Donald J. DeNucci, DDS, MS Program Director Practice-Based Research Networks

1. NIDCR - Sponsored Practice-Based Research Networks (PBRN)Designed to gather “real-world” evidence for the prevention and treatment of oral diseases Donald J. DeNucci, DDS, MS Program Director Practice-Based Research Networks National Institute of Dental and Craniofacial Research

2. Dental Practice-Based Research Networks - Purpose • Answer questions facing general dental practitioners in the routine care of their patients • Strengthen knowledge base for making clinical decisions • Observational studies • Clinical trials • Establish/use a flexible, adaptable electronic network/platform for connectivity, data sharing, & communication within and between dental and medical networks

3. Dental Practice-Based Research Networks-Objectives • Stimulate research proposals from practicing dentists and dental hygienists (i.e., practitioner-investigators) • Primary objectives: •Conduct 16-22 short-term clinical studies over 7 years •Emphasis on effectiveness of oral health treatment & disease prevention •Clear & clinically meaningful outcomes • Secondary objective: Provide data on disease and treatment trends and obtain estimates of the prevalence of less common conditions

4. Dental Practice-Based Research Networks-Outcomes • Draw on experience & insight of practitioners to help identify and frame questions • Establishes partnership between practitioners and experienced researchers • Rapid translation of findings into clinical practice • May reduce costs for certain types of studies when compare with traditional research models

5. General Dental Practice-Based Research Networks Cooperative Agreements Awarded 5/01/2005 $75 Million over 7 years Awardees • NYU PEARL Network • Universities of Alabama / Florida DPBRN Network Permanente Dental Associates Health Partners Georgia Mississippi Scandinavia • Universities of Washington / Oregon NW PRECEDENT Network • TransPBRN entity comprising all three networks CONDOR Network

6. Dental Practice-Based Research Networks-Goals Year One • At least 100 dental practices per Dental PBRN will be recruited to participate during the first year of operations. • Each PBRN will involve large numbers of practitioner-investigators in at leasttwo population centers.

7. Dental Practice-Based Research Networks-Present Status • Presently over 600 dental practices participating after 3 years • Each PBRN involves large numbers of practitioner-investigators in at four population centers.

8. Snapshot of PBRNs’ Current Membership, by State

9. Dental Practice-Based Research Networks – Organization • Network Chair • Coordinating Center • Executive Committee • NIDCR Staff • Protocol Review Committee • IRB • DSMB (Phase III Trials)

10. Dental Practice-Based Research Networks – Executive Committee • Composition • Network Chair • PI of Coordinating Center • *5-6 elected practitioner-investigators • NIDCR staff *Comprise the majority membership

11. Dental Practice-Based Research Networks – Executive Committee • Responsibilities • Provides governance and administrative support for the PBRN • Prioritizes research topics for submission to Protocol Review Committee • Reviews and approves protocols prior to submission to Protocol Review Committee

12. Dental Practice-Based Research Networks – Practitioner Profiles • PBRN trained and certified dentists and dental hygienists engaged in daily practice • From more than one state and population center • Representative of gender / racial / ethnic distribution of PBRN region • Limited number may be from outside U.S. if standard of dental care is comparable to that in U.S

13. Dental Practice-Based Research Networks – Practitioner Investigators • Roles and Responsibilities • Participate in Annual Meeting • Elect representatives to Executive Committee • Suggest studies to Executive Committee • Contribute to protocol development • Conduct studies in their practices • Conform to IRB, DSMB, HIPAA regulations • Contribute to manuscript preparation

14. Dental Practice-Based Research Networks – Review Process • Ideas for individual studies proposed to the PBRN Executive Committee • After review by the PBRN Executive Committee, all protocols must be approved by: • Protocol Review Committee • IRB • DSMB for Phase III Trials

15. Dental Practice-Based Research Networks-Typical Studies

16. PBRN Research Activities – Year Four • PEARL: Studies are focusing on treatment strategies for advanced dental caries, root canal therapy, sensitive teeth, periodontal disease, dental implant survival • DPBRN: Studies are focusing on treatment strategies for treating early carious lesions, reasons for replacing dental restoration • PRECEDENT: Studies focusing on caries risk assessment, dental pulp capping, wisdom tooth removal, orthodontic retention

17. PBRN Collaborative Research Activities Year Four • Networks collaborating on a study of the risk factors for osteonecrosis of the jaw in relation to a variety of factors including use of bisphosphonate drugs

18. PBRN Collaborative Research Activities Year Four • Networks are collaborating with the NIH National Cancer Institute’s Center for Bioinformatics in defining common data elements and establishing a common data vocabulary repository

19. PBRN Collaborative Research Activities Year Four • Networks collaboratively established a Practice Impact Research Group (PIRG) • Designed to measure and assess the impact of practice-based research on translation and ultimately changes in clinical practice leading to improvements in patient care and oral health

20. PBRN Collaborative Research Activities Year Four • Collaborating with the VA Dental Practice-based Research Network (VADER) • VADER comprised of over 600 dental professional using one integrated electronic medical and dental record

21. PBRN Collaborative Research Activities Year Four VADER ONJ Study in Veterans VADER Cranial Implant Study

22. PBRN Research ActivitiesPotential for collaboration with medicine • PEARL: Analgesic prescribing practices of dentists, drugs impacting oral health (xerostomia, gingival hyperplasia), impact of periodontal therapy on diabetes and cardiovascular disease • DPBRN: Infection after surgical procedures in diabetic patients, glycemic screening in dental offices, tobacco cessation • PRECEDENT: Computer assisted program for needle phobia, anxiety management

23. General Dental Practice-Based Research Networks • NYU PEARL Network • Universities of Alabama / Florida DPBRN Network Permanente Dental Associates Health Partners Georgia Mississippi Scandinavia • Universities of Washington / Oregon NW PRECEDENT Network • TransPBRN CONDOR Network comprising all three networks

24. NIDCR Funded Oral Health Disparities ProgramEstablished Community Networks Configured to Conduct Interventional Trials • University of Washington • University of Florida • University of California - San Francisco • University of Colorado - Denver • Boston University • *University of Michigan *Pilot Program in Detroit inner city

25. Donald J. DeNucci, D.D.S., M.S.Program DirectorPractice Based Research NetworksCenter for Clinical ResearchNational Institute of Dental and Craniofacial Research6701 Democracy Blvd., Room 632 Telephone: 301-451-5096Fax: 301-480-8322E-mail:  denuccid@nidcr.nih.gov