THE FIRST OF ITS KIND
Medelis is applying its expertise from designing and managing complex oncology clinical trials to the rapidly developing field of dental research, providing sites and sponsors with new research standards that deliver high-quality and clinically-relevant data and a new standard of patient safety.
DENTAL RESEARCH MARKET
The market is growing for dental implants, treatments for periodontal disease, periodontal regeneration, biologics and biomaterials that support esthetic soft tissue regeneration. The global dental implant market alone is estimated to grow from $7.4 billion in 2015 to $10 billion in 2020, a compounded annual growth rate of 7.2%. These changes are creating new opportunities for patients, sponsors and dental practices.
“ The new technology breakthroughs in implants, tissue regeneration and bone grafting procedures are driving the need to apply clinical standards to research performed in the private dental practice. ”
– Dr. Michael McGuire, Founder and Chairman of The McGuire Institute
CHALLENGES TO OVERCOME
New technology breakthroughs are driving more sophisticated dental study designs. While beneficial, these improvements create complexities for sponsors, patients and dentists.
As these new dental studies move from academia to private practices, dental sponsors gain the benefit of obtaining study results that are applicable in the “real world” practice of dentistry.
But let’s face it, dental offices are different entities compared to hospitals. Nearly 90% of dental practices are privately owned. Many are a family affair. The dentist’s reputation in the community is made with every new patient; but oversight, liability and regulations have not been stringent or troublesome.
That is changing with the new research. Navigating these new requirements is difficult for the uninitiated private practice. Typical study tasks such as blood draws, physical exams, cardiac imaging and performing MRIs become challenging, if not almost impossible. Completing these highly regulated or controlled studies requires a new skill set and mode of operation.
There is a clear need for a CRO who understands the needs and limitations of community dental practices and is able to provide sites with the necessary ancillary resources to complete these more complicated trials.
Medelis, in partnership with The McGuire Institute, allows study sponsors to initiate single or multi-centered studies quickly and reliably, with calibration and internal communications coordinated by the Institute and the study management handled by the clinical research professionals at Medelis.
Successful dental studies require a special understanding of study design, clinical and patient-reported outcomes, regulations, monitoring and data collection. Medelis’ staff is experienced in dentistry and our partnership with the practice-based research network The McGuire Institute provides us with a unique opportunity to deliver timely, relevant and respected results to the dental surgical community. We do not simply organize, conduct and monitor dental studies… we partner, train and problem-solve with our sponsors and investigators to conduct the most effective trials.
Medelis can create and implement a detailed study plan, carefully structured to address all regulatory needs and requirements. We’ll optimize the likely outcomes for your dental study, delivering maximum value for your clinical investment.
Site Selection & Management
Medelis provides a variety of well-trained dental sites for sponsors to use in a single or multi-centered study. Our previous work with these sites allows you to obtain clinically-relevant data quickly and reliably.
For new potential investigators and dental practices, Medelis provides rigorous training to provide the necessary ancillary resources to complete these more complicated trials and ensure the utmost standards for data collection and patient safety.
Dentist offices often have limited medical capabilities, facilities, and resources, making a simple blood draw or physical exam challenging. Medelis provides the ancillary resources and nurses to complete these more complicated trials.
Obtaining quality data is critical to the value of these changing dental studies. PK studies are necessary and the biologics have a different safety profile, so Medelis applies rigorous data collection methods to pass the increased regulatory scrutiny.
Because of the greater scrutiny by sponsors and regulatory agencies, dental studies carry greater risk for sponsors. Medelis has applied its rigid regulatory requirements and high standards from oncology studies to the dental market.
We work with large, midsize and small dental sponsors to help deliver the right clinical research, on time and on budget. Medelis has been applying the rigorous standards of our oncology research to the dental market since 2011.
Here are case studies from two of our recently-completed dental studies:
An international client contracted Medelis to conduct a phase II randomized study in the US to evaluate and compare treatment in adults needing posterior buccal dehiscence extraction.
This study included safety reviews as well as extensive site training for preparation and administration of the study drug and procedure. Many of the sites had never performed clinical research so proper training was critical to study success.
Despite these challenges, Medelis exceeded our goals during startup of the trial by two months. A total of 11 sites were selected and 10 of these were approved to enroll. 42 patients were consented and 40 were randomized meeting the protocol requirements. All sites enrolled a minimum of three patients at their location and open enrollment was initiated to complete enrollment based on the projected timeline. The study enrollment was completed two months ahead of schedule and the study was considered a success.
A US client contracted Medelis to conduct a trial in the US to evaluate the safety and effectiveness of their device compared to the industry standard. The client was hoping to conduct the trial in nine months from start-up to completion of the study report.
This study included eight US dental sites and required each participant to be evaluated for 15 weeks. To accomplish this in such a short timeframe, we used our network of dental professionals and required each of them to use a central IRB for study approval.
A total of 10 sites were selected and eight of these were approved to enroll. 46 patients were consented and 40 were randomized meeting the protocol requirements. Patients who were consented in the study presented for correction of an anterior tooth due to misalignment in the maxillary and/or mandibular arches. The study enrollment was completed two weeks ahead of schedule and the study device received approval for use.
“ We asked Medelis to be our preferred CRO because we wanted a CRO accustomed to working in an environment of rigid requirements and high standards. Medelis has done an excellent job. ”
– Dr. E. Todd Scheyer
THE McGUIRE INSTITUTE
The McGuire Institute, founded by Dr. Michael K. McGuire, is a not-for-profit organization focused on advancing the practice of dentistry through clinically-relevant research.
To accomplish this, The McGuire Institute is comprised of a select group of clinicians with outstanding technical skills. Strategically located throughout the United States, The McGuire Institute professionals and their practices are evaluated and trained by the institute to ensure that they have the competence and experience necessary for conducting successful clinical research.
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