Department of Translational Research, Tsurumi University School of Dental Medicine, Yokohama, Japan.
Department of Operative Dentistry, Tsurumi University School of Dental Medicine, Yokohama, Japan.
PLoS One. 2021 Sep 23;16(9):e0257247. doi: 10.1371/journal.pone.0257247. eCollection 2021.
Although a significant association between periodontal disease and atherosclerotic cardiovascular disease has been reported, their cause-to-effect relationship remains controversial. This randomized controlled clinical trial aimed to investigate the effect of advanced self-care on atherosclerotic cardiovascular disease-related vascular function markers flow-mediated brachial artery dilatation (FMD) and serum asymmetric dimethylarginine (ADMA) level in patients with early-stage periodontal disease. The study was designed as a parallel group, 3-month follow-up, open-label, randomized controlled trial. The control group received standard care for periodontal diseases, whereas the test group additionally applied disinfectant using a custom-fabricated prescription tray for advanced self-care twice a day. Overall, 110 patients provided data for FMD and serum ADMA level. No significant improvements in FMD were observed in the control (mean increase, -0.1%; 95% confidence interval [CI], -1.0-0.8; P = 0.805) or test (mean increase, -0.3%; 95% CI, -1.1-0.4; P = 0.398) group. No significant changes in serum ADMA levels were observed (mean reduction, 0.01 μmol/L; 95% CI, -0.00-0.02; P = 0.366 and mean reduction, 0.00 μmol/L; 95% CI, -0.01-0.01; P = 0.349, respectively). No significant between-group differences were found in FMD (mean difference, -0.2%; 95% CI, -1.4-0.9; p = 0.708) or serum ADMA levels (mean difference, 0.01 nmol/L; 95% CI, -0.00-0.03; p = 0.122). Significant improvements in the average probing pocket depth were observed in the control and test groups. The bleeding on probing score in the test group was significantly reduced, while that in the control group was reduced, although not significantly. Periodontal care for a 3-month duration did not provide better endothelial function although improvements of periodontal status in patients with early-stage periodontal diseases. This trial is registered in UMIN Clinical Trials Registry (www.umin.ac.jp/ctr/; ID: UMIN000023395).
尽管已有研究报道牙周病与动脉粥样硬化性心血管疾病之间存在显著关联，但它们之间的因果关系仍存在争议。本随机对照临床试验旨在探讨在牙周病早期患者中，高级自我护理对与动脉粥样硬化性心血管疾病相关的血管功能标志物——血流介导的肱动脉扩张（FMD）和血清不对称二甲基精氨酸（ADMA）水平的影响。该研究采用平行组、3 个月随访、开放标签、随机对照试验设计。对照组接受牙周病的标准护理，而试验组则每天使用定制的处方托盘进行两次消毒剂高级自我护理。共有 110 名患者提供了 FMD 和血清 ADMA 水平的数据。对照组（平均增加-0.1%；95%置信区间（CI）-1.0 至 0.8；P=0.805）或试验组（平均增加-0.3%；95%CI-1.1 至 0.4；P=0.398）的 FMD 均无显著改善。血清 ADMA 水平也无显著变化（平均降低 0.01 μmol/L；95%CI-0.00 至 0.02；P=0.366 和平均降低 0.00 μmol/L；95%CI-0.01 至 0.01；P=0.349）。FMD（平均差异-0.2%；95%CI-1.4 至 0.9；p=0.708）或血清 ADMA 水平（平均差异 0.01 nmol/L；95%CI-0.00 至 0.03；p=0.122）之间无显著组间差异。对照组和试验组的平均探诊袋深度均显著改善。试验组的探诊出血评分显著降低，而对照组虽有所降低，但无统计学意义。牙周护理 3 个月并未改善内皮功能，尽管早期牙周病患者的牙周状况有所改善。本试验已在日本临床试验注册中心（www.umin.ac.jp/ctr/；ID：UMIN000023395）注册。
