Effect of periodontal therapy on biomarkers of cardiovascular disease: a randomized clinical trial

This randomized clinical trial is currently under the process of submission to a peer-review scientific journal. Contents available in this Fileset (published via Figshare): Tables, figures, and anonymized patient-level raw data. Abstract is also available below. Related publications: 1. Periodontal treatment effects on endothelial function and cardiovascular disease biomarkers in subjects with chronic periodontitis: protocol for a randomized clinical trial. (2011) Ramírez, Arce, Contreras. Trials URL (open access): http://www.trialsjournal.com/content/12/1/46 2. Biomarkers of cardiovascular disease are increased in untreated chronic periodontitis: a case control study (2014). Ramírez, Parra, Gutierrez et al. Australian dental journal. URL (open access): http://figshare.com/articles/Biomarkers_of_cardiovascular_disease_are_increased_in_untreated_chronic_periodontitis_a_case_control_study_/1096115 --------------------------------------------------------------------- <strong>Abstract</strong> Introduction The purpose of this interventional study (parallel, single blind, randomized controlled trial) was to assess the effect of periodontal therapy on biomarkers of cardiovascular disease in patients with chronic periodontitis. Materials and methods Subjects with chronic moderate to severe periodontitis were invited to participate in the study. Patients were randomized (stratified by gender/smoking status) to periodontal intervention therapy using the full mouth disinfection protocol (one-stage supragingival/subgingival plaque cleaning plus chlorhexidine 1%) or adult dental prophylaxis (supragingival plaque removal). Participants were monitored at baseline, 24 hours and 12 weeks after the assigned intervention. The primary outcome was the change of brachial artery endothelium-dependent flow mediated dilatation at 12-weeks post-therapy. Secondary outcomes included biochemical cardiovascular disease biomarkers (C-reactive protein, E-selectin, MPO, ICAM-1, VCAM-1, MMP-9, tPAI-1), lipid profile and white-cell count. Probing depth, clinical attachment loss, number of periodontal pockets and subgingival microbiota (determined by microbial culture and polymerase chain reaction) were used to diagnose disease severity and to evaluate the effectiveness of periodontal therapy. Results Patients were randomized to dental prophylaxis (n=55) and periodontal intervention therapy (n=47). At 12 weeks of follow-up, forty-seven patients in the dental prophylaxis group and forty-one patients in the periodontal intervention therapy completed the study. Full mouth disinfection compared to dental prophylaxis group did not result in significant changes on endothelial dependent flow-mediated dilatation and cardiovascular disease biomarkers at 12 weeks post-treatment. Even though clinical periodontal and microbiological parameters were improved. Conclusions Non-surgical periodontal treatment of moderate to severe chronic periodontitis with the full mouth disinfection protocol did not improve endothelial function and other inflammatory biomarkers of cardiovascular disease. ClinicalTrials.gov Identifier: NCT00681564

本随机临床试验目前正处于提交至同行评议科学期刊的阶段。本数据集（通过Figshare发布）包含以下内容：表格、图片以及匿名化的患者水平原始数据。下文亦附有研究摘要。相关出版物如下：
1. 《慢性牙周炎患者牙周治疗对内皮功能及心血管疾病生物标志物的影响：一项随机临床试验方案》（2011），作者：Ramírez、Arce、Contreras，刊载于《Trials》期刊，开放获取链接：http://www.trialsjournal.com/content/12/1/46
2. 《未治疗慢性牙周炎患者心血管疾病生物标志物水平升高：一项病例对照研究》（2014），作者：Ramírez、Parra、Gutierrez等，刊载于《澳大利亚牙科杂志》（Australian dental journal），开放获取链接：http://figshare.com/articles/Biomarkers_of_cardiovascular_disease_are_increased_in_untreated_chronic_periodontitis_a_case_control_study_/1096115

**摘要**

引言
本干预性研究（平行、单盲、随机对照试验）旨在评估牙周治疗对慢性牙周炎患者心血管疾病生物标志物的影响。

材料与方法
本研究招募患有慢性中重度牙周炎的受试者。按照性别/吸烟状态分层后，将患者随机分为两组：采用全口消毒方案（full mouth disinfection protocol）的牙周干预治疗组（一次性龈上/龈下菌斑清除联合1%氯己定治疗），以及成人牙科洁治组（仅行龈上菌斑清除）。分别在基线、干预后24小时及12周对受试者进行随访监测。本研究的主要结局为治疗后12周肱动脉内皮依赖性血流介导舒张（brachial artery endothelium-dependent flow mediated dilatation）的变化。次要结局包括心血管疾病生化生物标志物：C反应蛋白（C-reactive protein）、E选择素（E-selectin）、髓过氧化物酶（MPO）、细胞间黏附分子1（ICAM-1）、血管细胞黏附分子1（VCAM-1）、基质金属蛋白酶9（MMP-9）、组织型纤溶酶原激活物抑制剂1（tPAI-1），以及血脂谱与白细胞计数。采用探诊深度、临床附着丧失、牙周袋数量以及龈下微生物群（通过微生物培养及聚合酶链反应（Polymerase Chain Reaction）检测）来评估疾病严重程度及牙周治疗效果。

结果
本研究共将患者随机分至牙科洁治组（n=55）与牙周干预治疗组（n=47）。随访12周后，牙科洁治组有47例患者、牙周干预治疗组有41例患者完成本研究。与牙科洁治组相比，采用全口消毒方案的患者在治疗后12周的内皮依赖性血流介导舒张及心血管疾病生物标志物均未出现显著变化，尽管两组的临床牙周及微生物学参数均得到改善。

结论
采用全口消毒方案对中重度慢性牙周炎进行非手术牙周治疗，并未改善内皮功能及其他心血管疾病炎症生物标志物水平。

ClinicalTrials.gov注册号：NCT00681564