TY - JOUR
T1 - Periodontal disease and chronic kidney disease among Aboriginal adults; An RCT
AU - Jamieson, Lisa
AU - Skilton, Michael
AU - Maple-Brown, Louise
AU - Kapellas, Kostas
AU - Askie, Lisa
AU - Hughes, Jaqui
AU - Arrow, Peter
AU - Cherian, Sajiv
AU - Fernandes, David
AU - Pawar, Basant
AU - Brown, Alex
AU - Boffa, John
AU - Hoy, Wendy
AU - Harris, David
AU - Mueller, Nicole
AU - Cass, Alan
N1 - Funding Information:
The Perio-CKD Study was funded by the National Health and Medical Research Council of Australia (NHMRC, Project Grant#1078077). LMJ is supported by NHMRC Fellowship #1045800. MRS is supported by a National Heart Foundation of Australia Future Leader Fellowship (#100419). LMB is supported by NHMRC Practitioner Fellowship (#1078477).
Funding Information:
The authors gratefully acknowledge the support of Perio-CKD study staff, Northern Territory Renal Services, Northern Territory Oral Health Service, Western Dessert Nganampa Walytja Palyantjaku Tjuteku and Central Australian Aboriginal Congress. The Perio-CKD Study was funded by the National Health and Medical Research Council of Australia (NHMRC, Project Grant#1078077). LMJ is supported by NHMRC Fellowship #1045800. MRS is supported by a National Heart Foundation of Australia Future Leader Fellowship (#100419). LMB is supported by NHMRC Practitioner Fellowship (#1078477). Funding bodies will have no role in the study design, in the collection, analysis or interpretation of data, in the writing of the manuscript or the decision to submit the manuscript for publication. Prepared for BMC Public Health.
Publisher Copyright:
© 2015 Jamieson et al.
PY - 2015/10/31
Y1 - 2015/10/31
N2 - Background: This study will assess measures of vascular health and inflammation in Aboriginal Australian adults with chronic kidney disease (CKD), and determine if intensive periodontal intervention improves cardiovascular health, progression of renal disease and periodontal health over a 24-month follow-up. Methods: The study will be a randomised controlled trial. All participants will receive the periodontal intervention benefits, with the delayed intervention group receiving periodontal treatment 24 months following baseline. Inclusion criteria include being an Aboriginal Australian, having CKD (a. on dialysis; b. eGFR levels of <60 mls/min/1.73 m2 (CKD Stages 3 to 5); c. ACR ≥30 mg/mmol irrespective of eGFR (CKD Stages 1 and 2); d. diabetes plus albuminuria (ACR ≥ 3 mg/mmol) irrespective of eGFR), having moderate or severe periodontal disease, having at least 12 teeth, and living in Central Australia for the 2-year study duration. The intervention involves intensive removal of dental plaque biofilms by scaling, root-planing and removal of teeth that cannot be saved. The intervention will occur in three visits; baseline, 3-month and 6-month follow-up. The primary outcome will be changes in carotid intima-media thickness (cIMT). Secondary outcomes will include progression of CKD or death as a consequence of CKD/cardiovascular disease. Progression of CKD will be defined by time to the development of the first of: (1) new development of macroalbuminuria; (2) 30 % loss of baseline eGFR; (3) progression to end stage kidney disease defined by eGFR <15 mLs/min/1.73 m2; (4) progression to end stage kidney disease defined by commencement of renal replacement therapy. A sample size of 472 is necessary to detect a difference in cIMT of 0.026 mm (SD 0.09) at the significance criterion of 0.05 and a power of 0.80. Allowing for 20 % attrition, 592 participants are necessary at baseline, rounded to 600 for convenience. Discussion: This will be the first RCT evaluating the effect of periodontal therapy on progression of CKD and cardiovascular disease among Aboriginal patients with CKD. Demonstration of a significant attenuation of CKD progression and cardiovascular disease has the potential to inform clinicians of an important, new and widely available strategy for reducing CKD progression and cardiovascular disease for Australia's most disadvantaged population.
AB - Background: This study will assess measures of vascular health and inflammation in Aboriginal Australian adults with chronic kidney disease (CKD), and determine if intensive periodontal intervention improves cardiovascular health, progression of renal disease and periodontal health over a 24-month follow-up. Methods: The study will be a randomised controlled trial. All participants will receive the periodontal intervention benefits, with the delayed intervention group receiving periodontal treatment 24 months following baseline. Inclusion criteria include being an Aboriginal Australian, having CKD (a. on dialysis; b. eGFR levels of <60 mls/min/1.73 m2 (CKD Stages 3 to 5); c. ACR ≥30 mg/mmol irrespective of eGFR (CKD Stages 1 and 2); d. diabetes plus albuminuria (ACR ≥ 3 mg/mmol) irrespective of eGFR), having moderate or severe periodontal disease, having at least 12 teeth, and living in Central Australia for the 2-year study duration. The intervention involves intensive removal of dental plaque biofilms by scaling, root-planing and removal of teeth that cannot be saved. The intervention will occur in three visits; baseline, 3-month and 6-month follow-up. The primary outcome will be changes in carotid intima-media thickness (cIMT). Secondary outcomes will include progression of CKD or death as a consequence of CKD/cardiovascular disease. Progression of CKD will be defined by time to the development of the first of: (1) new development of macroalbuminuria; (2) 30 % loss of baseline eGFR; (3) progression to end stage kidney disease defined by eGFR <15 mLs/min/1.73 m2; (4) progression to end stage kidney disease defined by commencement of renal replacement therapy. A sample size of 472 is necessary to detect a difference in cIMT of 0.026 mm (SD 0.09) at the significance criterion of 0.05 and a power of 0.80. Allowing for 20 % attrition, 592 participants are necessary at baseline, rounded to 600 for convenience. Discussion: This will be the first RCT evaluating the effect of periodontal therapy on progression of CKD and cardiovascular disease among Aboriginal patients with CKD. Demonstration of a significant attenuation of CKD progression and cardiovascular disease has the potential to inform clinicians of an important, new and widely available strategy for reducing CKD progression and cardiovascular disease for Australia's most disadvantaged population.
UR - http://www.scopus.com/inward/record.url?scp=84945903274&partnerID=8YFLogxK
U2 - 10.1186/s12882-015-0169-3
DO - 10.1186/s12882-015-0169-3
M3 - Article
C2 - 26520140
AN - SCOPUS:84945903274
SN - 1471-2369
VL - 16
JO - BMC Nephrology
JF - BMC Nephrology
IS - 1
M1 - 181
ER -
