Abstract
BackgroundThis 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.MethodsThe 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.DiscussionThis 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.Trial registrationThis trial is registered with the Australian New Zealand Clinical Trial Registry ANZCTR12614001183673.
Highlights
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
Chronic kidney disease (CKD); the problem CKD is characterised by a progressive loss of renal function over a period of months or years culminating with end stage kidney disease (ESKD), when a person will require ongoing dialysis or a kidney transplant to stay alive, being the final stage of this progressive loss [5]
In a non-randomised clinical trial involving 40 people, Artese et al reported that periodontal therapy significantly improved eGFR among patients with CKD, whereas there were no differences in serum creatinine [33]
Summary
Study design This will be a delayed intervention RCT, with all participants receiving the periodontal intervention benefits (Fig. 1). Progression of CKD will include time to the development of the first of: (1) new development of macroalbuminuria (defined as ACR ≥30 mg/mmol); (2) 30 % loss of baseline eGFR (defined as a reduction of eGFR of 30 % or more from baseline and eGFR of less than 60mLs/min/1.73 m2); (3) progression to ESKD defined by eGFR
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