Short Communication
Caries Res 2018;52:392–396
DOI: 10.1159/000480360
A Commentary on Caries Detection,
Validity, Reliability, and Outcomes of
Care
Amid I. Ismail a Marisol Tellez a Nigel B. Pitts b
a
Department of Pediatric Dentistry and Community Oral Health Sciences, Kornberg School of Dentistry, Temple
University, Philadelphia, PA, USA; b Dental Innovation and Translation Centre, Kings College London, London, UK
Keywords
Dental caries · Diagnosis · Management · Outcomes ·
Reliability · Validation
The aim of this commentary is to propose an approach
to the development and validation of caries diagnostic
criteria based on the desired outcomes of care. It is our
opinion that the field of cariology and caries management
needs a new perspective focused on pathways to achieve
oral health outcomes.
Advances in biological sciences and in health care are
directly related to advances in measurement of biological
markers, and in the health care field, health and disease
states. This observation is confirmed when considering
the advances made over the last few decades in the mea-
surement of diabetes and cardiovascular outcomes [Huis-
man et al., 1958; Dawber et al., 1959; Bookchin and Gal-
lop, 1968; Rahbar et al., 1969; Bunn et al., 1975; Koenig et
al., 1976; Grundy, 1978], and the classification and man-
agement of periodontal diseases [Knowles et al., 1979]. In
each of these diseases, a series of outcome-driven diag-
nostic criteria and tools were developed based on advanc-
es in understanding of the biology, etiology, and pathol-
ogy. For periodontal diseases, a series of clinical trials that
© 2018 S. Karger AG, Basel
E-Mail karger@karger.com
www.karger.com/cre
Received: June 9, 2017
Accepted: August 11, 2017
Published online: March 5, 2018
started in the 1970s [Knowles et al., 1979] defined treat-
ment modalities for different stages of severity. Evidence
on the outcomes of nonsurgical versus surgical therapies
influenced the definition of the diagnostic stages [Amer-
ican Academy of Periodontology, 2015]. The pioneering
research on the management of periodontal diseases
helped to usher the era of nonsurgical management in the
early 1980s and propelled revisions of the definition and
classification of periodontal diseases.
Unfortunately, the field of caries management did not
consistently and overwhelmingly follow this biological or
outcome-driven path. Rather, since the 1930s, epidemi-
ologists and clinical researchers focused on measuring
caries with less than acceptably valid and reliable criteria,
and mostly at advanced disease or cavitated stages [Klein
and Palmer, 1938]. The outcomes of management of car-
ies, namely cavitated or the so-called sickly lesions, have
been the successful placement of intracoronal or extra-
coronal restorations with or without pulpal therapy or,
sometimes, extraction. The gold standard for validation
This paper is based on a presentation given at the ORCA Saturday
Afternoon Symposium “Critical Appraisal of Current Clinical Caries
Diagnostic Systems” in Athens on July 6, 2016.
128.111.121.42 - 3/6/2018 12:31:12 PM
Univ. of California Santa Barbara
Amid I. Ismail
Temple University, Pediatric and Community Oral Health Sciences
3223 N. Broad Street
Philadelphia, PA 19140 (USA)
Downloaded by:
E-Mail ismailai @ temple.edu
has been predominantly focused on the histological ex-
tent of demineralization as seen in sections of extracted
teeth. There is no agreed upon in vivo method for valida-
tion of caries detection, diagnosis, and outcomes. The
lack of outcome-driven diagnostic criteria and in vivo
validation systems is one of the reasons for the slow prog-
ress in adoption of more contemporary secondary pre-
ventive or nonrestorative management of early caries. It
is our opinion that the best way forward is to define and
focus on measuring the outcomes of caries management.
Validation of Caries Detection Systems
The validity of caries detection criteria may include
evaluations of construct, content, and criterion validity in
comparison with a gold standard (criterion validity)
[Nyvad et al., 2003; Ismail, 2004a]. Assessment of crite-
rion validity generally requires comparison with estab-
lished gold standards. “Biopsying” of caries lesions or
separating teeth with orthodontic bands are two gold
standards used with in vivo studies [Chu et al., 2010; No-
vaes et al., 2010]. The removal of caries enamel or dentin
(biopsy) is a biased validation method because it relies on
the judgment of the operator on when caries is present or
not in a cavity and it cannot ethically be used for assessing
early enamel caries.
Histological sectioning of extracted teeth is the most
preferred validation gold standard for in vitro studies
[Özkan et al., 2015]. Cariologists have relied by and large
on histological validation of the extent of caries deminer-
alization in enamel and dentin [Braun et al., 2017]. Un-
fortunately, this standard cannot differentiate between
caries active and inactive lesions and relies on assessing
caries in a biased sample of extracted teeth.
Validation methods such as micro-CT [Kamburoğlu
et al., 2011; Soviero et al., 2012; Özkan et al., 2015; Shah-
moradi and Swain, 2017], Transverse microradiography
[Benson et al., 2003] and optical coherence tomography
[Shimada et al., 2015] have recently been used. These
methods, however, have the same limitation as histologi-
cal examinations, and they do not correlate well with clin-
ical management decisions.
We contend that it is time to rely instead on the longi-
tudinal assessments of outcomes. A valid caries manage-
ment system should be able to accurately classify tooth
surfaces into different management strategies and dem-
onstrate high likelihood ratios that the decisions to pre-
vent, medically manage, or surgically treat caries lesions
are made with low false-positive or -negative probabilities
Caries Detection, Validity, Reliability, and
Outcomes of Care
[Nyvad et al., 2003]. One study that had used the model
of validation of Nyvad et al. [2003] applied it to the In-
ternational Caries Detection and Classification System
(ICDAS) and found that the visual diagnostic criteria
discriminate, after 2 years of follow-up, between primary
teeth that will remain sound, progress to cavitation, or get
restored [Guedes et al., 2014].
Goal of Caries Management Systems
The primary goal of a contemporary caries manage-
ment system, in the wellness and health promotion era of
the 21st century, is to “preserve dental tissues (through
prevention, control, and minimal restorative techniques)
and restore (conservatively) only when indicated” [Ismail
et al., 2015]. This focused goal requires that dentists, or
other dental or health providers, should assess the pres-
ence of early or noncavitated stages of the caries process
that can be managed through secondary (or medical) pre-
ventive therapies. Dentists should also evaluate the extent
and size of the caries stages that are advanced beyond the
control phase. These caries stages should be restored with
minimal removal of sound tooth structure.
Outcomes of Caries Management
If dentists and cariologists accept the premise that the
preservation of tooth structure is the primary goal of den-
tal caries care, then the outcomes of caries care may be
measured as follows:
1 Number of teeth maintained caries free (no evidence
of caries demineralization neither clinically nor radio-
graphically)
2 Number of noncavitated caries lesions that are pre-
vented from progressing or, in the early stages, reversed
to clinically and/or radiographically caries-free status
3 Number of teeth with cavitated lesions that require
surgical therapies that are restored in a minimally in-
vasive way or extracted
These 3 outcomes represent simple yet powerful end
points for a comprehensive caries management system.
Management Strategies of Dental Caries
If we agree with the just defined outcomes of caries
management, then we need to redefine the research agen-
da in key aspects of cariology to focus on how best we can
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Caries Res 2018;52:392–396 393
DOI: 10.1159/000480360
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classify and manage caries through primary and second-
ary preventive care as well as restorative or surgical care.
As was reported before, the pioneering clinical trials that
challenged the surgical management of periodontal dis-
eases have revolutionized the way periodontists approach
treatment of this major disease [Ramfjord et al., 1987].
There is an extensive biological and clinical rationale for
staging the caries process for management [Pitts et al.,
2017], and we contend that this new approach, in epide-
miological studies, research, public health, and clinical
practice, is overdue and necessary [Selwitz et al., 2007].
The traditional restorative-only approach is not a therapy
for caries that will prevent future disease development
but rather the aim of restorative care is to replace lost
tooth structure, restore function, and remove decayed
and infected hard tissues. Any cavity preparation to place
a restoration has the potential side effect of weakening the
tooth structure and increases the probability of develop-
ing new caries at the margins of restorations. Hence, com-
prehensive and contemporary caries management should
incorporate the following 5 modalities of care [Ismail et
al., 2015] according to a minimally interventive philoso-
phy [Pitts et al., 2017]:
1 Prevention of caries development on sound tooth sur-
faces. Primary prevention includes education and be-
havioral changes to promote oral health
2 Control (medical care) of noncavitated caries lesions
that do not extend deep into dentin (the cutoff point
when these lesions should be restored varies among
different countries and practitioners). (We recom-
mend that these lesions have no clinical cavitation and
can extend radiographically to the outer one third of
dentin)
3 Preservative surgical (restorative) therapy to remove
the decayed structure and replace it with a restorative
material. This therapy may require in some cases pulp-
al therapy when the tissue is infected or necrotic
4 Tooth extraction of nonrestorable teeth
5 Review of outcomes, behavioral targets, and clinical
preventive care
Reliability Assessment of Caries Detection Criteria
The field of caries research and new detection methods
has focused on the measurement of caries status of each
tooth surface (up to 128 permanent tooth surfaces ex-
cluding third molars and 84 primary tooth surfaces) or
teeth (28 permanent and 20 primary). The volume of data
that is generated is unmatched in the assessment of any
394 Caries Res 2018;52:392–396
DOI: 10.1159/000480360
health condition or disease in epidemiological or clinical
research. One often neglected factor in analyzing data ob-
tained from tooth surfaces or teeth is the significant de-
gree of dependence or intracorrelation among caries
scores within each individual. Hence, caries data by de-
sign are clustered and using a single tooth surface or a
tooth as the unit of analysis in statistical analysis must ac-
count for variance within and among individuals sam-
pled in a study. In reliability assessment this fact is typi-
cally not recognized or adjusted for in the analysis.
In assessing reliability, the standard method has been
to use caries data from tooth surfaces or teeth to compute
agreement or correlation coefficients. However, these sta-
tistics assume independence and, most importantly for
kappa coefficients, homogeneity among the 2 assessers
(or examiners) in measuring of caries severity or distribu-
tion [Altarakemah et al., 2017]. When there is a lack of
confirmation of homogeneity of the marginal distribu-
tions of the stages of caries between 2 assessers, the con-
clusion that the 2 assessers were measuring the same dis-
ease states cannot be justified, violating an assumption for
computing kappa coefficients.
As new systems of caries detection methods start to
move away from the simple classification of decayed, miss-
ing, and filled, towards staging of the severity of caries, the
computation of agreement coefficients becomes statisti-
cally problematic because an overall agreement coefficient
represents not the agreement of each stage of disease but
rather agreement that is dominated by the most prevalent
stage, which in most reliability studies is the “sound” stage.
The question we raise in this short commentary can
only be resolved if we focus our assessment on the aggre-
gate measure of caries stages which is the sum of each car-
ies stage for each sampled individual. The aggregate mea-
sure is an interval-scaled statistic that can be correlated
across assessers. This model also fits the outcome-driven
approach proposed in this short commentary for valida-
tion studies.
Epilogue
It is our opinion that the traditional caries detection,
diagnosis, and management system(s) cannot enable us
to achieve the goal of promoting wellness and oral health
[Pitts, 2004]. Restorative care is the common modality of
caries management all over the world. The reason for this
situation was well described, with some frustration, by
Dr. G.V. Black in 1910, where he decried the push for re-
storative and prosthetic care at the expense of under-
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standing that “caries of the enamel represents the most
important stage” and the practical basis for caries man-
agement.
We “plea” in 2017 that we return to the basis which
Black realized to be the foundation for caries manage-
ment, which is making decisions based on understanding
of the biology and pathology of caries to promote well-
ness. He stated that:
In the practice of any profession, and especially of a profession
the basis of which is the conservation of the physical well-being of
the people, such as medicine or dentistry, it is a first duty of every
practitioner to continuously keep up the best study of both the un-
derlying principles of practice, and, within his sphere of action, the
intimate details of that practice.
and
Studies of the beginning caries should be continuously made,
as it appears in the teeth of patients in the chair from day to day,
with the view of becoming more familiar with its tendencies to
spread on the surface of the enamel and the positions and direc-
tions of spreading.
and
Recurrence of caries of enamel about the margins of fillings
should be sought for continuously.
Research) meeting in Athens in July 2016, we have, un-
fortunately and sadly, reiterated what G.V. Black had
concluded in 1910 before his death, that we need to base
the measurement and management of caries on the lat-
est biological knowledge we have and we should not
compromise by distorting our systems of diagnosis and
management to field conditions in public health set-
tings [Ismail, 2004b], and reimbursement methods in
dental practice. We submit that it is time to redefine the
field of caries management based on agreed upon out-
comes for clinical and public health care that will direct
the detection, diagnosis, and management of dental
caries.
Disclosure Statement
Amid I. Ismail and Nigel B. Pitts cofounded the International
Caries Detection and Assessment System. Marisol Tellez has re-
ceived funding from Colgate Palmolive. Amid I. Ismail is a mem-
ber of the Board of Directors of SS White Inc.
Author Contributions

A.I.I. is the primary author and the presenter of the paper at the
In this short commentary to the Symposium that was ORCA 2016 Symposium. M.T. and N.B.P. served as intellectual
held at the ORCA (European Organization for Caries contributors and coeditors.

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