February 2008, Volume 4, Issue 2
Published by AEGIS Communications
Does Office-Based = Evidence-Based?
Allison M. DiMatteo, BA, MPS
Dentists frequently comment that they need real information and evaluations that can be applied to their day-to-day use of products and techniques in the practice environment. There is also more commentary that bona fide evidence is needed to validate treatment decisions for everything from tooth extractions to caries prevention methods.
According to Gordon J. Christensen, DDS, MSD, PhD, co-founder of Clinical Research Associates, founder/director of Practical Clinical Courses, and Dean of the Scottsdale Center for Dentistry, what’s needed is a combination of external evidence (ie, research—both traditional and clinical) and a clinician’s own expertise (ie, ability to decide if the evidence is relevant) in order for a treatment or product decision to be made on a patient’s behalf. The broad spectrum approach to research—such as practice-based clinical studies—demonstrates how things relate and work in true practice, whereas the narrow spectrum approach—such as in traditional dental school studies—can provide insight into how one product relates to another in ideal circumstances, he says.
In response to demands for research of any type, however, members of the dental community at large have undertaken “research” initiatives at every opportunity. And now at every turn, dental practitioners are bombarded with information in one form or another about some potentially beneficial aspect of some new or even well-established product or technique they’re using or should incorporate and some type of effect it could have or has now been shown to have on some clinical outcomes in some patients. Yes, sorting through it all can be daunting.
“It humbles me to speak in generalities because I’m sensitive to the reality that there are many different takes on the words ‘evidence-based practice’,” explains Harold Slavkin, DDS, dean of the University of Southern California School of Dentistry. He elaborates that across the United States, there are different kinds of dental care in different parts of the country, and overall, the profession tends to tolerate an incredible variance in the standard of care. “Therefore, the value of being able to predict outcomes, the whole field of outcomes research, is still in its infancy.”
Even so, technology, networking, innovative research partnerships, and aggressive endeavors by manufacturers to bring products quickly to market have all contributed to an avalanche of published and/or otherwise available research reports, evaluations, reviews, or opinions/critiques of dental products, equipment, and techniques. They purport objectivity, practicality, and relevancy to modern practice and clinical treatment.
“We have more products available to us today than ever before, and I can’t say that the evidence that supports all of these product claims is in order, especially in light of what we’re seeing from the general population at large in terms of their concerns with safety and effectiveness,” observes David Hamlin, DMD, the owner/founder of Contract Dental Evaluations.
Perhaps the issue today is that certain products are introduced that aren’t properly tested, and clinicians make their buying decisions on either ease of use, at-tractiveness of a marketing campaign, or claims that are stretched beyond what the appropriate benefits are of a particular product, suggests George W. Tysowsky, DDS, MPH, vice president of technology for Ivoclar Vivadent, Inc. As a result, there is a need to elevate clinicians’ knowledge of the proper testing and evaluation protocols for products, as well as their awareness of evidence-based dentistry, he says. If they make inappropriate decisions and buy products that aren’t properly tested, they’re doing a disservice to the patient and also to the entire process of creating the right evidence-based considerations, Tysowsky adds.
John A. Sorensen, DMD, PhD, director of the Pacific Dental Institute, notes that clinicians seem less discerning today than they were in the past, so they are more accepting of what a company says about its products. Unfortunately, there has been a shortage of mid-term (ie, 2- or 3-year) clinical trials evaluating different products (eg, composites, implants), so clinicians need to be more proactive in asking for scientific research that is well-done and demonstrates that the products actually work.
However, along the journey through journals and tabloids and the purist of scientific publications, some have begun to question the true usefulness, appropriateness, and applicability of emerging “research data.” Is it research from a trust-worthy source, or is it a promotional product presentation disguised as an objective review? How realistic is the data that’s been cultivated from these initiatives?
“One could certainly point to some of the more esoteric studies that are being conducted in research universities as perhaps marginally relevant, particularly to the clinically practicing dentist,” explains Richard J. Simonsen, DDS, MS, dean of Midwestern University College of Dental Medicine. “But one can’t get away from the fact that any study, be it academically based or clinically based, must follow a strict protocol that encompasses the scientific method. Without that, no study is relevant.”
This month, Inside Dentistry explores the different types of research initiatives now being undertaken in dentistry that clinicians are destined to encounter by virtue of the sheer volume of information sources that cross their desks. As our experts explain, there are benefits and limitations among office-based and university-based research studies, and collectively they contribute to the evidence-based approach to dental treatment decision making and product selection. Each type of research is well-suited to examine specific aspects of dentistry and complement the others by supplementing the base of professional scientific knowledge. However, as we have suggested in past issues of this publication, an understanding of the basis for that respective research, any potential influences and biases, and the manner in which it was conducted, is essential for clinicians to judge for themselves its validity and relevancy in their own practice.
The Differences Between Office-Based and University-Based Research
According to John M. Powers, PhD, senior vice president of Dental Consultants, Inc, and editor of The Dental Advisor, both office-based and university-based research provide valuable information for the dental team (ie, dentists, dental assistants, dental hygienists, and dental manufacturers). University-based studies typically evaluate long-term outcomes (eg, wear, safety/efficacy, recurrent caries), control confounding variables, and provide objective measurements. Such research is conducted with a limited number of operators and evaluators that are independent of the operating clinicians, he explains. Clinical studies that require blinding and randomization, or that evaluate safety and efficacy, are typically carried out in a university setting or managed by trained clinical investigators, Powers says.
Michael B. Miller, DDS, president of Reality Publishing Company, explains that research conducted under the auspices of universities is, by and large, considered to be more reliable. The controls are better, he says, and the liability issues in terms of patient understanding/consent are fairly minimal and better understood. However, most of the clinical research studies that are conducted in universities usually involve a limited number of patients as a result of the time constraints and number of researchers available to actually perform or use whatever treatment or product is being investigated, he adds.
“If you talk to most statisticians, they’re accustomed to dealing with hundreds of patients, similar to what they do in drug studies, for instance,” Miller elaborates. “The studies conducted in universities are certainly better than nothing, but the amount of information coming out of them and the statistical relevance of it probably could be a little questionable.”
Office-based studies, on the other hand, most often offer a snapshot of real-world conditions (eg, immediate outcomes such as handling characteristics, immediate pa-tient sensitivity, and product color matches) based on the clinical observations of a number of clinicians who evaluate their own work, Powers elaborates.
“However, long-term outcomes and carefully controlled variables can be evaluated in office-based studies,” Powers says. When properly executed and organized, the dental teams in private practices provide a rich source of patients and manpower for clinical studies that are appropriate for the setting, he notes, adding that it is a positive step to seek data from private practices. “The evaluation of dental products and equipment is often well suited to office-based studies.”
The important point for future trends in office-based research seems to lie in standardization of the research method. “Most clinicians in private practice havenot been trained to conduct research,” Miller explains. “Therefore, it’s hard to consider most of this type of investigation as real research in the more traditional sense because there is typically a lack of standardization.”
Making the Practical Scientific, Now and in the Future
“There is a tremendous amount of valuable information sitting in the files of dental offices around the country, and I think if more clinicians realized that they could make a significant contribution to the value of evidence-based decision making in dentistry, I would hope that they would start to educate themselves as to how they can collect data in a reliable, scientific manner,” notes Simonsen. “A large component of clinical decision making that is based on evidence-based research lies in the valuable clinical experience of the practitioner, so I would be supportive of promoting more office-based research providing it’s conducted according to the scientific method.”1
But Slavkin cautions that it isn’t the physical location where the research takes place that’s important. Rather, it’s the people who are doing the research.
“The history of clinical dentistry to date is filled with examples of practitioners making discoveries, testing them, and coming up with very exciting new ideas. In my mind, it’s not the place that dictates the quality of research,” Slavkin recalls. “So, a group of clinicians in a study club somewhere in the United States could gain the knowledge to do translational and clinical research, could develop protocols that would make sense for the particular area they’re interested in, and could do a good job.”
Such an area of study should be one that’s not contaminated by private companies predetermining the outcomes and using marketing money to elicit sound bites from the research to push products, Slavkin continues. By putting all of that influence aside, in principle the research could, therefore, be conducted in a university or a clinical setting and be of comparable quality.
Tysowsky says that there is awareness in the profession of the need to bring more science-based and more evidence-based decision making into the appropriate selection and use of dental products and techniques. The trend, therefore, is to elevate the traditional “science” component to provide more rationale for why certain procedures should be completed or certain materials used. Simultaneously, he says, office-based research is evolving to become more standardized and calibrated, being conducted under stricter conditions.
According to Lawrence A. Tabak, DDS, PhD, director of the National Institute of Dental and Craniofacial Research (NIDCR), practice-based research networks such as the NIDCR’s that link academic researchers with practicing clinicians could help the entire dental community better understand what’s meant by evidence-based dentistry. What’s more, they could potentially provide the right venue to translate evidence into practice more rapidly.
The typical or traditional study designed to determine efficacy of a treatment, procedure, or material needs to take place in very controlled environments with carefully selected participants, Tabak explains. In these instances it’s important to normalize as many factors as possible in a study group so that the only difference is that one group receives the test or the treatment and the other group doesn’t.
“In the practice-based studies, you can’t control everything, so these are much better in determining whether a particular approach, treatment, or diagnostic is effective in real-world situations,” Tabak says. “You can develop the greatest idea in highly controlled circumstances, but if it doesn’t translate well to the real world, then perhaps you need to find a different way of doing it.”
Tabak emphasizes that one form of research isn’t better than the other. Rather, each is examining different things, and both types of approaches are required to fully formulate “evidence-based” evaluations.
“I think there may be dentists who are under the misconception that evidence-based dentistry is very formal or doesn’t apply to them,” Sorensen observes. “I think we need to emphasize that evidence-based dentistry is simply having a scientifically based reason for doing what they’re doing.”
What Constitutes Good Research?
Research that is well done is going to be good research whether it’s conducted at a dental school, a university, or an office, as long as a scientific methodology is followed, our interviewees suggest. When considering research that comes from a practice-based perspective, Sorensen encourages clinicians to look for controls and try to determine if the research was conducted with some standardization (ie, objectivity), rather than just rendering opinions.
“If office-based research is published in peer-reviewed journals, it would undergo the same scrutiny that would be exercised for any university-based type of research. It’s that peer-review process that then also helps to make sure that the standards and scientific basis of the research are being maintained,” Sorensen says. “Clinicians also need to be able to see if a study has sufficient numbers to actually validate the findings. If you’ve done three cases, I don’t think that really could be called research, or that you’re doing justice to what you’re studying.”
According to Hamlin, publications have done a very effective job of reaching each and every clinician and presenting information to them. Therefore, determining the validity and relevancy of research begins with re-education or re-familiarization of dentists with fundamentals of good research practice, he says. Natural sequelae would then be asking questions about sample size, whether or not the study design reflects the real world, and if the statistical relevance is also clinically relevant.
Implications for the Future of Dental School Curricula
Each component of research—controlled university studies or practice-based clinical trials/evaluations—comes with its own hierarchical value to the profession. While some in academia may only value randomized, controlled clinical trials carried out in a university setting, Simonsen says it’s clear—at least to him—that if carried out to a certain set of standards, office-based research has a lot to offer in terms of providing the multiple sources of information that are required to make an evidence-based, clinical treatment decision. In fact, at the Midwestern University College of Dental Medicine, students will be educated about the value that office-based research can play in the overall composition of evidence-based decision making.
“While a small number of students in each class will go on to carry out university-based, randomized, controlled clinical trials, perhaps 98% or so of each class will more than likely have the opportunity to carry out some form of office-based research,” Simonsen says. “As educators, it’s up to us to make sure that our students realize this and that they have the tools to do it in the most scientifically-based manner possible.”
Of course, different schools have different agendas, and the competencies that each defines as necessary for students to attain in order to graduate are not standardized across the country, Slavkin says. Some dental schools are very strong in outcomes research and predictions, evidence-based dentistry, and modern science and technology. Others are less so, he says, and there is variance in dental education. But, he agrees there is a place for more practical research to be brought into the learning environment, and he points to practitioner-based networks in clinical dentistry coordinated at such environments as New York University College of Dentistry (see The NIDCR’s Practice-Based Research Networks, page 112) as one example.
Sorensen believes that most dental schools are trying to make their education more evidence-based by incorporating such approaches as problem-based learning into the curricula, whereby students receive a description of a patient, along with clinical findings and symptoms, in order for them to develop a diagnosis and treatment plan. Additionally, he finds that more integration is taking place at dental schools, with an example being dental materials courses being integrated into prosthodontics courses or those discussing porce-lain-fused-to-metal restorations.
“It’s actually more applicable to what the students are doing, as opposed to getting “Dental Materials 101” in the first quarter and then not really using that for a couple of years,” Sorensen elaborates. “Schools have tried to integrate those types of materials and treatment decision-making processes into the actual class curriculum.”
The Role of Research-for-Hire and Industry Product Testing
Other “for-profit” and independent research groups are sprouting up in increasing numbers, perhaps in response to the growing trend to get products to market as quickly as possible. Tysowsky emphasizes that major manufacturers adhere to rigorous protocols, ensuring that products are thoroughly tested and evaluated before market release so that they meet the appropriate industry need and perform properly in clinical function.
“I think there is a value in learning from each other,” Tysowsky believes. “There is an industrial development side, and the balance in the profession comes with working with universities and some independent evaluation groups to learn from each other and focus on what the key criteria are for the success of those products.”
Tysowsky elaborates that there is a role for manufacturers to perform appropriate testing. Universities have a role in conducting validation studies and providing input that guides the final outcome of the product to ensure that it is clinically relevant. Independent groups, he says, offer the benefit of providing feedback related to the commercial performance of those products.
Tabak comments that there is a trend now toward private/public partnerships to develop new tests and new therapies. These public/private partnerships take various forms, he says, but through them both government agencies and private companies will co-sponsor initiatives and be involved in all aspects of development.
“An example of this is the Biomarker Consortium, which was created under the auspices of the Foundation for the National Institutes of Health,” Tabak explains. “Both industry and government would like to see more biomarkers discovered because they enhance one’s ability to detect disease at an early stage. So, industry has come to the table to help support this; the Food and Drug Administration has come to the table to support this. It’s just one example of these emerging public/private partnerships that’s been created.”
The Potential Influence of Manufacturer or Advertiser Involvement
There are many sources of research evaluations, whether office-, publication-, or university-based studies or reviews. When determining the validity of an information source, Powers emphasizes that the important factors to consider are the training and reputation of the investigators managing the studies, as well as the reputation of the publication. Another factor is the quality of the data, he says, and whether it is anecdotal or subjectively or objectively measured.
Simonsen says that any time clinicians read anything that is funded by any source, they should take that into account when assessing the value of that particular research. He adds that any source of funding that is commercially-based raises questions of validity.
“That is not to say that an ethical company can’t have a hands-off approach in the legitimately supported study,” he says. “The researcher has to make the ground rules clear from the start and, preferably, in a contract such that the data are protected against any changes or suppression by the company. A right to publish must be inherent in any study in order for it to be valid.”
Christensen notes, however, that if researchers have a financial interest in and/or receive compensation from a manufacturer whose product is being studied, then the validity of the results may come into question. If money isn’t there, then the validity is, he suggests. Also, Christensen says that if there is a basic science core to the research, not simply opinion-based questions (eg, How do you like this project?), then the evaluation likely has more validity.
But what about evaluations that appear in publications that accept advertising for the same products being studied? Simonsen says the information could be valid, “but that when it appears in a promotional article with an advertisement within or following the paper, it casts a huge ethical cloud over the study. I would, on principle, seriously question the validity of such a paper, even though it may in fact have some validity.”
Tysowsky comments that publication-based evaluations with advertising about that product represent a point of conflict, but that generally speaking, the totality of information from all evaluation programs should be considered cumulatively. “I don’t look at one article as being the absolute in endorsing a procedure or technique,” he explains. “Rather, I look at the overall picture of the whole body of evidence that supports or disclaims a specific product or technique.”
Questions regarding bias and conflict of interest are valid for any publication and any research initiative. Our interviewees suggest that important questions to ask are, “Have the investigators, editors, or authors who have significant financial interest in the products being evaluated disclosed the nature of those interests?” and “Is there a separation in the publishing process between editorial and scientific content and advertising content?”
Hamlin explains that for him, the question of advertising and conflict can become less of a concern if the “true” peer-review process is followed in spirit and intent, pointing out glaring attempts to over-reach the findings of the research or other abuses. Similarly, he says that sponsorship of research should not necessarily condemn it, but it should increase the requirement for greater review of the disclosure.
But sometimes manufacturer involvement is essential in order to ensure fair and educated use of a product during the evaluation process. It’s the nature of the involvement that could make a difference. According to David C. Sarrett, DMD, MS, the editor of the American Dental Association Professional Products Review, the ADA and he are very concerned about their relationship with manufacturers and eliminating or minimizing as much as possible the concern over bias when products are evaluated (see Organized Dentistry Takes to Members’ Offices, page 110).
First, the ADA PPR does not have any advertising, so that conflict doesn’t exist, Sarrett says. Secondly, recommendations regarding which product categories to evaluate come from members, outside of any input from manufacturers. For relatively low-cost products, the ADA PPR purchases them on the open market from a dental distributor. For major equipment such as digital radiography units or intraoral cameras, the ADA PPR asks for a product “loan,” as well as complete installation and instructions for the use of the product to ensure that no operator error could negatively impact the evaluation process, he says.
“We work in a cooperative effort with the manufacturer to ensure that we’re properly using the product, and once the data are collected, we send the company only their product data so that they can see the results and comment on them,” Sarrett explains. “We don’t change anything based on their comments, but we do take them into consideration before we complete our final write-up.”
“It is so difficult these days for clinicians to pick up reading material and assess what they’re reading in terms of validity, accuracy, and bias,” Simonsen observes. “It’s a common occurrence for authors to have contractual relationships with companies that are not disclosed, and information is put out there that is blatantly untrue about products, so readers have to be extremely careful.”
Developing a level of trust with certain publications and/or sources of research information is something that should occur over time. However, Simonsen says that once that level of trust has developed, it is then incumbent upon publishers to honor and respect that trust by being absolutely firm in their commitment to providing accurate, unbiased, and evidence-based information.
“Practitioners need to have the best and most relevant evidence to use in making their clinical decisions,” Tabak asserts. “However, at the end of the day, evidence-based dentistry is a guiding force, but it’s absolutely most effective when it’s coupled with the clinician’s own experience to solve the problem. At no point can you take the clinician’s unique perspective, experience, or expertise out of the equation.”
With that in mind, Hamlin believes that ultimately, all clinicians need to make their own judgments about how they’ll perceive and apply the research that’s presented to them. Because not enough research is conducted, he says any information presented by peer review—with or without advertising—is better than none, as long as full disclosure is provided.
“Keep an open mind, and don’t accept any research finding as gospel,” Hamlin recommends. “There is always another page to be turned and a better question to be asked.”
Questions to Ask When Presented with Research
Our interviewees suggest that it is an assessment of the totality of research-based information that will help clinicians best determine what products and/or techniques to incorporate into their practices for the ultimate benefit of their patients. In order to best weigh the value of the information with which they’re presented, the following questions could be asked.
• How was the research conducted and who conducted it?
• Were the research methods sound (ie, was the scientificmethod followed)?
• Were confounding variables controlled?
• Were there objective measurements established?
• Are the research methods repeatable, and can you access information about how the research was conducted?
• What was/is the training, experience, and independence of the evaluators and/or researchers?
• Is the evaluation criteria clearly outlined, or is it a haphazard opinion-based questionnaire?
• If a product evaluation, were the manufacturer’s instructions followed explicitly to avoid incorrect usage?
• How many cases, samples, or instances of product use were tested and/or studied? In other words, is the research statistically as well as clinically relevant?
• Is the research methodology used objective or subjective? Meaning, are the findings just based on someone’s opinion?
• Were other products or techniques in a given category also evaluated?
• Did the study design involve randomized clinical trials or in vitro testing?
• Was a control group used?
• Was there anything influencing the content of the research report or evaluation?
• Is this truly research, or is it a promotional product presentation disguised as an objective evaluation or review?
• Is the source of the information among those you trust and know to be credible?
• Is the publication in which the research is published peer-reviewed?
Organized Dentistry Takes to Members’ Offices
The American Dental Association turned its attention to products in 2006 when it introduced its ADA Professional Product Review (PPR). Established the year before by the ADA’s Council on Scientific Affairs, the PPR was intended to provide ADA members with comprehensive dental product information that would be scientifically sound, clinically relevant, and unbiased—and based on member evaluations of product use.
“One of the fundamental principles in the development of this publication is that the ADA really believes that dentists need scientific and clinical information in a relevant manner that makes sense to them for their practice,” explains David C. Sarrett, DMD, MS, the editor of the ADA PPR.
Such a product report was highly anticipated as an important form of research—a type of “consumer” evaluation of products that clinicians may want to use in their practices. To date the response to the PPR —which is provided as a free member benefit without the need for a separate subscription fee—has been overwhelmingly positive, Sarrett says.
“The area that we’re working on most intensively is improving the clinical relevance or clinical user information,” Sarrett notes. “Because we are bound to collect data on the use of products on human subjects in ways that conform to all national and international standards for human subjects research, we consequently at times have some difficulties or limits in how we can go about collecting clinical information, but it’s absolutely the right thing to do.”
Despite its limitations, Sarrett notes that the value of member-driven evaluations is that the information obtained is reflective of what occurs in real clinical practice. He admits that in this country, we are just at the very beginnings of moving science and evaluation of procedures and treatments from what are traditional and well-controlled, university-based trials to real-life situations.
“You still need to have the ability to ensure that you have credible data, so you cannot collect data in real life and do it in a haphazard, random way and expect those results to tell you anything meaningful,” Sarrett explains. “In clinical situations such as how the PPR evaluations are conducted, you deal with the lack of control (as opposed to a university setting that provides a controlled environment) by having access to many, many dentists, so the larger numbers of evaluations minimize your statistical variance, and the information you get is far more realistic.”
In addition to receiving the quarterly publication, Sarrett explains that members also have full access online via the ADA Web site to all of the background data involved in and/or obtained from the evaluations that is not included in the printed reports. These include the protocols that were written for the evaluations prior to their initiation, as well as both clinical and laboratory task methodologies.
The quarterly reports and reviews of products in three dental categories provide relevant research information that could be put to use right away, Sarrett explains. To date, the product categories examined have included carbide burs, posterior composites, digital radiography systems, steam sterilizers/water line cleaners, and LED curing lights, among others.
“In all of these product categories, the selection of the categories and products themselves is driven to a large extent by members of the ADA who participate in the ADA Clinical Evaluator Panel (ACE),” Sarrett says. “Also, we have the Product Forum during the ADA annual session, during which we have a product evaluation area set up where we garner dentists’ input about how a product works.”
During the 2007 meeting in San Francisco, dentists provided comments on eight intraoral cameras in terms of usability, ability to create good images, focus, etc. Sarrett expects the cumulative results of evaluations in this product category to be complete later this year.
The NIDCR’s Practice-Based Resaearch Networks
In 2005, the National Institute of Dental and Craniofacial Research (NIDCR) embarked on an ambitious experiment by launching a series of Practice-Based Research Networks. Three 7-year grants totaling $75 million were awarded in March 2005 to establish these networks, each of which investigates with greater scientific rigor everyday issues in the delivery of oral healthcare.
The Practice-Based Research Networks that were established are Practitioners Engaged in Applied Research and Learning (PEARL) Network, which is administered by the New York University College of Dentistry; the Dental Practice-Based Research Network (PBRN), administered by the University of Alabama at Birmingham; and the Northwest PRECEDENT, administered by the University of Washington.
According to NIDCR director Lawrence A. Tabak, DDS, PhD, the impetus behind the networks is the frequent lack of research data to guide treatment decisions in the dentist’s office. Planned and ongoing studies will answer such questions as:
How do dentists diagnose and treat dental caries?
What are dentists’ choices for restorative materials for small vs extensive and/or deep carious lesions?
What are some of the reasons to repair or replace existing dental restorations?
What are long-term outcomes for cracked teeth?
What is the usefulness of salivary diagnostic tests in identifying patients at an increased risk for dental decay?
How can a computer-assisted program reduce anxiety for patients who are afraid of intraoral injections?
Several hundred practices throughout the United States are linked together via these networks. Each regional network will conduct approximately 15 to 20 short-term clinical studies over 7 years, comparing the benefits of different dental procedures, dental materials, and prevention strategies under a range of patient and clinical conditions.
As the network matures, more complicated, randomized, and controlled clinical trials will be planned. Tabak says the first trial of this nature will compare the long-term outcomes of two different approaches to direct pulp capping: the standard calcium hydroxide and a newer material—mineral trioxide aggregate (MTA). This trial will use as its outcomes patient comfort and the long-term vitality of the pulp.
Additionally, an ongoing, collaborative project across all three networks is seeking to identify the risk factors for osteonecrosis of the jaw (ONJ) associated with bisphosphonate use, Tabak adds. In recent years, there have been reports of ONJ in patients treated with bisphosphonates for cancer or osteoporosis. Most of the cases occurred in cancer patients treated with high doses of intravenous bisphosphonates, but some were reported in patients treated with low doses of oral bisphosphonates for osteoporosis.
“This case-controlled study is designed to identify the specific factors that may contribute to the development of this complication,” Tabak elaborates. “I think this is extremely important in view of the increasing use of oral bisphosphonates. We are seeing more and more case reports and anecdotes about patients like this, and clinicians are still not quite sure how best to deal with this situation. We anticipate findings in the very near future.”
The NIDCR Practice-Based Research Network studies are still ongoing. Appreciation is warranted for the fact that the first year of the grant was used by the investigators to establish the needed infrastructure and recruit practitioners, Tabak notes. He adds that one of the reasons why the grant awards were made for 7 years is because the NIDCR recognized that it takes time to create and build that infrastructure.
Tabak expects that several of the ongoing studies will be completed in the next year or two. As momentum builds, those in the dental community will likely see more of these types of studies provide the evidence that practitioners can draw upon when making decisions for their patients.
And therein lies the most valuable aspect of coordinated projects such as these. “I think these networks are really important because they link academic researchers with practicing clinicians with the goal of solving the problem of a lack of research data to guide certain treatment decisions,” Tabak believes. “I think it helps researchers understand the real problems that are facing the people in the trenches—the average practitioner—and it helps the dentist better understand the complexities of conducting quality research.”
The Inside Look FROM
The staff and publishers of Inside Dentistry gratefully acknowledge the time, insight, and candid comments shared by our interviewees, without which this Inside look at office-based and traditional research would not have been possible. The following individuals, all well-respected in the general oral healthcare, academic, and research arenas, made invaluable contributions to this presentation.
Gordon J. Christensen, DDS, MSD, PhD
Co-Founder, Clinical Research Associates (CRA) Foundation/CRA Newsletter
Founder & Director, Practical Clinical Courses
Dean, Scottsdale Center for Dentistry
David Hamlin, DMD
Contract Dental Evaluations
Michael B. Miller, DDS
Reality Publishing Company
John M. Powers, PhD
Senior Vice President and Editor
Dental Consultants, Inc. (The Dental Advisor)
David C. Sarrett, DMD, MS
Associate Vice President for Health Sciences – Academic Affairs
Virginia Commonwealth University
Richard J. Simonsen, DDS, MS
Midwestern University College of Dental Medicine
Harold Slavkin, DDS
University of Southern California School of Dentistry
John A. Sorensen, DMD, PhD
Pacific Dental Institute
Lawrence A. Tabak, DDS, PhD
National Institute of Dental and Craniofacial Research (NIDCR)
George W. Tysowsky, DDS, MPH
Vice President, Technology
Ivoclar Vivadent, Inc.