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Jogikalmat Krithikadatta
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Invited Review
Abstract
The need for scientific evidence should be the basis of clinical practice. The field of restorative dentistry and endodontics is
evolving at a rapid pace, with the introduction of several materials, instruments, and equipments. However, there is minimal
information of their relevance in clinical practice. On the one hand, material and laboratory research is critical, however; its
translation into clinical practice is not being substantiated enough with clinical research. This four part review series focuses on
methods to improve evidence-based practice, by improving methods to integrate laboratory and clinical research.
Keywords: Clinical research; evidence-based dentistry; measurement iterative loop; Patient/Population/Problem, intervention,
comparison, and outcome format; research methodology
studies have good internal validity but poor external Table 1: Requisites of good research
validity which means that the results obtained are only Focus Area of interest/expertise
applicable to similar samples of the study. In other words, Meaningful progress
the results may not transfer to the clinical behaviour Rationale Clinically relevant
of the material. On the other hand, clinical studies have Proof of concept
Challenge /change current treatment methods
good external validity because they are tested on samples/
Validity Will the results be useful and to whom?
subjects that are closely related to the clinical condition
In-vitro studies – Good Internal Validity
and most often representative of all individuals with the Clinical studies – Moderate to good External Validity
condition; however they are more complex since so many Feasibility Time
other factors may influence the outcome of interest. Study population/ Samples
Infra-structure
Skill/aptitude
To understand validity, let us consider the research question
Ethics Do unto other what you would do unto you.
on dentin bonding agents (DBA). In-vitro assessment of
Budget Materials
dentin bonding agents is usually measured in terms of bond Manpower
strength and microleakage. In this scenario, all the samples Equipment
and procedures are standardized to a specific methodology,
that is, dentin cylinders 5 mm in height, with 4 mm of
composite material, x N force at 0.5 cross-head speed, dissociated from dental clinical research and is regarded to
and so on. The bond strength values obtained can be best be a practice under community dentistry. Hence research
extrapolated to a similar set of conditions in the laboratory methods described under epidemiology have also not
and may not deliver the same performance clinically to been used in answering many of our clinical research
patients. On the contrary, if we conduct a clinical study to questions. David Sackett, in 1969, coined the term clinical
evaluate the performance of dentin bonding agents, the epidemiology, which is the, “application, by a physician
methodology would include a randomized controlled trial who provides direct patient care, of epidemiological
involving the restoration of non-carious cervical lesions and biometric methods, to the study of diagnostic and
((NCCL), considered the ideal for bonding agent testing), therapeutic processes, in order to effect an improvement
the clinical evaluation criteria recommended by the United in health.”[5]This concept identifies the clinician as the
States Public Health System (USPHS), and followed over a epidemiologist, which chiefly includes practitioners
period of time. The results of the study can be extrapolated (general/specialist), students, and academicians, who are
to all similar patients requiring restoration of NCCLs. Hence, constantly involved in patient care. Almost four decades
the valid method of testing the ultimate performance of since this concept was introduced, our fraternity is waking
DBA is by a clinical trial and not just bond strength testing. up to this approach. It is important to note that knowledge
However, in-vitro studies provide an insight into which DBA of the disease process and treatment protocols constitute
is the best among the available, to be tested clinically. In- clinical knowledge. This forms only one essential part
vitro studies provide internal validity, that is, they tell us if of clinical epidemiology. In order to understand the
a particular drug or procedure works, but external validity involvement of clinicians in clinical research, we need to be
questions if it is of use to the patient population at large, aware of certain disease manifestations in the community,
which can only be determined by clinical trials on patients. with regard to the magnitude of the problem and measures
to deliver dental care.
Feasibility in terms of time, cost, samples, and infrastructure
are vital to set a logistic time frame for the functioning and Consider this question being asked by the Head of
completion of the study. Finally, a study that does not adhere Department of an institution, “What is the best endodontic
to ethical principles both for in-vitro and clinical designs, regime for patients being treated in my department?”
fails to answer clinically relevant questions. The principles Traditionally, this question would be answered by schools of
of ethics are not restricted only to the handling of human thought, textbook evidence, and findings reported in peer-
participants, but also encompass the ethics followed in the reviewed literature. In reality, this simple question has the
methodology and reporting of results. The Indian Council ability to raise meaningful research questions if we could
of Medical Research (ICMR) has comprehensive guidelines apply this to the measurement iterative loop proposed by
for conducting experimental studies in India.[3] Tugwell et al.[6] [Figure1]. The measurement iterative loop
breaks up the disease cycle into distinct component steps.
Clinical epidemiology It is iterative because, each step logically leads to the next,
The term Epidemiology refers to the study of the and thus comes back to the first step thus ‘closing’ the
distribution and determinants of health-related states or loop. Each step in the loop has the capacity to generate
events (including disease), and the application of these several research questions.
methods to the control of diseases and other health
problems.[4]Erroneously in India, this science is often In this loop, the first step is to ascertain the burden of illness.
accuracy 90% x health provider compliance 80% x patient the reliability of information or from evidence derived from
compliance 80% x coverage 90%) = 52% a scientific study,.[9]
After determining an effective treatment plan for the There are five levels, and each level has sub-ranks as shown
community/patients, the efficiency of the same needs to be in Figure 2.[7]
evaluated. This step determines the relationships between
costs and effects of options within and across the program. Level I
Cost could be a major deterrent in MTA pulpotomy. This a. Meta-Analysis
could propel ingenious preparations to match commercially b. Systematic review (SR) of Randomized Controlled Trials
available MTA, or allocate funds to deliver this treatment (RCT)
to indicated patients. This is followed by the synthesis c. Randomized Controlled Trials
and implementation of MTA pulpotomy as a standard of
care for indicated patients with irreversible pulpitis. This Level II
is done after integration of the feasibility of community a. Systematic review of Cohort Studies
effectiveness and efficiency. Any program implemented b. Cohort Studies/Poor quality RCT
needs to be followed up with systematic documentation
and monitoring. It should include markers for success and Level III
failure on the basis short-term, intermediate, and long- a. Systematic review of Case-Control Studies
term treatment outcomes. b. Case-Control Studies
c. In-vitro Studies
With success data in hand, the burden of illness should
again be re-assessed, to ascertain any modifications Level IV
required within the existing program. Case Series/Cross-sectional studies/Poor quality case
control studies
Era of evidence-based dentistry
Evidence-based practice is defined as, “the conscientious, Level V
explicit, and judicious use of current best evidence in Case Reports/Expert opinion/Literature review.
making decisions about the care of individual patients. The
practice of evidence-based medicine means integrating It must be noted, with caution, that the level of evidence
individual clinical expertise with the best available external is only a stratification based on the information that is
clinical evidence from systematic research.”[8] Individual obtained from each method, with minimal bias, and these
clinical expertise is the proficiency and clinical judgment levels in no way rank the study design. It is logical to
that is often a summation of clinical experience and perceive that study designs are chosen based on research
clinical practice. This systematic clinical research in our questions. For example, even though Randomized Clinical
field includes both in-vitro and clinical research, with equal Trials provide the best evidence, this study design is not
importance. The sensible transition to clinical research meant to identify risk factors for occurrence of disease
by making use of the conclusions of in-vitro research will (determined by case-control study) or disease occurrence/
contribute evidence to various steps of the measurement prognosis (determined by Cohort study). Hence, levels of
iterative loop. It is often observed that the thrust for evidence are a logical ranking for evidence rather than a
clinical research is feeble and as a result there is insufficient ranking for study designs.
evidence from laboratory research translating to clinical
practice. The ideal place to enable contribution to the best
clinical evidence would undoubtedly be the institutional
organization, which has the balance between clinical
expertise from the teachers end and the requirement for
research projects from the students’ end. The only missing
link is a properly planned research, which can be fullfilled by
employing the measurement iterative loop.
What is your research question? Intervention [or ‘exposure’-making it PECO for causation
With the understanding of the measurement iterative loop questions]— It is important to identify what has been planned
and the significance to generate relevant evidence for clinical for the patient or the problem. Depending on the problem, this
practice, the research question should aim at focusing on may include the use of a specific diagnostic test, treatment,
one primary issue at a time. The method to identify and medication or the recommendation to the patient, to
prioritize research questions is given in Figure 3. use a product or procedure. If the problem measures the
causation of a particular disease, then the etiological agent
is assumed as the intervention.
A well-built research question should include four parts,
referred to as the PICO format, which includes Patient/
Comparison — It is an alternative to the intervention under
Population/Problem, Intervention, Comparison, and
study.
Outcome (PICO).[10]
Outcome(s) — This pertains to the result of the study
Patient/population/problem — Defines the condition of preferably outcomes that can be measured accurately that
interest. This is usually derived from the patients’ chief are important to the patient.
complaint in a clinical situation (in particular or on a larger
population) or is derived from the problem faced in a The PICO format can be used to generate a research question
particular material research. for determining the causation of disease, diagnosis of a
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illness, with efficient clinical practice. This increases the
avenues for research studies in several directions. With
an increasing requirement to publish, articles with good
clinical evidence stand a definite chance to find their place
in scientific literature. How to cite this article: Krithikadatta J. Research methodology
in Dentistry: Part I - The essentials and relevance of research. J
ACKNOWLEDGMENT Conserv Dent 2012;15:5-11.
The author would like to thank Prof. Peter Tugwell, Professor Source of Support: Nil, Conflict of Interest: None declared.
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