title: The Kidney and Periodontal Disease (KAPD) study: A pilot randomized controlled trial testing the effect of non-surgical periodontal therapy on chronic kidney disease.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
authors.affiliation: 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.
authors.forename: Vanessa
authors.initials: V
authors.lastname: Grubbs
authors.affiliation: 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.
authors.forename: Faviola
authors.initials: F
authors.lastname: Garcia
authors.affiliation: 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.
authors.forename: Bonnie L
authors.initials: BL
authors.lastname: Jue
authors.affiliation: Division of Epidemiology & Biostatistics, University of California, San Francisco, 550 16th Street, San Francisco, CA 94158, USA. Electronic address: Eric.Vittinghoff@ucsf.edu.
authors.forename: Eric
authors.initials: E
authors.lastname: Vittinghoff
authors.affiliation: 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.
authors.forename: Mark
authors.initials: M
authors.lastname: Ryder
authors.affiliation: Division of Nephrology, San Francisco Veterans Affairs Medical Center, 4150 Clement Street, San Francisco, CA 94121, USA. Electronic address: David.Lovett@ucsf.edu.
authors.forename: David
authors.initials: D
authors.lastname: Lovett
authors.affiliation: 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.
authors.forename: Jacqueline
authors.initials: J
authors.lastname: Carrillo
authors.affiliation: 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.
authors.forename: Steven
authors.initials: S
authors.lastname: Offenbacher
authors.affiliation: Division of Cardiology, University of California, San Francisco, 1001 Potrero Avenue, Building 5, San Francisco, CA 94110, USA. Electronic address: Peter.Ganz@ucsf.edu.
authors.forename: Peter
authors.initials: P
authors.lastname: Ganz
authors.affiliation: 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.
authors.forename: Kirsten
authors.initials: K
authors.lastname: Bibbins-Domingo
authors.affiliation: Department of Medicine, University of California, San Francisco, 1001 Potrero Avenue, Building 5, San Francisco, CA 94110, USA. Electronic address: neil.powe@ucsf.edu.
authors.forename: Neil R
authors.initials: NR
authors.lastname: Powe
mesh_terms: D000328:Adult; D000419:Albuminuria / Q000378:metabolism; D003404:Creatinine / Q000378:metabolism; D018450:Disease Progression; D005260:Female; D006801:Humans; D000071068:Lipocalin-2 / Q000378:metabolism; D008297:Male; D008875:Middle Aged; D010510:Periodontal Diseases / Q000150:complications / Q000628:therapy; D010512:Periodontal Index; D010518:Periodontitis / Q000150:complications / Q000628:therapy*; D010865:Pilot Projects; D051436:Renal Insufficiency, Chronic / Q000150:complications / Q000378:metabolism*; D035862:Vulnerable Populations; D055815:Young Adult
chemical_list: C489506:LCN2 protein, human; D000071068:Lipocalin-2; D003404:Creatinine
keywords: (max 6) chronic kidney disease; Non-surgical periodontal disease treatment; Periodontal disease; Periodontitis, oral health