Received: 17 July 2020 

|
  Revised: 13 August 2020 
|  Accepted: 16 September 2020

DOI: 10.1111/ipd.12733

SPECIAL ISSUES

Guidelines for reporting randomized controlled trials in

paediatric dentistry based on the CONSORT statement

Jayakumar Jayaraman

Department of Developmental Dentistry,

University of Texas Health School of
Dentistry, San Antonio, TX, USA
Correspondence
Jayakumar Jayaraman, Department of
Developmental Dentistry, University of
Texas Health School of Dentistry, 7703
Floyd Curl Drive, San Antonio, TX 78229,
USA.
Email: jayakumar83@hotmail.com
Abstract
Background: The significance of randomized controlled trials (RCT) depends on
how thoroughly the results were reported. Reporting of RCTs should be accurate
and transparent and encompasses design, implementation, analysis, and results of
the trial. The Consolidated Standards of Reporting Trials (CONSORT) statement
and its extension were developed to guide the researchers to report clinical trials in
a systematic manner. Despite this recommendation, the overall reporting quality of
RCTs still remains suboptimal.
Aim: To describe the relevance and importance of CONSORT reporting guidelines
and explain the items using examples derived from randomized trials published in
Paediatric Dentistry.
Methods: This is a narrative review that illustrates the importance of reporting
items in the CONSORT guidelines from relevant sources. RCTs published in the
International Journal of Paediatric Dentistry between 2017 and 2020 were identified
from PubMed and Scopus databases and through handsearching. An explanation has
been provided for each of the 37 items in the 2010 CONSORT checklist and 17 items
in the CONSORT extension for reporting abstracts.
Conclusion: This explanation and elaboration document would enable investigators
to report trials in Paediatric Dentistry with accuracy and transparency as well as for
reviewers and editors in evaluating the suitability of RCTs for publication.

KEYWORDS
CONSORT, guidelines, paediatric dentistry, randomized, reporting, trials

1  |   IN TRO D U C T ION
Randomized controlled trials (RCTs) provide information for
making clinical decisions, and they are established as the ideal
type of research to examine the effectiveness of treatment in-
terventions in health sciences.1 The highest level of evidence
for an intervention is, however, obtained from the systematic
review of high-quality randomized controlled trials.2 The
significance of the randomized controlled trials depends on
how rigorously the study was conducted and how thoroughly
the results were reported. Reporting of RCTs should be ac-
curate and transparent and encompasses design, implemen-
tation, analysis, and results of the trial.3 The Consolidated
Standards of Reporting Trials (CONSORT) statement and its
extensions were developed to guide the researchers to report
clinical trials in a systematic manner. The CONSORT state-
ment comprises a checklist of essential items that should be
included in reports of RCTs and a diagram for documenting
the flow of participants through a trial. The checklist covers
all elements of reporting RCTs including Title and abstract,

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2020 BSPD, IAPD and John Wiley & Sons Ltd Int J Paediatr Dent. 2021;31(Suppl. 1):38–55.
JAYARAMAN
Introduction, Methods, Results, Discussion, and Other infor-
mation.2 Although this checklist is specific to primary reports
of RCTs with two groups and parallel arm design, several
extensions of CONSORT are currently available to report
other types of RCTs.2 This includes multi-arm parallel tri-
als,4 cross-over trials,5 within-person trials,6 non-inferiority
and equivalence trials,7 cluster trials,8 stepped wedge cluster
trials,9 pragmatic,10 and N-for-1 (effectiveness of interven-
tion in a specific individual) trials.11 Kindly refer to Table
1 for different types of randomized trials and links to the re-
porting guidelines.
Over 600 medical and dental journals have adopted the
CONSORT guidelines that recommend authors to strictly ad-
here to the guidelines.12 Despite this endorsement, the report-
ing quality of the RCTs still remains inadequate.13,14 A study
that assessed 540 RCTs published in dental journals from
1955 to 2013 found several discrepancies in the reporting of
RCTs; however, some improvement has been observed in the
RCTs published in recent years. Similarly, a study that as-
sessed 89 RCTs published in the field of Endodontics reported
that the overall reporting quality of RCTs was suboptimal.13
To date, two studies have evaluated the reporting quality of
RCTs in Paediatric Dentistry. The first study was based on
173 RCTs published between 1985 and 2006, and the authors
found that the overall quality of reporting clinical trials was
poor, showing heterogeneity in published studies.14 The same
authors evaluated 40 RCTs published during the period 2014-
2015 and reported some progress in all sections of reporting;
however, the overall reporting quality was still inadequate.15
  
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WHY THIS PAPER IS IMPORTANT TO
PAEDIATRIC DENTISTS
• This article highlights the implications and rel-
evance of reporting randomized controlled tri-
als based on the CONSORT guidelines and its
extensions.
• Explanation and elaboration have been provided
for each item in the CONSORT checklist with ex-
amples derived from RCTs published in Paediatric
Dentistry.
• Adherence to reporting guidelines would en-
able authors, reviewers, and editors in Paediatric
Dentistry to minimize potential sources of bias in
reporting and thereby improve the overall quality
of RCTs.
The International Journal of Paediatric Dentistry (IJPD)
has endorsed the CONSORT guidelines and mandates the
investigators to include the CONSORT checklist along with
the submission of RCTs to the journal.16 This is to ensure
that the authors have adhered to the CONSORT reporting
guidelines.2 There has been some improvement in the trials
published in the journal since these changes were introduced;
however, there is still scope for improvement to further en-
hance compliance with the CONSORT guidelines. The aim
of this article is to describe the relevance and importance of

T A B L E 1   Types of randomized
Link to reporting
controlled trials and their reporting
S.No Randomized trials Authors, Year guidelines
guidelines
1 Parallel arm, two groups2 Moher et al, 2010 https://www.bmj.com/
conte​nt/340/bmj.c869
2 Parallel arm, multiple Juszczak et al, https://jaman​etwork.
groups4 2010 com/journ​als/jama/
fulla​rticl​e/2731183
3 Cross-over5 Dwan et al, 2019 https://www.bmj.com/
conte​nt/366/bmj.l4378
4 Within-person Pandis et al, 2017 https://www.bmj.com/
(split-mouth)6 conte​nt/357/bmj.j2835
5 Non-inferiority and Piaggio et al, 2012 https://jaman​etwork.
Equivalence7 com/journ​als/jama/
fulla​rticl​e/1487502
6 Cluster8 Campbell et al, https://www.bmj.com/
2012 conte​nt/345/bmj.e5661
7 Stepped wedge cluster9 Hemming et al, https://www.bmj.com/
2018 conte​nt/363/bmj.k1614
8 Pragmatic10 Zwarenstein et al, https://www.bmj.com/
2008 conte​nt/337/bmj.a2390
9 N-of-111 Vohra et al, 2015 https://www.bmj.com/
conte​nt/350/bmj.h1738
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40       JAYARAMAN
items in the CONSORT checklist for parallel group random-
ized trials and explain each item with an example derived
from RCTs published in International Journal of Paediatric
Dentistry. This would enable authors, reviewers, and editors
in Paediatric Dentistry to minimize potential sources of bias
in reporting, thereby improving the overall reporting quality
of RCTs and the value of the published information.
2  |  M AT E R IA L S A N D ME T HODS
PubMed and Scopus databases were searched electronically
by a single trained and calibrated examiner (JJ) to identify
RCTs published in the International Journal of Paediatric
Dentistry using the following search terms: (“international
journal of paediatric dentistry”[Journal]) AND ((randomized
clinical trial) OR (randomized controlled trial) OR (ran-
domised controlled trial) OR (randomised controlled trial)
OR (trial)). A total of 198 and 39 articles were identified from
PubMed and Scopus databases, respectively. In addition,
hand searching was performed to identify randomized trials
published in International Journal of Paediatric Dentistry, but
it did not yield any additional studies. RCTs published be-
tween 2017 and 2020 alone were included in this review.
3  |   R EP O RT ING R A N D OMIZ ED
CO N TRO L L E D T R IA L
The reporting of main study of RCTs will be based on the
CONSORT checklist that comprises a total of 37 main and
subitems (see Table 2). Description for each item has been
provided in the explanation and elaboration document.2
The items described in this article were adapted from the
CONSORT guidelines to target the investigators, reviewers,
and editors in the field of Paediatric Dentistry.
3.1  |  Title and Abstract
3.1.1  |  Item 1a: Identification as a
randomized trial in the title
Example: “Anaesthetic efficacy of 4% articaine and 2% lido-
caine for extraction and pulpotomy of mandibular primary
molars: an equivalence parallel prospective randomized con-
trolled trial”.17
Explanation: The term “randomized” should be included
in the title. This could be indicated as “randomized clinical
trial”, “randomized controlled trial”, or simply, “randomized
trial”. This confirms that the study is adequately indexed
and identified during the search process from electronic
databases.
3.1.2  |  Item 1b. Structured summary of trial
design, methods, results, and conclusions
Example: “Background: Rapid maxillary expansion (RME)
is an orthopaedic procedure indicated for a wide variety of
clinical conditions. Aim: The aim of the study was to compare
the effects of ketoprofen lysine salt (KLS) vs paracetamol/
acetaminophen (P) on pain perception during RME. Design:
One hundred and fifty-one subjects (mean age 8.6 years) were
enrolled in this prospective controlled clinical trial according
to inclusion criteria: prepuberal stage of development, nega-
tive posterior transverse interarch discrepancy, non-concur-
rent use of other drugs. First phase: n.40 allocated to Group 1
used 40 mg of KLS, n.40 to Group 2 used 250 mg of P, n.36
to Group 3 as control group. Second phase: n.35 allocated to
Group 4 used 40 mg ketoprofen lysine salt once a day for the
first 3 days of activation. Pain experience was reported on
a numeric rating scale (0-4) and a 100-mm visual analogue
scale. Pain perception was tested with the Mann-Whitney test
(P < .05). Results: Pain perception was higher during the first
3 days of activation and it was described as mild to moderate.
Group 1 experienced significantly less pain during the fourth,
fifth, and sixth day (P < .05) compared with Group 2. Patients
of the Group 4 reported significantly lower pain during the
whole period of RME activation (P < .05). Conclusions: The
perceived higher pain was reported during the second and
third day of expansion. The analgesic effect of KLS is more
effective than P during the fourth, fifth, and sixth day. The use
of KLS during the first 3 days of activation seems to be able
reducing pain during the whole active phase”.19
Explanation: The Abstract of an article is an important
document. It is commonly used as a screening tool and a
gateway to read the full article. An abstract should contain
important information about an RCT to serve as an accu-
rate record of its methods and findings within the space
constraints and format of a journal. The IJPD requires the
Abstract to be structured and less than 200 words. For spe-
cific guidance, refer to CONSORT extension for Abstracts
that provides a list of items that authors should include
when reporting a randomized trial in a journal or confer-
ence abstract.18
3.2  | Introduction
3.2.1  |  Background and Objectives
Item 2a. Scientific background and explanation of
rationale
Example: “Zirconia pediatric crowns showed higher mean
bond strength when cemented with NuSmile BioCem than
when cemented with conventional glass ionomer cement.
There are, however, apparently no clinical trials to test the
JAYARAMAN   
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T A B L E 2   CONSORT 2010 checklist for reporting a randomized controlled trial (adapted from Moher et al.2)

Item
Section No Checklist item
Title & Abstract
1a Identification as a randomised trial in the title
1b Structured summary of trial design, methods, results, and conclusions (see CONSORT for
Abstract for specific guidance)
Introduction
Background and objectives 2a Scientific background and explanation of rationale
2b Specific objectives or hypotheses
Methods
Trial design 3a Description of trial design (such as parallel, cross-over, split-mouth) including allocation ratio
3b Important changes to methods after trial commencement (such as eligibility criteria), with
reasons
Participants 4a Eligibility criteria for participants
4b Settings and locations where the data were collected
Interventions 5 The interventions for each group with sufficient details to allow replication, including how and
when they were actually administered
Outcomes 6a Completely defined pre-specified primary and secondary outcome measures, including how and
when they were assessed
6b Any changes to trial outcomes after the trial commenced, with reasons
Sample size 7a How sample size was determined
7b When applicable, explanation of any interim analyses and stopping guidelines
Randomisation
Se sequence generation 8a Method used to generate the random allocation sequence
8b Type of randomisation; details of any restriction (such as blocking and block size)
A Allocation concealment 9 Mechanism used to implement the random allocation sequence (such as sequentially numbered
mechanism opaque envelopes), describing any steps taken to conceal the sequence until interventions were
assigned
Implementation 10 Who generated the random allocation sequence, who enrolled participants, and who assigned
participants to interventions
Blinding 11a If done, who was blinded after assignment to interventions (such as participants, treatment
providers, those assessing outcomes) and how
11b If relevant, description of the similarity of interventions
Statistical methods 12a Statistical methods used to compare groups for primary and secondary outcomes
12b Methods for additional analyses, such as subgroup analyses and adjusted analyses
Results
Participant flow (a diagram is 13a For each group, the numbers of participants who were randomly assigned, received intended
strongly recommended) treatment, and were analysed for the primary outcome
13b For each group, losses and exclusions after randomisation, together with reasons
Recruitment 14a Dates defining the periods of recruitment and follow-up
14b Why the trial ended or was stopped
Baseline data 15 A table showing baseline demographic and clinical characteristics for each group
Numbers analysed 16 For each group, number of participants (denominator) included in each analysis and whether the
analysis was by original assigned groups
Outcomes and estimation 17a For each primary and secondary outcome, results for each group, and the estimated effect size
and its precision (such as 95% confidence interval)
17b For binary outcomes, presentation of both absolute and relative effect sizes is recommended

(Continues)
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42       JAYARAMAN

T A B L E 2   (Continued)

Item
Section No Checklist item
Ancillary analyses 18 Results of any other analyses performed, including subgroup analyses and adjusted analyses,
distinguishing pre-specified from exploratory
Harms 19 All-important harms or unintended effects in each group (see CONSORT for harms for specific
guidance)
Discussion
Limitations 20 Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity
of analyses
Generalisability 21 Generalisability (external validity, applicability) of the trial findings
Interpretation 22 Interpretation consistent with results, balancing benefits and harms, and considering other
relevant evidence
Other information
Registration 23 Registration number and name of trial registry
Protocol 24 Where the full trial protocol can be accessed, if available
Funding 25 Sources of funding and other support (such as supply of materials), role of funders

clinical performance of the cement up to date… So, this
study was carried out to compare retention and fracture of
posterior zirconia pediatric crowns, and gingival condition
around them when cemented with bioactive cement versus
when cemented with packable glass ionomer”.20
Explanation: An introduction is a general outline that
consists of scientific background and rationale for the ran-
domized trial. The rationale may be explanatory (eg to as-
sess the possible influence of a specific sedative medication
for paediatric dental procedures) or pragmatic (eg to guide
practice by comparing the effectiveness of two pulpotomy
medicaments). Authors should report any evidence of the
benefits and harms of active interventions included in a
trial. The Declaration of Helsinki states that biomedical
research involving humans should be based on a thorough
knowledge of the scientific literature and that it is unethical
to expose them to unnecessary risks of research.21 Children
are relatively more vulnerable to biomedical research due
to physical and emotional development and hence addi-
tional consideration should be taken when designing and
reporting trials.22
Item 2b. Specific objectives or hypotheses
Example 1: “Hence, this study was carried out to evaluate the
effect of this relaxation training exercise on dental anxiety,
dental behaviour, and pain intensity during buccal infiltra-
tion of the local anaesthetic in children. The null hypothesis
was that the bubble breath exercise has no effect on dental
anxiety, dental behaviour, and pain intensity during the ad-
ministration of buccal infiltration anaesthesia in children”.23
Example 2: “Thus, the aim of the present study was to
evaluate, through controlled clinical trial, whether there is a
significant difference in the accuracy of the electronic apex
locators compared to the conventional radiograph method in
primary molar working length measurement”.24
Explanation: Aims or Objectives are the question(s)
that the trial attempts to answer. Similarly, hypotheses are
pre-specified questions being tested to help meet the objec-
tives. Hypotheses are more specific than objectives and are
amenable to explicit statistical evaluation.2 Since objectives
and hypotheses could not be practically differentiated, it is
preferable to mention objectives alone or in addition to the
hypothesis of a trial.
3.3  | Methods
3.3.1  |  Trial design
Item 3a. Description of trial design (such as parallel,
factorial) including allocation ratio
Example: “Briefly, this is a two-armed phase II randomized
controlled trial that compared the computer game to one-to-
one oral health education in a sample of children with such
severe dental caries as to merit a hospital GA admission for
tooth extraction”.25
Explanation: The authors should indicate the type of trial
design, such as parallel, cross-over, within-person (split-mouth
in dentistry), cluster, equivalence, superiority trials Although
most of the trials use equal randomization, such as 1:1 for two
groups, the ratio might vary based on the allocation. If the
ratio is unequal, it is essential to report the appropriate alloca-
tion ratio to the control and intervention groups, respectively.
Although rare in Paediatric Dentistry, when reporting drug
trials, it is imperative to mention the phase of the trial (Phase
I to IV).
JAYARAMAN
Item 3b. Important changes to methods after trial
commencement (such as eligibility criteria), with reasons
Example: No changes occurred to the methods after the com-
mencement of the trial.
Explanation: Changes to methods in the trial after com-
mencement could happen due to external information becom-
ing available from other studies, internal financial restrictions
to conduct with the initial sample size, or due to an unex-
pected recruitment rate. Such changes to the methods can be
accommodated without hindering main outcomes of the trial.
Whether the modifications are explicitly part of the trial de-
sign or in response to changing circumstances, it is vital that
they are fully reported to help the reader interpret the results.2
3.3.2  | Participants
Item 4a. Eligibility criteria for participants
Example: “Four to seven-year-old, cooperative patients. They
should be free from any systematic disease as indicated by
their medical history, and they should show no signs of oral
deleterious habits. Included children should have their bilateral
mandibular first primary molars suffering from deep caries in-
volving more than one tooth surface. Molars should have sound
cervical margins, not hypoplastic or hypocalcified. Molars with
malocclusion, active periodontal condition, or with no oppos-
ing functioning teeth were excluded from study”.20
Explanation: Eligibility criteria were mostly applied be-
fore randomization was performed, and, hence, it does not
usually affect the internal validity of a trial. It is, however,
important as they have implications on generalizability of the
trial results, particularly for external validity. It is not required
to report inclusion and exclusion criteria of the same criterion
as the same can be phrased to include or exclude participants.
Any additional criterion not a part of the inclusion criteria
should alone be reported in the exclusion criteria.
Item 4b. Settings and locations where the data were
collected
Example: “A randomised clinical trial was conducted with
66 children and a total of 214 teeth with a sensitivity score
≤3. The study was developed at the paediatric dentistry clinic
of educational institution in the city of São Luís, Brazil, be-
tween March and December 2018”.26
Explanation: Information on the settings and locations is
important to evaluate the applicability and generalizability
of a trial. In addition, the authors should report the number
and type of settings and describe the care providers involved.
The location and immediate environment should be reported;
for example, community dental clinic, private dental prac-
tice, ambulatory surgical centre, hospital-based dental clinic
or operation room. Authors should also report other relevant
information about the setting where the trial was conducted
  
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   43
that could have influenced the observed results, for example
transportation or influence of parenting style that might af-
fect participation of the child in a trial.
3.3.3  | Intervention
Item 5. The interventions for each group with sufficient
details to allow replication, including how and when they
were actually administered
Example: “One group (treatment group) received mandibu-
lar infiltration with 4% articaine, with intrapapillary infiltra-
tion for lingual analgesia; the other group (control group)
received an IDB with 2% lidocaine (Figure 1) supplemented
by long buccal infiltration. Local anaesthetic used for buc-
cal infiltration was articaine hydrochloride 4% with adrena-
line (epinephrine) injection 1:100,000 solution for injection
(Septanest 1:100,000, 2.2 mL SEPTODONT Ltd). Ultra
Safety Plus, Sterile injection system with protective sheath
was used in the study. The buccal infiltration was admin-
istered at the buccal apex of the mandibular primary molar
under treatment and was combined with buccal intrapapillary
infiltration to anaesthetize the lingual area”.17
Explanation: The authors should report each intervention
and clearly indicate the control and experimental groups.
If the control group or intervention group is to receive a
combination of interventions, the authors should provide a
thorough description of each intervention, an explanation of
the order in which the combination of interventions is intro-
duced or withdrawn, and justification for such introduction.27
Furthermore, the details of the commercial products used in
the trial must be reported.
3.3.4  | Outcomes
Item 6a. Completely defined pre-specified primary and
secondary outcome measures, including how and when
they were assessed
Example: “Primary outcome - Pain on biting: recorded by
asking the patient if it present or absent. Secondary outcomes
- Pain on percussion: detected by tapping the tooth with the
back of the mirror; Swelling: detected by visual examination
of the labial vestibule; Sinus or fistula: detected by visual ex-
amination of the labial vestibule; Mobility: detected by apply-
ing pressure with the ends of two metal instruments; Crown
discoloration: detected by visual examination of the crown;
Root lengthening: calculated radiographically in mm and per
cent by Digora. The same radiographic procedures and image
analysis methods used preoperatively were repeated postop-
eratively at 3, 6, 9, and 12 months with the same exposure
parameters and measurements to exclude any human errors
due to geometric variations or image analysis”.28
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44       JAYARAMAN

F I G U R E 1   An example of flow chart to exhibit steps involved in the randomized controlled trial (obtained from Muniz et al.26)

Explanation: The primary outcome is the pre-specified
outcome which is of great importance in a trial. Some trials
might have more than one primary outcome; however, it is
desirable to have limited outcomes due to the interpretation
associated with multiple analyses. Secondary outcomes are
additional outcomes that are of interest. All outcome mea-
sures, including primary and secondary, should be identified
and defined clearly. The information provided should be thor-
ough for other investigators to replicate using the same out-
comes. When outcomes are assessed at different time points,
authors should indicate the outcomes measured at each time
point and modifications in the measures, if any. In addition to
direct measures, any surrogate endpoints should be defined
and addressed. In such cases, the authors should provide a
clear justification for using the surrogate endpoints.
Item 6b. Any changes to trial outcomes after the trial
commenced, with reasons
Example: There were no changes to the outcomes after com-
mencement of the trial.
Explanation: Introduction of new primary and secondary
outcomes other than those indicated at the beginning of the
trial might result in selective reporting of the results; hence,
it should be avoided. In some trials, circumstances, however,
JAYARAMAN
require a change in the way an outcome is assessed, or the need
arises to switch to a different outcome. Although not prefera-
ble, such changes may become inevitable and should be jus-
tified with reasons. Similarly, authors should explicitly report
all major changes made to the protocol after commencement
of the trial, including changes to the eligibility criteria, inter-
ventions, examinations, data collection, methods of analysis,
and outcomes.2
3.3.5  |  Sample size
Item 7a. How sample size was determined
Example: “To obtain a representative sample for the primary
outcome (behaviour), a comparison of two proportions was per-
formed based on a previous study, in which 66.7% of children
had negative behaviour prior to undergoing a tooth extraction
and 29.4% of children had negative behaviour prior to under-
going endodontic treatment. Considering an 80% test power
and 5% significance level, a two-tailed test was established, de-
termining a minimum of 27 children per group, to which 20%
was added to compensate for possible losses (questionnaires
returned blank), leading to a total 99 children”.29
Explanation: Authors should indicate how the sample
size was calculated. The sample size should be large enough
to have a high probability (power) of detecting a statistically
significant difference. In most instances, sample size calcu-
lation should take into consideration the following: (1) esti-
mated outcomes in each group; (2) α (type I) error level; (3)
β (type II) error level (statistical power); and (4) standard
deviation of the measurements for continuous outcomes.2
If power calculation was used, the authors should identify
the primary outcome of which the calculation was based,
all quantities used in the calculation, and the resulting target
sample size for each study groups. The type of study should
be taken into account during sample size calculation. For
example, RCTs can be conducted to establish a difference
between two treatment regimens or prove similarity be-
tween groups (refer to Item 3a). A smaller sample will give
a result which may not be sufficiently powered to detect a
difference between the groups and the study may turn out
to be falsely negative. In contrast, a very large sample size
is not recommended as it has its own consequences: waste
of limited available resources, recruiting more subjects than
required, denying a better regimen to a large group of peo-
ple. The sample size reported should be checked by review-
ers in the registered protocol.
Item 7b. When applicable, explanation of any interim
analyses and stopping guidelines
Example: Interim analyses were not performed during the
trial.
  
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   45
Explanation: Some trials in Paediatric Dentistry have
a long follow-up period and may extend to a few years. In
some particular circumstances, it is possible to end the study
earlier than the proposed follow-up duration if the inter-
vention demonstrated desired outcomes or the intervention
caused harm to the participants due to ethical reasons. In
such cases, the results of the trial must be examined by an
independent data monitoring committee for interim analyses
of the data and the data must be presented based on their
recommendation.
3.4  | Randomization
3.4.1  |  Sequence generation
Item 8a. Method used to generate the random allocation
sequence
Example: “The study cohort was randomly divided into two
groups of 30 patients each. Randomization was based on a
computer-generated code prepared at a remote site and sealed
in sequentially numbered, opaque envelopes”.30
Explanation: Randomization is performed to avoid like-
lihood of bias in assignment of participants to the control or
experimental group. With random allocation, each participant
has a known probability of receiving an intervention before
one was assigned, but the assigned intervention was deter-
mined by a chance process and cannot be predicted. Authors
should specify the method of sequence generation, such as a
random-number table or a computer-generated random num-
ber method.2 If the randomization is unequal, for example 2:1
(experiment: control) ratio, it should be stated with adequate
explanation.
Item 8b. Type of randomization; details of any restriction
(such as blocking and block size)
Example: “The statistician, who was otherwise not involved
in the intervention nor assessment, carried out the randomiza-
tion. Block randomization method with a block size of four
was used. The block sequences (ABAB, BABA, AABB, etc.)
were generated following which the statistician performed
random allocation of the samples to the blocks using a ran-
dom number table”.23
Explanation: The term “simple randomization” should
be mentioned if no restriction was used to generate similar
numbers in the trial groups. If block randomization was per-
formed, authors should report details on how the blocks were
generated, the block sizes, the block sequences, and whether
the block size was fixed or randomly varied. Similarly, de-
tails of stratification should be mentioned to establish that
the numbers of participants receiving each intervention are
closely balanced within each stratum.
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46       JAYARAMAN
3.4.2  |  Allocation concealment
Item 9. Mechanism used to implement the random
allocation sequence (such as sequentially numbered
containers), describing any steps taken to conceal the
sequence until interventions were assigned
Example: “Concealed random allocation for the participants
was achieved using sequentially numbered, opaque, sealed
envelopes prepared in advance by an independent party and
opened in sequence only after participant details and consent
were obtained”.17
Explanation: The mechanism of random allocation se-
quence should be reported explicitly. This can be achieved
through sequentially numbered sealed envelopes contain-
ing the participant information or assigned at a remote lo-
cation monitored through a centralized and independent
body. Allocation concealment helps to prevent selection
bias and protects the assignment sequence until appropri-
ate intervention is allocated to the trial groups. The term
“allocation concealment” should not be confused with
“blinding” that pursues to prevent performance and as-
certainment bias and further protects the sequence after
allocation.
3.4.3  | Implementation
Item 10. Who generated the allocation sequence, who
enrolled participants, and who assigned participants to
interventions
Example: “The randomisation of the treatments (L, FV,
or L + FV) was performed using Sealed Envelope (www.
seale​denve​lope.com/power) in blocks of six such that al-
location concealment was ensured. The implementation of
the random allocation sequence was performed by a re-
searcher (MCF) using envelopes on which a random code
and the identification number of the block were printed.
The interior of the envelopes contained the treatment
corresponding to the random code. The envelopes were
sealed. As each child was included in the study, an enve-
lope of random sequence received the name of the partici-
pant. The envelope was opened prior to the treatment to
be instituted”.26
Explanation: It is critical to report the sequel of ran-
domization including how the sequence was implemented,
who generated the allocation sequence, who enrolled par-
ticipants, and who assigned participants to trial groups. If
envelopes were used to conceal the randomization, they
should be opaque and sealed to mask their contents. The
randomization process usually involves three steps: se-
quence generation, allocation concealment, and imple-
mentation. Although the same person may perform all of
the processes under each heading, it is preferable to have
a separate person perform the above steps to avoid unwar-
ranted error in such assignments.
3.4.4  | Blinding
Item 11a. If done, who was blinded after assignment to
interventions (for example, participants, care providers,
those assessing outcomes) and how
Example 1: “The patients were blinded to the type of injec-
tion and were not informed to which treatment group he/she
belonged. Only partial information was given about the ex-
pected anaesthetic effect. The data analysis was conducted by
a blinded analyst”.17
Example 2: “The trial was double-blinded, and in that, pa-
tients, parents, and anesthesiologist were all blinded to the
treatment groups. Nurses and physicians who evaluated post-
operative pain and collected data in post-anesthesia care unit
(PACU) were blinded to patient allocation”.30
Explanation: Blinding refers to withholding infor-
mation about the assigned interventions from people
involved in the trial who may potentially be influenced
by this knowledge. Blinding is paramount to safeguard
against bias, particularly when assessing subjective out-
comes.2 Whenever possible, it is required to blind (mask)
the people involved in the trial including the participants,
providers, and assessors of the outcome, including those
analysing the data.
Item 11b. If relevant, description of the similarity of
interventions
Example: “Participants, legal guardians, and operator were
not blinded due to difference in mode of application of each
cement. Statistician was blinded”.20
Explanation: It may not be possible to blind all com-
ponents after assignment to interventions. In Paediatric
Dentistry, this may be due to property of the material (colour,
consistency, smell) or nature of the intervention (self-cured
versus light-cured restorations). If unable to perform blinding
of the providers or assessors of the outcome, it should be re-
ported in detail with specific reason(s).
3.4.5  |  Statistical methods
Item 12a. Statistical methods used to compare groups for
primary and secondary outcomes
Example: “The statistical analysis was performed using the
Statistical Package for the Social Sciences (SPSS) version
21.0 program for Mac OS (SPSS Inc, Chicago, IL, USA).
Nonparametric Kruskal–Wallis analysis of variance and the
JAYARAMAN
Bonferroni- corrected Mann–Whitney U-test was used to
determine the statistical significance of differences in the
children’s behaviour between treatments. Repeated meas-
ures Poisson regression analysis with robust variance was
performed to test associations between behaviour and the
independent variables as well as between dental anxiety
and the independent variables. Independent variables with
a P-value < .20 were incorporated into the adjusted model.
Prevalence ratios (PR) and 95% confidence intervals (CI)
were calculated. The level of significance was set to 5% (P
< .05)”.29
Explanation: The authors should report the statistical
analyses employed in the study that assess both primary and
secondary outcomes. Definition of variables, normality test
results leading to parametric or nonparametric assessment, and
justification for use of appropriate statistical analysis should
be provided. It is good to follow the principle “Describe sta-
tistical methods with enough detail to enable a knowledgeable
reader with access to the original data to verify the reported
results”.2 It is necessary to present a minimum 95% confi-
dence interval, and, when reporting p-values, it is preferable
to report the actual P-value (for example, P = .02) compared
to threshold reports such as P < .05.
Item 12b. Methods for additional analyses, such as
subgroup analyses and adjusted analyses
Example: “The differences in the mean anxiety at the first
and second visit be- tween the groups were compared using
the Mann-Whitney U test, and intragroup comparison was
done using the Wilcoxon signed-rank test. Intergroup com-
parisons of the pulse rate at the three different time intervals
were done using the repeated measures ANOVA. Intergroup
comparison of behaviour at the time of injection and the out-
comes of the pain scale (FLACC) were done using Pearson’s
chi-square test. Intergroup comparison of the outcomes of
the Wong-Baker FACES pain rating scale was done using the
Mann-Whitney U test”.23
Explanation: In addition to reporting the main analy-
sis, it is crucial to indicate the additional analyses, such
as subgroup analyses and adjusted analyses. Sometimes,
the strongest analyses are “tests of interaction” that look
into evidence of a difference in treatment effect within the
subgroups. Highlighting “significant” findings alone from
subgroup analyses could result in misinterpretation of the
overall findings of the trial, and such inferences could
lead to a high false-positive rate. Subgroup and adjusted
analyses are usually discouraged; for example, post hoc
subgroup analyses that could not be confirmed by other
studies. The authors should clarify the variables that were
adjusted, and such adjustment should be reported in detail
in the protocol.
  
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   47
3.5  | Results
3.5.1  |  Participant flow
Item 13. Participant flow (a diagram is strongly
recommended)26
Item 13a. For each group, the numbers of participants who
were randomly assigned, received intended treatment, and
were analysed for the primary outcome.  Example: Refer to
“Figure 1”26
Explanation: A flow chart provides a schematic presenta-
tion of the study design and it is usually comprised of four
sections, namely enrolment, allocation, follow-up, and analysis
(Figure 1). Although this diagram corresponds to the parallel
arm study design, the flow chart can be modified according to
the features of the trial design, for example, split-mouth, cross-
over trials, etc. Additional components, if required, can be in-
cluded in the flow diagram, for example, additional follow-up
period, and multiple group analysis. For the purpose of clarity,
acronyms should not be encouraged in flow charts, or should
be fully described in the legend. Preferably, the follow-up pe-
riod should be included within the figure.
Item 13b. For each group, losses and exclusions after
randomization, together with reasons
Example: “The flow of the patients throughout the study pre-
sented in Figure 2 showed that 23 patients with 25 teeth had
completed the 12-month study period, whereas only one sub-
ject with one tooth did not finish the entire follow-up period.
This patient attended 3-, 6-, and 9-month follow- up. At 12-
month follow-up, the patient refused to participate in, and his
parent reported on the phone that he has no complaint”.28
Explanation: Some loss in the follow-up is expected ir-
respective of any trial design (superiority, equivalence or
non-inferiority trial, etc.). A higher dropout ratio is usually
expected in children due to several reasons: school time, ill-
ness, parental support, transport, etc. Although “drop-out”
ratio is accounted for at the beginning of trial, dropouts at
different follow-up time intervals should be reported with
specific reasons. In addition, details of the participants who
were excluded after randomization due to any deviation to the
original protocol should be reported.
3.5.2  | Recruitment
Item 14a. Dates defining the periods of recruitment and
follow-up
Example: “The study was conducted at the Department of
Paedodontics and Preventive Dentistry over a period of 8
months from June 2017 to January 2018”.23
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48       JAYARAMAN
Explanation: Timing and duration could provide informa-
tion on the historical context of the trial. The period of study
could be of value to future investigators to plan or replicate
the study in a different setting. In some trials, the length of
follow-up period cannot be fixed with pre-specified time
points since it would be dependent on the event outcome; for
example, physiological exfoliation of pulp-treated primary
molars. In such cases, the timing of ending the trial and the
appropriate event outcome should be reported.
Item 14b. Why the trial ended or was stopped
Example: The trial did not end abruptly.
Explanation: Authors should report whether the trial
ended early, including information on the timing and reasons
for early termination. This could be due to poor response rate
at follow-up periods, costs, or unexpected detrimental effects
of the intervention.
3.5.3  |  Baseline data
Item 15. A table showing baseline demographic and
clinical characteristics for each group
Example: Refer to “Figure 2”17
Explanation: It is imperative to report characteristics of the
participants involved in the trial. When possible, this should
include age, sex, ethnicity, and basic clinical characteristics
relevant to the study. It is preferable to report differences be-
tween the presented characteristics using relevant statistical
analyses. Baseline information should also contain details of
F I G U R E 2   An example to show
baseline demographic and clinical
characteristics for each group involved in
the study (obtained from Alzahrani et al.17)
JAYARAMAN
the continuous variables using mean and standard deviation
(SD) or median and interquartile ranges (IQR). Ideally, it is
not desirable to report the standard error and confidence in-
terval as they are inferential data and do not describe variabil-
ity within the included samples. Acronyms should be fully
described in table legend.
3.5.4  |  Numbers analysed
Item 16. For each group, number of participants
(denominator) included in each analysis and whether the
analysis was by original assigned groups
Example: “Twenty-five (11 girls and 14 boys), 4- to 7-year-
old (mean = 5.23) patients were included in this split-
mouth randomized controlled trial. The number of dropout
patients was maximum in the 3- and 9-month follow-ups,
but it did not exceed the estimated 25%. One patient missed
the 1-week follow-up due to guardian’s illness. At 1-month
follow-up, a mother expressed that she was unwilling to
abide to follow-up appointments; she reported that eve-
rything was fine with the crowns. At 3-month follow-up,
two patients dropped out due to relocation, another could
not be contacted, and a patient missed it due to illness. At
9-month follow-up, another patient missed the follow-up
due to illness”.20
Explanation: The flow diagram should provide most of the
information pertaining to the enrolment and follow-up of the
participants. The number of participants in each group with the
number of participants lost at each review appointment should
be reported along with the reason for the loss at follow-up. In
addition, for binary outcomes like relative risk and relative dif-
ference, denominators or event rates should be reported.
3.5.5  |  Outcomes and estimation
Item 17a. For each primary and secondary outcome,
results for each group, and the estimated effect size and
its precision (such as 95% confidence interval)
Example: “Table 1 displays the distribution of the behaviour
ratings according to type of treatment. No significance differ-
ence was found (P = .084). However, when dichotomised as
positive or negative behaviour, a significant difference was
found among treatments (P = .020). Two children in both the
endodontic treatment and tooth extraction groups had defi-
nitely negative behaviour and five in each group had negative
behaviour. The adjusted Poisson regression analysis (Table
2) revealed that negative behaviour was not associated with
the type of procedure. In contrast, the negative behaviour was
2.81-fold more prevalent among children who had to be re-
strained during a previous dental appointment (PR = 2.81;
95% CI: 1.25-6.30)”.29
  
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   49
Explanation: When reporting the primary outcome, the
authors should provide a summary of the outcome in each
group along with difference between the groups, known as
the effect size. For binary outcomes, the effect size could
be the relative risk, relative risk reduction, odds ratio or risk
difference.12 The difference in means is required for con-
tinuous data. For survival analysis, the difference should
be reported as hazard ratio or difference in median survival
time. For both primary and secondary outcomes, authors
should provide a confidence interval to indicate the preci-
sion of the estimate. A 95% confidence interval is usually
reported, but occasionally other levels are used (ie 99% CI).
They are useful to show the differences that do not meet
statistical significance but provide additional information
on the clinical difference in a study. Although not always
necessary, it is preferable to provide P values in addition to
confidence intervals.
Item 17b. For binary outcomes, presentation of both
absolute and relative effect sizes is recommended
Example: “When using VAS, the success rate was 73.5% for
articaine group and 79.6% for lidocaine group, with an abso-
lute difference of 0.06 (95% CI: 0.11 to 0.23). The upper 95%
confidence interval limit was outside the margin of equiva-
lence suggesting nonequivalence of the two local anaesthet-
ics during injection with VAS”.17
Explanation: When reporting binary outcomes, it is rec-
ommended to include both relative risk (odds ratio or relative
risk) and absolute effect (risk difference) between the out-
comes along with appropriate confidence intervals. The use
of relative risk, however, depends on the rarity of the disease
outcome.
3.5.6  |  Ancillary analyses
Item 18. Results of any other analyses performed,
including subgroup analyses and adjusted analyses,
distinguishing pre- specified from exploratory
Example: For the subgroup “both deep caries and MIH”,
the mean VAS scores were 0.93 ± 1.03 cm for the IOA
and 1.47 ± 1.59 cm for the CIA groups. The mean (95%
CI) for the difference in paired proportions was −0.54
cm (−1.52 to 0.44), indicating that patients felt less pain
on the insertion of the needle and the injection with IOA
compared to CIA, with a statistically significant differ-
ence (P = .04)’.31
Explanation: Authors should try to minimize per-
forming multiple subgroup analyses. Whenever possible,
analyses pre-specified in the protocol alone should be
conducted and reported. If any new subgroup analysis was
performed that deviates from the protocol, it should also
be indicated with specific reason(s). In addition, selective
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50       JAYARAMAN
reporting of some sections of subgroup analyses should
be avoided as it might lead to bias. If evaluations of inter-
action are performed, it should be reported as estimated
the difference with P-values with confidence intervals for
each subgroup.
3.5.7  | Harms
Item 19. All important harms or unintended effects in
each group
Example: “Only one child had nausea in the pre-emp-
tive group. In the preventive group, only one child had
a fever. There were no other reported side effects in both
groups”.30
Explanation: Reporting the harms as well as the benefits of
interventions helps clinicians to make balanced decisions. It is
recommended to indicate the harms specific to an intervention
as not all adverse events observed during a trial are necessarily
a consequence of the intervention; some may be a consequence
of the condition being treated.2 For further details on reporting
harms or unintended effects, refer to extension of CONSORT
on reporting harms in a randomized trial.32
3.6  | Discussion
3.6.1  | Limitations
Item 20. Trial limitations, addressing sources of potential
bias, imprecision, and, if relevant, multiplicity of analyses
Example: “Thirdly, evaluation of the long-term retention of
the children’s dietary knowledge, as we had originally in-
tended, was not possible due to the poor attendance of the
follow-up appointment. Finally, only 55% of the recruited
sample completed the telephone follow-up 3 months after the
child’s GA. Hence, the reported dietary improvements need
to be interpreted with caution”.25
Explanation: The discussion section of randomized trials
is an important section that provides information on advan-
tages and disadvantages of the study. Considering immense
amount of information, it is recommended to report the dis-
cussion under the following sections as recommended in
the CONSORT statement: (1) a brief synopsis of the key
findings, (2) consideration of possible mechanisms and ex-
planations, (3) comparison with relevant findings from other
published studies (whenever possible, include a systematic
review combining the results of the current study with the
results of all previous relevant studies), (4) limitations of
this study as well as methods used to minimize for those
limitations, and (5) a brief section that summarizes the clin-
ical and research implications of the work, as appropriate.2
Limitations should cover any imprecision in the reporting
of primary and secondary outcomes, multiple comparisons,
subgroup analyses, significant attrition rate due to dropouts,
and any child-specific factors that could influence the out-
come of the trial.
3.6.2  | Generalizability
Item 21. Generalizability (external validity, applicability)
of the trial findings
Example: “Although this study was carried out in a single
school and could compromise the external validity of its
results, the selection of the participants was obtained by
calculations that guaranteed the representativeness of the
study population. In addition, the homogeneous character-
istics observed among the four intervention groups showed
the effectiveness of the randomization process, an essential
step in clinical trials. The lack of a validated questionnaire
for the evaluation of outcomes can also be considered a
limitation of this study, which deserves a more appropriate
investigation”.33
Explanation: External validity refers to how the results
could be extrapolated or generalized to other circumstances.
The outcomes of a trial should be applicable to other target
populations under similar conditions. Some of the factors that
influence external validity in Paediatric Dentistry are age,
sex, behaviour, socio-economic status, parental attitudes, etc.
Similarly, investigators should try to minimize the internal
validity that refers to reducing the possibility of bias during
the design and conduct of a trial.
3.6.3  | Interpretation
Item 22. Interpretation consistent with results, balancing
benefits and harms, and considering other relevant
evidence
Example: “Furthermore, it showed that children and families
from poorer socio-economic backgrounds could be motivated
to participate in media-based studies. Previous developers of
diet education computer games only targeted school children
across the wider socio-economic groups and did not target a
particular high-risk population. The only other study that did
target high-risk children had a small sample size (ten partici-
pants in each group)”.25
Explanation: It is important to report balanced discus-
sion on the benefits and harm of a trial. This should be
presented in a systematic way by not only focusing on the
studies that supports the results of the trial, but by also
comprehensively appraising other trials that published con-
tradictory results.
JAYARAMAN
3.7  |  Other information
3.7.1  | Registration
Item 23. Registration number and name of trial registry
Example: “The study was registered in the clinicaltrials.gov
database under number NCT03216746”.33
Explanation: The authors should report the registration of
the trial, details of the name of the public trial registry, and
the registration number; this allows the readers to assess fur-
ther information about the trial. If the trial is not registered,
the authors should indicate in the article and provide specific
reason(s).
3.7.2  | Protocol
Item 24. Where the full trial protocol can be accessed, if
available
Example: “The present research followed the guidelines of
the Standard Protocol Items: Proposition for Interventional
Trials (Appendices S1 and S2)”.24
Explanation: Complete details of the trial protocol should
be reported including the date of registration and the source
to access the protocol. Registering trial protocol provides
additional validation for the study, thereby ensuring that all
elements in the trial research have been followed according to
the protocol. In addition, it provides an opportunity to track
any changes that deviated from the original protocol. The au-
thors should explain in their paper why changes in the study
protocol were needed. Prior to starting a trial, it is strongly
recommended to check the public registry for trials to avoid
duplication of study. The authors and reviewers are recom-
mended to crosscheck the article and study protocol for any
inconsistencies.
3.7.3  | Funding
Item 25. Sources of funding and other support (such as
supply of drugs), role of funders
Example: “This study was supported by the Fundação de
Amparo à Pesquisa e ao Desenvolvimento Científico e
Tecnológico do Maranhão (FAPEMA) (State of Maranhão
Foundation for Assistance to Research and Scientific and
Technological Development) (Universal # 01060/17)”.26
Explanation: Sources of funding agency and specific
role of funders in the trial should be stated. It is neces-
sary to report other sources of support, such as supply of
dental products or equipment to conduct analyses. If the
funder does not have any involvement in the design, con-
duct, and reporting of the trial, it should be reported explic-
itly. In addition, authors should also state whether sponsors
  
|
   51
had any involvement in the decision or not to publish the
manuscript.
4  |   REPORTING ABSTRACT
OF RANDOM IZED CONTROLLE D
TRIAL
A clear, transparent, and sufficiently detailed abstract of
journal articles and conference abstracts is important as
it provides required information to the readers to be able
to obtain quick and reliable information for clinical deci-
sions. An extension on reporting abstracts of randomized
trials has been developed to address the shortcomings of
inadequate information available in the existing published
abstracts of RCTs.18 The checklist contains 17 items under
the topics: Title, Authors (only for conference abstracts),
Trial Design, Methods, Results, Conclusions, Trial regis-
tration, and Funding (see Table 3). The following illustra-
tion on reporting abstract of trials in Paediatric Dentistry
is obtained from one conference abstract34 and two journal
abstracts.17,31
4.1  | Title
1. Identification of the study as randomized: “Giomer tech-
nology composite resin for occlusoproximal art restorations in
primary molars: 1-year randomized controlled clinical trial”.34
4.2  | Authors
2. Contact details for the corresponding author: This is only
required for conference abstracts.18
4.3  |  Trial design
3. Description of the trial design (eg, parallel, cluster, nonin-
feriority): “This was equivalence parallel prospective RCT”.17
4.4  | Methods
4. Eligibility criteria for participants and the settings where
the data were collected: “…a total of 182 4-9 years old chil-
dren were selected in Cerquilho, SP, Brazil”34
5. Interventions intended for each group: “A total of 98
children aged 5-9 years old were randomly assigned into two
groups: BI supplemented by buccal intrapapillary infiltration
with 4% articaine; IDNB with 2% lidocaine supplemented
with long buccal infiltration”.17
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52       JAYARAMAN

T A B L E 3   Checklist of items
Item Description
for reporting abstract of a randomized
Title Identification of the study as randomized controlled trial (adapted from Hopewell et
Authors Contact details for the corresponding author (only for conference al. 18)
abstracts)
Trial design Description of the trial design (such as parallel, cross-over,
split-mouth)
Methods
Participants Eligibility criteria for participants and the settings where the data
were collected
Interventions Interventions intended for each group
Objective Specific objective or hypothesis
Outcome Clearly defined primary outcome for this report
Randomization How participants were allocated to interventions
Blinding Whether or not participants, care givers, and those assessing the
outcomes were blinded to group assignment
Results
Numbers randomized Number of participants randomized to each group
Recruitment Trial status
Numbers analyzed Number of participants analysed in each group
Outcome For the primary outcome, a result for each group and the estimated
effect size and its precision
Harms Important adverse events or side effects
Conclusions General interpretation of the results
Trial registration Registration number and name of trial register
Funding Source of funding

6. Specific objective or hypothesis: “To evaluate the survival
of Atraumatic Restorative Treatment (ART) restorations using
high viscosity glass ionomer cement (GIC) and Giomer tech-
nology composite resin (GIO) for occlusoproximal cavitated
dentin caries lesions in primary molars after 12 months”.34
7. Clearly defined primary outcome for this report:
“Only restorations with no repair needs were considered as
success”.34
8. How participants were allocated to interventions:
“They were randomly allocated according to restorative ma-
terial: GIC (Equia Forte – GC Corp.) and GIO (Beautibond
followed by Beautifil Bulk Restorative – Shofu)”.34
9. Whether participants, caregivers, and those assessing
the outcomes were blinded to group assignments: “The oper-
ator therefore was not blinded in this trial as the intervention
administered to both groups could not be blinded”.17 This
information was obtained from the main article, not abstract.
11. Trial status: “The overall survival rate of occlusoprox-
imal ART restorations after 3, 6 and 12 months were 82.4%,
77.1% and 68.97% (SE = 0.03), respectively”.34
12. Number of participants analysed in each group: “After
12 months, 167 of the 182 restorations were evaluated (drop-
out rate = 8.2%)”.34
13. For the primary outcome, a result for each group
and the estimated effect size and its precision: “We com-
bined treatment effect estimates by using an inverse-vari-
ance weighting meta-analysis approach. Pain scores were
significantly decreased with IOA vs CIA (mean differ-
ence −0.69 cm, 95% confidence intervals −1.13 to −0.25
cm)”.31
14. Important adverse events or side effects: “The main
failure reason was bulk fracture and absence of restorative
material, followed by undefiled restoration with no gap. No
difference was found between materials (OR = 1.43; CI =
0.83-2.47; P = .196)”.34

4.5  | Results
10. Number of participants randomized to each group: “A
total of 98 children aged 5-9 years old were randomly as-
signed into two groups”.17
4.6  | Conclusions
15. General interpretation of the results: “Giomer tech-
nology composite resin seems to be a suitable alternative
JAYARAMAN
for occlusoproximal ART restorations in primary molars,
showing an equivalent survival to GIC after 12 months
evaluation”.34
4.7  |  Trial registration
16. Registration number and name of trial register:
(ClinicalTrials.gov NCT02084433).31
4.8  | Funding
17. Source of funding: “This study was externally funded”.31
This information was obtained from the main article, not
abstract.
5  |   D IS C U SSION
Accurate and transparent reporting is an integral part in the
triage of designing, conducting, and reporting randomized
trials. In research, methodological quality and reporting
quality are closely related but are considered as two different
entities. Methodological quality is “the confidence that the
trial design, conduct, and analysis has minimized or avoided
biases in its treatment comparisons”. In contrast, reporting
quality is the process that involves “information about the
design, conduct, and analysis of the trial”.1 Whilst the report-
ing quality is specific to study designs (ie, randomized tri-
als), many other reporting guidelines are available for other
study designs (ie, animal studies,35 case reports,36 observa-
tional studies,37 systematic reviews and meta-analysis38 and
clinical practice guidelines).39 Complete details of report-
ing guidelines and extensions for different study designs are
available in the Enhancing the Quality and Transparency
of Health Research website.40 The reporting guidelines ad-
dress study designs and application to all clinical special-
ties; however, they do not necessarily enhance the quality
of reporting specifically to a clinical specialty. For example,
research in Paediatric Dentistry encompasses several child-
specific reporting items, but this has not been covered in the
CONSORT guidelines or any other study-specific reporting
guidelines. To address this issue, the Reporting Standards for
Research in Pediatric Dentistry (RAPID) team is currently
working on developing standards for reporting research fo-
cusing on themes specific to Paediatric Dentistry.41,42 This
statement will help authors to prepare their reports as well as
aid journal editors and peer reviewers to critically appraise
them, thereby improving research and  clinical practice in
Paediatric Dentistry.
It has been shown that compliance with CONSORT guide-
lines has greatly improved the quality of trials published in
  
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   53
recent years.3,13,15 In addition to the main findings, reporting
of randomized trials also includes clinical, diagnostic, and
laboratory images. Hence, images within the trial should be
reported with accuracy and clarity. Lang and co-workers have
published a set of guidelines to improve the quality of report-
ing images in a clinical study. The Clinical and Laboratory
Images in Publications (CLIP) contains 6 principles that
includes details of the subject of the image, acquisition, se-
lection, any modifications of the image, details of the image
itself, and analysis or interpretation of the image.43 It is im-
portant for the investigators to follow the CLIP principles
to support interpretations and conclusions based on images
presented in the randomized trial. It is to be noted that the
checklist items in this report have been adapted from the
CONSORT statement for reporting two groups parallel arm
trials. The readers are hence advised to follow extensions of
other trial designs specific to the study.40 The CONSORT
checklist items cover all aspects of reporting RCTs; however,
each trial is unique and not all items may be applicable to the
reported study. In a circumstance when any of the item is not
reported, the authors should provide explanation for non-ap-
plicability with explicit justification.
All of the RCTs included in this review have been carefully
reviewed, and the most relevant sections alone were chosen to
represent the items in the CONSORT checklist. Examples rele-
vant to Paediatric Dentistry have been provided for all the items
in the CONSORT checklist except for 3b, 5b, 7b, and 14b. The
authors are advised to refer to the explanation provided for the
above items in the CONSORT document.2 The endorsement
of the CONSORT checklist by several journals has resulted in
improvement in the quality of reporting randomized trials in
recent years.3,13 For this reason, trials published between 2017
and 2020 alone were included for the purpose of illustration
in this article. Although several multidisciplinary and specialty
journals publish randomized trials in Paediatric Dentistry, only
articles published in the International Journal of Paediatric
Dentistry were identified considering the readership of the jour-
nal. This, however, did not hinder the scope of this explanatory
article, as the objective was to emphasize the relevance and im-
portance of the CONSORT guidelines using examples of RCTs
in Paediatric Dentistry.
6  |  CONCLUSION
This article highlights the importance of the CONSORT
statement for reporting parallel group randomized con-
trolled trials as well as the extension of CONSORT for
specific trial designs. The illustrations provided in this
article using randomized trials published in Paediatric
Dentistry would enable investigators to report trials with
accuracy and transparency. It is also relevant to reviewers
and editors involved in evaluating randomized controlled
 |
54       JAYARAMAN
trials suitability for publication to this and other Paediatric
Dentistry journals.
CONFLICT OF INTEREST
The author do not have any conflict of interest to declare
ORCID
Jayakumar Jayaraman  https://orcid.
org/0000-0003-1737-6891
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How to cite this article: Jayaraman J. Guidelines for
reporting randomized controlled trials in paediatric
dentistry based on the CONSORT statement. Int J
Paediatr Dent 2021;31(Suppl. 1):38–55. https://doi.
org/10.1111/ipd.12733