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RESEARCH IN OMFS BY VINEETHA.K CRI

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A GIST OF HOW TO CONDUCT A RESEARCH STUDY AND THE RECENT RESEARCH ADVANCES IN THE FIELD OF ORAL AND MAXILLOFACIAL SURGERY

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RESEARCH IN OMFSBY

VINEETHA.KCRI

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WHAT IS RESEARCH?RESEARCH- “is the continual search for truth

using the scientific method”ORAL HEALTH RESEARCH – “refers to

laboratory, clinical and field investigations that lead to improvement in the control of oral diseases and health care delivery”

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WHY DO CLINICAL RESEARCH?• To promote the oral health of the public• To contribute new knowledge or reevaluate current

knowledge.• To improve techniques and practices of identifying ,

preventing and treating oral diseases.• To develop and test theories related to oral health

care.• To solve problems in advancement , decision making

and change in oral health delivery.

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542-03-#4

CLASSIFICATION OF RESEARCH STUDIES:

OBSERVATIONAL STUDIES:OBSERVATIONAL STUDIES:• Groups are studied & contrasts made between groups

ANALYTIC STUDIES:ANALYTIC STUDIES:• Study the impact of a certain therapy

CLINICAL TRIAL:CLINICAL TRIAL:• Considered the “true” experimental study• “Gold Standard” of clinical research

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THE DIFFERENT STUDY DESIGNS

• Case-control • Cohort• Case Reports • Survey Research:

Questionnaires Polls Surveys

• Meta Analyses• Randomized Clinical Trial

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BASIC RESEARCH TERMINOLOGY• Case Control Study:Case Control Study: Persons w/ disease &

those w/out are compared• Cohort Study:Cohort Study: Persons w/ and/or w/out

disease are followed over time• Cross-sectional Study:Cross-sectional Study: Presence or

absence of exposure to possible risk factor measured at one point in time.

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• LoLongitudinal study :ngitudinal study : study that provides data about events or changes during a period of time.

• Prevalence:Prevalence: The # of new cases and existing cases during specified time period.

• Incidence:Incidence: The # of NEW cases per unit of a population at risk for disease occurring during stated time period.

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RESEARCH DESIGNFormulating a hypothesis

Review of the literature

Methods and materials

Statistical evaluation

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GETTING STARTED• FORMULATION AND SET FRAMEWORK OF

RESEARCH PROBLEM

• “A RESEARCHABLE PROBLEM IS A STATEMENT OR QUESTION THAT POSES AN UNKNOWN RELATIONSHIP BETWEEN VARIABLES AND SERVES TO FOCUS THE ENTIRE INVESTIGATION”

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HYPOTHESIS

• HYPOTHESIS is defined as “a tentative prediction or explanation of the relationship between two or more variables.”

• Hypothesis is the foundation on top of which you build your thesis

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REVIEW OF LITERATUREThe literature that is relevant to the problem must be concisely reviewedIt can be -Indices -Computer based literature searches - Bibliographies

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ELIGIBILITY CRITERIA

Eligibility criteria are guidelines that describe characteristics that must be minimally shared by all participants. The criteria differ from study to study. Criteria include:

• Age• Gender• Medical history• Current health status• Lab values

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INCLUSION/EXCLUSION CRITERIA

•Factors that allow someone to participate in a clinical trial are "INCLUSION CRITERIA“

• Factors that exclude or do not allow participation in a clinical trial are"EXCLUSION CRITERIA“

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SAMPLING

• What is your population of interest?– To whom do you want to generalize your results?

SAMPLING“Is the process or technique of selecting a sample of appropriate Characteristics and adequate size “

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n

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TYPES OF SAMPLES

• PROBABILITY (RANDOM) SAMPLES – Simple random sample– Systematic random sample– Stratified random sample– Cluster sample

• NON-PROBABILITY SAMPLES– Convenience sample– Purposive sample– Quota

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SAMPLE SIZE•Bigger the sample higher will be the precision of the estimates of the sample .

•An optimum size of the sample is to be considered.

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INFORMED CONSENT

Informed consent is the process of providing potential participants with important facts about a clinical trial before they decide to participate.

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BIASSELECTION BIAS- occurs when a group studied does not reflect the same distribution of characteristics like age, sex, occupation , race etc. as occuring in general population.

INFORMATION BIAS-occurs when there is an error in the classification of individuals with respect to the outcome variable. This may result from measurement errors, imprecise measurements and misdiagnosis of cases.

CONFOUNDING BIAS – confounding occurs when other factors that are associated with the outcome and exposure variables do not have the same distribution in the exposed and unexposed groups.

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BLINDINGA)Single blind trial : the trial is so planned that the participant is not aware whether he belongs to the study group or control group.

B)Double blind trail: The trial is so planned that neither the investigator nor the participant is aware of the group allocation and the treatment received.

c)Triple blind trial : The participant , the investigator and the person analyzing the data are all blind.

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EPIDEMIOLOGY VS RCT

• Epidemiology allows the study of the real world and the development of hypothesis regarding disease states

• Randomized, controlled trials allow the rigorous testing of hypothesis in a well characterized manner that is less real world in nature

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CASE CONTROL STUDY

• The same problem could also be studied in a case-control study. A case-control study begins with the selection of cases (people with a disease) and controls (people without the disease). The controls should represent people who would have been study cases if they had developed the disease (population at risk).

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COHORT STUDY

• Cohort studies begin with a group of people (a cohort) free of disease. The people in the

cohort are grouped by whether or not they are exposed to a potential cause of disease. The whole cohort is followed over time to see if the development of new cases of the disease (or other outcome) differs between the groups with and without exposure.

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RANDOMIZED CONTROLCLINICAL TRIAL

• Patients assigned at random to either treatment(s) or control

• Considered to be “Gold Standard”

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ETHICS OF CLINICAL TRIALS: PROTECTION OF PARTICIPANTS

3 ethical principles guide clinical research:• Respect for Persons:Respect for Persons: Treatment of person

as autonomous• Beneficence:Beneficence: Issue re: potential conflict

between good of society vs. individual• Justice:Justice: Treatment of all fairly & all equally

share benefits & risks

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DATA

• Data are the facts you measure• They should be carefully recorded in an

unbiased manner• They should be measured in a manner that

minimizes random variation• They should be derived from the operational

definitions you have developed

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COLLECTION OF DATAQualitative data: when the data is collected on the basis of attributes or qualities like age , sex etc., it is called qualitative data.

Quantitative data: When the data is collected through measurement example – LA drug dose ,

SOURCE OF DATA

Primary source – Data obtained by the researcher himself. This is first hand information.

Secondary source – The data already recorded is utilized to serve the purpose of the objective of the study. Eg . The records of the OPD of dental clinics

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METHODS OF DATA COLLECTION

INTERVIEWS QUESTIONNAIRES ORAL EXAMINATION

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ANALYSIS AND INTERPRETATION

•Analysis and interpretation is done using biostatistics

•BiostatisticsBiostatistics- is that branch of statistics concerned with mathematical facts and data related to biological events.

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RELIABILITY AND VALIDITY

• RELIABILITY– The extent to which a test is repeatable and yields

consistent scores– Affected by random error/bias

• VALIDITY– The extent to which a test measures what it is supposed to

measure– A subjective judgment made on the basis of experience

and empirical indicators– Affected by systematic error/bias

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WRITING IT UP• If you don’t write it, then it didn’t happen• Order of writing:

– Title– Abstract– Introduction– Aims and objectives– Methods– Results– Discussion– Conclusion– References

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SENDING IT IN• When writing the paper, have the

journal you will submit to in mind

• Pick journals that will match your paper’s topic and the quality and importance of your work.

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PRESENTING THE RESEARCH• Scientific writing

– Original / full research reports– Short communications– Case stories– Systematic reviews / meta-analysis– Books or book chapters– Academic thesis– Conference abstracts

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ORAL PRESENTATIONS

– lectures

– Seminars

– Courses

PUBLIC RELATIONS

– Media - press release

– Internet

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EVIDENCEEVIDENCE B BASED ASED DDENTISTRYENTISTRY

Evidence-based dentistry is the practice of Evidence-based dentistry is the practice of dentistry that integrates the best dentistry that integrates the best available evidence with clinical available evidence with clinical experience and patient preference in experience and patient preference in making clinical decisions.making clinical decisions.

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THE STAGES IN EVIDENCE-BASED PRACTICETHE STAGES IN EVIDENCE-BASED PRACTICE

Identify Clinical ProblemIdentify Clinical Problem

Produce a Focused Clinical QuestionProduce a Focused Clinical Question

Search for EvidenceSearch for Evidence

Evaluate the EvidenceEvaluate the Evidence

Incorporate Evidence into PracticeIncorporate Evidence into Practice

Evaluate the Impact on PracticeEvaluate the Impact on Practice

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META-ANALYSISMETA-ANALYSIS

• Meta-analysisMeta-analysis 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 risk factor and a disease, or accuracy of a diagnostic test.

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WeakerWeaker

StrongerStronger

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RESEARCH ADVANCES IN OMFSLABORATORY RESEARCH• Bone tissue engineering with human serum• Gene Expression Profiling of the “Field of Injury” in Head and Neck

Cancer

• CASE CONTROL STUDIES• Open vs. closed treatment of bilateral mandibular condyle and

anterior mandibular fractures:

• CLINICAL TRIALS Temporomandibular Joint - Clinical Trials Orthognathic Surgery – Relapse Implants

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TEMPOROMANDIBULAR JOINT – ANIMAL MODEL

- SEVERAL MODELS OF INTERNAL DERRANGEMENT , OSTEOARTHRITIS AND ANKYLOSIS HAVE BEEN DEVELOPED.

-THESE MODELS ARE USED TO UNDERSTAND PATHOPHYSIOLOGY OF CONDITIONS.

-TO EVALUATION VARIOUS MEANS OF SURGICAL RECONSTUCTION

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TEMPOROMANDIBULAR JOINT - CLINICAL TRIALS

A NUMBER OF PROSPECTIVE TRIALS OF VARIOUS TREATMENT METHODS ARE IN PROGRESS. THESE INCLUDE

-ARTHROSCOPY -TEMPORALIS MUSCLE RECONSTRUCTION-OPEN REDUCTION OF FRACTURE DISLOCATIONS -TMJ IMPLANTS.

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IMPLANTS

-TRANSMANDIBULAR IMPLANT FOLLOW-UPS

-PROSPECTIVE TRIALS OF HYDROXYAPATITE COATED TITANIUM IMPLANTS

-EVALUATION OF EXTRA ORAL IMPLANTS

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CLEFT LIP AND CLEFT PALATE

• MAXILLARY ADVANCEMENT WITH CONVENTIONAL ORTHOGNATHIC SURGERY

• STUDY OF OPERATIVE OR ANATOMIC FACTORS AFFECTING DENTAL ARCH DEVELOPMENT.

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ORAL CANCER

• UNDERSTANDING MOLECULAR BIOLOGY OF ORAL CANCINOGENESIS.

• CREATION OF A TUMOUR PROGRESSION MODEL

• ASSESSMENT OF QUALITY OF LIFE IN PATIENTS WHO HAVE UNDERGONE SURGERY FOR ORAL CANCER.

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JOURNALS OF OMFS

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“To do successful research, you don't need to know everything, you just need to know of one thing that isn't known.”