Vanessa Grubbs1, Faviola Garcia2, Bonnie L Jue3, Eric Vittinghoff4, Mark Ryder5, David Lovett6, Jacqueline Carrillo7, Steven Offenbacher8, Peter Ganz9, Kirsten Bibbins-Domingo10, Neil R Powe11. 1. Division of Nephrology, University of California, San Francisco, 1001 Potrero Avenue, Building 100, Room 342, San Francisco, CA 94110, USA. Electronic address: vanessa.grubbs@ucsf.edu. 2. Division of Nephrology, University of California, San Francisco, 1001 Potrero Avenue, Building 100, Room 342, San Francisco, CA 94110, USA. Electronic address: faviola.garcia@ucsf.edu. 3. Division of Oral Epidemiology & Dental Public Health, Department of Preventive & Restorative Dental Sciences, University of California, San Francisco, 3333 California Street, Ste 495, San Francisco, CA 94118, USA. Electronic address: bonnie.jue@ucsf.edu. 4. Division of Epidemiology & Biostatistics, University of California, San Francisco, 550 16th Street, San Francisco, CA 94158, USA. Electronic address: Eric.Vittinghoff@ucsf.edu. 5. Division of Periodontology, Department of Orofacial Sciences, School of Dentistry, University of California, San Francisco, 533 Parnassus Avenue, UC Hall, 94143, San Francisco, CA, USA. Electronic address: Mark.Ryder@ucsf.edu. 6. Division of Nephrology, San Francisco Veterans Affairs Medical Center, 4150 Clement Street, San Francisco, CA 94121, USA. Electronic address: David.Lovett@ucsf.edu. 7. Division of General Internal Medicine, University of California, San Francisco, 1001 Potrero Avenue, Building 10, San Francisco, CA 94110, USA. Electronic address: jacqueline.carrillo@ucsf.edu. 8. Department of Periodontology, Center for Oral and Systemic Diseases, UNC School of Dentistry, Koury Health Sciences Building, 385 S. Columbia Street, Room 3501F, Chapel Hill, NC 27599, USA. Electronic address: steven_offenbacher@unc.edu. 9. Division of Cardiology, University of California, San Francisco, 1001 Potrero Avenue, Building 5, San Francisco, CA 94110, USA. Electronic address: Peter.Ganz@ucsf.edu. 10. Division of General Internal Medicine, University of California, San Francisco, 550 16th Street, San Francisco, CA 94158, USA. Electronic address: Kirsten.bibbins-domingo@ucsf.edu. 11. Department of Medicine, University of California, San Francisco, 1001 Potrero Avenue, Building 5, San Francisco, CA 94110, USA. Electronic address: neil.powe@ucsf.edu.
Abstract
INTRODUCTION:Chronic kidney disease (CKD) remains a prevalent public health problem that disproportionately affects minorities and the poor, despite intense efforts targeting traditional risk factors. Periodontal diseases are common bacterial plaque-induced inflammatory conditions that can respond to treatment and have been implicated as a CKD risk factor. However there is limited evidence that treatment of periodontal disease slows the progression of CKD. METHODS/ DESIGN: We describe the protocol of the Kidney and Periodontal Disease (KAPD) study, a 12-month un-blinded, randomized, controlled pilot trial with two intent-to-treat treatment arms: 1. immediate intensive non-surgical periodontal treatment or 2. rescue treatment with delayed intensive treatment. The goals of this pilot study are to test the feasibility of conducting a larger trial in an ethnically and racially diverse, underserved population (mostly poor and/or low literacy) with both CKD and significant periodontal disease to determine the effect of intensive periodontal treatment on renal and inflammatory biomarkers over a 12-month period. RESULTS: To date, KAPD has identified 634 potentially eligible patients who were invited to in-person screening. Of the 83 (13.1%) of potentially eligible patients who attended in-person screening, 51 (61.4%) were eligible for participation and 46 enrolled in the study. The mean age of participants is 59.2years (range 34 to 73). Twenty of the participants (43.5%) are Black and 22 (47.8%) are Hispanic. DISCUSSION: Results from the KAPD study will provide needed preliminary evidence of the effectiveness of non-surgical periodontal treatment to slow CKD progression and inform the design future clinical research trials.
RCT Entities:
INTRODUCTION:Chronic kidney disease (CKD) remains a prevalent public health problem that disproportionately affects minorities and the poor, despite intense efforts targeting traditional risk factors. Periodontal diseases are common bacterial plaque-induced inflammatory conditions that can respond to treatment and have been implicated as a CKD risk factor. However there is limited evidence that treatment of periodontal disease slows the progression of CKD. METHODS/ DESIGN: We describe the protocol of the Kidney and Periodontal Disease (KAPD) study, a 12-month un-blinded, randomized, controlled pilot trial with two intent-to-treat treatment arms: 1. immediate intensive non-surgical periodontal treatment or 2. rescue treatment with delayed intensive treatment. The goals of this pilot study are to test the feasibility of conducting a larger trial in an ethnically and racially diverse, underserved population (mostly poor and/or low literacy) with both CKD and significant periodontal disease to determine the effect of intensive periodontal treatment on renal and inflammatory biomarkers over a 12-month period. RESULTS: To date, KAPD has identified 634 potentially eligible patients who were invited to in-person screening. Of the 83 (13.1%) of potentially eligible patients who attended in-person screening, 51 (61.4%) were eligible for participation and 46 enrolled in the study. The mean age of participants is 59.2years (range 34 to 73). Twenty of the participants (43.5%) are Black and 22 (47.8%) are Hispanic. DISCUSSION: Results from the KAPD study will provide needed preliminary evidence of the effectiveness of non-surgical periodontal treatment to slow CKD progression and inform the design future clinical research trials.
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