Surveillance and Characterization of Oral Health in Opioid Use Disorder (SCOPE)

 

SCOPE is a clinical study conducted in two states significantly impacted by the opioid epidemic: Kentucky and North Carolina. It is the first large-scale, controlled, longitudinal study designed to assess whether sublingual (SL) buprenorphine is a risk factor for oral disease. The study also investigates the underlying mechanisms contributing to oral disease, while accounting for a range of other risk factors, including lifestyle. 
 
SL buprenorphine is the most prescribed medication for opioid use disorder (OUD). 4-7 However, FDA data indicates a potential association with serious oral health complications. While the FDA recognizes that the benefits of SL buprenorphine “clearly outweigh the risks,” there is limited evidence regarding the prevalence and long-term of oral health outcomes in adults with OUD using SL buprenorphine.8  

The SCOPE study aims to evaluate whether SL buprenorphine contributes to onset, severity, and progression of oral disease in individuals with a history of OUD. Findings from this study will offer data-driven insights into the oral health burden within this population and support the development of targeted preventive strategies.  

 

By the Numbers

80,000

2.4 Million

51.7%

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.

 

This study aims to recruit 372 adults currently receiving treatment for OUD. Treatment may include pharmacological options (e.g., buprenorphine, methadone, naltrexone) or non-pharmacological interventions (e.g., abstinence-based programs, counseling).  

 

For more information about the study, please contact us at: SCOPEstudy@uky.edu 

 

Meet the Team

RojasMarcia Rojas Ramirez, College of Dentistry, UK - Dr. Rojas-Ramirez 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 brings over 10 years of experience in chronic pain management.  
 
Dr. Rojas-Ramirez will collaborate closely with Dr. Oyler to ensure the successful implementation of the study. She will oversee all phases of the study, ensuring seamless coordination and alignment of the multiple processes involved.  

OylerDouglas Oyler, College of Pharmacy, UK - 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.  

FaganBlake Fagan, School of Medicine, UNC; MAHEC - 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.

BoggeroIan Boggero, College of Dentistry, UK - 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.

Dr. Boggero will contribute to the study design, assessment of behavioral factors, and aid in evaluation and dissemination of findings. He will also be responsible for linking interested study participants to mental health counselling.

Ali Bunch, MAHEC - Ali is a public health dental hygienist at the Mountain Area Health Educational Center (MAHEC) in Asheville, NC. Ali works clinically at MAHEC Dental Clinic, with a School Based Oral Health Initiative and as an adjunct faculty member of the Adams School of Dentistry of The University of North Carolina at Chapel Hill. Ali graduated from Asheville Buncombe Technical Community College with an Associate in Applied Science in Dental Hygiene in 2014 and from East Tennessee State University with a Bachelor of Science in Dental Hygiene in 2022.   

DawsonDawn Dawson, College of Dentistry, UK - 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, College of Dentistry, UK  -  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. 

FriesenTess Friesen, MAHEC - 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.

GonzalezOctavio Gonzalez, College of Dentistry, UK - 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.

KirakoduMalini Kirakodu, College of Dentistry, UK - 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. 

KirakoduSree Kirakodu, College of Dentistry, UK - 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, College of Medicine, UK - 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.  

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Brennan Lundie, College of Dentistry, UK - Brennan Lundie, BA, is a research coordinator of five years. He obtained his degree in psychology from Transylvania University and since has been integrally involved with the inception of two clinical research sites local to the area. Additionally, he was part of team at UK that enrolled the highest number of participants globally for J&J’s initial Covid-19 vaccine trial during the pandemic in 2020. His areas of academic interest and research include behavioral pharmacology, abnormal psychology, and cognitive neuroscience.  

Brennan will work closely with the study and project teams to recruit participants, collect survey information, report study metrics, and maintain regulatory compliance. 

Craig S. Miller, College of Dentistry, UK - Craig S. Miller, DMD, MS, is the Alvin L. Morris Professor of Oral Health Research and Associate Dean for Faculty Affairs and Development at the University of Kentucky’s College of Dentistry. He is board certified in Oral Medicine, with 35 years of experience in the diagnosis and management of complex oral health issues and medically compromised patients. Dr. Miller has authored more than 200 publications, co-authored four internationally recognized textbooks, and has maintained funding from the National Institutes of Health for more than 30 years.

Dr. Miller will facilitate study design and standardization, assist in ensuring protocol adherence, and aid in evaluation and dissemination of the findings.

MogaDaniela Claudia Moga, College of Pharmacy, UK - Daniela Claudia Moga, MD, PhD is an Associate Professor and Assistant Dean for Research at the College of Pharmacy with a secondary appointment in the College of Public Health.

Dr. Moga will serve as an expert in the field of study design, with specific focus on establishing the cohort. She will also contribute to the interpretation and dissemination of the findings.  

OmamiGalal Omami, College of Dentistry, UK - Galal Omami, BDS, MSc, MDentSc, FRCD is an Associate Professor in the Department of Oral Health Practice at the University of Kentucky.

Dr. Omami is a recognized dental radiologist and will be contributing to this project by reviewing and analyzing all the radiographic images obtained from the participants. He will also participate in the interpretation of radiographic findings and dissemination of this study.

ShaddoxLuciana Shaddox, College of Dentistry, UK - Luciana Shaddox, DDS, PhD is a Professor and Associate Dean for Research at the University of Kentucky’s College of Dentistry, Division of Periodontology. Dr. Shaddox directs all research activities at the college of Dentistry, the Kentucky Oral health Innovation Initiative, actively participates in Periodontology and other courses at UK and several local and national/international committees and has a clinical translational research program supported by NIH since 2009, with a main focus in immunological, microbiological and genetic factors involved with localized aggressive periodontal disease (Grade C Molar incisor pattern) in children and adolescents. She has over 80 publications, has been a member of NIH study sections, she is an editorial board member for the Journal of Clinical of Periodontology, associate editor for the Journal of Periodontology and is the recipient of several research student-mentored awards and personal awards, including the prestigious American Academy of Periodontology Teaching Award and the University of Florida and University of Kentucky Professorship Awards.

Dr. Shaddox will work with MPIs in the study design, will serve as expert in the dental clinical research and the development of standard operating procedures as they pertain to inflammatory biomarkers. She will also contribute to the interpretation of the results and dissemination of the findings of this study.

Lorie Snow, RDH, College of Dentistry, UK - Lorie Snow, RDH is a research coordinator in the Center for Oral Health Research (COHR) at the University of Kentucky.  Before joining COHR in 2022, she practiced full time as a clinical dental hygienist in the College of Dentistry’s Faculty Practice Clinic for 13 years, where her focus was helping patients understand the importance of oral health and prevention of dental disease.  

Lorie will work closely with the study team to recruit participants and promote the study at OUD clinics.  Lorie will also obtain informed consent, collect data, and gather all the clinical and radiographic findings, as well as collect all of the survey information. 

Philip Westgate, College of Public Health, UK - Philip Westgate, Ph.D., is a Professor and Acting Chair of the Department of Biostatistics at the University of Kentucky’s College of Public Health. His methodological areas of  interest include cluster, group, or community randomized trials, longitudinal studies, and clustered data in general. Furthermore, he has applied interests in a variety of areas, including the substance use area.  

Dr. Westgate will serve as the statistical lead and oversee statistical planning/design, and measurement of variables. Dr. Westgate will also oversee data quality and completeness reporting as well as analysis of all outcomes. 

Olive Wilbur, MAHEC - Olive Wilbur, BA is a Project Manager at Mountain Area Health Education Center (MAHEC) in Asheville, NC. Olive works on the Substance Use Disorder Initiatives team managing the SCOPE project, Steps to Recovery project, and the North Carolina Substance Treatment and Recovery Network (NCSTAR Network) project, a statewide grant-funded effort to expand access to medications for opioid use disorder (MOUD) in NC through trainings and coaching. 

Olive will manage the daily operations of the project at MAHEC including project implementation, budget tracking, and reporting. Olive will assist with enrolling patients into the study and provide proper and required documentation and samples. 

 

References

1. US Department of Health and Human Services, CDC. State Unintentional Drug Overdose Reporting System (SUDORS). Available at: Access at: https://www.cdc.gov/drugoverdose/fatal/dashboard. 

2. Han B, Jones CM, Einstein EB, Compton WM. Trends in and Characteristics of Buprenorphine Misuse Among Adults in the US. JAMA Netw Open 2021;4:e2129409. 

3. Oyler DR, Rojas-Ramirez MV, Nakamura A, et al. Factors influencing opioid prescribing after tooth extraction. Journal of the American Dental Association 2022;153:868-877. 

4. Hoffman KA, Ponce Terashima J, McCarty D. Opioid use disorder and treatment: challenges and opportunities. BMC Health Serv Res 2019;19:884.  

5. Mauro PM, Gutkind S, Annunziato EM, Samples H. Use of Medication for Opioid Use Disorder Among US Adolescents and Adults With Need for Opioid Treatment, 2019. JAMA Netw Open 2022;5:e223821. 

6. Bell J, Strang J. Medication Treatment of Opioid Use Disorder. Biol Psychiatry 2020;87:82-88. 

7. Donohue JM, Jarlenski MP, Kim JY, et al. Use of Medications for Treatment of Opioid Use Disorder Among US Medicaid Enrollees in 11 States, 2014-2018. Jama 2021;326:154-164. 

8. Aschenbrenner DS. New Dental Warning for Buprenorphine. Am J Nurs 2022;122:18. 

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