EVIDENCE BASED

DECISION MAKING
PART I
 CONTENTS

 INTRODUCTION

 HISTORY

 TERMINOLOGIES

 PROCESS OF EBDM

 ASSESSING EVIDENCE
 INTRODUCTION

Each day, dental care professionals make decisions about clinical care.


It is important that these decisions incorporate the best available

scientific evidence in order to maximize the potential for successful

patient outcomes.

“The ability to find, discriminate, evaluate & use information is



the most important skill that can be learned as a professional”.

Traditionally, decisions regarding clinical problematic situations
were solved by..
 Individual experience.

 Use of information gained by consulting authorities

(colleagues/text books).

As clinical research & the publication of findings increased, so

did the need to use the medical literature for improvising patient
care..
 The concept of evidence-based medicine dates back to the time
of Frederick II, Emperor of the Romans and King of Sicily and
Jerusalem, who lived from 1192 to 1250 AD, and who was
interested in the effect of exercise on the digestion, took 2
knights and gave them identical meals.

 One was then sent out hunting and the other ordered to bed. At
the end of several hours he killed both and examined the contents
of their alimentary canals; digestion had proceeded further in the
stomach of the sleeping knight.
 Evidence based medicine was pioneered at the Mc Master
University, Ontario, Canada in 1980.

 It was defined by Sackett et al in 2000 as “ the integration of the

best evidence with clinical expertise and patient values.”
 HISTORY

 1980s: Bouckoms and colleagues challenged the

methods and quality of periodontal clinical research.
 1994: Oral Health Group as part of the Cochrane
Collaboration set up
 1996: World Workshop in Periodontology held by
the American Academy of Periodontology included
elements of evidence- based healthcare, supported by
Michael Newman at UCLA.
 1997: The editorial base of the Oral Health group
subsequently moved to Manchester University with Bill
Shaw and Helen Worthington as co-coordinating editors.
 2001: The first Cochrane systematic review in
periodontology was published and researched the effect of
guided tissue regeneration for infrabony defects.
 2002: European Workshop on Periodontology
became the first international workshop to use rigorous
systematic reviews to inform the consensus.
What is evidence-based practice?

 According to Sacketts, .Evidence-based practice involves

integrating individual clinical practice with the best available
external clinical evidence from systematic research..

 According to Muir Gray, .An approach to decision-making in

which the clinician uses the best available evidence, in
consultation with the patient, to decide upon the option which
suits the patient best..
 The use of evidence to help guide clinical decision has 3 new
aspects.

1.Evidence obtained from randomised controlled trials.

2.Systematic review and meta-analysis to synthesise and analyse

the evidence.

3.Electronic databases to access the evidence.

 Clinical skills & patient
assessment

Best available
EBD Patient preferences &
evidence values
 Terminologies used in evidence-based
approach

Systematic review: Review of a clearly formulated

question that attempts to minimize bias using systematic and
explicit methods to identify, select, critically appraise and
summarize relevant research.
 Interpretation: It is the process by which qualitative methods
seek to identify subjective meaning of a phenomenon.
 Process: Qualitative methods used to identify the social
processes that underlie healthcare.
 Interaction: Encounter between physician and patient helps in
bringing together conflicting views of health and illness.
Bias: Bias is a systematic error. It leads to results which are
consistently wrong in one/other direction. Bias leads to incorrect
estimate of the effect of a risk factor/exposure.
 Confounding: Describes the situation where an estimate of
the association between an exposure and the disease is mixed up
with the real effect of another exposure on the same disease, the
two exposures being the same.
 Confidence interval: A method of statistical inference that
allows statement to be made about the publication using data
from the sample.
Odds ratio: Ratio of exposure among cases to exposure
among controls.
Chance: Chance/sampling error plays a role in most
studies of humans, since it is rarely if ever possible to
include an entire population in an investigation. We
therefore attempt to infer information about the population
on the basis of information obtained from representative
samples drawn from the population.
Naturalism: Qualitative methods seek to understand health
and health-related behavior in its every day or natural context.
 NEED FOR EBDM:

1. Daily need for valid information about diagnosis, therapy ,

prognosis and prevention.

2.The inadequacy of traditional sources for this information

because they are out of date, frequently wrong, ineffective
or too overwhelming in their volume and too variable in
their validity for practical clinical use.
3. Increased disparity between diagnostic skills and clinical judgment
with increased experience.

4. Decline in our up-to date knowledge and clinical performance.

5. Inability to afford more than a few seconds per patient for finding
and assimilating this evidence or to set aside more than at least half
an hour per week for general reading and study.
We can’t keep up with the literature.

“Standards” often become myths!!

We often practice anecdotally..

We often rely on low-quality information.

Classic example for the need for evidence: William Hunter’s focal
infection theory- originally proposed in 1900, discarded in 1940s
due to lack of proper evidence. Again accepted in 1989, due to
studies which proved the same with proper evidence.
 Advantages of evidence-based approach compared with other assessment methods:

 
EBA is

Objective.
Scientifically sound.
Patient-focused.
Incorporates clinical experience.
Stresses good judgment.
Is thorough and comprehensive.
Uses transparent methodology.

Newman et al
 PROCESS OF EVIDENCE BASED DECISION MAKING

 Asking good questions- PICO process

 Searching for and acquiring evidence
1. Levels of evidence
2.Sources of evidence- primary & secondary.

 Appraising the evidence

 Evaluating the outcome.
 To focus the question- use the PICO format

 ‘P’ is identifying the Patient or population, with the Problem or

condition (e.g., risk of infective endocarditis & penicillin allergy),

The Intervention (e.g., clindamycin),

 The Comparison (e.g., erythromycin), and

The specific Outcome (e.g., provide effective antibiotic prophylaxis, in

terms of safety, better absorption, & more sustained serum levels).

 In this example, these elements form the question….

 Using PICO to frame questions serves 3 key purposes:

1.Force the clinician to focus on most important single issue or

outcome.
2.Facilitates computerised search by identifying the key terms used
in the search.
3.Identifying the problem, the result and outcomes related to the
specific care provided to that patient.
This allows identification of the type of evidence required to
solve the problem as well as considerations for measuring the
effectiveness of the intervention.
 Searching for and acquiring evidence

 Evidence typically comes from studies related to questions about

the treatment/ prevention, diagnosis,etiology/harm and prognosis
of disease as well as from questions about the quality and
economics of care.

 Once synthesized, evidence can help inform decisions about

whether a method of diagnosis or a treatment is effective relative
to other methods of diagnosis or to other treatments and under
what circumstances.
 LEVELS OF EVIDENCE

Rules of evidence have been established to grade Randomized

Control Trials

evidence according to its strength. Cohort

Studies

Case Control
Studies

 Systematic reviews and randomized controlled trials

represent the highest levels of evidence.
Cross Sectional
Studies and Case
Reports

Ideas, Editorials
and Opinions

Case reports and expert opinion are the lowest

Animal
Research

In vitro (test
tube) research
 The Current Hierarchy Of Quality Of
Evidence:

 1a: Systematic review of randomized controlled trials (RCTs)

 1b: Individual RCT (with narrow confidence intervals)
 2a: Systematic review of cohort studies
 2b: Individual cohort study (including low-quality RCT; e.g.
<80% follow-up)
 2c: "Outcomes" research; ecologic studies
 3a: Systematic review of case-control studies
 3b: Individual case-control study
 4: Case series (and poor-quality cohort and casecontrol studies)
 5: Expert opinion without explicit critical appraisal, or based on
physiology, bench result research, or "proof of principle
study"describes how the intervention is more effective.
 The systematic review (SR) and meta analysis using two or more
randomized controlled trials(RCTs) forms the highest level of
evidence or the gold standard because of their strict protocols to
reduce bias.

 They provide a summary of multiple research studies that have

investigated the same specific question.
 SYSTEMATIC REVIEWS

 A systematic review can be defined as a review of a clearly

formulated question that attempts to minimize bias using
systematic and explicit methods to identify, select, critically
appraise and summarize relevant research.

 Systematic reviews are a research design termed research

synthesis.
 That is, they use research methodology to pool data from
multiple studies that address a particular hypothesis.
 META ANALYSIS

 It is a statistical process often used with SRs.

 It involves combining the statistical analysis of several individual
studies into one analysis.
 When data from these studies are pooled, the sample size and
power usually increase.
 As a result the combined effect can increase the precision of
estimates of treatment effects and exposure risks.
 In this hierarchy of evidence as we progress up the pyramid, the
number of studies and correspondingly the amount of available
literature decrease, while at the same time their relevance of
answering clinical questions increases.
 Evidence is judged on its rigor of methodology and the level of
evidence is directly related to type of question asked, such as
those derived from issues of prevention , diagnosis, etiology and
prognosis.
Type of question Methodology of choice Question Focus
Therapy, prevention Systematic reviews (SR)of Study the effect of therapy
randomized controlled or test on real patients;
trials(RCTs) allows for comparison
SR of cohort studies between intervention and
control group.

Diagnosis SR of controlled Measures reliability of a

trials(prospective cohort particular diagnostic test
study) for a disease against the
“gold standard”
diagnostic measure for
the same disease.
Etiology, causation, harm SR of prospective cohort Compares a group
study exposed to a particular
agent with an unexposed
group.Important for
understanding the
prevention and control of
the disease
Prognosis SRs of inception cohort Follows progression of a
studies. group with a particular
Retrospective cohort. disease and compares
with a group without the
disease

 Knowing which type of study will provide the best evidence for
clinical decision making and how to retrieve this information
quickly from scientific literature is important to evidence based
practice.
 SOURCES OF EVIDENCE

 The two types of evidence based sources are:

 Primary sources- original research publications that have not

been filtered or synthesized.
 Secondary sources- Systematic reviews, meta analysis, evidence
based article reviews and clinical practice guidelines and
protocols synthesized from primary sources.
 Both primary and secondary sources can be found by conducting
a search using various biomedical databases.
 Other, more specific, databases are

PsycINFO (psychology and  For topics in social care

psychiatry), ASSIA(Applied Social
AMED (complementary Sciences Index and
medicine), Abstracts),
CSA Sociological Abstracts
 MANTIS (osteopathy and
and CSA Social Services
chiropractic)
Abstracts.
CINAHL (nursing and
Other databases that are
allied health professions). population specific are
AgeInfo, Ageline and
ChildData
 PRIMARY SOURCES OF EVIDENCE

 PubMed is designed to provide access to both primary and

secondary research from biomedical literature.

 It provides access to MEDLINE, the National Library of

Medicines premier bibliographic database covering the fields of
medicine, nursing, dentistry, veterinary medicine, the health care
system and the preclinical sciences.
 MEDLINE contains a bibliographic citations and author abstracts
from more than 4800 biomedical journals published in the United
States and 70 other countries.

 The database contains over 12 million citations dating back to

1966 and it adds more than 520,000 new citations each year.
 The search terms should be related to all four parts of the PICO
question.

 The terminologies should be related to the topic but with

different ways of expression in order to best capture the
literature.
 After the search terms are entered, any exclusion criteria can also
be entered, for example, year of publication, language preference,
journal restriction, subject restriction, or types of studies.

 When conducting the search, choices are also given to include all
root terms (various word endings denoted by $) and subject
headings (denoted by ⁄ after the term)
 SECONDARY SOURCE OF EVIDENCE

1. Summaries of systematic reviews and research articles- Evidence

based journals such as Journal of Evidence Based Dental Practice
and Evidence Based Dentistry – a one to two page structured
abstract, with an expert commentary highlighting the most
relevant and practical information is generally provided.

 In addition to summaries with commentary of SRs , selected

abstracts of new SRs from the cochrane Collaboration Library are
provided.
 The Cochrane Collaboration is an international , volunteer,
nonprofit organization.

 There are approximately 50 specialist review groups in 13

countries, including an oral health group and a tobacco addiction
group.

 All cochrane groups provide peer- reviewed SRs that meet

international standards and have an obligation to update their
reviews every 2-4 years to account for new evidence.
 The results of their work are stored in cochrane library databases,
one of which is the cochrane database of systematic reviews a
rapidly growing collection of SRs of the medical literature.
2. Clinical practice guidelines and protocols-
Guidelines are defined by the instituition of Medicine in 2000 as
Systematically developed statements to assist practitioner and
patients decision about appropriate health care for specific
clinical circumstances.

3. AAP position papers, statements and parameters of care: AAP

regularly monitors treatments, products and concepts to ensure
that eventhough these have been evaluated once , they are still
the best available or as useful as originally envisioned.
4.The ADA posts information on a broader range on their website.

The ADA guidelines, positions and statements can be assesed

under the section professional issues and research.
Practice guidelines related to treatment of specific medical
conditions are found on other websites such as American Heart
Association.
 COMPARISON OF SYSTEMATIC REVIEWS AND LITERATURE
REVIEWS
CHARACTERISTIC SYSTEMATIC LITERATURE
REVIEW REVIEW
Focus of review Specific problem,narrow Range of issues on a topic
focus. or a broad focus.
Eg- effectiveness of Eg-Effectiveness of an
periostat as an adjunct to adjunctive antimicrobial
scaling and root planing agent for treating
for treatment of adult periodontitis.
periodontitis

Who conducts it Multidisciplinary team Individual

Selection of studies to All the studies that meet Criteria is not pre
include pre established established.Inherent bias
criteia.Bias is minimized due to lack of criteria
Reported findings Description of study Descriptive in
design,subjects, length of nature.Reports the
trial, state of health / outcomes of the study
disease, outcome rather than the study
measures. design.
Synthesis of selected Results are Studies are reported
studies statistically combined. without combining
(meta analysis) data.

Main results Summary of trials , total Summary of findings by

no of subjects.Definitive author in relation to
statements about findings purpose of literature
in relation to objectives review and specific
and outcomes measures. objectives.
Conclusion or comments Discussion of key findings Discussion of key findings
with interpretation of the with interpretation of the
results , including results , including
potential biases and limitations and
recommendations for recommendations for
future trials future trials.
 APPRAISING THE EVIDENCE

 After identifying the evidence gathered in order to answer a

question, it is important to have skills to understand the evidence
found.
 In all cases it is necessary to review the evidence whether it is an
SR or an original study to determine if the methods were
conducted rigorously and appropriately.
 International evidence based groups have made this easier by
developing appraisal forms and checklist that guide the user
through a structured series of Yes/ No questions to determine the
validity of individual study or SR.
 CRITICAL APPRAISAL

 “Critical appraisal is the process of systematically examining

research evidence to assess its validity, results, and relevance
before using it to inform a decision”
Hill and Spittlehouse, 2001
 Guidelines are available to help the publication of clinical
research.

 These guidelines are well accepted by high impact biomedical

journals and offer guidance not only to authors but also to editors
and reviewers.
 EXAMPLES OF CRITICAL ANALYSIS GUIDES

Guide Purpose
CONSORT statement (Consolidated To improve the reporting and review of
Standards of Reporting Trials) RCTs.
STARD(Standards for Reporting of For reporting studies on diagnostic tests
Diagnostic Accuracy)
QUOROM (Quality of Reporting of To improve the reporting and review of
Meta-analyses) RCTs.
MOOSE (Meta-analysis Of For reporting SRs.
Observational Studies in Epidemiology)
QUADAS (Quality Assessment of For reporting SRs.
studies of Diagnostic
Accuracy included in Systematic
reviews)
 EVALUATING THE OUTCOMES

 The final step in evidence based decision making are to evaluate

the effectiveness of the intervention and clinical outcomes and to
determine how effectively the EBM process was applied.

 This can be achieved through self evaluation, by questioning the

effectiveness of each step.
 ASSESSING EVIDENCE

There are 12 different tools to assess evidence

1.Scepticism
2.Deductive resoning
3.Inductive resoning
4.Cause preceeding effect
5.No change in hypothesis
6.Clinically relevant pretrial hypothesis
7.Size of association
8.Contradictory studies
9.Randomization
10.Non randomized evidence
11.Placebo effect
12.Conflict of interest
 SCEPTICISM

 In 1900 William Hunter- Focal infection theory....

 Therefore the theories should be viewed with scepticism and

there must be no unsubstantiated attributions, no theories without
evidence.
 Evidence on how to cure, manage or prevent chronic disease is
notoriously contradictory, inconsistent and unreliable.

 3 reasons why most studies on periodontics is inaccurate.

 a) Identifying a successful treatment for a chronic disease is
challenging.
 b)Most chronic diseases are complex and include both
environmental and genetic factors.
 c) Poor scientific methodology employed by researches lead to
inaccurate results.
 DEDUCTIVE REASONING

 Causal chain thinking (If A causes B, and B causes C, therefore A

causes C).
 This system of deductive resoning was developed by Greeks.
 Also called as deductive inference.

 In medicine or dentistry decisions based on deductive reasoning

have not been correct for all the times.
 In evidence based medicine evidence that is based on the
deductive inference is classified as level 5, the lowest level of
evidence available.
 Eg: classic study in 1965 on experimental gingivitis by Loe.....

 Also use of antibiotics to treat periodontal abscess..

 Indiscriminate use of antibiotics is not justified, because use of
antibiotics when not required has led to development of
resistance on a global scale.
 INDUCTIVE REASONING

 Rationale thought or inductive reasoning is based on systematic

experiments.
 Galileo is typically credited with the start of systematic
experimentation in physics.
 Three systematic experiments used in clinical research are:
1. Case control study
2.Cohort study
3.Randomized control trial
 EXPOSURE: Refers to a suspected etiologic factor or an
intervention such as treatment or a diagnostic test.

 END POINT: Refers to the outcome of the disease, quality of life

measures or any type of condition that may be of interest in
clinical studies.
 RANDOMIZED CONTROLLED TRIALS

 Individuals are randomly assigned to different exposures and

monitored longitudinally for the end point of interest.

 If the end points frequency differs between the exposure groups,

an association between exposure and end point is present.

 RCT is the gold standard design in clinical research.It is the level

1 or the best level of evidence.
 COHORT STUDY

 Exposed individuals are compared with the non exposed

individuals and monitored longitudinally for end point occurence.

 If the end point differs between exposed and non exposed

individuals an association between exposure and end point is
present.

 It is the optimal study design in non experimental clinical

research and is the level 2 of evidence.
 CASE CONTROL STUDY

 Cases (individuals with end point interest) are compared with

controls (individuals without end point interest) with respect to
prevalence of the exposure.

 If prevalence of exposure differs between cases and controls , an

association between exposure and endpoint is present.

 Most challenging study design to use and is called level 3

evidence.
 CAUSE PRECEDING EFFECT

 Temporality is the only criteria that needs to be satisfied for

claiming causality, cause needs to preceed the effect.

 Eg: Ecological plaque hypothesis by P D March.....

 Hence it is hard to say with certainity which is the cause and

which the effect is.
 NO CHANGE IN HYPOTHESIS

 A well defined hypothesis should be established at the start of the

study and this should be adhered to for the rest of the study.

 No change can be made in the hypothesis once the study is

started.
 Modifying study sample definition:
Once the study sample is decided, this sample population should
not be tampered with.
 Modifying exposure definition:
Exposure defined in the hypothesis should not be changed
during the study.
 Modifying end point definition:
Almost all major trials specify one primary endpoint in the pre-
trial hypothesis.Any modification of this end point during or after
the trial is the cause for concern
 Deviating from the pre trial hypothesis is called data torturing.

 Manipulating the data to take only the values which prove our
point of view is called procrustean data torturing.
 CLINICALLY RELEVANT PRE-TRIAL
HYPOTHESIS
 Trials on clinically relevant questions dramatically change
clinical practice.
 Usually, clinically relevant questions share 4 important
characteristics of the pre trial hypothesis.
1.A clinically relevant end point (outcome of PICO)
2.Relevant exposure comparisons( Intervention and Control in
PICO question)
3.A study sample representative of real world clinical
patients( patient defined in PICO question)
4.Small error rates.
Clinically relevant end point

 An End point is a measurement related to a disease process or a

condition and is used to assess the exposure effect.
 Two clinically relevant endpoints are recognized.

 1.True end point: Tangible outcomes that directly measures how

a patient feels, functions or survives.
Eg:tooth loss, death, pain.
 2.Surrogate end points: Intangible outcomes used as a substitute
for a true end point.
Eg: reduction of pocket depth or gain in clinical attatchment
level.

The first requirement for a clinically relevant study is a pretrial

specification of a true end point.
Relevant exposure comparisons
 The more prevalent a studied exposure, the more relevant is the
clinical question.
 A clinically relevant exposure comparison implies:
1.Absence of contrived control groups
2.Use of placebo control group when appropriate

Eg of irrelevant exposure is comparison of 0.12% chlorhexidine

mouth wash when it is known that 0.05% mouthwash is
ineffective.
Representative study sample:
 The larger discrepancy between the study sample and the patient
one seeks to treat, the more questionable the applicability of the
study conclusion becomes.

 Studies done on population similar to the patients we treat are

considered relevant.
Small Error rates:
 Type I error rate: likelihood concluding that there is an effect
when in truth there is no effect.
 Set by investigator and values are 1%or 5%

 Type II error rate: likelihood concluding that there is no effect

when in truth there is an effect.
 Set by investigator and values are 10%or 20%
 SIZE OF ASSOCIATION
 The larger the association, the less likely it is caused by bias and
more likely it is causal.
 The size of association can be calculated by calculating the odds
ratio- the probability that the event happens divided by the
probability that the event does not happen.

End point
Failure Success
Exposure experimental A B
control C D

 Odds ratio: AD/BC

 The size of the odds ratio ranges between 0 and infinity.

 An odds ratio of 1 indicates absence of association.

 An odds ratio larger than 1 (experimental failure ӽ success of

control) indicates harmful effect.

 An odds ratio smaller than 1(experimental success ӽ control

failure) indicates protective effect.
 CONTRADICTORY STUDIES

 Studies disproving the hypothesis have a greater value than those

which accept it.
 Eg: studies on root conditioning....

 Another reason is presence of confounding factor.

 Confounding: Describes the situation where an estimate of the
association between an exposure and the disease is mixed up with
the real effect of another exposure on the same disease, the two
exposures being the same.
 Eg: Smoking and diabetes mellitus are confounding factors for
periodontitis.
 In randomized studies confounding is not an issue because
randomisation balances known and unknown confounders across
the compared groups with a high degree of certainity.

 In nonrandomised studies ,the following questions concerning

confounding arise:
1.Whether all the confounders have been included: multiple
confounders need to be included in statistical analysis.

Crude association: An association

unadjusted for any potential confounders.

Adjusted association: When the crude

association is adjusted for potential
confounders.
2.Whether confounders can be accurately measured:eg potential
confounders like smoking and life style could be difficult to
measure.

 A discrepancy between what is measured and what is the truth

will result in incomplete removal of bias.

 The remaining bias is referred to as residual confounding

 RANDOMISATION

 Creates heterogeneity.

 Takes control over treatment assignment away from physician

 Leads to a situation in which patients are randomly assigned to

treatments and if they refuse treatment, they are still analysed as
if they have received treatment.
Steps in Randomisation
 NON RANDOMISED EVIDENCE

 Ethical principles dictate that proposed interventions do more

good than harm, that the populations in whom the study will be
conducted will benefit from the findings and that an informed
consent is obtained from enrolled subjects.

 Eg: studies on gene therapy using viral vectors and studies on

humans are difficult due to safety concerns.

 Also sample size considerations may prevent conduct of RCTs.

 The smaller the rates at which endpoints occur in RCT, the larger
the required sample size will be.

 For rare events such as bacterial endocarditis subsequent to

dental procedures or HIV conversion after exposure to an HIV
contaminated needle,RCTs may never be possible because the
required sample size are in 100,000 or million of subjects.
 PLACEBO EFFECT

 Placebo effects are beneficial effects some patients experience by

simply participating on a study, by patient physician interaction,
by patient anticipation for improvement or by patients desire to
please the physician.

 A small controlled study in 11 patients showed that placebo

effects can cause changes in brain function, providing
plausibility to the argument that placebo effects may have
biological effects.
 Due to such placebo effects, without mock surgeries it would be
impossible to tell whether the improvement observed in clinical
trials are caused by placebo effects associated with surgical
procedures or the hypothesised active ingredients of the surgery
itself.
 CONFLICT OF INTEREST

 Is defined as a set of conditions in which professional judgement

concerning a primary interest such as patients welfare or validity
of research tends to be unduly influenced by a secondary
interest.

 Secondary interests may be financial, religious or scientific

beliefs, ideological or political beliefs or academic interests.
 Eg of how conflict of interest can bias evidence....

 A drug is truly noneffective with a type I error rate of 5%, one

can expect that 2of 40 trials will provide positive results by
chance.If the 38 negative trial reports go into file drawer, and if
two positive reports are published in leading journals, a
misleading perception of the drugs effectiveness will be given to
the practicing community.
GOOD MORNING
EVIDENCE BASED
DECISION MAKING
PART II
 CONTENTS

 IMPLEMENTING EVIDENCE INTO CLINICAL PRACTICE

 EVIDENCE BASED PERIODONTOLOGY

 EVIDENCE-BASED APPROACH IN PERIODONTAL

THERAPY

 CONCLUSION

 REFERENCES
 IMPLEMENTING EVIDENCE BASED DECISIONS
INTO CLINICAL PRACTICE

 Evidence Based Practice : Defined as an approach to decision

making in which the clinician uses best available evidence in
consultation with the patient to decide upon the option that suits
the patient best.
 Implementing evidence based decisions into clinical practice
includes the following steps:
1. Managing uncertainity
2.Incorporating evidence into practice
3.Linking outcomes with diagnosis and treatment
4.Implementing evidence based decisions
5.Change management
Managing uncertainity:
 Decision making is an important skill in clinical practice.This
could be complicated in periodontics as establishing a prognosis
is inherently imprecise.

 There are psychological issue in making decisions, especially

while facing clinical uncertainities.Simply repeating old
behaviour patterns is generally more comfortable than
insightfulness needed to question ones own actions and embrace
change.
 Some individuals are more comfortable and skilled at making
decisions whereas others are inherently indecisive by nature.
 A reason for our indecisiveness is that our classic elementary
education has trained us not to make decisions on our own ,but to
follow a prescribed set of rules.
 Most of us has been educated under a pedagogical system of
learning.
 In this system the dominant teacher disseminates known facts to
the submissive students.
 Motivation is external, here learning is not generally applied and
students are not encouraged to think and question but blindly
accept what is taught to them.
 Androgical theory is an adult form of learning and encourages
students to apply their mind.
 Androgical theory states that adults learn best by internal
motivation and have urgency to solve problems by drawing on
existing knowledge.
 It is about discovering about what is known,accepting
uncertainity, yet being able to apply new found knowledge
immediately.
 Traditional dental education has generally been pedagogical in
nature.
A linear approach to clinical decision making is followed.

Condition treatment outcome

 Training is limited in diagnosis, treatment planing and assessing
disease susceptibility, hence students instead of establishing a
diagnosis, identify a presenting dental condition as needing a
specific treatment to achieve or avoid a certain out come.
 Eg: extraction of impacted wisdom teeth and replacing a missing
teeth.

 Thus a linear cook book approach to dental treatment could lead

to successful outcomes, but it raises the question of over
treatment.

 This forms the basis of traditional decision making in dentistry.

INCORPORATING EVIDENCE INTO PRACTICE:

 Publication of research advances allowed the practitioners to

incorporate this evidence into clinical practice.This process is
known as science transfer.
 Dental practitioner including the periodontist may not be aware
of the current best evidence in dentistry due to sheer no of dental
journals and the rate at which the studies are being published.
 This problem is partly alleviated by the development of evidence
based journals or systematic reviews.
 Searching for and critically appraising the evidence are
significant barriers facing dental practitioners.
 When reading a scientific investigation, the dental professional
should keep in mind the following three questions.

1. What are the results?

2.Are the results valid?
3.Are the findings relevant to my patient population?
 These questions form the basis of critical appraisal, the ability to
access a study for clarity, validity and generalisability.

 The effectiveness of the method used to disseminate evidence is

also important.

 Passive diffusion of information and continuing education

lectures are generally ineffective than small interactive group
work , problem based learning and practice specific
interventions.
 LINKING OUTCOMES WITH DIAGNOSIS AND TREATMENT

a.Outcome:
Dentistry is a treatment oriented profession and interventions are
considered superior to watchful waiting.
 This often leads to over estimation of the patients risk of disease
progression and often leads to overtreatment.
 Though periodontal disease causes significant morbidity and alter
the quality of life, it is upto the clinician to decide when
intervention is crucial and when it is preferable to wait and
watch.
b.Diagnosis:
Periodontal disease tends to be over-diagnosed by novice
practitioner, as well as to be underdiagnosed by experienced
practitioner.

 Treating before establishing diagnosis or with a misdiagnosis

usually leads to poor decisions and ultimately unfavourable
outcomes.
c.Treatment:
Patients and dentists usually view dentistry as treatment oriented
profession that tends to discount the diagnostic phase of dental care.

 Another form of bias , financial bias, occurs when the compensation

from more lucrative types of procedure unduly influence the
decision making process.

 In periodontics surgical procedures are compensated at higher rate

than non surgical therapies and clinicians have a built in incentive to
provide more costly services.
Ideally when a patient visits the clinic following are the phases that should be followed..

Assess
disease
Presenting
condition

Establish
diagnosis

Evaluate need/
level of
intervention

Establish
prognosis
IMPLEMENTING EVIDENCE BASED DECISIONS
 A diagnosis should be established prior to deciding to intervene.

 If diagnosis is established , one might decide to intervene

depending on the evidence based pattern of decision making
process as follows:
 4 step process of making decision to intervene, with or without
diagnosis

condition

 diagnosis
No diagnosis

Treatment No treatment Treatment No treatment

Outcome Outcome
 CHANGE MANAGEMENT:

 3 Main challenges lie ahead with implementation of evidence

based decisions:

 A. Individual changes
 B. Organisational changes
 C.Allowing research findings to guide decision making process
 Change can be implemented by:

Recognising the need for change

Performing an organisational analysis and identifying all

stakeholders

Including all stakeholders in the process

Monitor and evaluate to ensure lasting change

An evidence based method closes the gap between clinical research
and realities of practice by providing the dentists with skills to
find, efficiently filter and interpret apply research findings so
what is known is reflected in the care provided.
 What is evidence-based
periodontology?

 Evidence-based periodontology is the application of evidence-

based health care to periodontology.

 Therefore, evidence-based periodontology is a tool to support

decision making and integrating the best evidence available with
clinical practice.
STEPS IN EVIDENCE BASED PERIODONTOLOGY
 Evidence based Traditional
periodontology periodontology

 Uses best available evidence.  Unclear basis of evidence.

 Systematic appraisal of
quality of evidence.
 More objective, more
transparent & less biased
process.
 Greater acceptance of levels
of uncertainty.
 Unclear/absent appraisal of
quality of evidence.
 More subjective, more
opaque & more biased
process.
 Greater tendency to black &
white conclusions.

SIMILARITIES:
High value of clinical skills & experience.
Fundamental importance of integrating evidence with patient values.
 Evidence-based approach in periodontal therapy will be dealt
under the following topics:

 EBA and mechanical nonsurgical pocket therapy

 Effect of smoking on NST
 EBA in periodontal regeneration
 EBP and open flap debridement
 EBA and mucogingival surgery
 EBA and dental implants
 EBA and HMT
 Periodontal diseases and cardiovascular diseases
 Periodontal disease and pre term LBW
 Periodontal disease and DM
Evidence-based approach and mechanical nonsurgical pocket
therapy

 A total of nine reviews were searched for the best evidence

 Nonsurgical pocket therapy (NST) was found to have a positive
effect with the exception of pockets <3 mm.
 Patient, environmental, and operator factors affect therapy
delivery.
 No difference was found between the effect of hand and
machine-driven instruments.
 Machine-driven instruments were faster than hand-driven
instruments.
 Conclusions from 1996 world workshop on periodontics
 Chemical plaque control
 The various antiplaque and/or antigingivitis agents do not offer a
substantial benefit for the treatment of periodontitis.
 They may however contribute to the control of gingival
inflammation that exists with periodontitis.
 Supragingival irrigation may be used as an adjunct to
toothbrushing and has been shown to aid in the reduction of
gingival inflammation.
 Even when subgingival irrigation is used, the evidence shows that
there are no clear substantial long-term benefits for the treatment
of periodontitis.
 Antibiotic therapy and periodontics

 The risk.benefit ratio indicates that systemic antibiotics should

not be used for the treatment of gingivitis and common forms of
adult periodontitis.

 But evidence suggests that systemic antibiotics may be useful in

aggressive forms of periodontitis.
 Local delivery of antimicrobial agents

 There was modest gain in clinical attachment level and decrease

in probing depth and gingival bleeding.
 A few side effects were demonstrated namely, transient
discomfort, erythema, recession, allergy, and rarely, candida
infection.
It was concluded that though adjunctive therapies continue to be
explored, mechanical debridement is still the single best option
available.

It remains the foundation treatment for many adjunctive

antimicrobial treatment investigations.
 Effect of smoking on nonsurgical therapy

 Systematic review of the effect of smoking on NST was

conducted by Labriola et al.
 Search strategy included Medline,Embase and Central.
 Study design was controlled clinical trial.

 The outcomes were:

 There was reduced pocket depth reduction in smokers, compared
with nonsmokers.
 There was no significant difference in the change of Clinical
Attachment Level (CAL) between smokers and nonsmokers.
 The reason could be that the increased vasoconstriction in
peripheral blood vessels of smokers leads to decrease in bleeding
and edema.

 Also, smokers would have less potential for resolution of

inflammation and edema within the marginal tissues and
therefore less potential for gingival recession.
 Evidence-based approach in periodontal regeneration

 Guided tissue regeneration:

 The study population included chronic periodontitis patients in
subjects 21 years or older.
 The outcomes assessed were:

1. Short-term clinical outcomes

 It included soft tissue changes such as increased CAL and
decreased PPD.

2. Long-term clinical outcomes

 It included disease recurrence and tooth loss.
3. Patient-centered outcomes
 It included various factors such as ease of maintenance, change in
esthetics, p/o complications, cost/benefit ratio, and patient well-
being.
The meta-analysis done by Needleman et al and Murphy et al,
revealed that:

1. When compared with OFD, guided tissue regeneration (GTR)

showed increase in CAL, decrease in PPD, and defect fill.
2. When GTR with bone substitutes was compared with GTR alone,
the results were similar.

3. No evidence was found for difference in use of ePTFE versus

bioabsorbable membranes.

4. Long-term clinical outcomes/patient-centered outcomes could

not be determined due to lack of available data. Heterogeneity
was large and bias could not be eliminated.
 Grafting procedures

 Meta-analysis was done by Reynolds et al and Trombelli et al.

 The therapeutic end points used were
 Short-term changes [12 months after intervention]
 Long-term changes [13 months or more]
 Patient-oriented changes
Short-term changes
 Autogenous bone
 Trombelli et al, in his review demonstrated greater CAL gain in
autogenous graft group than the control group, but the result was
not statistically significant. Reynolds et al, showed a statistically
significant gain in CAL.

 Bone allograft
 Use of bone allograft showed gain in CAL, PPD reduction and
increased defect fill.
 Dentin allograft
 Use of dentin allograft showed a gain in CAL of 2.8 mm in
grafted patients as compared with 2 mm CAL gain in controls.

 Coralline calcium carbonate

 Use of the graft showed a gain in CAL and bone fill. But there
was no improvement in pocket depth reduction.
Bioactive glass
 There was improvement of bony lesion when compared with
open flap debridement [OFD].
 Mean difference in CAL between the two was 1.04mm. Change
in bone fill noted was greater for bioactive glass, but the change
was not statistically significant.
 Heterogeneity was present due to a study conducted by Org et
al,which demonstrated a more favorable change following an
OFD procedure.
Long-term outcomes
 Fleming et al,did a 6-36 months follow-up study and found that
there was 0.12 mm gain in clinical attachment level gain in test
group and 0.43mm decrease in clinical attachment level in
control group.

 Galgut et al, assessed and compared clinical attachment level at

12 months and 48 months.
 The results showed a 0.27mm decrease in clinical attachment
level in grafted group and 0.14mm gain in clinical attachment
level gain in open flap debridement group.
 Yukna et al followed up hydroxyapatite grafted patients for a
period of five years.
 The results showed that two-thirds of the patients showed a gain
in clinical attachment level in the grafted group and onethird of
open flap debridement showed a decrease in clinical attachment
level.

Patient-centered outcome
 In most of the studies reviewed, there were no systemic or local
adverse effects
 The adverse effects noted in some of the studies were

 Pebbled surface texture of grafted site

 Transient slight gingival inflammation
 Delayed soft tissue healing
 Exfoliation/shedding of graft material
 So, it could be concluded that

 All grafts produce CAL gain, decrease in PPD, and bone fill,
except polylactic acid.
 There was considerable heterogeneity in the studies.
 The studies could not tell treatment-related adverse effects and
cost.benefit ratio.
Emdogain
 The main advantage of emdogain is formation of acellular
cementum.

Outcomes measured
 Primary outcome
 Secondary outcome
 Long-term benefits
 Patient-centered outcomes
 Esposito et al, conducted the systematic reviews and found that
when emdogain was compared with open flap debridement, the
results favored emdogain.

 When emdogain was compared with GTR, GTR was better in

relation to decrease in probing pocket depth.
Drawbacks of emdogain

 Gel-like consistency which limits the space making

 If primary closure is not assured, displacement of material takes
place
 Adequate preservation of interdental soft tissue to limit collapse
of flap into bony defect
Concluding remarks

 Emdogain showed an improvement in CAL gain and PPD

reduction.
 General conclusions about clinical relevance are limited.
 There is no difference between emdogain and GTR except for
slightly increased reduction in pocket depth due to increased
recession in GTR treated sites.
 Long-term effects are unknown.
Evidence-based approach and open flap debridement

 Sytematic reviews were conducted by Heitz May field et al and

Antczak et al.
Clinical implications of the whole review regarding open flap
debridement
 If pocket depth reduction is the main aim, surgical treatment is
the treatment of choice.
 If increase in clinical attachment level gain is the main aim,
nonsurgical therapy is of more benefit for shallow and moderate
pockets and surgical therapy is the treatment of choice for deep
pockets.
 Evidence on mucogingival therapy

 Carlo Clauser in his meta-analysis found that:

 All the surgical procedures allow complete root coverage.

 Connective tissue grafting achieves complete root coverage more
frequently than does GTR.
 The probability of complete root coverage is high if the initial
recession is shallow, irrespective of the surgical procedure
employed.
 The probability of achieving complete root coverage decreases
dramatically as the initial recession depth increases.
 Dental implants

 Most evidence is available for titanium implants, but some

evidence exists to support the use of hydroxyapatite and
titanium-plasma sprayed implant surfaces.
 There is also evidence to support the use of both two-stage
systems which require a second surgery to expose the implant,
and one-stage implant systems.
 Clinicians should exercise caution when treating patients who
smoke and those with untreated periodontal diseases, poor oral
hygiene, uncontrolled systemic disease and a history of radiation
therapy in the region or active skeletal growth.
 HMT

 A SR was conducted to assess the adjunctive efficacy of

antiproteinase, anti-inflammatory, and bone-sparing host-
modulating agents in the treatment of gingivitis, aggressive
periodontitis, and chronic periodontitis.
 FOCUSSED QUESTION
 1. In patients with periodontal diseases, what is the effect of host-
modulation agents, alone or combined with conventional therapy,
compared to conventional therapy alone as assessed by clinical,
radiographic, adverse, and patient-centered outcomes?

 2. In patients with dental implants, what is the effect of host-

modulation agents on implant success assessed by clinical,
radiographic, adverse, and patient-centered outcomes?
 The primary outcomes for assessment were changes in bone or
clinical attachment levels (CAL);

 Secondary outcomes included clinical measures of plaque,

gingival inflammation, probing depth (PD), and mobility.
 MAIN RESULTS:
 1. A meta-analysis done on the studies reporting changes in CAL
and PD following administration of sub-antimicrobial doses of
doxycycline (SDD) in conjunction with scaling and root planing
(SRP) in patients with periodontitis showed a statistically
significant beneficial adjunctive effect.

 2. There were insufficient data to provide meta-analyses on

periodontal patients treated with other host-modulating agents;
 REVIEWERS' CONCLUSIONS:

 1. Large multi-center trials are needed to evaluate the role of

host-modulating agents in the treatment of periodontitis.
 2. NSAIDS and bisphosphonate drugs may have a potential
adjunctive role in periodontal therapy.
 3. The adjunctive use of SDD with SRP is statistically more
effective than SRP alone in reducing PD and in achieving CAL
gain.
 Periodontal diseases and cardiovascular diseases

 A systematic review published studied the evidence supporting

the association between PD and CVD. Thirty-one human studies
were selected.

 The authors concluded that "periodontal disease may be modestly

associated with atherosclerosis, myocardial infarction and
cardiovascular events".

 Other three systematic reviews reported a modest but significant

association between CVD and periodontal disease.
 Another question is whether periodontal treatment can decrease
the risk for adverse cardiovascular events.

 Some investigations reported the effects of periodontal treatment

on surrogate endpoints, such as C-reactive protein, which is
associated with CVD.

 However, a recent systematic review concluded that, up to now,

there is no evidence that periodontal treatment can significantly
reduce C-reactive protein levels.
 Evidence grade associating periodontitis to preterm birth
and/or low birth weight: I. A systematic review of prospective
cohort studies.

Chambrone L, Guglielmetti MR, Pannuti CM, Chambrone LA.

J Clin Periodontol 2011; 38: 795–808.

The aims of this systematic review (SR) were to evaluate

the association between maternal periodontitis and preterm
birth (PB) and/or low birth weight (LBW)
Methods:
MEDLINE, EMBASE and Cochrane Central Register of Controlled Trials
(CENTRAL) databases were searched up to and including October 2010 to
identify prospective studies on the association of periodontitis with PB and/or
LBW.
RESULTS

Nine studies (81.8%) found an association between periodontitis

and PB and/or LBW.

Meta-analysis showed a significant risk of preterm delivery for

pregnant women with periodontitis [risk ratio (RR): 1.70 (95%
confidence interval (CI): 1.03, 2.81)] and a significant risk for
LBW [RR: 2.11 (95% CI: 1.05,4.23)] or PB/LBW [RR: 3.57
(95% CI: 1.87, 6.84)], as well as a high and unexplained degree
of heterogeneity between studies.
 Conclusion:

Although this SR found a consistent association between

periodontitis
and PB and/or LBW, this finding should be treated with great
caution until the sources
of heterogeneity can be explained.
 Evidence grade associating periodontitis with preterm birth
and/or low birth weight: II. A systematic review of randomized
trials evaluating the effects of periodontal treatment

Chambrone L, Pannuti CM, Guglielmetti MR, Chambrone LA.

J Clin Periodontol 2011; 38: 902–914

ABSTRACT
Aim:
The aim of this systematic review was to evaluate whether maternal
periodontal disease treatment (MPDT) can reduce the incidence
of preterm birth (PB) and/or low
birth weight (LBW).
 Methods:
The Cochrane Central Register of Controlled Trials, MEDLINE and
EMBASE were searched for entries up to October 2010 without
restrictions regarding the language of publication. Only
randomized-controlled clinical trials (RCTs) that
evaluated the effect of MPDT on birth term and birth weight were
included.
 Results:
The results of eight studies (61.5%) showed that MPDT may reduce
the incidence of PB and/or LBW. However, the results of all
meta-analyses showed contrasting results for PB [RR: 0.88 (95%
CI: 0.72, 1.09)], LBW [RR: 0.78 (95% CI: 0.53, 1.17)] and
PB/LBW [RR: 0.52 (95% CI: 0.08, 3.31)].
 Conclusion:
The results of this review show that MPDT did not decrease the risk
of PB and/or LBW; however, the influence of specific aspects
that were not investigated (disease diagnosis, extension and
severity and the success of MPDT) should be evaluated by future
RCTs.
 Effect of Periodontal Treatment on Glycemic Control of Diabetic
Patients
A systematic review and meta-analysis
Diabetes Care February 2010 vol. 33 no. 2 421-427

RESEARCH DESIGN AND METHODS

A literature search (until March 2009) was carried out using two
databases (MEDLINE and the Cochrane Library) with language
restriction to English. Selection of publications was based on 1)
original investigations, 2) controlled periodontal intervention
studies where the diabetic control group received no periodontal
treatment, and 3) study duration of ≥3 months.
RESULTS

A total of 371 patients were included in this analysis with

periodontitis as predictor and the actual absolute change in A1C
(ΔA1C) as the outcome.
The duration of follow-up was 3–9 months. All studies described
a research population of type 2 diabetic patients in whom
glycemic control improved after periodontal therapy compared
with the control group (range ΔA1C: Δ−1.17 up to Δ−0.05%).
 The studies in a meta-analysis demonstrated a weighted mean
difference of ΔA1C before and after therapy of −0.40% (95% CI
−0.77 to −0.04%, P = 0.03) favoring periodontal intervention in
type 2 diabetic patients.

 Nevertheless, this improvement in %A1C must be interpreted

with care due to limited robustness as evidenced by heterogeneity
among studies (59.5%, P = 0.04).
CONCLUSIONS

The present meta-analysis suggests that periodontal treatment

leads to an improvement of glycemic control in type 2 diabetic
patients for at least 3 months.
 CONCLUSION

 A major push to integrate the principles of the evidence-based

approach into the mainstream of clinical practice has come from
the fact that there is great variation in both clinical decision-
making and results of therapy.

 Evidence based approach conducts systematic appraisal of

quality evidence, is more objective, transparent and less biased. It
allows greater acceptance of levels of uncertainty.
 The traditional approach however has unclear basis of evidence,
unclear or absent appraisal or quality evidence, is more
subjective, more opaque and more biased. It has greater tendency
to black and white conclusions.

 Despite the cited differences both the evidencebased and

traditional approach emphasize on high value of clinical skills,
experience and integrating evidence with patient values.
 Research evidence helps to decide which interventions are most
effective.

 It should not replace our clinical findings from history and

examination, but harness our clinical intuition from years of
experience and help us recognizing gaps and uncertainties in our
knowledge.
 REFERENCES

 Clinical Periodontology: Carranza; 9th ,10th ed.

 Evidence based medicine: what it is and what it isn't; Sackett et
al: BMJ Jan 1996;312:71-72. 
 Application of evidence-based dentistry: from research to clinical
periodontal practice .Perio 2000 Vol. 59, 2012, 61–74
 Evidence-based periodontology, systematic reviews and research
quality .Perio 2000.Vol. 37, 2005, 12–28
 Evidence-based periodontal therapy:An overview. R.
Vijayalakshmi JISP 2008
 Evidence-based periodontal therapy:A REVIEW. NILIMA S et al
JCDR 2008
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