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Sealants for preventing dental caries in primary teeth

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 Cochrane Database of Systematic Reviews

Sealants for preventing dental caries in primary teeth

(Protocol)

Ramamurthy P, Rath A, Sidhu P, Fernandes B, Nettem S, Muttalib K, Fee PA, Zaror C, Walsh T

Ramamurthy P, Rath A, Sidhu P, Fernandes B, Nettem S, Muttalib K, Fee PA, Zaror C, Walsh T.
Sealants for preventing dental caries in primary teeth.
Cochrane Database of Systematic Reviews 2018, Issue 3. Art. No.: CD012981.
DOI: 10.1002/14651858.CD012981.

www.cochranelibrary.com

Sealants for preventing dental caries in primary teeth (Protocol)

Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
 TABLE OF CONTENTS
HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Figure 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Figure 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
APPENDICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
CONTRIBUTIONS OF AUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
DECLARATIONS OF INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
SOURCES OF SUPPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Sealants for preventing dental caries in primary teeth (Protocol) i

Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
[Intervention Protocol]

Sealants for preventing dental caries in primary teeth

Priyadarshini Ramamurthy1 , Avita Rath1 , Preena Sidhu1 , Bennete Fernandes1 , Sowmya Nettem2 , Khairiyah Muttalib1 , Patrick A Fee
3,Carlos Zaror4 , Tanya Walsh5
1 Faculty of Dentistry, SEGi University, Kotadamansara,Malaysia. 2 Department of Periodontics, Faculty Of Dentistry, Melaka-Manipal
Medical College, Melaka, Malaysia. School of Dentistry, University of Dundee, Dundee, UK. 4 Department of Pediatric Dentistry
3

and Orthodontic, Faculty of Dentistry, Universidad de la Frontera, Temuco, Chile. 5 Division of Dentistry, School of Medical Sciences,
Faculty of Biology, Medicine and Health, The University of Manchester, Manchester, UK

Contact address: Priyadarshini Ramamurthy, Faculty of Dentistry, SEGi University, No.9 Jalan Teknologi, PJU 5, Petaling Jaya,
Kotadamansara, Selengor, 47810, Malaysia. reachdocpriya@rediffmail.com.

Editorial group: Cochrane Oral Health Group.

Publication status and date: New, published in Issue 3, 2018.

Citation: Ramamurthy P, Rath A, Sidhu P, Fernandes B, Nettem S, Muttalib K, Fee PA, Zaror C, Walsh T. Sealants for
preventing dental caries in primary teeth. Cochrane Database of Systematic Reviews 2018, Issue 3. Art. No.: CD012981. DOI:
10.1002/14651858.CD012981.

Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

ABSTRACT
This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:
To evaluate the effects of sealants in preventing pit and fissure caries in primary molars.

BACKGROUND Under favourable conditions, the mineral loss is reversible (rem-

ineralisation); however, if the cariogenic challenge persists, it will
lead to the further dissolution of dental hard tissues and possi-
Description of the condition bly visible caries (Figure 1). In the absence of timely treatment,
caries can spread through the hard tissues of the tooth to the soft
Dental caries is a multifactorial disease of the teeth that results tissue (pulp), leading to pain, inflammation and loss of function
in the localised destruction of tooth structure. Once considered (Ten Cate 1999). If left untreated, caries can result in difficulty
solely an infectious disease, caries is currently defined as “a com- in chewing, tooth loss, weight loss, changes in behaviour ), and
plex disease caused by an imbalance in physiologic equilibrium be- poor academic performance and cognitive development in young
tween tooth mineral and biofilm fluid” (Fejerskov 2003). Caries is children (Acs 1992; Abanto 2011; Ayhan 1996; Miller 1992). It
caused by an interplay between the tooth substrate, carbohydrates can negatively impact quality of life (Filstrup 2003). Besides per-
in the diet and cariogenic bacteria in the dental biofilm. The bac- sonal and public health implications, the management of dental
teria metabolise refined carbohydrates (sugars) and produce acid, caries can have a substantial economic impact. In some resource-
causing fluctuations in the pH of the biofilm and disturbances in poor settings, the cost of treating dental caries exceeds the entire
the physiologic equilibrium between the tooth and biofilm, result- allocated national healthcare budget (Yee 2002).
ing in mineral loss (demineralisation) (Herald 2013; Kidd 2011).

Sealants for preventing dental caries in primary teeth (Protocol) 1

Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
 Figure 1. Aetiopathogenesis of pit and fissure caries

Sealants for preventing dental caries in primary teeth (Protocol) 2

Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
As the most common dental disease affecting people of all ages,
caries is a significant health problem in children. Untreated dental ria. However, the recently introduced International Caries Detec-
caries in primary teeth is considered the 10th most prevalent con- tion and Assessment System (ICDAS) integrates several new cri-
dition, affecting about 621 million children globally (Kassebaum teria into one standard system, which simplifies caries assessment
2015). The prevalence and burden of caries are higher among (Ismail 2007). With ICDAS, the codes for assessment range from
children in low- and middle-income countries than among those 0 to 6 depending on the severity of the carious lesion. A code 0,
in high-income countries (WHO 2014). Susceptibility to caries 1 or 2 represents an assessment ranging from sound tooth surface
is highly variable among individuals and teeth. Teeth are marked to caries in enamel without cavitation. At this level of severity,
with pits and fissures: a pit is a small pinpoint depression located teeth have a greater potential for remineralisation than teeth with
at the junction of developmental grooves or at the terminals of higher severity caries (ICDAS codes 3 to 6, which represent assess-
those grooves, whereas a fissure is a deep cleft between adjoin- ments ranging from cavitated caries in enamel to caries in dentin)
ing cusps (Tandon 2009). Within the mouth, pits and fissures on (ICDAS II 2008).
the occlusal (chewing) surfaces of posterior (back) teeth are more Prevention of caries in primary molars is important as the progres-
prone to the development of dental caries than those of other teeth sion of caries is faster here than in permanent molars, owing to
surfaces due to increased plaque retention, permeable immature thinner enamel and greater porosity (Mortimer 1970; Low 2008).
enamel structure and the reduced effectiveness of fluoride on pits Description of the intervention
and fissures (Beauchamp 2008). Pit and fissure caries account for
90% of all dental caries in permanent molars even though occlusal Pit and fissure sealants are applied to the pit and fissure sur-
surfaces represent only 12.5% of the total surfaces of the teeth faces of teeth that are highly susceptible to dental caries and re-
(CDC and National Center for Health Statistics 2005). Caries is sistant to other therapeutic approaches such as fluorides and me-
also prevalent in the primary molars with about 44% of all caries chanical plaque control (Wright 2016). They can be categorised
seen in pits and fissures (Dye 2007), even though the occlusal broadly as resin-based sealants, glass ionomer sealants and hy-
morphology of primary molars is flatter and less fissured than that brid sealants (Figure 2). The first materials used as pit and fis-
of permanent molars (Carol 2015). sure sealants were methyl methacrylate or cyanoacrylate cements
Grading the severity of carious lesions is complex, due in part (Cueto 1967; Herald 2013). With the invention of bisphenol A-
to a lack of consistency among contemporary assessment crite- glycidyl methacrylate (BIS-GMA), resin-based sealants were in-
troduced (Bowen 1982).

Sealants for preventing dental caries in primary teeth (Protocol) 3

Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
 Figure 2. Classification of sealants

• Resin-based sealants can be classified into four generations

based on their content and method of polymerisation. First- cements and can bond chemically to the tooth structure. These
generation sealants were cyanoacrylates activated using an sealants are used widely due to their fluoride-releasing properties.
ultraviolet light source of 365 nm. Due to observed degradation They have the advantage of being less sensitive to moisture,
in the oral cavity over time, these sealants are no longer available making them a potential alternative to resin-based sealants when
(Pinkham 2005). Second-generation resin sealants contain BIS- moisture control is an issue. However, glass ionomer sealants
GMA or urethane dimethacrylate-based products, which are have poor retention rates on teeth compared with resin-based
autopolymerising or chemically cured (Donly 2002; Pinkham sealants (Simonsen 2002). Glass ionomer sealants can be
2005). Third-generation sealants contain a di-ketone initiator conventional (chemically cured) or resin modified, in which
and a reducing agent to initiate polymerisation, and are visible conventional GICs are combined with resin components that are
light-activated (Sanders 2015). Fourth-generation sealants are light cured (Anusavice 2013; Arrondo 2009).
fluoride-releasing resin-based products, which have an additional • Hybrid sealants, such as compomers and giomers, are a
potential benefit in terms of caries prevention (Donly 2002). combination of resin and GICs. Compomers are polyacid-
• Glass ionomer sealants are made from glass ionomer modified composite resins and giomers are fluoride-releasing

Sealants for preventing dental caries in primary teeth (Protocol) 4

Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
materials made of urethane resins containing surface prereacted part of preventive programmes for young children (AAPD 2013;
glass ionomer filler particles (Carol 2015). These are relatively Gooch 2009).
newer materials and data on their caries-preventive effects are There is uncertainty regarding the use of sealants in primary mo-
limited. lars. Opponents of the placement of sealants in primary molars
believe that the flatter fissures of primary molars do not support
long-term sealant retention (Horowitz 1982). Apprehension about
How the intervention might work sealing over incipient (white spot) and non-cavitated carious le-
The anatomy of the pit and fissure surfaces makes them difficult sions is another concern (Ripa 1976). However, this concern may
to clean, and they are thus at higher risk for caries development. be unfounded. A report from the American Dental Association
If the morphology of fissures is deep and complex, it can lead to indicated that children with sealed sound or non-cavitated pit and
the entrapment of food debris, which in turn acts as a niche for fissures in primary molars had a 76% lower risk of developing new
plaque formation and bacterial growth (Figure 1). Cleaning deep caries than children without sealants; retention levels in primary
and complex fissures is difficult as a toothbrush bristle cannot molars ranged from 74% to 93% (Beauchamp 2008).
reach into the depth of the fissure. Thus, even excellent home care This review is intended to provide healthcare policymakers, practi-
may not be successful in cleaning a deep fissure (Vann 1999). tioners and consumers with evidence about the effectiveness of pit
Sealants applied to sound occlusal teeth surfaces occlude these pits and fissure sealants for preventing dental caries in primary teeth.
and fissures forming a physical barrier that helps to prevent caries It will complement the existing Cochrane Review on sealant use
development. The physical barrier may block the carbohydrates in permanent teeth (Ahovuo-Saloranta 2017).
from reaching the bacteria at the base of these structures, as well
as making the surfaces easier to clean (Herald 2013; Vann 1999).
While resin-based sealants prevent caries by forming a physical
barrier (Mertz-Fairhurst 1984), GIC sealants bond chemically to
dental tissues and have anticariogenic effect by releasing fluoride OBJECTIVES
(McLean 1992).
To evaluate the effects of sealants in preventing pit and fissure
caries in primary molars.

Why it is important to do this review

The use of sealants in preventing caries in permanent teeth in chil- METHODS
dren and adolescents is well established. A Cochrane systematic
review found moderate-quality evidence that resin-based sealants
were more effective than no sealant for preventing tooth decay in
the permanent dentition, reducing it by between 11% and 51% Criteria for considering studies for this review
more than in children without sealant when measured two years
after sealant application (Ahovuo-Saloranta 2017). However, re-
sults were inconclusive when glass ionomer-based sealants were
compared with no sealant and when one type of sealant material Types of studies
was compared with another. In the four included studies that as- We will include randomised controlled trials (RCTs) of parallel-
sessed possible problems from the use of sealants, no adverse ef- group and split-mouth study designs that have investigated the
fects were reported. Use of sealants for the prevention of caries in prevention of caries in primary molars, with a follow-up period of
permanent teeth have been recommended in clinical guidelines any time interval after sealant application. We will include studies
from professional bodies like the American Dental Association, in which sealants were placed on the occlusal surfaces of primary
the American Association of Pediatric Dentistry and the British molar teeth (ICDAS codes 0, 1 and 2 (ICDAS II 2008) for the
Society of Paediatric Dentistry (Beauchamp 2008; AAPD 2013; purpose of preventing caries, regardless of who undertook the ap-
BSPD 2000). When it comes to primary teeth, however, empir- plication. The unit of randomisation can be the tooth or teeth,
ical data and systematic reviews on the effectiveness of sealants the individual or a group (e.g. school, class).
exclusively in primary molars are lacking. The clinical recommen-
dations for the management of deep pits and fissures on primary
teeth have been extrapolated from the findings of sealant effec-
Types of participants
tiveness in permanent teeth (AAPD 2013). The lack of synthe-
sised evidence from trials in the primary dentition is a concern as Children with sound primary molars or with non-cavitated enamel
sealants in primary teeth are increasingly being recommended as caries on primary molars.

Sealants for preventing dental caries in primary teeth (Protocol) 5

Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Types of interventions The subject strategies for databases will be modelled on the search
We will include studies comparing sealants with no sealant or a strategy designed for MEDLINE Ovid (Appendix 1). Where ap-
different type of sealant for the prevention of caries on primary propriate, this will be combined with subject strategy adaptations
molars. We will also include studies in which additional caries of the highly sensitive search strategy designed by Cochrane for
prevention treatments were used concurrently with sealants, pro- identifying randomised controlled trials and controlled clinical tri-
viding that the same adjunct was used with the intervention and als (as described in the Cochrane Handbook for Systematic Re-
comparator (the use of sealant was the only systematic difference views of Interventions Version 5.1.0, Box 6.4.c. (Lefebvre 2011)).
between the trial arms).
We will exclude studies of complex interventions for the preven-
Searching other resources
tion of dental caries in primary teeth, such as preventive resin
restorations, or studies that have used sealants in cavitated lesions. We will search the following trial registries:
• US National Institutes of Health Ongoing Trials Register
ClinicalTrials.gov (clinicaltrials.gov/));
Types of outcome measures • World Health Organization International Clinical Trials
Registry Platform (apps.who.int/trialsearch).

Primary outcomes We will check the bibliographies of included studies and any rele-
vant systematic reviews identified for further references to relevant
1. Incidence of new dental caries on the treated occlusal
trials.
surface(s) of sound surfaces of primary molar(s) (dichotomous
We will not perform a separate search for adverse effects of this
outcome - absence or presence of a new carious lesion)
intervention. We will consider adverse effects described in included
2. Progression of non-cavitated enamel caries (dichotomous
studies only.
outcome - progression into enamel/dentine or no progression)
3. Mean caries increment, measured continuously as change in
decayed, missing and filled teeth/surfaces (dmft/s) at the occlusal
surface Data collection and analysis

Secondary outcomes
Selection of studies
1. Duration of retention of sealant
Two review authors will independently screen the titles and ab-
2. Adverse events (any type) and safety of sealant
stracts retrieved from the electronic searches, and exclude studies
that clearly do not meet the eligibility criteria. We will retrieve
and independently assess full-text articles for eligibility in dupli-
Search methods for identification of studies cate. We will resolve any disagreement through discussion or, if re-
quired, by consultation with a third review author. We will record
all studies excluded at the full-text stage that do not meet the inclu-
Electronic searches sion criteria, along with reasons for exclusion, in ’Characteristics
Cochrane Oral Health’s Information Specialist will conduct sys- of excluded studies’ tables. We will present a summary of the study
tematic searches for randomised controlled trials and controlled selection process in a PRISMA flow diagram (PRISMA 2009).
clinical trials. Due to the Cochrane Centralised Search project
to identify all clinical trials on the database and add them to
CENTRAL, only recent months of the Embase database will Data extraction and management
be searched. Please see the searching page on the Cochrane Oral Two review authors will independently extract data from each
Health website for more information. No other restrictions will included study using a specially designed data extraction form,
be placed on the language or date of publication when searching which we will first pilot on a small sample of studies. We will re-
the electronic databases. solve disagreements through discussion, consulting a third review
The Information Specialist will search the following databases for author to achieve a consensus when necessary. We will contact
relevant trials: study authors for clarification or missing data where necessary and
• Cochrane Oral Health Trials Register; feasible. We will record the following data for each included study
• the Cochrane Central Register of Controlled Trials in a ’Characteristics of included studies’ table.
(CENTRAL) in the Cochrane Register of Studies; • Trial characteristics - author, title, source, date of
• MEDLINE Ovid (from 1946 onwards); publication, country and language, trial design, location,
• Embase Ovid (previous 6 months to present). number of centres, recruitment period, study duration, number

Sealants for preventing dental caries in primary teeth (Protocol) 6

Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
of participants at the start of the study, method of allocation, We will also present a ’Risk of bias’ summary graphically.
inclusion and exclusion criteria, number of participants
randomised and analysed, masking of participants, outcome
assessors and personnel, exclusion of participants after Measures of treatment effect
randomisation, proportion of follow-up losses For continuous outcomes measured on the same scale, we will use
• Participant characteristics - age, sex, dmft/s, stage of caries, the means and standard deviations (SDs) to obtain the difference
comparability of baseline characteristics in means and 95% confidence intervals (CIs). Where the same
• Intervention characteristics - detailed description of the outcomes are measured on different scales, we will use the stan-
intervention and comparator, including timing and duration, dardised mean difference with 95% CIs. For dichotomous out-
information on compliance with the intervention (type of comes, we will express the estimate of effect as odds ratios (OR)
sealant, type and number of operators, instruments used) with 95% CIs.
• Comparator characteristics - detailed description of the
comparator, type of control (placebo, no sealant, different sealant
Unit of analysis issues
type)
• Outcome characteristics - details of the outcomes reported, For parallel-group and cluster-randomised studies, we will use the
including method of assessment and time(s) assessed individual as the unit of analysis. If clustered data are provided
• Other characteristics - adverse events, contact address of (e.g. several measurements per individual, more than one tooth
authors, funding sources, declarations or conflicts of interest or surface, clustering of children at school or class level), we will
adjust the standard errors of the estimates to take clustering into
account (as outlined in Section 16.3.4 of the Cochrane Handbook
Assessment of risk of bias in included studies for Systemic Reviews of Interventions (Higgins 2011).
For split-mouth studies, we will use the tooth pair within an in-
Two review authors will independently assess the risk of bias in dividual as a unit of analysis.
each included study using the Cochrane domain-based, two-part For studies that have used a split-mouth design but reported the
tool as described in Chapter 8 of the Cochrane Handbook for Sys- data as a parallel-group study, we will calculate the OR using the
temic Reviews of Interventions (Higgins 2011). We will contact Becker-Balagtas method, as outlined in (Curtin 2002), using Stata
study authors for clarification or missing information where nec- software version 14.
essary and feasible. We will resolve any disagreements through dis-
cussion, consulting a third review author to achieve a consensus
when necessary. Multiple-armed trials
We will complete a ’Risk of bias’ table for each included study. For We will include multiarmed trials and combine the relevant in-
each ’Risk of bias’ domain, we will first describe what was reported tervention groups to create a single pair-wise comparison or select
to have happened in the study. This will provide the rationale for one pair of relevant interventions and exclude the others in our
our judgement of that domain as at low, high or unclear risk of meta-analysis.
bias.
We will assess the following domains:
1. random sequence generation (selection bias); Dealing with missing data
2. allocation concealment (selection bias); We will attempt to contact the author(s) of all included studies,
3. blinding of participants and personnel (performance bias); where feasible, for clarification of missing data and details of any
4. incomplete outcome data (attrition bias); outcomes that may have been measured but not reported. We
5. selective outcome reporting (reporting bias); will use the methods described in Section 7.7.3 of the Cochrane
6. other bias. Handbook for Systemic Reviews of Interventions to estimate missing
We will categorise the overall risk of bias of individual studies as SDs (Higgins 2011). We will not use any other statistical methods
being at low, high or unclear risk according to the following criteria or perform any further imputation to account for missing data.
(Higgins 2011):
• low risk of bias (plausible bias unlikely to seriously alter the
results) if all domains are at a low risk of bias; Assessment of heterogeneity
• high risk of bias (plausible bias that seriously weakens If a sufficient number of studies is included in a meta-analysis, we
confidence in the results) if one or more domains are at high risk will assess clinical heterogeneity in the included studies by exam-
of bias; ining the similarity between the types of participants, interven-
• unclear risk of bias (plausible bias that raises some doubt tions and outcomes. We will also assess heterogeneity statistically
about the results) if one or more domains are at unclear risk of using the Chi2 test, where a P-value < 0.1 indicates statistically
bias but none are at high risk of bias. significant heterogeneity. We will quantify heterogeneity using the

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Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
I2 statistic. A guide to interpretation of the I2 statistic, given in Sensitivity analysis
Section 9.5.2 of the Cochrane Handbook for Systemic Reviews of We will perform sensitivity analyses to assess the impact of exclud-
Interventions, is as follows: 0% to 40% heterogeneity might not ing studies with unclear or high risk of bias from the analyses. In
be important; 30% to 60% may represent moderate heterogene- meta-analyses that include several small studies and a single very
ity; 50% to 90% may represent substantial heterogeneity; 75% to large study, we will undertake a sensitivity analysis comparing the
100% represents considerable heterogeneity (Higgins 2011). effect estimates from both random-effects and fixed-effect models.
If these are different, we will report on both analyses in the results
Assessment of reporting biases section, and consider the possible interpretation of such findings.

If at least 10 studies are included in a meta-analysis, we will assess

publication bias according to the recommendations on testing for
funnel plot asymmetry provided in the Cochrane Handbook for Presentation of main results
Systemic Reviews of Interventions (Sterne 2011). If asymmetry is We will produce a ’Summary of findings’ table for each com-
identified, we will examine possible causes. parison and for the main outcomes (caries incidence; caries pro-
gression into enamel, dentine or both; retention of sealant; and
adverse events) using GRADE methods and software (GRADE
Data synthesis
2004; GRADEpro 2014). We will assess the quality of the body of
We will carry out meta-analyses using Review Manager 5.3 evidence for each comparison and outcome by considering study
(RevMan 2014). For each comparison, we will pool the results of design limitations (i.e. the overall risk of bias of the included stud-
studies with similar characteristics in terms of participants, inter- ies, in particular, which, if any, domains are assessed as being at
ventions and outcome measures. We will group and analyse studies high risk of bias), the directness of the evidence, the consistency of
according to whether they have evaluated the effects of different the results, the precision of the estimates and the risk of publica-
sealant types, or compared a sealant with placebo or no sealant. tion bias. We will categorise the quality of each body of evidence
Our approach will be to use a random-effects model. With this as high, moderate, low or very low.
approach, the CIs for the pooled intervention effect will be wider
than those obtained using a fixed-effect approach, leading to a
more conservative interpretation. Where feasible, we will pool the
results of parallel-group and split-mouth studies using the generic
inverse variance method. ACKNOWLEDGEMENTS
We will provide an additional table reporting the results from
studies not suitable for inclusion in meta-analysis. We would like to thank Anne Littlewood (Information Special-
ist) and Laura MacDonald (Managing Editor) of Cochrane Oral
Health for their suggestions and help during protocol preparation.
Subgroup analysis and investigation of heterogeneity We also thank Professor Jan E Clarkson, Jo C Dumville and Joanne
If data are available, we will perform subgroup analyses based on Elliott, and external referees Siobhan Barry and Carly Dixon, for
the following characteristics: their comments on the protocol. We thank Gillian Gummer for
• type of sealant used; final copy editing. We would like to express our heartfelt apprecia-
• duration of follow-up (short duration (12 months or less) tion to Jo Weldon (Research Co-ordinator, Cochrane Oral Health)
versus long duration (more than 12 months)); and Professor Jacqueline Ho of Penang Medical College, Malaysia,
• grade of caries (sound tooth versus non-cavitated enamel for their valuable guidance and support. We thank SEGi Univer-
caries). sity, Malaysia for supporting this work.

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Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
 REFERENCES

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∗
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APPENDICES

Appendix 1. MEDLINE Ovid search strategy

1. “Pit and Fissure Sealants”/
2. ((resin$ or fissure$ or dental or compomer or tooth or composite$ or “glass ionomer” or glassionomer or cyanoacrylate$ or
methacrylate or BIS-GMA$ or dimethacrylate$ or “light activat$” or fluorid$ or “chemical$ cure$” or “light cure$” or GIC$ or
Giomer$) adj seal$).mp.
3. 1 or 2
4. exp Child/
5. (child$ or adolescen$ or teen$ or pediatric or baby or babies or toddler$ or pre-school or “pre school” or infant$ or paediatric or
minor$ or (immature adj5 teeth)).mp.
6. Tooth, deciduous/
7. ((tooth or teeth) adj2 (primary or deciduous or milk$)).mp.
8. or/4-7
9. 3 and 8
This search will be combined with the Cochrane Highly Sensitive Search Strategy (CHSSS) for identifying randomised trials in
MEDLINE: sensitivity-maximising version (2008 revision) as referenced in Chapter 6.4.11.1 and detailed in box 6.4.c of The Cochrane
Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011] (Lefebvre 2011).
1. randomized controlled trial.pt.
2. controlled clinical trial.pt.
3. randomized.ab.
4. placebo.ab.
5. drug therapy.fs.
6. randomly.ab.
7. trial.ab.
8. groups.ab.
9. or/1-8
10. exp animals/ not humans.sh.
11. 9 not 10

CONTRIBUTIONS OF AUTHORS
Drafting of the protocol - Priyadarshini Ramamurthy (PR), Avita Rath (AR), Preena SIdhu (PS), Bennete Fernandes (BF), Sowmya
Nettam (SN), Khairiyah Muttalib (KM), Patrick A Fee (PF), Carlos Zaror (CZ) and Tanya Walsh (TW)

Screening trials - PR, AR, PS, BF

Study selection - PR, PS, AR, BF, SN

Data extraction - PR, AR, PF, CZ, PS, TW, KM

Assessment of risk of bias - PR, TW, PF

Sealants for preventing dental caries in primary teeth (Protocol) 11
Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
 Data analysis - PR, TW
Drafting of the review - PR, AR, PS, BF, KM, PF, CZ, TW

DECLARATIONS OF INTEREST
Priyadarshini Ramamurthy: none known
Avita Rath: none known
Preena Sidhu: none known
Bennete Fernandes: none known
Sowmya Nettem: none known
Khairiyah Muttalib: none known
Patrick A Fee: none known. Dr Fee is a clinical advisor with Cochrane Oral Health.
Carlos Zaror: none known
Tanya Walsh: none known. Dr Walsh is an Editor with Cochrane Oral Health.

SOURCES OF SUPPORT

Internal sources
• SEGi University, Malaysia.
Provided fund for training in ’Writing a Protocol for Cochrane Systematic Reviews’
• The University of Manchester, Manchester Academic Health Sciences Centre (MAHSC) and NIHR Manchester Biomedical
Research Centre, UK.

External sources
• National Institute for Health Research (NIHR), UK.
This project was supported by the NIHR, via Cochrane Infrastructure funding to Cochrane Oral Health. The views and opinions
expressed herein are those of the review authors and do not necessarily reflect those of the Systematic Reviews Programme, the NIHR,
the NHS or the Department of Health.
• Cochrane Oral Health Global Alliance, Other.
The production of Cochrane Oral Health reviews has been supported financially by our Global Alliance since 2011 (
oralhealth.cochrane.org/partnerships-alliances). Contributors over the past year have been the American Association of Public Health
Dentistry, USA; AS-Akademie, Germany; the British Association for the Study of Community Dentistry, UK; the British Society of
Paediatric Dentistry, UK; the Canadian Dental Hygienists Association, Canada; the Centre for Dental Education and Research at All
India Institute of Medical Sciences, India; the National Center for Dental Hygiene Research & Practice, USA; New York University
College of Dentistry, USA; and NHS Education for Scotland, UK; Swiss Society of Endodontology, Switzerland.

Sealants for preventing dental caries in primary teeth (Protocol) 12

Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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