Original Paper
Caries Res 2015;49:91–98 Received: January 13, 2014
DOI: 10.1159/000365948
Clinical Relevance of Studies on the
Accuracy of Visual Inspection for Detecting
Caries Lesions: A Systematic Review
Thais Gimenez a Chaiana Piovesan a, b Mariana M. Braga a Daniela P. Raggio a
Chris Deery c David N. Ricketts d Kim R. Ekstrand e Fausto Medeiros Mendes a
a
Department of Pediatric Dentistry, School of Dentistry, University of São Paulo, São Paulo, and b School of Dentistry,
Centro Universitário Franciscano, Santa Maria, Brazil; c School of Clinical Dentistry, University of Sheffield, Sheffield, and
d
Dundee Dental Hospital and School, University of Dundee, Dundee, UK; e Department of Cariology and Endodontics and
Clinical Genetics, School of Dentistry, Faculty of Health Sciences, University of Copenhagen, Copenhagen, Denmark
Key Words
Accuracy · Clinical relevance · Dental caries · Performance ·
Systematic review · Visual inspection
Abstract
Although visual inspection is the most commonly used
method for caries detection, and consequently the most in-
vestigated, studies have not been concerned about the clin-
ical relevance of this procedure. Therefore, we conducted a
systematic review in order to perform a critical evaluation
considering the clinical relevance and methodological qual-
ity of studies on the accuracy of visual inspection for assess-
ing caries lesions. Two independent reviewers searched sev-
eral databases through July 2013 to identify papers/articles
published in English. Other sources were checked to identify
unpublished literature. The eligible studies were those which
(1) assessed the accuracy of the visual method for detecting
caries lesions on occlusal, approximal or smooth surfaces, in
primary or permanent teeth, (2) used a reference standard,
and (3) reported data about sample size and accuracy of the
methods. Aspects related to clinical relevance and the meth-
odological quality of the studies were evaluated. 96 of the
5,578 articles initially identified met the inclusion criteria. In
© 2015 S. Karger AG, Basel
0008–6568/15/0492–0091$39.50/0
E-Mail karger@karger.com
www.karger.com/cre
Accepted after revision: July 9, 2014
Published online: January 7, 2015
general, most studies failed in considering some clinically
relevant aspects: only 1 included study validated activity sta-
tus of lesions, no study considered its prognosis, 79 studies
did not consider a clinically relevant outcome, and only 1
evaluated a patient-centred outcome. Concerning method-
ological quality, the majority of the studies presented a high
risk of bias in sample selection. In conclusion, studies on the
accuracy of the visual method for caries detection should
consider clinically relevant outcomes besides accuracy;
moreover, they should be conducted with higher method-
ological quality, mainly regarding sample selection.
© 2015 S. Karger AG, Basel
Visual inspection is the most commonly used method
for caries lesion detection in daily clinical practice, prob-
ably because it is an easy technique without any extra cost
to the practitioner [Braga et al., 2010]. Because of that,
several studies have evaluated the accuracy of visual in-
spection in detecting carious lesions [Bader et al., 2002].
However, a ‘correct’ diagnosis made by clinicians is not
necessarily translated into a direct benefit for patients
[Baelum, 2010; Mendes et al., 2012]. According to Baelum
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Fausto Medeiros Mendes
Faculdade de Odontologia da Universidade de São Paulo
Av. Lineu Prestes, 2227
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São Paulo, SP 05508-000 (Brazil)
E-Mail fmmendes @ usp.br
et al. [2006], the method of caries detection, including vi-
sual inspection, should also consider the best treatment
decision taking into account patient-centred outcomes.
Therefore, the evaluation of caries detection methods
should encompass accuracy, applicability and clinical
utility. In fact, few studies have been concerned with the
usefulness of the methods and the possible benefits for
patients [Baelum et al., 2012; Mendes et al., 2012]. In ad-
dition, only few papers evaluated the prognosis of caries
lesions in longitudinal studies [Nyvad et al., 2003; Ferreira
Zandona et al., 2012; Guedes et al., 2014]. Thus, more in-
formation on these issues and on other points related to
the clinical relevance of visual inspection is necessary.
Systematic reviews are useful to summarize original
studies in order to provide the best evidence on a subject
for the profession, patients and policy makers, and conse-
quently to support the correct translation, implementa-
tion and adoption of research knowledge in everyday prac-
tice [Leeflang et al., 2008]. Previous systematic reviews on
caries detection methods have been published, however
they have focused on summarizing criterion [Bader et al.,
2002; Gimenez et al., 2013] or content validity [Ismail,
2004]. A comprehensive review of the available studies
would also permit a critical appraisal of the clinical appli-
cability of the caries detection methods, in this case visual
inspection, as well as their utility in improving patients’
oral health. Lack of concern regarding methodological
quality of the studies is another point that could threaten
the clinical relevance of the methods. To the best of the
authors’ knowledge, no previous systematic review has
been performed to evaluate the clinical relevance or meth-
odological quality of studies on visual inspection for as-
sessing caries lesions. Therefore, the aim of this study was
to perform a systematic review with the objective of criti-
cally evaluating the clinical relevance for dental practice
and the methodological quality of studies on the accuracy
of visual inspection in assessing coronal caries lesions.
Materials and Methods
To conduct this review, we were anchored in the following re-
view question: what aspects related to the clinical relevance and
methodological quality are considered in studies conducted to
evaluate the accuracy of the visual inspection method in detecting
caries lesions? In carrying out this review we followed the guideline
Preferred Reporting Items for Systematic Reviews and Meta-Anal-
yses (PRISMA) [Moher et al., 2009]. The PRISMA checklist is pre-
sented in online supplementary table 1 (for all online suppl. mate-
rial, see www.karger.com/doi/10.1159/000365948). This system-
atic review was registered at the PROSPERO platform (registration
number CRD42013003718).
92 Caries Res 2015;49:91–98
DOI: 10.1159/000365948
Information Sources
The literature was searched for articles that reported the accu-
racy of detecting caries lesions by visual inspection published until
July 22nd 2013, without any restriction on the initial date, in the
MEDLINE (PubMed), Embase and Scopus databases. Unpub-
lished documents were tracked through OpenSIGLE and in the
Annals of the European Organisation for Caries Research (ORCA)
Congress for the last 10 years in order to reduce publication bias.
We also manually checked the references of the articles included
for verification of possible items not identified by the search pro-
cedures.
Search
The search of electronic databases was divided into three parts.
The first part corresponded to the optimal search strategy for di-
agnostic studies [Deville et al., 2000]. The second part was related
to the clinical situation under investigation (caries lesions), and the
third was associated with the caries detection method. Each part
was associated to the other with the Boolean tool ‘AND’. The syn-
tax was developed to search in the MEDLINE database and was
then adapted for the other databases. The entire search strategy is
presented in online supplementary figure 1. The results of search-
es in the different databases were cross-checked in order to locate
and eliminate duplicates.
Study Selection and Eligibility Criteria
First the titles and abstracts of located studies were examined
to ensure they fulfilled the following inclusion criteria: (1) they had
to have some mention of visual inspection or clinical examination
in detecting primary caries lesions, (2) they had to have been per-
formed with primary or permanent human teeth, either in vitro or
in vivo, and on smooth, approximal or occlusal surfaces, and (3)
they had to have been written in English. No restrictions were
made with respect to the study design.
Since we focused on studies on the accuracy of visual inspec-
tion, the articles whose titles and abstracts met the inclusion crite-
ria were then searched to ensure that they presented a clearly de-
fined reference standard (gold standard) and that they reported
data related to the sensitivity and specificity of visual inspection in
assessing caries lesions.
Two reviewers (T.G. and C.P.) independently identified poten-
tial references and eliminated ineligible studies. Doubts or dis-
agreements were resolved by discussion with a third researcher
(F.M.M.). Articles that reported performance in diagnosing root
caries, artificially developed caries lesions and caries lesions
around restorations were excluded. Studies that made compari-
sons among methods without a clear definition of a reference stan-
dard method were also excluded.
Data Collection Process
One reviewer (T.G.) extracted the data from the full texts of
included studies using structured tables. A second researcher
(M.M.B.) independently verified the extracted data. Discrepancies
were resolved by discussion after rechecking the source.
The following information was extracted from papers: refer-
ence standard test used, setting (clinical or laboratory studies),
type of teeth (primary or permanent), surface evaluated (smooth,
approximal or occlusal), methodological aspects and data on clin-
ical relevance.
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 Clinical Relevance Appraisal
To assess the clinical relevance of the studies for dental practice,
five different topics were independently evaluated: (1) whether the
paper reported any link between the diagnostic method employed
with the treatment decision (yes or no), (2) whether the visual
method used in the study considered clinical relevant characteris-
tics related to non-operative treatment decision (evaluation of ini-
tial caries lesions, caries activity assessment, both issues or neither
of them), (3) whether the method considered clinically relevant
characteristics related to the operative treatment decision (wheth-
er the method assessed the presence of cavitation or not), (4) the
clinical relevance of the reference standard method (whether the
reference standard method evaluated presence of cavitation, lesion
activity, any measure associated with caries lesions prognosis or
none of them), and (5) whether the studies evaluated any patient-
centred outcome (yes or no).
Methodological Quality of the Studies
We used the Quality assessment of studies of diagnostic perfor-
mance included in systematic reviews (QUADAS-2) checklist to
assess the risk of bias of the included studies [Whiting et al., 2011].
We opted for the current version, which is recommended to eval-
uate the risk of bias and applicability of primary diagnostic accu-
racy studies. It consists of four key domains: patient selection, in-
dex test, reference standard and flow and timing.
For the ‘patient selection’ domain, we considered as at high risk
of bias studies which had not employed a sample that resembled
the actual spectrum of the disease in the population (unobvious
caries lesions which would benefit from a more meticulous diag-
nosis). Thus, studies with high risk of bias were those which in-
cluded obviously cavitated lesions or those with non-consecutive
or non-random inclusion of patients/teeth. On the other hand,
studies with low risk of bias at this domain were those that includ-
ed patients consecutively or randomly and considered only non-
cavitated caries lesions following well-defined inclusion criteria.
With regard to applicability, consideration was given to those
studies in which the case mix was relevant and which reflect the
real-life diagnostic scenario. Thus, studies that used no clinically
representative teeth (samples only composed of premolars and/or
third molars), included frankly cavitated lesions and studies per-
formed under ideal conditions (in vitro studies) were classified as
having a high concern of applicability to the clinical situation.
Concerning the index test, studies that performed the visual
inspection with previous knowledge of the reference standard re-
sults and that had not specified a predetermined threshold were
classified as at high risk of bias. Moreover, if the caries detection
method differed from the review question, that is the detection of
non-evident caries lesions, they were also classified as with high
concern of applicability at this domain.
Considering the other domain of QUADAS-2, the reference stan-
dard, studies with reference standard methods that assessed presence
of cavities (for example, in approximal surfaces after temporary sep-
aration) or evidence of caries tissue by histological evaluation or after
operative intervention were considered as at low risk of bias. More-
over, papers where different operators performed the visual inspec-
tion and the reference standard analysis and studies that had not in-
corporated the results of the diagnostic test when performing the
reference standard method were also classified as at low risk of bias.
Studies classified with low concern of applicability were those that
actually identified the presence of initial or advanced caries lesions.
Clinical Relevance of the Visual
Inspection Method
For the ‘time and flow’ domain, if the reference standard meth-
od was not applied in all samples or if different reference standard
methods were used, the study was considered as at high risk of bias.
Also, studies that did not include the whole sample in the analysis
and with an inadequate time between the examination and the ref-
erence standard method were classified as at high risk. We consid-
ered an interval up to 1 month as an adequate time period to pre-
vent changes in the dental surface status.
Results
Study Selection
The study selection flow diagram is shown in figure
1. MEDLINE (PubMed), Embase and Scopus searches
yielded 7,567 studies. Using MEDLINE as reference,
1,989 articles were excluded due to duplication. The
three databases identified 5,578 non-duplicated studies.
Based on the title and abstract, a further 5,137 articles
were excluded. After reading the full text, a further 345
papers were excluded, due to the reasons detailed in
figure 1. Thus, we evaluated and extracted the data
from 96 studies in the systematic review. The search of
OpenSIGLE and abstracts from Annals of the ORCA
Congress yielded 78 investigations (fig.  1), but none
were included, mainly due to lack of full data about ac-
curacy.
Study Characteristics
Publication years ranged from 1975 to 2013. The vast
majority of studies were conducted in the laboratory, us-
ing the occlusal surfaces of permanent teeth with a histo-
logical reference standard, and only one study was per-
formed on smooth surfaces. A summary detailing the
characteristics of each included study and the references
related to these included studies is provided in online
supplementary table 2.
Clinical Relevance of the Studies
24 of 96 studies (25.0%) reported considerations on
the relationship between the diagnosis and treatment de-
cision (fig. 2).
Considering the characteristics of the visual inspection
method related to non-operative treatment decisions, 85
studies evaluated only the presence of initial caries lesions
(88.6%), 5 assessed both presence and activity of initial
caries lesions (5.2%) and the other 6 papers did not report
any of these parameters (6.2%). For operative treatment
decisions, 74 studies (77.1%) employed diagnostic meth-
ods that assessed the presence of cavitation and 22 (22.9%)
did not (fig. 2).
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Fig. 1. Flow diagram with the information through the phases of study selection.
Concerning the clinical relevance of the reference
standard method, only 1 included study tried to validate
the activity status of the lesions (1.0%), no study consid-
ered the prognosis of the lesions (0.0%), 16 studies vali-
dated for the presence of cavitation (16.7%) and 79 stud-
ies did not consider a clinically relevant outcome in the
reference standard method (82.3%). Furthermore, only 1
included study (1.0%) evaluated a patient-centred out-
come (discomfort of the children after the application of
several diagnostic methods) (fig. 2).
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The full data with the individual classification of each
study concerning these parameters are presented in on-
line supplementary table 2.
Methodological Quality of the Studies
The overview of the QUADAS-2 checklist for all stud-
ies demonstrated some differences in terms of risk of bias
analysis (fig. 3). The great majority of studies presented a
high risk of bias in the sample selection. Only 8 studies
(8.3%) selected an adequate spectrum of the sample and
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Fig. 2. Graphical summary of the studies regarding some aspects related to the clinical relevance of the visual inspection method.

Fig. 3. Graphical summary of study quality

considering the QUADAS-2 checklist.

selected the participants consecutively or randomly.
Moreover, nearly 50% of studies presented high or un-
clear risk of bias regarding the reference standard proce-
dure (gold standard). On the other hand, most studies
revealed a low risk of bias in the application of the meth-
od and in the timing of exams and the flow of patients or
teeth.
Concerns were raised in relation to most studies re-
garding applicability considering patient or tooth selec-
tion, since they did not clearly describe whether the spec-
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trum of caries lesions present in the study sample matched
the expected prevalence in the target population. Most
studies were classified with high concerns regarding their
applicability because they did not select an appropriate
case mix. Most of these studies were performed in a labo-
ratory setting or included teeth that usually are not a di-
agnostic challenge or are non-representative such as third
molars or teeth with frank cavitations. Moreover, con-
cerns regarding the applicability of the reference standard
used were observed in almost 40% of studies. However,
the conduct and interpretation of the index test in all
studies did not differ from the review question, indicating
that there were no concerns regarding the applicability
considering this topic (fig. 3). The classification of each
study considering the QUADAS-2 domains is shown in
online supplementary table 3.
Discussion
Many studies have been conducted in order to ascer-
tain the accuracy of different diagnostic methods for as-
sessing caries lesions. Despite the importance of evaluat-
ing the accuracy of the visual inspection methods for as-
sessing caries, other aspects have to be considered in a
framework for diagnostic strategy evaluation. Visual in-
spection methods for caries assessment described in the
literature are not always directly related to the clinical rel-
evance and to the improvement of patients’ oral health
[Baelum, 2010]. Therefore, we performed this systematic
review in order to collect information related to clinical
relevance of the studies on the diagnostic accuracy of vi-
sual inspection in assessing caries lesions. This is the first
report about visual inspection for detecting caries lesions
that evaluated methodological aspects of the studies. We
also pioneered the critical evaluation of clinical relevance
of the studies included in a systematic review, considering
several aspects, such as index test used, reference stan-
dard methods and benefits for the patients.
An important gap in most of the research performed
on dental caries diagnosis is the lack of concerns related
to clinical relevance and to the patients’ oral health out-
comes. To be clinically relevant, the method should eval-
uate aspects directly related to treatment decision. Taking
into account dental caries, the clinicians need to know if
a surface presents an initial lesion with high probability
of progression to a worse condition (activity assessment)
in order to opt for treatment aiming to arrest the caries
process. Moreover, they have to assess the severity status
of the lesion, e.g. the presence of cavitation, which would
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be linked in most cases to the operative treatment deci-
sion [Baelum et al., 2006; Braga et al., 2010; Baelum et al.,
2012]. We observed that most studies did not encompass
these issues in the index tests or reference standard meth-
ods. Although the visual inspection methods consider the
evaluation of non-cavitated and cavitated caries lesions,
most of them do not include the caries lesion activity as-
sessment in their set-up. In addition, authors usually per-
form the validation (reference standard method) based
on lesion depth, independently of the presence of cavita-
tions, caries activity or prognosis of the lesions.
The ultimate value of a diagnostic method should be
to provide health benefits for the patients rather than cor-
respondence with the ‘truth’ [Sackett and Haynes, 2002;
Baelum et al., 2012]. This could be addressed by assessing
the prognosis of caries lesions and patient-centred out-
comes in longitudinal studies. Some primary longitudinal
studies have considered these aspects [Nyvad et al., 2003;
Ferreira Zandona et al., 2012; Guedes et al., 2014], but
they were not designed to be identified by our search
strategy. An ideal study design would be a randomised
controlled trial to assess whether the patients fare better
with different diagnostic strategies [Sackett and Haynes,
2002]. Our systematic review did not include any of this
study type. This fact is comprehensible since our system-
atic review was designed for retrieving diagnostic accu-
racy studies. Further systematic reviews should be con-
ducted in order to provide evidence on this topic. More-
over, primary studies should evaluate whether the caries
detection methods really bring long-term health benefits
for the patients instead of evaluating again the validity of
already validated methods.
Considering the methodological quality of the studies,
the QUADAS-2 checklist showed that almost 90% of
studies presented high risk of bias in the selection of pa-
tients (in clinical studies) or teeth (in laboratory studies)
and the great majority presented concerns regarding the
applicability of the research due to the sample selection
procedure. Studies about caries detection methods are
usually designed to evaluate the performance in detecting
unobvious/non-evident caries lesions that are the major
challenge for clinicians. Inclusion of teeth evidently
sound or with frank cavitations should be avoided since
this can introduce a case-control bias [Lijmer et al., 1999].
Non-consecutive or non-randomised inclusion of sub-
jects, as well as inclusion of teeth that are not clinically
representative (for instance, studies that used only pre-
molars and/or third molars), can also threaten the exter-
nal validity of the study. We observed that the prevalence
of carious surfaces in the samples within studies classified
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with high risk of selection bias (mean = 37.5; range 5.3–
80.7%) was significantly higher (p < 0.001 by Student’s t
test) than that within studies with low risk of this type of
bias (mean = 12.2; range 1.3–31.3%). Although the prev-
alence is not expected to mathematically change the sen-
sitivity and specificity of the method, samples with high-
er prevalence tended to have teeth with more severe and
hence clinically obvious conditions [Montori et al., 2005],
hence the performance would be overestimated [Lijmer
et al., 1999]. Taking into account other domains evalu-
ated by the QUADAS-2, most studies presented low risk
of bias and no concerns regarding applicability.
A possible limitation of our study was the exclusion of
articles published in languages other than English. None-
theless, some studies showed that the exclusion of articles
published in other languages does not seem to bias sys-
tematic reviews [Moher et al., 2000; Juni et al., 2002]. Fur-
ther, a recent systematic review performed by our re-
search group about fluorescence-based methods for car-
ies detection showed that the inclusion of articles written
in other languages did not influence the final results
[Gimenez et al., 2013]. Regarding the databases searched,
we attempted to minimize the occurrence of bias due to
missing studies [Whiting et al., 2008] by searching for ar-
ticles in other sources, including gray literature. Unfortu-
nately, this search did not add any study in our review,
mainly because abstracts lacked the data needed.
In conclusion, most studies on the accuracy of visual
inspection method for caries detection failed in present-
ing data about clinical relevance of the caries detection
method or of the reference standard used. Moreover, few
studies assessed the relationship of the visual inspection
and caries prognosis or patients’ oral health benefits.
Also, the majority of studies presented risk of bias and
concerns regarding applicability related to the sample se-
lection procedures. Therefore, future studies about caries
inspection methods should evaluate clinically relevant
and patient-centred outcomes besides accuracy. In addi-
tion, the methodological quality of such studies should be
improved to reduce the risk of bias.
Acknowledgements
This study was supported by the Conselho Nacional de Desen-
volvimento Científico e Tecnológico (CNPq), Fundação de Am-
paro à Pesquisa do Estado de São Paulo (FAPESP – Process
2012/17888-1) and CAPES. The authors also wish to thank the
participants of the Post-Graduation in Paediatric Dentistry Semi-
nar of FOUSP for the critical comments put forth.
Author Contributions
T. Gimenez, F.M. Mendes, C. Deery, D.N. Ricketts and M.M.
Braga designed the study; T. Gimenez, C. Piovesan and F.M.
Mendes performed the review; T. Gimenez and M.M. Braga col-
lected the data; T. Gimenez and D.P. Raggio performed the data
analysis; T. Gimenez, F.M. Mendes and K.R. Ekstrand performed
the data interpretation; T. Gimenez and F.M. Mendes drafted the
manuscript. All authors critically revised the manuscript for im-
portant intellectual content and gave final approval for the version
to be published.
Disclosure Statement
The authors certify that they have no affiliation with or finan-
cial involvement in any organisation or entity with a direct finan-
cial or personal interest in the subject matter or materials discussed
in this paper.

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