SCOPE is a large longitudinal study being performed at the University of Kentucky and MAHEC. This is the first large, controlled, longitudinal study to determine whether and why sublingual buprenorphine is a risk factor for oral disease burden, while accounting for previous history of oral disease and lifestyle. Sublingual (SL) buprenorphine is the most common medication used to treat opioid use disorder, however, FDA data suggests it may be linked to serious oral complications. The SCOPE study aims to examine if SL buprenorphine influences the extent, onset, and progression of oral disease in patients with opioid use disorder. This study will produce data-driven conclusions about the burden of oral disease in those taking SL buprenorphine and provide insights in how to implement preventive strategies to mitigate oral disease.
The Center for Disease Control and Prevention (CDC) attributed over 80,000 deaths to opioid use during 2021, a rise of five-fold over the past two decades. (1)
A national survey estimated that approximately 2.4 million Americans were taking SL buprenorphine in 2019. (2)
A pilot study at UK revealed that in a sample of 205 adults taking SL buprenorphine, 51.7% of patients had at least one dental extraction.
The most effective strategy to manage OUD and reduce overdose deaths involves taking medication for OUD.4-7
While the FDA recognizes that the benefits of SL buprenorphine “clearly outweigh the risks,” there is limited available evidence on the prevalence of oral health complications in those using SL buprinoprine.8
This is the first large, controlled, longitudinal study to determine whether and why SL buprenorphine is a risk factor for oral disease burden, while accounting for previous history of oral disease and lifestyle.
Marcia Rojas-Ramirez, DDS, MS, MPH is an Assistant Professor at the University of Kentucky’s College of Dentistry with a background in Public Health. She is a Diplomate of the American Board of Orofacial Pain and has over 10 years of experience in the field of chronic pain management.
Dr. Rojas-Ramirez will work closely with Dr. Oyler to ensure the study is successfully implemented by overseeing all aspects of the study, including study planning, personnel calibration, and harmonization of the processes.
Douglas Oyler, PharmD is an assistant professor in the University of Kentucky’s Department of Pharmacy Practice and Science at the University of Kentucky’s College of Pharmacy. His research focuses on safe opioid prescribing and other strategies to mitigate harm from the opioid crisis in Kentucky and beyond. He has served as principal or co-investigator on numerous projects funded by NIH, FDA, DOJ, DOD, and others.
Dr. Oyler is one of the principal investigators and, along with Dr. Rojas-Ramirez, will oversee all aspects of the study and lead the safety oversight and quality control and assessment of the project.
Blake Fagan, MD is the Clinical Director of Substance Use Disorders at the Mountain Area Healthcare Education Center (MAHEC) in Asheville, NC, and a Professor in the Department of Family Medicine at UNC Chapel Hill. He is a Diplomate of the American Board of Preventative Medicine, Board-Certified in Addiction Medicine.
As the MAHEC site principal investigator, Dr. Fagan will provide leadership and oversight, and serve as primary clinical contact. He will engage with project staff at the University of Kentucky and direct the day-to-day operations of the MAHEC study site including providing project oversight for the MAHEC study team
Ian Boggero, PhD, is an Assistant Professor in the University of Kentucky’s Department of Oral Health Science in the College of Dentistry. He is also the Director of Psychological Services and Research at the UK Orofacial Pain Clinic and has joint appointments in the College of Medicine (Department of Anesthesia) and the College of Arts and Science (Department of Psychology).
Dawn Dawson, RDH, CCRC has been employed full time in the Center for Oral Health Research at the University of Kentucky since 2001. After working on both NIH and Industry sponsored studies at UK, she received her Certified Clinical Research Coordinator Certificate from the Association of Clinical Research Professionals in 2005.
Dawn will work closely with the study team to recruit participants and promote the study at OUD clinics. Dawn will also be in charge of obtaining informed consent, collecting data, and gathering all the clinical and radiographic findings, as well as collecting all the survey information.
Jennifer Dolly Prothro, MPH, CCRP is the Research Project Manager for this study and has been employed full-time in research administration at the University of Kentucky since 2012. She received her MPH from the UK College of Public Health, with a focus on Health, Behavior & Society. Her research interests include clinical research in substance use disorders, behavioral methodology, and implementation science. Jennifer will work closely with the project team to oversee research coordination, regulatory oversight, and network operations.
Tess Friesen, MPH, is a project manager at MAHEC who focuses on grant work in substance use disorder treatment and public health initiatives. These initiatives include training, education, research, and clinical programming.
Tess will manage the daily operations of the project at MAHEC including project implementation, budget tracking, and reporting. Tess will assist with enrolling patients into the study, provide required documentation, and specimen samples
Octavio Gonzalez, DDS, PhD is a Professor in the College of Dentistry. He has over 20 years of experience working in the pathogenesis of periodontitis particularly focused in oral microbiome changes and oral host responses associated with this oral disease. His work has been continuously funded by NIH/NIDCR. He is a permanent member of NIH/ODCS study section and serves as editorial board member of the Journal of Periodontology and Journal of Dental Research among others.
Dr. Gonzalez will support the design and data interpretation of the immunoinflammatory responses and oral microbiome changes. He will also contribute to the dissemination of findings from this proposal.
Malini Kirakodu, BSc, HDSE works as a Data Management Specialist with extensive experience extracting data from electronic health records and development of surveys and questionnaires using REDCap.
Malini will be responsible for REDCap survey and quality management forms development, IT consultation, sample labeling design and printing, and sample tracking.
Sree Kirakodu, PhD (Research Scientist III) is the Center for Oral Health Research (COHR) main lab manager.
Dr. Kirakodu will be responsible for all aspects of the oral microbiome and inflammatory analysis including samples barcoding processes, checking samples in and checking samples out for other sites, and database entry of all samples and organization into the freezers in the lab. He also will conduct the DNA isolation, primers designs, and interfacing with the UK Genomics Core for the next generation sequencing and data gathering. He will be overseeing and helping the other laboratory technician and the postdoctoral scholar in the lab for all analysis conducted at University of Kentucky, including preparing samples for further analysis.
Michelle Lofwall, MD, DFASAM is a Professor, board-certified in Psychiatry and Addiction Medicine at the University of Kentucky. Dr. Lofwall is the Bell Alcohol and Addictions Chair and medical director of two outpatient addiction treatment clinics in the UK Center on Drug and Alcohol Research. She enjoys conducting clinical research, teaching, and mentoring all aimed at improving the treatment of persons with substance use disorders. Dr. Lofwall is well-aware of comorbid dental disease seen among patients receiving buprenorphine and is looking forward to this new study that will better establish the role of sublingual buprenorphine in the development of dental problems.
Dr. Lofwall’s clinical and research expertise in psychiatry and addiction medicine make her well-suited to be a co-investigator and serve as an expert in the field of opioid use disorder. Dr. Lofwall will help with recruitment, substance use measure assessment, and interpretation of study outcomes and manuscript writing.
Ali Bunch is a Public Health Dental Hygienist at MAHEC (Mountain Area Health Education Center) .