community ch 20

FDA

• federal agency that regulates dental products for safety and effectiveness

• organizationally housed with the department of health and human services

• responsibility to ensure that food, cosmetics, medicines, and radiation-emitting products are safe

• without approval, a manufacturer may not legally market a product

ADA seal of acceptance

• a voluntary ADA program recognizing products that meet established scientific standards

peer-reviewed article

• a research article evaluated by experts before publication

• have been reviewed for content and accuracy by other dental health researchers

pubmed

• a searchable database of peer-reviewed biomedical literature

abstract

• a brief summary of the entire research study

• is a study section that basically outlines it content by concisely stating its purpose, intent, previous findings, methodology, results, and suggestions for future studies in no more than 250 words

literature review

• a summary of previous research related to the study

randomization

• selecting study participants by chance to reduce bias

sample size

• the number of participants included in a study

calibration

• training examiners to evaluate patients consistently

statistical significance

• Indicates study results are unlikely due to chance (commonly p ≤ 0.05).

the difference between FDA regulations and ADA seal

• FDA regulation is required by law while ADA seal of acceptance is voluntary

• ADA seal is no mandatory for any dental care product and does not imply the superiority of that product to other products on the market

Why should dental hygienists rely on peer-reviewed research instead of advertisements?

• advertisements and sales representatives are knowledgeable about the products they carry and frequently about competitors products, but have inherent bias

What makes PubMed a reliable source of scientific information?

• it is a website from the US national library of medicine that includes more than 17 million citations from medline (the national librarys medical literature analysis and retrieval system online) and life science journals for biomedical articles back to the 1950s

• brings together authoritative information from NLM, the national institutes of health and other government agencies

What information is found in an abstract?

• is a study section that basically outlines it content by concisely stating its purpose, intent, previous findings, methodology, results, and suggestions for future studies in no more than 250 words

Why are sample size and randomization important in research?

• needs to be large enough to be representative of the population

• randomization ensures that subjects in the study are selected by chance

• for clinical trials, data on at least 30 subjects is important

What does a p-value of ≤ 0.05 indicate?

• considered the cutoff point for statistical significance, meaning that an obtained result could happen by chance only five times or less in 100 instances

d. Both the statements are false.

The ADA Seal of Approval program is regulated by the FDA. It is mandatory for all over-the counter dental care products.

a. The first statement is true; the second statement is false.

b. The first statement is false; the second statement is true.

c. Both the statements are true.

d. Both the statements are false.

c. Both the statements are true.

PubMed is a service of the US National Library of Medicine (NLM). It includes more than 17 million citations from MEDLINE and other life science journals for biomedical articles back to the 1950s.

a. The first statement is true; the second statement is false.

b. The first statement is false; the second statement is true.

c. Both the statements are true.

d. Both the statements are false.

d. All of the above

Which of the following is/are part of a research report’s methods and materials section?

a. Research design

b. Ethical considerations

c. Sample size

d. All of the above

d. Peer reviewed

Which of the following terms defines the review of manuscripts by experts for content and accuracy before they can be included in refereed journals?

a. Critique

b. Double blind

c. Primary evaluation

d. Peer reviewed

b. Chance

Statistical significance means that the result was not caused by

a. Control

b. Chance

c. Placebo effect

d. Sugar pill

dental hygienist’s role in evaluation

• treatment driven

• quality care

• education of patients

dental hygiene recommendations

•Product and treatment modalities should be based upon documented evidence.

•Documented evidence includes scientific literature and reported product findings.

•A seal is not always a reliable gauge of safety or effectiveness.

An RDH must know how to effectively critique published research in order to make accurate recommendations

evaluation of advertisements

•Be aware of what advertisements imply or promote to patients.

•Branding can be found in magazines, movies, infomercials, and billboards.

•Making information about dental products available to the patients allows them to assess the validity of manufacturers’ claims.

•The R D H should be familiar with common ingredients used in dental care products.

level 1 evidence (gold standard)

• systemic reviews, meta-analysis, and randomized controlled trials

level 2 evidence

• case-control studies

level 3 evidence

• case series

level 4 evidence

• traditional narrative reviews (no critical appraisal)

level 5 evidence

• studies that do not involve human subjects

introduction

• Briefly orient the reader to the given subject with an overview of the research problem studied with enough detail to ensure clarity.

• Provides a clear, concise purpose statement for the research study

• is a very important component of the study

literature review

• Cite a variety of relevant, current studies. Compare findings, clearly indicating all sources of concepts and data. When a source is quoted, use quotation marks. Note the current status of the topic, and if further study is needed, provide a sound case for it. Define the variables, the hypotheses or research objectives, and how this study relates to previous research.

methods and materials

• Describe the research instruments, equipment, procedures, and method of data analysis. Specify the measurements and statistical tests used as well as their significance. Furthermore, assure the reader that all pertinent federal and state regulations concerning the protection of the rights and welfare of all human and animal subjects have been adhered to.

• must contain:

–A sample selection

–A sample size

–Ethical considerations

–A research design

–The product usage

–The quality of the examiners

–The statistical significance

results

Summarize all relevant data including statistics and data characteristics.

discussion

•Evaluate and interpret the findings. Compare them with those of other related studies. Discuss study limitations and the study's implications to dental hygiene practice, education, and research and recommendations/ plans for further study.

conclusion

State the conclusions, theories, or implications that may be drawn from the study. Discuss how they relate to the dental hygiene practice, profession, education, and research. Include overall health promotion and disease prevention, clinical and primary care for individuals and groups, and basic and applied science.