendations on caries prevention should be in
as essential in preventing caries development.18 This might
accordance with the patients’ individual expectations and
be applicable to RBS because caries-preventive efficacy was
preferences74–76. The dental patient-reported outcomes
found significantly associated with complete material
(dPROs) of pediatric patients and parents regarding the
retention.64 However, the same claim may not be upheld in
dental procedures are also of paramount importance in
GIS because both findings in the current review and
treatment planning.77,78 Therefore, it should be considered
previous literatures22,64 have suggested that the
apart from the service providers’ standpoints. Among
dislodgement of GIS might not necessarily indicate an
pediatric patients, dPROs including pain, anxiety, and
increased caries occurrence. The possible mechanism
diminished oral health–related quality of life may have a
proposed is that the remnants of GIS might be
prolonged negative impact, leading to dental anxiety and
microscopically retained at the base of the pits and
treatment avoidance in adolescence and adulthood.79–81
fissures,65,66 which continuously serve as reservoirs for
fluoride ions65,66 and provide a caries-preventive ef-
Concerning the dPROs and satisfactions toward fissure
fect.65,66 Therefore, the retention rate of GIS might not be
sealants and other caries-preventive interventions among
an accurate surrogate endpoint, reflecting the true
pediatric patients, Morgan et al.82 explored the perception
effectiveness of the material on caries prevention and
of RBS among children aged 3-16 years through interviews
arrest.64
shortly after placement of RBS. Positive or neutral reviews
In the perspective of health care professionals, placement of regarding the ease of procedures were received from 96%
fissure sealants is deemed 1 of the most cost-effective of the patients,83 while a mixture of positive and negative
caries-preventive interventions well recommended by responses was obtained about the taste and feeling of
various guidelines.13,14,67,68 By impeding and halting the sealant.84 However, in contrast to invasive operative

18 Volume 20, Number 2


procedures under local anesthesia wherein patients’
acceptance drops over successive dental appointments,83
patients with past sealant experience are more likely to
accept the treatment.82 Parents’ attitudes toward fissure
sealant were generally supportive,83 where mothers with
lower education level were significantly more likely to
satisfy with this preventive treatment.83
Nonetheless, dPROs toward caries-preventive procedures
among younger pediatric populations are difficult to assess
and the available literature in this subject remains scarce. To
date, no studies with a long-term follow-up have been un-
dertaken to assess the dPROs toward caries prevention
among pediatric patients and their parents because patient-
reported outcomes can help in evaluating the impact and
satisfaction of health care interventions brought to pa-
tients85,86 and aid in resource allocation,81,82 thus improving
health outcomes,81,82 patient compliance85,87 and bringing
further benefits to the health care system as a whole.85,86
Further investigations on patient-reported outcomes with
appropriately validated and tailor-made patient-reported
outcome measures among pediatric patients are strongly
encouraged.87,88
Summary of Evidence
The effectiveness of different types of pit and fissure seal-
ants in preventing occlusal caries and arresting occlusal
noncavitated carious lesions in primary molars was evalu-
ated in randomized controlled trials. The evidence for the
effectiveness of GIS compared with no sealant is of very low
certainty. Low-certainty evidence was also found for no
difference in overall effectiveness in caries prevention and
arrest between RBS together with topical fluoride applica-
tion in caries prevention and fluoride varnish application
alone in 1-year and 2-year follow-up. However, significantly
higher caries-preventive efficacy in RBS with topical fluoride
application when used in sound occlusal surfaces without
localized enamel breakdown was found in 1-year follow-up.
This review also identified low-certainty evidence for
comparing conventional RBS versus ACP-RBS or F-RBS and
autopolymerized RBS versus light-polymerized RBS. Very
low certainty of evidence was perceived for no difference
between resin infiltration versus sealants in preventing
progression of occlusal caries in primary molars. No evi-
dence was recognized for comparing conventional RBS or
new types of sealants versus no sealant in primary molars.
Therefore, the effectiveness of these treatment modalities is
still uncertain.
The retention rates of RBS in primary molars were more than
85% and did not differ significantly at the 3 evaluated time
points (6, 12, and 18 months). The long-term retention rate
of GIS was poor. The reported retention rate of 95% at
6 months after placement dropped to below 25% at
The Journal of EVIDENCE-BASED DENTAL PRACTICE
18 months. The certainty of both outcomes was very low
because of the high risk of overall bias and imprecision.
CONCLUSIONS
There are currently insufficient well-controlled randomized
controlled clinical trials to determine the benefits of pit and
fissure sealants to prevent occlusal caries or arrest non-
cavitated occlusal carious lesions in primary molars. This
review identified no currently available evidence regarding
the effectiveness of different sealants in preventing and
arresting pit and fissure caries in primary molars in children
and adolescents compared with no sealants. Limited evi-
dence was also found in suggestion of any superiority
among different types of sealants or with other kinds of
caries-preventive measures. However, the high risks of bias
associated with a majority of the identified studies placed
the validity of the current findings uncertain. High-quality
clinical trials are required in the future to generate reliable
evidence to support the use of pit and fissure sealants to
prevent occlusal caries or arrest of noncavitated occlusal
carious lesions in primary molars.
This review thus encourages more high-quality studies that
fulfill the current standards of case definitions, study design
and administration, and analysis and reporting to be carried
out, such that more concrete evidence related to the
effectiveness in preventing and arresting occlusal caries in
primary molar can be established.
SUPPLEMENTARY DATA
Supplementary data related to this article can be found at
https://doi.org/10.1016/j.jebdp.2020.101404.
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