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1
BASED ORTHODONTICS
Dr. Sonal Sahasrabudhe
Post Graduate
2
Contents
• Introduction
• Definition
• History
• Need for evidence based orthodontics
• Evidence based practice & EBDM
• Clinical scenarios
• Experience Vs Evidence
• Conclusion
• References
3
INTRODUCTION
• The field of orthodontics has the distinction of being the first
recognized speciality in dentistry.
• With this, we also inherited the responsibility to lead in the
acquisition , evaluation and dissemination of scientific
knowledge.
• But the mechanisms by which we acquire, assess and transfer
the knowledge have changed considerably over the period of
time.
4
SO WHAT ELSE CHANGED ?
The Patient
Informed, aware, curious ,skeptical
Definitely more demanding
Doctor-Patient Relationship
A partnership
The need
Treatment on demand, timed,
Needs to fit in with lifestyle
A result
5
DEFINITIONS
• EVIDENCE
• Generally, an article published in a scientific journal- reporting
results of a clinical trial- is considered as evidence.
• EVIDENCE BASED DENTISTRY
• ADA: “ an approach to oral health care that requires the
judicious integration of systematic assessments of clinically
relevant scientific evidence , relating to patient’s oral and
medical condition and history, with the dentist’s clinical
expertise and patient’s treatment needs and preferences.
6
HISTORY OF EBD
• Origin in the middle of 19th century in Paris, when young
graduates started challenging the validity of clinical decisions
based solely upon personal experience.
• McMaster University in Canada in 1985 , introduced some
concepts in its curriculum.
• American College of Physicians followed.
• Establishment of Center for Evidence- based Medicine in Oxford,
UK in 1995.
• The litigious nature of society further fueled the need for
practicing evidence based health care
7
Dr. Angle’s contributions
Teaching
Invention
of new
appliances
Conducting
clinical
research
Age of
Edward
Angle
• His Views
• His
teaching
Age of
Education
• Teaching in
dental
schools
Age of
Science
• World war
II
• Scientific
innovations
Age of
Evidence
• Public-
better
informed
• Questioning
of
established
ideas
Evolution of knowledge acquisition
8
Need for clinical evidence…?
9
Need for evidence based orthodontics???
“Simply because we, as health care
professionals, owe it to our patients, to
provide the currently best care available”
10
• Its primary purpose is to improve patient care.
• Intended to close the gap between what is known and what is
practiced; to improve patient care based on informed
decision-making.
• EBP consists of three components or legs of support:
Doctor’s
education
and
experience
Patient’s
preferences and
values
Best
available
evidence
11
Health care is all about decision making
Right time
Right intervention
Right patient
Right method
Best results
12
How does one arrive at a clinical decision
that is valid, current and applicable to
one’s patient?
Evidence-Based Care
13
How EB is developed?
• Evidence-based clinical recommendations are developed
through critical evaluation of the collective body of evidence
on a particular topic to provide practical applications of
scientific information that can assist orthodontists in clinical
decision-making.
14
TYPES OF STUDIES
STUDIES
EXPERIMENTAL OBSERVATIONAL
RCT COHORT CASE
CONTROL
CASE
REPORT
15
Types of Reviews
Reviews
Systematic
Narrative
Syntheses
Meta-analyses
Pooled Estimates
Narrative
16
HIERARCHY OF EVIDENCE
17
1. SYSTEMATIC REVIEWS & META ANALYSES
• Systematic reviews are a synopsis of the existing evidence on
a specific topic.
• It is a process of systematically locating, appraising and
synthesizing evidence from scientific studies in order to obtain
a reliable overview.
• Provides means to keep up with numerous articles published
annually in every field.
• Concentrates on a very specific and narrow, clinically relevant
question.
• Team of experts
• Inclusion and exclusion criteria is used
• Bias less likely to happen
18
• Guidelines for the conduct of a systematic review- COCHRANE
COLLABORATION.
• Provision of software to perform statistical analyses of pooled
data.
• Systematic reviews are often considered qualitative
assessments, whereas meta-analyses are quantitative
evaluations.
• Meta-analyses may be inappropriate where heterogeneity in
clinical, methodological, or statistical approach argues against
combining studies.
19
What is meta-analysis?
• It is a review that uses quantitative methods to combine the
statistical measures from two or more studies and generates a
weighted average of the effect of an intervention, degree of
association between a risk factor and a disease, or accuracy of
a diagnostic test.
• Distinguishing feature of meta-analyses- Use of statistical
analysis because the other steps involved in meta-analyses
are identical to those of systematic reviews.
• Most often, the results of meta-analyses - presented using
forest plots.
20
Forest Plot
21
Types of Meta-analysis
22
Random effect analysis
Fixed analysis
STEPS IN PERFORMING SYSTEMATIC REVIEW
• FIRST STEP : framing an important and well defined
question that is relevant to patient care.
• Framing a question in a proper format and identifies four
crucial “ PICO” elements. These elements are:
1. Population or patient type
2. Intervention
3. Comparison
4. Outcome
23
• SECOND STEP: determining inclusion and exclusion to select
the eligible studies.
• THIRD STEP: design a search strategy.
• Employed to search available studies include both electronic
databases such as MEDLINE, EMBASE, Web of science and
Cochrane, databases and manual searches.
24
• FOURTH STEP: involves application of the selection criteria
identified in step Two to the potential studies retrieved from
both electronic and manual search strategies determined in
step Three.
• This action will result in selection of the eligible studies for the
review and appraising these studies.
25
• FIFTH STEP: Performing a statistical summary of the
abstracted data, or Meta- analysis.
• Data from different study designs are summarized with the
purpose of the following six tasks:
1. Deciding whether to combine the data or defining what to
combine
2. Evaluating the statistically heterogeneity of the data
3. Estimating a common effect
4. Exploring and explaining heterogeneity
5. Assessing the potential for bias
6. Presenting the results in the form of a table
• FINAL STEP: Interpret the evidence to answer the research
question
26
Drawbacks of SRs and MAs
• SRs
• Selection bias
• Publication bias
• Heterogeneity
• MAs
• Ability of researchers to
combine studies that differ in
study populations,
experimental designs, and
quality controls
• Possibility of publication or
selection bias when
conducting such studies
• Oversimplifying the results
of a research area
27
2. RANDOMISED CONTROL TRIALS
• An experimental study on patients with a particular disease or
disease –free subjects in which the individuals are randomly
assigned to either an experimental intervention or a control
group to determine the ability of an agent or a procedure to
diminish symptoms, to decrease risk of death from disease
during follow up period.
• Provide strongest evidence of causation.
28
Drawbacks
• Raise ethical concerns in control groups
• Costly and time consuming to implement
• Because of the strict eligibility criteria and loss to follow-up,
RCT sample size requirements are difficult to attain and
maintain
29
3. COHORT STUDIES
• An observational study that follows an exposed cohort
compared to an unexposed cohort to determine the incidence
of given outcome.
• Well designed cohort study provides strong support for
causation
• Require large sample size
• Take a long follow-up time to generate useful data of the
studies - result in misclassification in outcome status
• Expensive to conduct
• Are sensitive to attrition
30
4. CASE CONTROL STUDIES
• An observational epidemiological study of persons with the
disease (or another outcome variable) of interest and a suitable
control group of persons without the disease (comparison
group, reference group) – Done retrospectively
• Quick, relatively inexpensive
• Appropriate in studying rare diseases
• Assessment of multiple risk factors for a particular disease
within the same study
 Potential recall bias.
 Confounding of exposure variable.
 Matching control to cases is challenge.
31
5. CASE REPORT AND CASE SERIES
• Document unusual occurrences of outcomes
• First clues of a new diseases or adverse effects of exposure
• Case series are an extension of case reports
32
How to search for the evidence?
33
Sources
Personal experience
Textbooks
Own professional education
Clinical guidelines
Colleagues ,other professionals
Patient
Personal intuition
Trial and error
Supplier ,infomercial literature
Journal articles
Online reference
Unpublished evidence
Overviews
34
Sources
• The National Library of Medicine’s searchable database
of more than 12 million indexed citations from more
than 4600 medical, dental, health, and scientific journals
1. PubMed
• An international non-profit organization that develops
evidence-based systematic reviews on health care
interventions
2. Cochrane
Collaboration
• A resource for evidence-based dentistry that is
periodically updated and accessible to dentists and the
public.
3. ADA Center of
Evidence-Based
Dentistry
• An example is the evidence-based website that the AAO
Library maintains at its member website.4. Websites
35
• The group conducts systematic reviews of randomized controlled trials of
health-care interventions and diagnostic tests, which it publishes in The
Cochrane Library.
• The group was formed to organize medical research information in a
systematic way to facilitate the choices that health professionals, patients,
policy makers and others face in health interventions according to the
principles of evidence-based medicine.
The Cochrane Oral Health Group
• Part of The Cochrane Collaboration
• Established in the USA in 1994
• Comprises an international network of researchers
involved in producing and disseminating systematic reviews
of controlled RCTs in the field of oral health.
• Publishes summaries of the best quality research available
to help people (patients, carers, clinicians, researchers and
funders) make better informed decisions about oral
healthcare choices.
Evidence Based Decision Making
(EDBM)
EBDM is the formalized process and structure for learning these
skills with the purpose of closing the gap between what is known
and what is practiced in order to improve patient care based on
informed decision-making.
38
Evidence based decision making
39
The Need for EBDM
• Forces driving the need to improve the quality of
care include:
Variations in practice
Slow translation and
assimilation of the
scientific evidence
into practice.
Managing the information
overload, and changing
educational competencies
that require students to
have the skills for lifelong
learning
40
• Convert information needs/problems into clinical questions so
that they can be answered
• Conduct a computerized search with maximum efficiency for
finding the best external evidence with which to answer the
question
• Critically appraise the evidence for its validity and usefulness
(Clinical applicability).
• Apply the results of the appraisal, or evidence, In Clinical practice.
• Evaluate the process and your performance.
EBDM PROCESS
41
Clinical scenarios in Orthodontics
42
Face mask protraction therapy in early skeletal Class III
AJO DO 2005 128; 299-309
• Does RME enhance the efficiency of maxillary protraction with
face mask in developing Class III malocclusion?
• Results: Face mask therapy effective in early Class III MO
• The need for palatal expansion in the absence of a transverse
discrepancy or a skeletal/ dental cross bite is not supported.
• Correction due to combined skeletal and dental change.
43
Critical appraisal
EBD 2006:7,16-17.
• First prospective RCT of the subject
• Inclusion of control group to quantify growth before recruiting
participants.
• Results are conclusive.
• The skeletal change following protraction is significant, but
has no correlation with expansion.
44
Skeletal and dental changes with fixed slow maxillary
expansion treatment. Systematic review.
JADA Feb 2005
• Eight studies were selected, each lacked a control group, and
four also did not have a measurement error treatment.
• A control group is necessary to factor out normal growth
changes in the dental arch and cranio facial structure.
• No strong conclusion could be made on dental and skeletal
changes after SME.
45
Meta analysis of immediate changes with RME
treatment
JADA Jan 2006
• Results: Of the 31 selected abstracts, 12 were rejected
because they failed to report immediate changes after the
activation phase of RME and instead reported changes only
after the retention phase.
• The greatest changes were in the maxillary transverse plane in
which the width gained was caused more by dental expansion
than true skeletal expansion.
• Few vertical and antero-posterior changes were statistically
significant, and none was clinically significant.
46
A systematic review concerning early orthodontic
treatment of unilateral posterior cross bite
Angle Orthod 2003;73:588-596
• The aim of this study was to assess the orthodontic treatment
effects on unilateral posterior cross bite in primary and early
mixed dentition by systematically reviewing the literature.
• Two RCT’s of early treatment of cross bite have been found and
these two studies support grinding as treatment in the primary
dentition.
• There is no scientific evidence to show which of the treatment
modalities, grinding, quad helix, expansion plates or RME is
most effective
47
Orthodontics and Temporo-mandibular Disorders –
A meta-analysis
AJO DO 2002;121:438-446
• Orthodontists are blamed for causing TMD. Epidemiologic
studies show that TMD symptoms are most prevalent among
patients between 15-25 years of age. Orthodontists may
encounter patients who complain about TMD during or after
treatment.
• Does traditional orthodontic treatment change the prevalence
of TMD?
• No study indicated that traditional appliance increased the
prevalence of TMD, except for mild or transient signs
48
The effect of topical fluorides on decalcification in
patients with fixed orthodontic appliances: A systematic
review
AJO DO 2005; 128: 601-606
• Decalcification is a significant problem during fixed orthodontic
treatment. Topical fluorides can reduce or eliminate the problem,
but the relative effectiveness of different or combinations of
topical fluoride preparations is unknown.
• Results: The use of topical fluorides in addition to fluoride
toothpaste reduced the incidence of decalcification in populations
with both fluoridated and non fluoridated water supplies.
Different preparations and formats appear to decrease
decalcification but there was no evidence that any one method
was superior.
49
Incremental versus maximum bite advancement
during Twin block therapy: A randomized controlled
clinical trial.
AJO-DO 2004;126:583-8
•Experimental patients had 2mm initial bite advancement and
subsequent 2mm advancements at 6 weekly intervals with a Twin
block appliance incorporating advancement screws.
•The aim of this study was to evaluate the effectiveness of
incremental and maximum bite advancement during treatment of
class II div 1 malocclusion with the Twin-block appliance in the
permanent dentition.
•The use of incremental advancement of the twin block did not
confer any advantage in terms of process and outcome of the
treatment.
50
Outcomes in a 2-phase RCT of early class II
treatment
AJO DO 2004;125:657-667
This study was a RCT designed to examine the 2 major strategies used
to treat class II malocclusion: 1 phase Vs 2 phase
Results: there was no differences in the findings between the ‘intent
to treat’(ITT) sample,who had completed phase 1,and an ‘efficacy
analyzable’(EA)sample(n=137),which comprised only patients who
completed phase 2.During phase 2 of the trial,the advantage created
during phase 1 treatment in the 2 early treatment group was lost,and
by the end of fixed appliance treatment,there was no significant
difference between any of the 3 groups for all anteroposterior and
vertical skeletal and dental measures.
51
The experienced-based
view
The evidence-based
view
1. Only clinical experience,
and years of it, is relevant
to the practitioner.
2. Denies the usefulness of
science
3. Research journals are biased
against the experienced-base
view.
4. There are no good clinical
studies or clinical researchers.
1. Science and scientific
methods are relevant to
practitioner.
2. Benefits and usefulness of
science have been
demonstrated
3. Referred research journals
are not biased.
4. Clinical research is adequately
performed and published.
Experience based Vs. Evidence based
• A common criticism is that the findings of clinical trials are
not relevant to patients in private practice, because the
operators in trials are working to such tight protocols that
their treatment bears no resemblance to the real world.
• Treatment decisions based on clinical experience and
beliefs are extremely difficult to change.
• Clinical experience suggests that some conditions are best
treated for biological, social, or practical reasons
53
Experience based Vs. Evidence based
• For the experience- based orthodontist, what is accepted as
the knowledge of the field is apparently based on some
combination of:
1. empiricism
2. authority
3. rationalism and
4. tenacity
54
Drawbacks of experience based approach
Definitive answer is not available with the provider but
working plan is provided based on knowledge of
pathophysiological processes / memory of similar clinical
problems.
Fear of unconventional problems which do not follow
the textbook pattern & failure to update with current
trends & treatment modalities.
A difference in opinions of clinical experts, will not
provide adequate scientific information for consistent &
reliable clinical decision making
55
CONCLUSION
• The main challenge for the orthodontist is the necessity of
integrating the gathered evidence into clinical practice.
• Without the incorporation of current best evidence, clinical
practice may be based more on anecdote or tradition, and
risks becoming rapidly out of date which surely is not in the
best interest of our patients.
• Nevertheless, the AAO states that an evidence-based
approach does not set a standard of care, and that the
treatment for each patient should be based on a combination
of the doctor’s clinical expertise, the patient’s needs and
preferences, and the evidence.
56
REFERENCES
• Rinchuse D J, Rinchuse D J. Evidence- Based Clinical Orhtodontics. Edited
by Miles P G. Quintessence Publishing co, Inc.
• Making the case for evidence- based orthodontics- Greg J Huang. Am J
Orthod Dentofac Orthod 2004; 125: 405-6.
• Putting the evidence first- David L Turpin. Am J Orthod Dentofac Orthod
2005; 128:415.
• Adeyemo WL. Is there evidence against evidence based dentistry? Am J
Orthod Dentofacial Orthop 2007;132:3.
• Isaacson RJ. Evidence based Orthodontics. Angle Orthod. 2002; 72(6): iv.
• Rubin RM. On Evidence-based Orthodontics. Angle Orthod. 2006; 76(5):
911-12.
• Cunha-Cruz J. Practicing evidence-based Orthodontics: How to critically
appraise a randomized controlled trial. Dental Press J Orthod. 2015 Mar-
Apr;20(2):12-5.
• Angelieri, F. Evidence-based Orthodontics: Has it something to do with
your patient? Dental Press J Orthod. 2013 Sept-Oct;18(5):11-3.
57
REFERENCES
• Gianelly A. Evidence-Based therapy: An Orthodontic dilemma Am J Orthod
Dentofac Orthod,Volume 129,Number 5.
• Phil Banks, Jean Wright & Kevin O’Brein . Incremental versus maximum
bite advancement during twin block therapy : A randomized controlled
clinical trial. AJODO 2004; 126: 583-8.
• J.F.Camilla Tulloch, William R. Proffit & Ceib Phillips. Outcomes in a 2-
phase randomized clinical trail of early Class II treatment. AJODO 2004;
125: 657-67.
• Mahmoud Torabinejad & Khaled Babjri. Essential elements of evidenced-
based endodontics: Steps involved in conducting clinical research. JOE
2005; 35: 563-8.
• Barbara L Chadwick, Jayne Roy, Jeremy Knox & Elizabeth T Treasure. The
effect of topical fluorides on decalcification in patients with fixed
orthodontic appliances: A systematic review. AJODO 2005; 128: 601-6.
• Myung- Rip Kim, Thomas M Graber & Marlos A Viana. Orthodontics &
temporomandibular disorder: A meta- analysis. AJODO 2002; 121: 438-
46.
58
REFERENCES
• Petren S, Bondemark L, Soderfeldt B. A Systematic Review Concerning
Early Orthodontic Treatment Of Unilateral Posterior Crossbite. Angle
Orthodontist, Volume 73, Number 5,2003.
• Kalha A S. Face mask protraction therapy in early skeletal class III
malocclusion. EBD 2006:7.1.
• Manuel Lagravere,Paul Major,Carlos Flores-mir. Skeletal and dental
changes with fixed slow maxillary expansion treatment. JADA,Volume-
136,February 2005.
• Manuel Lagravere,Giseon Heo,Paul Major,Carlos Flores Mir. Meta-analysis
of immediate changes with rapid maxillary expansion treatment.
JADA,Vol.137,January 2006.
• Graber, Vanarsdall, Vig. Orthodontics: Current Principles and Techniques.
5e. Elsevier. Searching for evidence in orthodontics. Chapter 21. 2027-
2042.
59
Thank You 60

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Sonal evidence based orthodontics

  • 1. 1
  • 2. BASED ORTHODONTICS Dr. Sonal Sahasrabudhe Post Graduate 2
  • 3. Contents • Introduction • Definition • History • Need for evidence based orthodontics • Evidence based practice & EBDM • Clinical scenarios • Experience Vs Evidence • Conclusion • References 3
  • 4. INTRODUCTION • The field of orthodontics has the distinction of being the first recognized speciality in dentistry. • With this, we also inherited the responsibility to lead in the acquisition , evaluation and dissemination of scientific knowledge. • But the mechanisms by which we acquire, assess and transfer the knowledge have changed considerably over the period of time. 4
  • 5. SO WHAT ELSE CHANGED ? The Patient Informed, aware, curious ,skeptical Definitely more demanding Doctor-Patient Relationship A partnership The need Treatment on demand, timed, Needs to fit in with lifestyle A result 5
  • 6. DEFINITIONS • EVIDENCE • Generally, an article published in a scientific journal- reporting results of a clinical trial- is considered as evidence. • EVIDENCE BASED DENTISTRY • ADA: “ an approach to oral health care that requires the judicious integration of systematic assessments of clinically relevant scientific evidence , relating to patient’s oral and medical condition and history, with the dentist’s clinical expertise and patient’s treatment needs and preferences. 6
  • 7. HISTORY OF EBD • Origin in the middle of 19th century in Paris, when young graduates started challenging the validity of clinical decisions based solely upon personal experience. • McMaster University in Canada in 1985 , introduced some concepts in its curriculum. • American College of Physicians followed. • Establishment of Center for Evidence- based Medicine in Oxford, UK in 1995. • The litigious nature of society further fueled the need for practicing evidence based health care 7
  • 8. Dr. Angle’s contributions Teaching Invention of new appliances Conducting clinical research Age of Edward Angle • His Views • His teaching Age of Education • Teaching in dental schools Age of Science • World war II • Scientific innovations Age of Evidence • Public- better informed • Questioning of established ideas Evolution of knowledge acquisition 8
  • 9. Need for clinical evidence…? 9
  • 10. Need for evidence based orthodontics??? “Simply because we, as health care professionals, owe it to our patients, to provide the currently best care available” 10
  • 11. • Its primary purpose is to improve patient care. • Intended to close the gap between what is known and what is practiced; to improve patient care based on informed decision-making. • EBP consists of three components or legs of support: Doctor’s education and experience Patient’s preferences and values Best available evidence 11
  • 12. Health care is all about decision making Right time Right intervention Right patient Right method Best results 12
  • 13. How does one arrive at a clinical decision that is valid, current and applicable to one’s patient? Evidence-Based Care 13
  • 14. How EB is developed? • Evidence-based clinical recommendations are developed through critical evaluation of the collective body of evidence on a particular topic to provide practical applications of scientific information that can assist orthodontists in clinical decision-making. 14
  • 15. TYPES OF STUDIES STUDIES EXPERIMENTAL OBSERVATIONAL RCT COHORT CASE CONTROL CASE REPORT 15
  • 18. 1. SYSTEMATIC REVIEWS & META ANALYSES • Systematic reviews are a synopsis of the existing evidence on a specific topic. • It is a process of systematically locating, appraising and synthesizing evidence from scientific studies in order to obtain a reliable overview. • Provides means to keep up with numerous articles published annually in every field. • Concentrates on a very specific and narrow, clinically relevant question. • Team of experts • Inclusion and exclusion criteria is used • Bias less likely to happen 18
  • 19. • Guidelines for the conduct of a systematic review- COCHRANE COLLABORATION. • Provision of software to perform statistical analyses of pooled data. • Systematic reviews are often considered qualitative assessments, whereas meta-analyses are quantitative evaluations. • Meta-analyses may be inappropriate where heterogeneity in clinical, methodological, or statistical approach argues against combining studies. 19
  • 20. What is meta-analysis? • It is a review that uses quantitative methods to combine the statistical measures from two or more studies and generates a weighted average of the effect of an intervention, degree of association between a risk factor and a disease, or accuracy of a diagnostic test. • Distinguishing feature of meta-analyses- Use of statistical analysis because the other steps involved in meta-analyses are identical to those of systematic reviews. • Most often, the results of meta-analyses - presented using forest plots. 20
  • 22. Types of Meta-analysis 22 Random effect analysis Fixed analysis
  • 23. STEPS IN PERFORMING SYSTEMATIC REVIEW • FIRST STEP : framing an important and well defined question that is relevant to patient care. • Framing a question in a proper format and identifies four crucial “ PICO” elements. These elements are: 1. Population or patient type 2. Intervention 3. Comparison 4. Outcome 23
  • 24. • SECOND STEP: determining inclusion and exclusion to select the eligible studies. • THIRD STEP: design a search strategy. • Employed to search available studies include both electronic databases such as MEDLINE, EMBASE, Web of science and Cochrane, databases and manual searches. 24
  • 25. • FOURTH STEP: involves application of the selection criteria identified in step Two to the potential studies retrieved from both electronic and manual search strategies determined in step Three. • This action will result in selection of the eligible studies for the review and appraising these studies. 25
  • 26. • FIFTH STEP: Performing a statistical summary of the abstracted data, or Meta- analysis. • Data from different study designs are summarized with the purpose of the following six tasks: 1. Deciding whether to combine the data or defining what to combine 2. Evaluating the statistically heterogeneity of the data 3. Estimating a common effect 4. Exploring and explaining heterogeneity 5. Assessing the potential for bias 6. Presenting the results in the form of a table • FINAL STEP: Interpret the evidence to answer the research question 26
  • 27. Drawbacks of SRs and MAs • SRs • Selection bias • Publication bias • Heterogeneity • MAs • Ability of researchers to combine studies that differ in study populations, experimental designs, and quality controls • Possibility of publication or selection bias when conducting such studies • Oversimplifying the results of a research area 27
  • 28. 2. RANDOMISED CONTROL TRIALS • An experimental study on patients with a particular disease or disease –free subjects in which the individuals are randomly assigned to either an experimental intervention or a control group to determine the ability of an agent or a procedure to diminish symptoms, to decrease risk of death from disease during follow up period. • Provide strongest evidence of causation. 28
  • 29. Drawbacks • Raise ethical concerns in control groups • Costly and time consuming to implement • Because of the strict eligibility criteria and loss to follow-up, RCT sample size requirements are difficult to attain and maintain 29
  • 30. 3. COHORT STUDIES • An observational study that follows an exposed cohort compared to an unexposed cohort to determine the incidence of given outcome. • Well designed cohort study provides strong support for causation • Require large sample size • Take a long follow-up time to generate useful data of the studies - result in misclassification in outcome status • Expensive to conduct • Are sensitive to attrition 30
  • 31. 4. CASE CONTROL STUDIES • An observational epidemiological study of persons with the disease (or another outcome variable) of interest and a suitable control group of persons without the disease (comparison group, reference group) – Done retrospectively • Quick, relatively inexpensive • Appropriate in studying rare diseases • Assessment of multiple risk factors for a particular disease within the same study  Potential recall bias.  Confounding of exposure variable.  Matching control to cases is challenge. 31
  • 32. 5. CASE REPORT AND CASE SERIES • Document unusual occurrences of outcomes • First clues of a new diseases or adverse effects of exposure • Case series are an extension of case reports 32
  • 33. How to search for the evidence? 33
  • 34. Sources Personal experience Textbooks Own professional education Clinical guidelines Colleagues ,other professionals Patient Personal intuition Trial and error Supplier ,infomercial literature Journal articles Online reference Unpublished evidence Overviews 34
  • 35. Sources • The National Library of Medicine’s searchable database of more than 12 million indexed citations from more than 4600 medical, dental, health, and scientific journals 1. PubMed • An international non-profit organization that develops evidence-based systematic reviews on health care interventions 2. Cochrane Collaboration • A resource for evidence-based dentistry that is periodically updated and accessible to dentists and the public. 3. ADA Center of Evidence-Based Dentistry • An example is the evidence-based website that the AAO Library maintains at its member website.4. Websites 35
  • 36. • The group conducts systematic reviews of randomized controlled trials of health-care interventions and diagnostic tests, which it publishes in The Cochrane Library. • The group was formed to organize medical research information in a systematic way to facilitate the choices that health professionals, patients, policy makers and others face in health interventions according to the principles of evidence-based medicine.
  • 37. The Cochrane Oral Health Group • Part of The Cochrane Collaboration • Established in the USA in 1994 • Comprises an international network of researchers involved in producing and disseminating systematic reviews of controlled RCTs in the field of oral health. • Publishes summaries of the best quality research available to help people (patients, carers, clinicians, researchers and funders) make better informed decisions about oral healthcare choices.
  • 38. Evidence Based Decision Making (EDBM) EBDM is the formalized process and structure for learning these skills with the purpose of closing the gap between what is known and what is practiced in order to improve patient care based on informed decision-making. 38
  • 40. The Need for EBDM • Forces driving the need to improve the quality of care include: Variations in practice Slow translation and assimilation of the scientific evidence into practice. Managing the information overload, and changing educational competencies that require students to have the skills for lifelong learning 40
  • 41. • Convert information needs/problems into clinical questions so that they can be answered • Conduct a computerized search with maximum efficiency for finding the best external evidence with which to answer the question • Critically appraise the evidence for its validity and usefulness (Clinical applicability). • Apply the results of the appraisal, or evidence, In Clinical practice. • Evaluate the process and your performance. EBDM PROCESS 41
  • 42. Clinical scenarios in Orthodontics 42
  • 43. Face mask protraction therapy in early skeletal Class III AJO DO 2005 128; 299-309 • Does RME enhance the efficiency of maxillary protraction with face mask in developing Class III malocclusion? • Results: Face mask therapy effective in early Class III MO • The need for palatal expansion in the absence of a transverse discrepancy or a skeletal/ dental cross bite is not supported. • Correction due to combined skeletal and dental change. 43
  • 44. Critical appraisal EBD 2006:7,16-17. • First prospective RCT of the subject • Inclusion of control group to quantify growth before recruiting participants. • Results are conclusive. • The skeletal change following protraction is significant, but has no correlation with expansion. 44
  • 45. Skeletal and dental changes with fixed slow maxillary expansion treatment. Systematic review. JADA Feb 2005 • Eight studies were selected, each lacked a control group, and four also did not have a measurement error treatment. • A control group is necessary to factor out normal growth changes in the dental arch and cranio facial structure. • No strong conclusion could be made on dental and skeletal changes after SME. 45
  • 46. Meta analysis of immediate changes with RME treatment JADA Jan 2006 • Results: Of the 31 selected abstracts, 12 were rejected because they failed to report immediate changes after the activation phase of RME and instead reported changes only after the retention phase. • The greatest changes were in the maxillary transverse plane in which the width gained was caused more by dental expansion than true skeletal expansion. • Few vertical and antero-posterior changes were statistically significant, and none was clinically significant. 46
  • 47. A systematic review concerning early orthodontic treatment of unilateral posterior cross bite Angle Orthod 2003;73:588-596 • The aim of this study was to assess the orthodontic treatment effects on unilateral posterior cross bite in primary and early mixed dentition by systematically reviewing the literature. • Two RCT’s of early treatment of cross bite have been found and these two studies support grinding as treatment in the primary dentition. • There is no scientific evidence to show which of the treatment modalities, grinding, quad helix, expansion plates or RME is most effective 47
  • 48. Orthodontics and Temporo-mandibular Disorders – A meta-analysis AJO DO 2002;121:438-446 • Orthodontists are blamed for causing TMD. Epidemiologic studies show that TMD symptoms are most prevalent among patients between 15-25 years of age. Orthodontists may encounter patients who complain about TMD during or after treatment. • Does traditional orthodontic treatment change the prevalence of TMD? • No study indicated that traditional appliance increased the prevalence of TMD, except for mild or transient signs 48
  • 49. The effect of topical fluorides on decalcification in patients with fixed orthodontic appliances: A systematic review AJO DO 2005; 128: 601-606 • Decalcification is a significant problem during fixed orthodontic treatment. Topical fluorides can reduce or eliminate the problem, but the relative effectiveness of different or combinations of topical fluoride preparations is unknown. • Results: The use of topical fluorides in addition to fluoride toothpaste reduced the incidence of decalcification in populations with both fluoridated and non fluoridated water supplies. Different preparations and formats appear to decrease decalcification but there was no evidence that any one method was superior. 49
  • 50. Incremental versus maximum bite advancement during Twin block therapy: A randomized controlled clinical trial. AJO-DO 2004;126:583-8 •Experimental patients had 2mm initial bite advancement and subsequent 2mm advancements at 6 weekly intervals with a Twin block appliance incorporating advancement screws. •The aim of this study was to evaluate the effectiveness of incremental and maximum bite advancement during treatment of class II div 1 malocclusion with the Twin-block appliance in the permanent dentition. •The use of incremental advancement of the twin block did not confer any advantage in terms of process and outcome of the treatment. 50
  • 51. Outcomes in a 2-phase RCT of early class II treatment AJO DO 2004;125:657-667 This study was a RCT designed to examine the 2 major strategies used to treat class II malocclusion: 1 phase Vs 2 phase Results: there was no differences in the findings between the ‘intent to treat’(ITT) sample,who had completed phase 1,and an ‘efficacy analyzable’(EA)sample(n=137),which comprised only patients who completed phase 2.During phase 2 of the trial,the advantage created during phase 1 treatment in the 2 early treatment group was lost,and by the end of fixed appliance treatment,there was no significant difference between any of the 3 groups for all anteroposterior and vertical skeletal and dental measures. 51
  • 52. The experienced-based view The evidence-based view 1. Only clinical experience, and years of it, is relevant to the practitioner. 2. Denies the usefulness of science 3. Research journals are biased against the experienced-base view. 4. There are no good clinical studies or clinical researchers. 1. Science and scientific methods are relevant to practitioner. 2. Benefits and usefulness of science have been demonstrated 3. Referred research journals are not biased. 4. Clinical research is adequately performed and published.
  • 53. Experience based Vs. Evidence based • A common criticism is that the findings of clinical trials are not relevant to patients in private practice, because the operators in trials are working to such tight protocols that their treatment bears no resemblance to the real world. • Treatment decisions based on clinical experience and beliefs are extremely difficult to change. • Clinical experience suggests that some conditions are best treated for biological, social, or practical reasons 53
  • 54. Experience based Vs. Evidence based • For the experience- based orthodontist, what is accepted as the knowledge of the field is apparently based on some combination of: 1. empiricism 2. authority 3. rationalism and 4. tenacity 54
  • 55. Drawbacks of experience based approach Definitive answer is not available with the provider but working plan is provided based on knowledge of pathophysiological processes / memory of similar clinical problems. Fear of unconventional problems which do not follow the textbook pattern & failure to update with current trends & treatment modalities. A difference in opinions of clinical experts, will not provide adequate scientific information for consistent & reliable clinical decision making 55
  • 56. CONCLUSION • The main challenge for the orthodontist is the necessity of integrating the gathered evidence into clinical practice. • Without the incorporation of current best evidence, clinical practice may be based more on anecdote or tradition, and risks becoming rapidly out of date which surely is not in the best interest of our patients. • Nevertheless, the AAO states that an evidence-based approach does not set a standard of care, and that the treatment for each patient should be based on a combination of the doctor’s clinical expertise, the patient’s needs and preferences, and the evidence. 56
  • 57. REFERENCES • Rinchuse D J, Rinchuse D J. Evidence- Based Clinical Orhtodontics. Edited by Miles P G. Quintessence Publishing co, Inc. • Making the case for evidence- based orthodontics- Greg J Huang. Am J Orthod Dentofac Orthod 2004; 125: 405-6. • Putting the evidence first- David L Turpin. Am J Orthod Dentofac Orthod 2005; 128:415. • Adeyemo WL. Is there evidence against evidence based dentistry? Am J Orthod Dentofacial Orthop 2007;132:3. • Isaacson RJ. Evidence based Orthodontics. Angle Orthod. 2002; 72(6): iv. • Rubin RM. On Evidence-based Orthodontics. Angle Orthod. 2006; 76(5): 911-12. • Cunha-Cruz J. Practicing evidence-based Orthodontics: How to critically appraise a randomized controlled trial. Dental Press J Orthod. 2015 Mar- Apr;20(2):12-5. • Angelieri, F. Evidence-based Orthodontics: Has it something to do with your patient? Dental Press J Orthod. 2013 Sept-Oct;18(5):11-3. 57
  • 58. REFERENCES • Gianelly A. Evidence-Based therapy: An Orthodontic dilemma Am J Orthod Dentofac Orthod,Volume 129,Number 5. • Phil Banks, Jean Wright & Kevin O’Brein . Incremental versus maximum bite advancement during twin block therapy : A randomized controlled clinical trial. AJODO 2004; 126: 583-8. • J.F.Camilla Tulloch, William R. Proffit & Ceib Phillips. Outcomes in a 2- phase randomized clinical trail of early Class II treatment. AJODO 2004; 125: 657-67. • Mahmoud Torabinejad & Khaled Babjri. Essential elements of evidenced- based endodontics: Steps involved in conducting clinical research. JOE 2005; 35: 563-8. • Barbara L Chadwick, Jayne Roy, Jeremy Knox & Elizabeth T Treasure. The effect of topical fluorides on decalcification in patients with fixed orthodontic appliances: A systematic review. AJODO 2005; 128: 601-6. • Myung- Rip Kim, Thomas M Graber & Marlos A Viana. Orthodontics & temporomandibular disorder: A meta- analysis. AJODO 2002; 121: 438- 46. 58
  • 59. REFERENCES • Petren S, Bondemark L, Soderfeldt B. A Systematic Review Concerning Early Orthodontic Treatment Of Unilateral Posterior Crossbite. Angle Orthodontist, Volume 73, Number 5,2003. • Kalha A S. Face mask protraction therapy in early skeletal class III malocclusion. EBD 2006:7.1. • Manuel Lagravere,Paul Major,Carlos Flores-mir. Skeletal and dental changes with fixed slow maxillary expansion treatment. JADA,Volume- 136,February 2005. • Manuel Lagravere,Giseon Heo,Paul Major,Carlos Flores Mir. Meta-analysis of immediate changes with rapid maxillary expansion treatment. JADA,Vol.137,January 2006. • Graber, Vanarsdall, Vig. Orthodontics: Current Principles and Techniques. 5e. Elsevier. Searching for evidence in orthodontics. Chapter 21. 2027- 2042. 59

Notas do Editor

  1. ---which is older than 100 years --- This seminar describes the evolun to EBO and why we should all utilize this approach in providing care to our pts.
  2. In Today’s times, Society driven by speed !! Orthodontists are challenged to manage sophisticated patient needs and demands. On the other hand keeping the advances in orthodontics and medical dental sciences up to date, following the current techniques and relevant literature and applying knowledge to daily practice is practicioner’s priority. So The quest in orthodontic care is, and will continue to be, to provide the best care. However, best care demands the best evidence, which is the least biased in terms of design, analysis or interpretation.
  3. EBD involves tracking down the available evidence, assessing its validity and relevance, and then using the “best” evidence to inform decisions regarding care.
  4. Dentistry and Orthodontics have lagged behind medicine in the quest to incorporate science in to clinical practice. Perhaps, the art in the practice of dentistry has overshadowed the need for science.
  5. Edward H. Angle lived life to the fullest, inventing new appliances, conducting clinical research, and teaching. His views were most influential in an era when people tended to look to the experts for guidance in all matters of life. When Dr. Angle died in 1930, the teaching of orthodontics gradually moved into existing dental schools, and we entered the “Age of Education.” With the beginning of World War II, scientific innovation flourished out of necessity as entire countries underwent tremendous advances and development in an effort to respond to challenging new conditions. Scientists who migrated to new countries found opportunities to develop new medications, surgical techniques, sources of energy, etc., and we entered the “Age of Science.’ As the public became better informed, many of the accepted ideas in medicine and dentistry were called into question, opening the door to what many now call the “Age of Evidence.”
  6. –Truths of today ,myths of tomorrow! In the current times, New techniques,procedures,products,materials Claims of Superiority !!! In order to incorporate new techniques materials or procedures in to the practice, we should have a vaid proof of their effectiveness or efficacy. That’s where the need for…….
  7. Evidence-based practice calls for integration of the highest levels of research evidence along with clinical expertise and patient values. First, of course, treatment procedures are based on the “best available evidence.” The second leg of support calls for a doctor’s education and experience in the decision making process. And last, your patient’s preferences and values form the third leg of support. All three are critical in making the best, evidence-based decisions.
  8. In the era, where there are multiple options to treat a particular condition, HOW DO YOU REACH A CLINICAL DECISION? HOW DO YOU DEFEND YOUR CLINICAL DECISION?
  9. The evidence is generated by of various studies like RCTs, case control, cohort studies or even by case series and case reports. And by SRs and Mas.
  10. To gather the evidence…
  11. To judge the quality of studies a “hierarchy of evidence” exists the relative strength of various studies. RCTs can produce very strong evidence [ 8, 9 ] in contrary to other study designs, because with their use the effectiveness of a treatment intervention can be better evaluated [ 10 ] ,& it’s feasible to assess if one treatment intervention is better than another [ 7 ] . Further, systematic reviews (SRs) of RCTs should be credited with the production of even more strong evidence of treatment effects, because the source studies are precisely selected, and after appropriate evaluation, the outcomes are qualitatively synthesized following a specific protocol [ 7, 11– 14 ] . MA is regarded as the highest level of analysis, in which conclusions are made by quantitatively synthesizing the source data of several studies, such as of RCTs, providing already strong evidence, and therefore the evidence produced from MAs should be considered as the strongest possible [ 15 ] .
  12. The tremendous volume of information that is available today makes it difficult for any clinician to stay current on all orthodontic topics. SR and MA are valuable resources to assist clinicians who wish to quickly locate the best evidence on a particular issue. A SR of the existing evidence provides us with the current best information for a specific clinical question. Findings from systematic reviews may be used for decision-making about research and the provision of health care.
  13. After 1st line--- These methods are extremely helpful in producing thorough and clinically useful systematic reviews. With a SR a qualitative synthesis of the available data without any statistical analysis is performed when the data derived from the original studies are not similar and they cannot be combined, while with a MA a quantitative data synthesis with specific statistical meta-analytic procedures is attempted when there is data similar enough to be combined. In other words, a MA is a SR with statistical analysis. For this reason, Forest plot is designed to illustrate the relative strength of treatment outcomes in multiple quantitative studies addressing the same question.
  14. meta - analysis refers to analysis of the data of several independent studies. Meta-analyses are similar to SRs because they are based on thorough reviews of the literature about a single research topic. Nevertheless, they differ from these articles, in that they statistically combine the results of several studies into a single outcome measure.
  15. It is a graphical display of estimated results from a number of scientific studies addressing the same question, along with the overall results. In the graphical portion, the vertical line indicates no difference, while the area to the left of this line indicates that the experimental group performed better, and the area to the right indicates that the control performed better. Each study’s mean is indicated by the green square, and the horizontal line indicates the 95% confidence interval. If the horizontal line touches the vertical line, then there is no statistically significant difference for that study. At the bottom of the graph, there is usually a diamond, which indicates the overall mean and 95% confidence interval. Again, if this diamond touches the vertical line, the summary finding is not statistically significant.
  16. Standardized mean differences are sometimes used when the measurements used in various studies are not the same, and some statistical method is necessary to allow comparison and pooling of these different measures. Random-effects analyses are used most where there are likely differing treatment effects being assessed. Fixed analyses are used to evaluate a common treatment effect measured in a group of studies. The I2 index value is a percentage of the total between-studies variability due to heterogeneity.
  17. Knowing how to ask the right question is the start of every search for evidence. One method of specifying a research question is often referred to as asking the “PICO” question. What is the Problem or Population you wish to investigate? What Intervention do you propose to use? Are you Comparing different treatment methodologies? What is the Outcome that will be assessed? Example of mandibular ant crowding… Study with Amount of crowding in concerned population group might call for the use of fixed orthodontic appliances or something less complex. The comparable procedure being considered might concern the need to extract one mandibular incisor or to attempt nonextraction treatment. And last, what is the outcome that will be assessed? How will alignment of the mandibular teeth be measured, and is long-term stability of interest?
  18. Selective study inclusion. That is only studies with favourable outcome are selected in a SR. Studies with significant results are more likely to be published than studies with non-significant results. Heterogeneity of included studies- sample size, population type, sampling, blinding may not be exactly the same. The inclusion of studies in a SR, which are not sufficiently homogenous in quality, no of participants, interventions and outcomes- impedes the generation of valid results.
  19. The inclusion of studies other than randomized trials may be necessary if randomized trials are scarce or absent. However, these studies should be carefully analysed to determine if adequate measures have been taken to prevent biases affecting the validity of results.
  20. Necessary to know the type of randomization done, by going through the methodology of study. Element of blinding too should be apparent in the study. Even though the study is determined to be valid , still may not be applicable to one’s patient. Different characteristics of patient Results may be weak Statistical analysis may not be adequate
  21. Every once in a while, as clinicians we are asked by patients or parents about various appliances or treatment approaches. For example, we have all been asked, “Are extractions necessary for my daughter?” “What is the advantage of early treatment?” and “Can we use ‘invisible’ braces to treat my crooked teeth?” A decade ago, patients would have had to either rely on the doctor’s reply or extract this information themselves from journals. However, the Internet has changed all that, and the conclusions from many systematic reviews are now quickly and easily accessible via the Internet. Thus, practitioners need to be familiar with the available evidence, including the methods to access and assess this information.
  22. In addition to scientific journals, dental schools, and approved courses, sources of this information may be found in the following locations: PubMed is a free search engine accessing primarily the MEDLINE database of references and abstracts on life sciences and biomedical topics. The United States (NLM) at the National Institutes of Health maintains the database as part of the Entrez system of information retrieval.(wiki) Scopus is a bibliographic database containing abstracts and citations for academic journal articles. It covers nearly 22,000 titles from over 5,000 publishers, of which 20,000 are peer-reviewed journals in the scientific, technical, medical, and social sciences. 3. --- It houses guidelines and collections of systematic reviews for general dentistry, as well as specialty areas. It also provides critical summaries of systematic reviews. 4. --- Websites for various dental specialty organizations The NCBI houses a series of databases relevant to biotechnology and biomedicine and an important resource for bioinformatics tools and services. 
  23. The Cochrane Collaboration is named in honor of Archie Cochrane, a British medical researcher who contributed greatly to the development of epidemiology as a science University College Hospital in London To start with: This is the the Cochrane Collaboration logo. The outer blue semicircles represent The Cochrane Collaboration and the inner circles the globe to represent international collaborations. The forest plot of clinical trials represents the effectiveness of agent used in study; the diamond to the left of the “no effect” line indicates meta-analysis favored the intervention.
  24. 3 factors involved in EBDM are -
  25. Assimilate – to incorporate or absorb knowledge into the mind
  26. Before first point - Skills needed to apply the EBDM Process. The EBO is all about 5 A’s that are - Appraise – to estimate, to praise. ASK a focused question… ACQUIRE the best epidemiological evidence to answer the question… APPRAISE evidence for its validity, magnitude of effect and precision… APPLY evidence to practice… ASSESS actual practice against best evidence-based practice
  27. early treatment in mixed dentition before adolescence,followed by a second phase of comprehensive treatment in permanent dentition; and 1-phase treatment during the adolescent growth spurt and early permanent dentition.
  28. IOM – institute of medicine, Washington DC
  29. Empiricism is knowledge acquired through personal experience or perception. “If I have observed something, it must be real and true.”
  30. Helmstadler believes these are very poor ways to acquire knowledge, and each has shortcomings when applied to clinical practice.
  31. The best evidence can inform, but can never replace, individual clinical expertise because it is this expertise which decides where the evidence applies to the individual patient and, if so, how it should be integrated into a clinical decision.