Premium
The Periodontitis and Vascular Events (PAVE) Pilot Study: Adverse Events
Author(s) -
Beck James D.,
Couper David J.,
Falkner Karen L.,
Graham Susan P.,
Grossi Sara G.,
Gunsolley John C.,
Madden Theresa,
Maupome Gerardo,
Offenbacher Steven,
Stewart Dawn D.,
Trevisan Maurizio,
Van Dyke Thomas E.,
Genco Robert J.
Publication year - 2008
Publication title -
journal of periodontology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.036
H-Index - 156
eISSN - 1943-3670
pISSN - 0022-3492
DOI - 10.1902/jop.2008.070223
Subject(s) - medicine , adverse effect , periodontitis , randomization , scaling and root planing , randomized controlled trial , clinical trial , periodontal disease , population , tooth loss , bleeding on probing , dentistry , chronic periodontitis , oral health , environmental health
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.