How does a treatment problem encountered by a practicing dentist become a PEARL Network research protocol? Developing and implementing research protocols aimed at finding solutions to everyday, real-life practice problems is the goal of the PEARL Network, a $26.7 million grant project funded by the NIH to identify key outcomes from dentistry, performed within private practices that are linked together into a large network of practitioners.
In this issue of Global Health Nexus, we provide an inside look at how one practitioner’s search for an answer to a treatment question became the basis for the PEARL Network’s first formal clinical trial, when Dr. Kay Oen, a general practitioner in Port Chester, New York, sought guidance on treating deep caries in teeth that are still vital.
Dr. Oen, a member of the PEARL Practitioner Advisory Group, wanted
to know if he should remove all the affected tissue and risk encroaching
the pulp, or leave some of the involved tissue to avoid directly
entering the pulp and restore the lesion by indirectly capping
and sealing it. He suspected that there was a crucial gap in knowledge
when he attended continuing education courses on caries treatment,
but found little information about deep caries. Fellow members
of the Academy of General Dentistry shared his concerns, and when
a search for published data comparing deep caries treatment options
turned up no new information, Dr. Oen discussed the need for an
authoritative study with other PEARL Network practitioners and
with Executive Committee* members, and urged the Network to undertake
the study. Dr. Oen spoke to Global Health Nexus about the process
of turning his idea into a research study.
GHN: Why did you propose a research study?
Dr. Oen: Because this was a once-in-a-lifetime opportunity to take ownership of a research idea and shape it into a clinical trial that will yield practical information on patient care.
GHN: Why did you choose to focus on deep caries treatment?
Dr. Oen: Whenever I wanted to consider more than one treatment option for my patients, I didn’t have practical information to guide me through the decision-making process. Studies performed in the past decade found that when the affected dentin has been only partially removed in cases of deep caries with little or no effect on pulp, an adequately-sealed indirect cap can arrest the caries process and lead to dentin remineralization. But since these studies have been conducted in clinical research centers rather than real-world dental practice settings, we know little about whether dentists are translating the growing evidence on sealing deep caries into practice.
And since there haven’t been any clinical trials comparing partial dentin removal and sealing with
the traditional approach of removing all carious tissue, practitioners don’t have published data to help them evaluate the pros and cons of each option in different cases.
GHN: What was the first step you took to formulate a research protocol that would seek to address this gap in knowledge?
Dr. Oen: I reviewed my idea for a formal study with the PEARL Network Protocol Development Core Director, Dr. Van Thompson, to ensure that it met the following criteria:
After PEARL’s Executive Committee accepted my idea, Dr. Thompson prepared a three-page preliminary clinical trial outline, which was reviewed by my colleagues in the Practitioner Advisory Group and refined based on their suggestions.
- Importance. Study results that can improve the practice of dentistry.
- Feasibility. The study can be conducted efficiently and effectively in a PEARL Network member’s office over a reasonable time period.
- Relevance. The study will be of value to a large number of dentists.
GHN: What happened next?
Dr. Oen: The Executive Committee voted to develop a full-study protocol with the help of PEARL’s data coordinating center, the EMMES Corporation. I reviewed the proposed protocol, providing suggestions from the practitioner’s viewpoint. For example, I recommended that additional time be allotted to filling out patient consent forms. Finally, the Executive Committee
voted to send the protocol to the National Institute
of Dental and Craniofacial Research (NIDCR) and to an institutional review board for final approval.
GHN: What happened after the proposal
was formally approved?
Dr. Oen: The first thing we
did was to send PEARL Network members a survey that asked how frequently they chose the two major treatment options – partially removing carious dentin and sealing the lesion, or removing all of the affected tissue – as well as what factors influence
their choice, and what the perceived outcomes are.
I presented these results, and those from a similar nationwide survey we conducted of practitioners in Met Life’s dentist network, at the PEARL Network’s annual meeting in April. Next fall, we’ll
launch a three-year prospective study that focuses on treatment outcomes.
Every practitioner in our network will be asked to report clinical outcomes,
such as tooth vitality and retention, as well as patients’ perspectives on symptom relief, treatment satisfaction, and overall
GHN: How much time did you spend developing the study?
Dr. Oen: I averaged about an hour a day during
the development phase, which lasted approximately eight weeks. I expect to spend roughly the same amount of time over the next three years as the principal investigator conducting the study. PEARL compensates me for my time, and provides training, guidance and support every
step of the way.
GHN: What would you say to other practitioners to encourage them to submit proposal ideas?
Dr. Oen: We are looking for ideas from practicing dentists, so it’s perfectly fine if you have never worked as a researcher. It didn’t matter that I had no formal research training because the experienced researchers on PEARL’s leadership team provide me with plenty of guidance. You’ll receive recognition for your idea, including the chance to lead your own study and present the findings to other practitioners. Also, it’s easy to develop and submit an idea: just go online and fill out the short proposal form at www.pearlnetwork.org.
*The PEARL Network Executive Committee consists of Page W. Caufield, DDS, PhD; Frederick A. Curro, DMD, PhD; Ananda P. Dasanayake, BDS, MPH, PhD; Jonathan A. Ship, DMD; and Van P. thompson, DDS, PhD.