The periodontitis and vascular events (PAVE) pilot study: Adverse events
The periodontitis and vascular events (PAVE) pilot study: Adverse events
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DOI：
10.1902/jop.2008.070223
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发表时间：
2008-01-01
影响因子：
4.3
通讯作者：
Genco, Robert J.
中科院分区：
文献类型：
--
作者：
Beck, James D.;Couper, David J.;Genco, Robert J.
背景资料：在过去的15年中，大量的基于人群的临床，实验室和动物研究已经发表，报告了牙周病和心血管疾病之间的关系的结果。牙周炎和血管事件（PAVE）试点研究旨在调查随机二级预防试验的可行性，以测试牙周病治疗是否可以降低心血管疾病的风险。本文介绍了不良事件的发生在pilot study.Methods：PAVE试点研究是一项多中心，随机试验比较牙周治疗社区牙科护理。基线和随访门诊访视包括牙周检查;血液、龈下菌斑和龈沟液标本采集;病史和牙科病史。电话随访联系安排在随机化后3个月，此后每6个月评估不良事件或endpoints.Results：心血管不良事件发生的频率相似（23与24 [P= 0.85]在社区对照组和治疗组，分别）。有15起严重不良事件（SAE），社区护理组发生的百分比无显著性升高（6.6% vs 3.3%; P = 0.19）。对严重不良事件模式的时间分析表明，牙周治疗组的受试者在整个25个月的研究中发生严重不良事件的可能性较小。对于那些留在研究中的人，似乎向心脏病患者提供牙周洁治和根面平整治疗导致了与社区护理组相似的不良事件模式，也接受了一些治疗。
Background: During the last 15 years, a substantial number of population-based, clinical, laboratory, and animal studies have been published that reported findings on the relationship between periodontal disease and cardiovascular disease. The Periodontitis and Vascular Events (PAVE) pilot study was conducted to investigate the feasibility of a randomized secondary prevention trial to test whether treatment of periodontal disease reduces the risk for cardiovascular disease. This article describes the occurrence of adverse events during the pilot study.Methods: The PAVE pilot study was a multicenter, randomized trial comparing periodontal therapy to community dental care. Baseline and follow-up clinic visits included a periodontal examination; blood, subgingival plaque, and crevicular fluid specimen collection; and medical and dental histories. Telephone follow-up contacts were scheduled to occur 3 months after randomization and every 6 months thereafter to assess adverse events or endpoints.Results: Cardiovascular adverse events occurred with similar frequency (23 versus 24 [P= 0.85] in the community control and the treatment groups, respectively). There were 15 serious adverse events (SAEs) with a non-significantly higher percentage occurring in the community care group (6.6% versus 3.3%; P = 0.19). A time-to-event analysis of patterns of SAEs indicated that subjects in the periodontal therapy group tended to be less likely to experience an SAE over the entire 25 months of the study.Conclusion: For those individuals who remained in the study, it appears that provision of periodontal scaling and root planing treatment to individuals with heart disease resulted in a similar pattern of adverse events as seen in the community care group, which also received some treatment.