Missing from the everyday dental practice equation has been a compilation of ‘real-world’ practice data that would help ground treatment decisions on a preponderance of unbiased, scientifically sound clinical evidence.
It is an everyday experience in dental practices across America: a middle-income patient with limited dental insurance presents complaining of discomfort in a premolar. An oral examination reveals that the tooth contains an old, two-surface amalgam restoration that has fractured. Replacing the restoration would provide a quick, viable and economical solution for the patient. After removing the old restoration, however, you note a hairline fracture near the mesial marginal ridge, and you may need to extend the cavity preparation. A composite might be a better choice for esthetic reasons. Then again, because the tooth may be at risk of developing further fractures, a more costly crown might be more appropriate and economical in the long run.
Which is the correct treatment choice? What are the relative benefits and risks of the three treatment alternatives? For decades, dentists have worked their way through these everyday scenarios based on their clinical experience, relevant clinical information and weighing their patient’s needs and preferences. Missing from the equation has been a compilation of "real-world" practice data that would help ground treatment decisions on a preponderance of unbiased, scientifically sound clinical evidence.
The National Institute of Dental and Craniofacial Research, or NIDCR, recently launched a new clinical research initiative to study everyday problems that confront dental practitioners. The initiative, called the Oral Health Practice-Based Research Networks, or PBRNs, will generate a tremendous amount of data comparing various oral health treatments, preventive regimens and dental materials. The PBRNs also will conduct anonymous chart reviews, as allowed by the Health Insurance Portability and Accountability Act of 1996, to provide data on disease and treatment trends and estimate the prevalence of less common oral conditions.
How will the PBRNs work? Each network will be a grass-roots effort involving 100 or more fellow practitioners—real-world dentists and dental hygienists—to join the clinical-trials network within at least a two-state geographic area, which must span two distinct population centers. This will allow networks to have a regional flavor and better capture the racial, ethnic and socioeconomic diversity among the patient populations that are seen. Once enrolled, practitioners will gain the opportunity to participate in and contribute data to the various clinical studies. The NIDCR foresees that each network will conduct approximately 16 to 22 clinical trials over the seven-year duration of the project, although the final number may vary from PBRN to PBRN. It should be noted that such a heavy volume will be possible because the clinical trials typically will be short-term, quick-turnaround investigations that yield large amounts of data.
Ideally, the NIDCR would like to support several PBRNs throughout the country. The final number of networks will be decided in the coming months based on the number of high-quality applications that are received.
What’s in it for practitioners to participate in the network? First and foremost, the data generated will be extremely beneficial to the practice of dentistry and to patients. What’s also particularly attractive about the network is that practitioners themselves will propose and prioritize which clinical trials to pursue. Here’s how the process will work: five or six practitioners enrolled in the network also will serve on the PBRN executive committee, to which they will lend their experience and expertise to suggest possible future studies. Each proposal will be further evaluated by a protocol review committee on its scientific merits and feasibility. Proposals deemed to be meritorious will be launched only after independent review by appropriate committees to ensure patient safety and confidentiality. Another obvious benefit is that dentists and hygienists will have the opportunity to attend annual meetings of PBRN participants. This will allow them to exchange information with like-minded dental professionals, discuss needed clinical trials, and otherwise enhance their knowledge base. Moreover, in recognition of their essential contributions, practitioners will share authorship on the resulting = publications.
The PBRN will not cost participants significant time or money. The NIDCR recognizes that dentists and hygienists already have numerous responsibilities during the day, and the institute is taking every step to ensure that participation in the network does not add unduly to their already long days. If they or their staff members spend extra time performing study-related activities, such as patient recruitment and data management, compensation will be provided. Treatment costs, however, will not be reimbursed.
From the broader biomedical research perspective, a major impetus behind NIDCR’s decision to pursue this initiative was the recent launch of the NIH Roadmap for Medical Research. "The Roadmap" is an NIH-wide endeavor that attempts to transform the nation’s medical research capabilities and speed scientific discoveries from the bench to the bedside. (For those interested in learning more about the NIH Roadmap, which I recommend, please visit the following Web sites: "nihroadmap.nih.gov" or "www.nidcr.nih.gov/news/inside_scoop_roadmap.asp".)
In developing the NIH Roadmap, its organizers placed a high priority on integrating existing practice-based, clinical research networks under one organizational umbrella. This will allow the respective networks to function in a more collaborative and unified manner that better informs NIH on its research opportunities. That, in part, is why NIDCR took the lead in organizing the PBRN initiative. It ensures that when the integration and link up of existing medical-based systems has coalesced via the NIH Roadmap, dental professionals will have a viable network of their own whose voice will be actively engaged with their medical colleagues. In a future column, I will detail other features of the NIH Roadmap and how it will help catalyze advances in oral health.
The NIDCR has issued a Request for Applications (available at "www.nidcr.nih.gov/Funding/FundingAnnouncements/RequestForApps.htm"), and the first studies and data collection of a PBRN should get under way give soon. But NIDCR staff members remain mindful that this initiative will need more than high-quality grant applications. It will need the enthusiastic support and participation of dental practices throughout the country. It is my hope that dentists and hygienists will avail themselves of this unique opportunity that has so much to offer to patients, to dental practices and to dentistry as a whole.
