Jamieson Lisa, Skilton Michael, Maple-Brown Louise, Kapellas Kostas, Askie Lisa, Hughes Jaqui, Arrow Peter, Cherian Sajiv, Fernandes David, Pawar Basant, Brown Alex, Boffa John, Hoy Wendy, Harris David, Mueller Nicole, Cass Alan
Indigenous Oral Health Unit, University of Adelaide, Adelaide, Australia.
Boden Institute, Unversity of Sydney, Sydney, Australia.
BMC Nephrol. 2015 Oct 31;16:181. doi: 10.1186/s12882-015-0169-3.
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.
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 m(2) (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 m(2); (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.
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.
This trial is registered with the Australian New Zealand Clinical Trial Registry ANZCTR12614001183673.
本研究将评估患有慢性肾脏病（CKD）的澳大利亚原住民成年人的血管健康和炎症指标，并确定强化牙周干预在24个月的随访期内是否能改善心血管健康、肾脏疾病进展和牙周健康状况。
该研究将是一项随机对照试验。所有参与者都将获得牙周干预的益处，延迟干预组将在基线后24个月接受牙周治疗。纳入标准包括为澳大利亚原住民、患有CKD（a.正在接受透析；b.估算肾小球滤过率（eGFR）水平<60毫升/分钟/1.73平方米（CKD 3至5期）；c.无论eGFR如何，尿白蛋白肌酐比值（ACR）≥30毫克/毫摩尔（CKD 1和2期）；d.糖尿病加白蛋白尿（ACR≥3毫克/毫摩尔），无论eGFR如何）、患有中度或重度牙周疾病、至少有12颗牙齿，并且在为期2年的研究期间居住在澳大利亚中部地区。干预措施包括通过龈上洁治、根面平整以及拔除无法保留的牙齿来强化清除牙菌斑生物膜。干预将分三次进行；基线、3个月和6个月随访。主要结局将是颈动脉内膜中层厚度（cIMT）的变化。次要结局将包括CKD进展或因CKD/心血管疾病导致的死亡。CKD进展将根据以下情况首次出现的时间来定义：（1）新出现大量白蛋白尿；（2）基线eGFR下降30%；（3）进展至终末期肾病，定义为eGFR<15毫升/分钟/1.73平方米；（4）进展至终末期肾病，定义为开始肾脏替代治疗。在显著性标准为0.05且检验效能为0.80的情况下，需要472个样本量才能检测到cIMT有0.026毫米（标准差0.09）的差异。考虑到20%的损耗率，基线时需要592名参与者，为方便起见四舍五入为600名。
这将是第一项评估牙周治疗对患有CKD的原住民患者的CKD进展和心血管疾病影响的随机对照试验。证明CKD进展和心血管疾病有显著减轻，有可能为临床医生提供一种重要、新颖且广泛可用的策略，以减少澳大利亚最弱势群体的CKD进展和心血管疾病。
本试验已在澳大利亚新西兰临床试验注册中心（ANZCTR）注册，注册号为ANZCTR12614001183673。
