Keeping the evidence in the forefront
by Christine Nathe, RDH, MS
As dental hygienists, we are frequently asked about our opinion on dental products and treatment modalities, whether in the office or at a local basketball game. Consumers see dental hygienists as experts in preventive dental care. The recent branding campaign that was conducted for the American Dental Hygienists' Association (ADHA) indicated that most patients seek advice first and foremost from their dental hygienists regarding dental care products.1 In essence, dental hygienists, as a fundamental component of practice, are responsible for educating patients on products and therapies which are evidenced–based and scientifically sound.
Compounding the need for dental hygienists to understand how to effectively critique new products and treatments is the emergence of the dental care product market. A few decades ago, stores had only a small portion of shelves available for dental care products; now an entire aisle is generally dedicated to oral health. This increase in availability and promotion underscores the need for professionals who are able to provide consumers with valuable information. For these reasons, the dental hygienist must have a background in research as it concerns the recognition of effective dental care products, product ingredients, and treatment modalities.
Dental hygienists' advice should be based on known methods with predictable results rather than anecdotes. The concept of evidence–based dental hygiene suggests that the practice of dental hygiene is based on research done by practitioners and scientists as reported in peer–reviewed journals. Evidenced–based practice also takes into account past clinical experience and the preferences of the individual patient.
Dental hygienists frequently encounter patients who have selected an oral care product because of an advertisement or because the product worked for their friends. The benefit of understanding something about research methods is that it allows any dental hygienist, whether directly involved in conducting research or only occasionally reading about it, to critically decide whether the product or treatment has scientific merit and should be applied in daily practice.
Dental product regulation
One important component of product evaluation is the understanding of how products are regulated for safety and effectiveness in the United States. Currently, dental products are under the regulation of the Food and Drug Administration (FDA), which is housed within the Department of Health and Human Services. The FDA has the authority to encourage a company that violates enforceable FDA laws to voluntarily correct the problem or to recall a faulty product from the market. If a company cannot or will not correct a public health problem, the FDA can bring legal sanctions to bear and impose criminal penalties, including imprisonment if warranted. FDA approval of drug products is mandated by law, and without FDA approval, a manufacturer may not legally market a product.2,3
The ADA offers guidelines for testing and advertising products through its ADA Seal of Acceptance Program. Although the program is strictly voluntary and not regulated by the government, many companies participate in the program. The ADA's Council on Scientific Affairs and staff scientists review oral care products and declare them safe, effective, and worthy of the ADA Seal, which is generally awarded for a three–year period. A manufacturer that applies for the seal must meet specific guidelines and, upon its expiration, reapply to continue using the ADA Seal. In some instances, the ADA may conduct or request additional product testing.4,5 The ADA Seal is not mandatory for any dental care product and does not imply the superiority of a product to other products on the market.
Sales representatives, dental hygiene schools, and continuing education can be valuable when looking for information on dental products. Additionally, the Internet provides a great deal of information regarding dental health care. Most sites are not peer–reviewed, so information from the Internet should be used with caution. One reliable source is PubMed, http://www.ncbi.nlm.nih.gov/pubmed/, which includes more than 17 million citations and has authoritative information from NLM, the National Institutes of Health (NIH), and other government agencies and health–related organizations.6
Internet sites are usually reliable if they originate from well–established, reputable professional organizations, government agencies, accredited universities, and community foundations and agencies. However, a dental hygienist should research Web sites to determine accuracy and scientific merit.
Evaluation of product literature
Dental hygienists can rely on scientific literature such as published literature reviews, commentaries, and research reports to gather information about products and treatment modalities. It is important, though, that hygienists can assess the credibility of the scientific content.
There are many more periodicals than ever before, and many of these new venues focus on literature reviews, which contain findings of studies conducted on a particular topic. These reviews should contain an introduction explaining the significance, a main body describing advantages and disadvantages, and a summary. Although not actual research, these reviews can be valuable in helping the dental hygienist stay current with ever–changing technological and therapeutic advances.
There are also systematic reviews that can be helpful when researching a topic. These reviews answer clinical questions about the effectiveness of treatments. A great Web site for systematic review is www.cochrane.org.
Commentaries can be used to find out about new products or other treatment advances. The references contained within the commentaries can be searched for more knowledge and scientific merit.
It is also important for the dental hygienist to be able to review research reports, which can be accessed at www.adha.org (Journal of Dental Hygiene) or PubMed at http://www.ncbi.nlm.nih.gov/pubmed/. Knowing how to assess each part of a study helps the dental hygienist evaluate the quality of the study. Table 1 details areas of research reports that the dental hygienist should consider.
The abstract is the section of a study that condenses the purpose and significance of the study, previous findings, the methodology, and the results of the discussion into one page or less. Recommendations for future studies are reported here as well. The abstract gives an overview of the entire project, so that basically readers can decide if the article is of interest to them.
The introduction should provide a clear, concise purpose statement for the research study. Remember, it is important, because if a company wants to portray a specific claim for a product, the purpose of the study could be designed to an intended outcome. The literature review should provide a brief, detailed outline of the previous research, clinical care standards, landmark studies, and commentaries that impact the study. The methodology section of the research reports describes the methods and materials used for the study. Important considerations when evaluating the quality of the study are indicated in Table 2.
The results and discussion section includes the findings of the study and a discussion regarding the study as compared with previous studies. This section discusses implications for dental hygiene practice, education, and research; and recommendations or plans for further study. The conclusion will explain the final comments of the researcher and recommendations for the future.
Evaluation of advertisements
The dental hygienist should be able to critique lay magazine advertisements and infomercials in order to be a good consumer advocate. This role is becoming increasingly important with the growth of advertising in print, electronic, and nontraditional formats, such as brand recognition in movies. It is important to research references when scientific claims are promoted about products. Another important aspect is to find out what exactly is being promoted; some claims are not promoting oral health or product effectiveness and may just be an effective marketing strategy to sell a product.
The need for hygienists to be savvy, consumer–oriented health providers is an important role of the dental hygienist. This role underscores the need to review critically the scientific literature when making decisions about treatment or providing education to patients. Evidence–based practice begins by being able to critique information appropriately.
For more information about evaluating products and treatments, please see Nathe, CN. Dental Public Health and Research. 3rd edition. Upper Saddle River, NJ: Pearson, 2010.
- ADHA Branding Campaign Video shown at New Mexico Dental Hygienists' Scientific Session. Albuquerque, NM. Oct. 15, 2007.
- U.S. Department of Health and Human Services: What We Do. Retrieved from http://www.hhs.gov/about/whatwedo.html/ on Sept. 15, 2008.
- How a drug is approved. U.S. Food and Drug Administration. Retrieved from http://www.fda.gov/cder/info/consumer_approved.htm on Sept. 15, 2008.
- Ripper EJ. FDA regulation of OTC oral health care drug products. Journal of Public Health Dentistry 1992; 52:329–32.
- Whall C. The how and why of the ADA's evaluation program for dental therapeutic products. Journal of Public Health Dentistry 1992; 52:338–42.
- About Medline Plus. Retrieved from http://www.nlm.nih.gov/medlineplus/aboutmedlineplus.html on Sept. 15, 2008.
Table 1. Questions for Judging a Research Report
- Was the report published in a peer–reviewed journal?
- Is the purpose clearly stated?
- Is the research design described?
- Have variables that could change the findings been controlled?
- Is the sample appropriate?
- If there is a comparison, is it logical?
- Have the research question(s) been answered?
Table 2. Considerations of Study Review
Sample selection. Randomization ensures that subjects in the study are selected by chance.
Sample size. The sample needs to be large enough to be representative of the population.
Ethical considerations. The study must be free of plagiarism, copyright or patent infringement, falsifying or fabricating data, misrepresenting data, and conflict of interest. Participation must be voluntary.
Research design. A double–blind study is accomplished when neither the researcher nor the subjects participating in the study knows who receives placebos. This, however, is not always possible.
Product usage. Uses of the product need to be defined, including patient education protocols and the number and specific times the product was used. The study should be at least six months in duration. The longer the study period, the more valid the results.
Quality of examiners. The examiners should be calibrated, and the same examiners should be used throughout the study.
Statistical significance. The result is unlikely to have occurred by chance. In the scientific community, a p £ 0.05 is considered the cutoff point for statistical significance, meaning that an obtained result could happen by chance only five times or less in 100.
About the Author
Christine Nathe, RDH, MS, is a professor and graduate program director at the University of New Mexico, Division of Dental Hygiene, in Albuquerque, N.M. She is also the author of “Dental Public Health” (www.prenhall.com/nathe), which is in its third edition with Prentice Hall. She can be reached at [email protected] or (505) 272–8147.