期刊
JOURNAL OF PERIODONTOLOGY
卷 79, 期 1, 页码 90-96出版社
WILEY
DOI: 10.1902/jop.2008.070223
关键词
cardiovascular disease; controlled clinical trial; periodontal disease; pilot study; subgingival scaling
资金
- NATIONAL INSTITUTE OF DENTAL &CRANIOFACIAL RESEARCH [U01DE013940] Funding Source: NIH RePORTER
- NIDCR NIH HHS [U01 DE13940] Funding Source: Medline
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.
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