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Feasibility of a Randomized Clinical Trial on Periodontal Therapy for Type 2 Diabetes

This study explores the potential effects of periodontal therapy on glycemic control in patients with type 2 diabetes. It examines systemic factors, clinical research challenges, and proposed explanatory mechanisms, supported by grant funding.

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Feasibility of a Randomized Clinical Trial on Periodontal Therapy for Type 2 Diabetes

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  1. Feasibility of a Randomized Clinical Trial in FQHCs to Determine the Effects of Periodontal Therapy on Glycemic Control in Type 2 Diabetes Taylor GW, Bozzone J, Hames C, Salyk R, Svarcbergs JM, Borgnakke WS, Manz MC, Zhou R, Khalida C, Tobin JN Supported by NIH/NIDCR Grant 1R21DE017339

  2. Overview • Systemic Factors & Periodontal Disease • Overview of Clinical Directors Network’s (CDN) Practice Based Research Network (PBRN) • Periodontal Diabetes Randomized Clinical Trial Pilot Study (PDRCT) • Objectives • Methods • Results • Challenges and Prospects of Conducting Clinical Research in FQHCs

  3. CHC Patients by Diagnosis, 2005 Source: HRSA BPHC UDS, 2005 – Special Tabulation e: HRSA BPHC UDS, 2005 – Special Tabulation)

  4. Average HbA1c Test Results Source: Update on Analyses from the Northeast Cluster Health Disparities Collaboratives, Tobin, JN, et al., 2006 4

  5. Diabetes & Oral Health Periodontal diseases Tooth loss Dental caries Xerostomia Oral candidiasis Oral lichen planus Burning mouth syndrome

  6. Periodontal Diseases • Chronic inflammatory disease • Bacterial etiology • Destruction of periodontal tissues • Formation of pathologic pockets around teeth • Loss of connective tissue attachment • Loss of alveolar bone • Can lead to tooth loss • Chronic source of systemic challenge • Bacterial products (e.g. LPS) • Inflammatory mediators

  7. Gingivitis Periodontitis Bacterial plaque Initial periodontal disease Inflamed gingiva Reversible Can progress if untreated Bacterial plaque Advanced periodontal disease Connective tissue loss Periodontal ligament loss Supporting bone loss

  8. Periodontal Diseases in the US Adult Population Source: NHANES 3 (1989-94), US Population

  9. Diabetes & Periodontal Health Number of studies: smallest dot= 1 or 2; Middle sized dot= 4-5; Largest dot= 27

  10. Proposed Explanatory Mechanisms of the Diabetes → Periodontitis Association Altered host response Alterations in connective tissue Microangiopathy Alterations in gingival crevicular fluid Altered subgingival microflora Hereditary predisposition

  11. % Children & Adolescents with 1+ Sites with Periodontal Attachment Loss ≥ 2mm Source: Lalla E. et al. 2006

  12. US Adults, Aged 45+ with Severe “Active” Periodontitis by Glycemic Control Status Source: NHANES III *1+ sites: LPA 6+ mm and gingival bleeding

  13. Inflammation, Insulin Resistance & Diabetes Conceptual Model: Adapted from Richard Donahue, 2004 13

  14. Periodontal infection and glycemic control: Observational studies Taylor et. al., 1996: Pima Indian adults, ages 20-64 years. Collin et. al., 1998: Finnish adults, ages 58-76 years. Taylor et. al., preliminary: U.S. adults, ages 45+ 14

  15. Observational Evidence: Incidence of Poorer Glycemic Control at 2 yrs. Follow-up in Pima Indians Source: Taylor et al., 1998

  16. Locations of Clinical Therapeutic Studies

  17. Non-surgical Periodontal Therapy Studies: Organizing the Evidence • Randomized clinical trials (RCT) • Non-treated control group: 1 positive/3 studies • Positive control group: 3 positive/3 studies • Usual source of care: 0 positive/1 study • Non-randomized clinical treatment studies (non-RCT) • Non-treated control group: 1 positive/2 studies • No control group: 7 positive/10 studies

  18. Supporting Epidemiologic Evidence (1) Inflammation & insulin resistance Insulin resistance & diabetes Inflammation & diabetes Periodontitis & systemic inflammation/acute-phase response Periodontitis & insulin resistance

  19. Supporting Epidemiologic Evidence (2) • Cross-sectional studies: associations in people with diabetes • Subjects with newly diagnosed or established type 2 diabetes compared to control without diabetes • Elevated acute-phase reactants (CRP, IL6 & TNFα) • Correlation between HOMA & makers of inflammation: CRP, serum amyloid A, secretory phospholipaseA2, IL6, TNFα, & endothelia dysfunction (soluble cell adhesion molecules)

  20. Supporting Epidemiologic Evidence (3) • Cross-sectional studies: associations in people without diabetes or with metabolic syndrome • Subjects without diabetes, general population, or those with IGT/IFG • Correlation of acute-phase reactants & pro-inflammatory mediators (CRP, IL6 & TNFα) with: • Measures of insulin resistance/plasma insulin • Triglycerides & HDL cholesterol • Increasing number of components of the metabolic syndrome

  21. Supporting Epidemiologic Evidence (4) • Longitudinal studies: markers of inflammation predicting type 2 diabetes • ARIC: WBC, low serum albumin, a1-acid glycoprotein, fibrinogen, sialic acid • US Women’s Health Study: CRP, IL-6 • US Cardiovascular Health Study: CRP • US Insulin Resistance & Atherosclerosis Study: CRP, fibrinogen, PAI-1 • West of Scotland Coronary Prevention Study: CRP

  22. Supporting Epidemiologic Evidence (5) • Longitudinal studies: markers of inflammation predicting type 2 diabetes (Cont.) • NHANES: WBC • Hoorn Study in the Netherlands: CRP • European Prospective Investigation into Cancer & Nutrition-Postdam Study: IL-6, IL-1β • MONICA Augsburg Study: CRP • Mexico City Diabetes Study: CRP (significant in man only)

  23. Periodontal Therapy: Effects on Systemic Inflammation • Improved endothelial function • Seinhost et al., 2005 • Elter et al., 2006 • Tonetti et al., 2007 • CRP level reduced • Seinhost et al., 2005 • D’Aiuto et al., 2005 • Ebersole et al., 1997 • IL-6 levels reduced • D’Aiuto et al., 2005 • Iwamoto et al., 2003 • TNFα levels reduced • Iwamoto et al., 2003

  24. Overview of CDN’s Practice-Based Research Network(PBRN) • Clinical Directors Network (CDN) • An informal network of clinical leaders who practice as primary care clinicians in low income and minority community • A research and educational organization • A means to translate research into practice www.CDNetwork.org www.eclinician.org

  25. CDN’s Strategic Objectives Translate clinical research into practice Diffuse knowledge through collaboration Build enduring partnerships among clinicians, researchers & policy-makers Ensure adequate representation of neglected subgroups (providers & patients) Include relevant stake-holders in design, conduct, analysis, implementation & sustainability

  26. CDN’s Research Projects Hypertension Hyperlipidemia Diabetes Asthma Depression Stress Migraine Oral health Immunizations Infections Cancer prevention/early detection HIV/AIDS Tobacco/smoking cessation Prenatal care

  27. States/Territories Where CDN Conducts Research New York New Jersey Puerto Rico Virgin Islands Connecticut Florida California Missouri Utah Oklahoma Maine Massachusetts Rhode Island Vermont New Hampshire Virginia West Virginia Maryland Delaware Pennsylvania Washington DC Texas

  28. CDN’s Clinical Educational Activities Online clinical leadership webcasts Educational CD-ROM production services Onsite training programs eClinician project training programs Continuing education (CE) credits for physicians (CME), dentists (CDE), pharmacists, dieticians & other health care providers

  29. PDRCT Pilot Study - Objectives To assess the feasibility of conducting a multi-center randomized clinical trial (RCT) evaluating the effect of treating periodontal infection on glycemic control in type 2 diabetes in Federally Qualified Health Centers (FQHCs),

  30. PDRCT Pilot Study - Aims Identify potentially eligible participants from diabetes registries Evaluate different recruitment methods Conduct screenings assessing RCT-related characteristics: periodontal disease, HbA1c levels, other eligibility criteria, and willingness to participate in an RCT Collect information for RCT sample size estimation Assess the association between periodontal infection and poor glycemic control among participants.

  31. PDRCT Pilot Study at4 CDN Participating FQHCs CAMCare Health Corporation, Camden, NJ Hudson River Health Care, Peekskill, NY Morris Heights Health Center, Bronx, NY Open Door Family Medical Center, Ossining, NY 31

  32. PDRCT Pilot Study – Methods (1)Inclusion & Exclusion Criteria • Inclusion Criteria • 18 years and old • registered as a patient for at least 6 months at one of the four participating CHCs • having a history of type 2 diabetes • having at least 6 natural teeth • willingness to participate in the pilot clinical examination and interview session

  33. PDRCT Pilot Study – Methods (2)Inclusion & Exclusion Criteria (cont.) • Exclusion Criteria • blood dyscrasias • pregnancy or breast feeding • presence of severe cognitive or communicative impairment • being HIV+ positive • having a cardiac pacemaker • requiring prophylactic antibiotics before dental treatment • being medically unstable

  34. PDRCT Pilot Study – Methods (3) Potential eligible patients were identified through diabetes registries 200 potential eligible patients from each participating CHC were randomly selected & contacted 189 patients were recruited from 4 participating CHCs & went through simple physical exams, questionnaires & dental exams

  35. PDRCT Pilot Study – Results (1) 3,729 potential participants in all 4 CHCs’ diabetes registries were identified 189 eligible patients from 4 CHCs were recruited into the study Physical exams, questionnaires & dental exams were administrated among all 189 patients

  36. PDRCT Pilot Study – Results (2) 34% of patients recruited were from diabetes registries 66% of patients recruited were from other sources, including waiting room, flyers & referrals

  37. PDRCT Pilot Study –Results (3) # of eligible based on the eligibility algorithm, who have periodontal disease for several levels of minimum hemoglobin HbA1c

  38. Patient Breakdown by Site

  39. Mean HbA1c by Site

  40. Average HbA1c Values vs. % of Patients with Periodontal Disease Diagnosis by Site

  41. PDRCT Pilot Study –Results (4) • Willingness to participate in the full-scale, multicenter RCT • All but 1 eligible participants likely to be willing to participate in the full-scale, multicenter RCT, based on response to that question in the interview

  42. PDRCT Pilot Study –Results (5) Patients with diabetes & periodontal disease were twice as likely to have poorer glycemic control than those without periodontal disease

  43. Challenges of Conducting Clinical Research in FQHCs • Competing priorities for patient care among medical and dental providers • Learning process for medical and dental providers at FQHCs • Dealing with special patient populations • Lack of current contact information • Lack of understanding of dental health & diabetes • Lack of access to regular dental care

  44. Prospects for Conducting Clinical Research in FQHCs Provides access to large populations of potential participants Adds diversity to clinical research Adds fuel for evidence-based care Translates research into direct clinical practices

  45. University of Michigan School of Dentistry Thank you for your attention • For the tougher questions Contact: George W. Taylor gwt@umich.edu

  46. NIH/NIDCR Grant # 1R21DE017339 University of Michigan staff CDN staff Study Patients Dental Providers and Staff at CamCare Health Corporation Hudson River Health Care Participating Sites Morris Heights Community Health Center Open Door Family Medical Center Acknowledgements

  47. ORAL HEALTH WEBCASTS • Effective Dental Billing and Coding for FQHCs • Presented by: Janet Bozzone, DMD, FAGD - Director of Dentistry at Open Door Family Medical Center • Infant Oral Health • Presented by: Janet Bozzone, DMD, FAGD - Director of Dentistry at Open Door Family Medical Center • Implementation of an Electronic Dental Record Following Expansion to Multiple Locations for CHCs • Presented by:  Clifford Hames, DDS – Chief Dental Officer/Chief Infection Control Officer – Hudson River • Health Center • Infection Control Programs in Community Health Centers • Presented by:  Ron Salyk, DDS – Vice President, Dentistry and Chair of Infection Control Committee, • Morris Heights Health Center • Practical Pediatric Dentistry for General Practitioners • Presented by: Janet Bozzone, DMD, FAGD - Director of Dentistry at Open Door Family Medical Center • School-Based Preventive Dentistry Sealant & Flouride Rinse Programs:  20 Years of Success • Presented by:  Clifford Hames, DDS – Chief Dental Officer/Chief Infection Control Officer – Hudson River • Health Center 47

  48. ORAL HEALTH WEBCASTS • Periodontal Diseases Effects on Diabetes Control and Complications • Presented by George W. Taylor, DMD, DrPH – The University of Michigan School of Dentistry & Department of Epidemiology • Considerations Regarding Osteonecrosis of the Jaw • Presented by Robert Francis Gagel, MD – the University of Texas, Anderson Cancer Center & Elgene G. Mainous, DDS, FACD – The University of Texas Medical Branch • Dental Risk Management for Health Center Oral Health Programs • Presented by Ron Salyk, DDS – Vice President, Dentistry and Chair of Infection Control Committee, Morris Heights Health Center & Juris Svarcbergs, DMD, MPH – CAMcare Health Corporation/University of Pennsylvania School of Medicine/ Morris Heights Health Center • And more… check http://www.cdnetwork.org/NewCDN/LibrarySearch.aspx?name=Dental/Oral%20Medicine Dental Quality Assurance Software, Manual and Dental/Oral Medicine Webcasts http://www.cdnetwork.org/NewCDN/CDROM.aspx 48

  49. To register for upcoming CDN webcasts, go to www.CDNetwork.org and click on “Upcoming Webcasts”. Please visit our webcast “Library” to view many more archived webcasts.To receive email announcements of our upcoming webcasts and events, send an email to eLearning@CDNetwork.orgwith “subscribe” in the subject line. For more information about webcasts production, please contact us at: 212-382-0699 ext. 231 - eLearning@CDNetwork.org Clinical Directors Network, Inc (CDN) 5 West 37th Street – 10th Floor New York, NY 10018 49

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