Article

The Periodontitis and Vascular Events (PAVE) pilot study: recruitment, retention, and community care controls.

Department of Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill, NC 27514, USA.
Journal of Periodontology (Impact Factor: 2.57). 02/2008; 79(1):80-9. DOI: 10.1902/jop.2008.070216
Source: PubMed

ABSTRACT Population-based clinical and laboratory studies have reported findings providing support for a possible 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.
Five clinical centers recruited participants who had documented coronary heart disease and met study criteria for periodontal disease. Eligible participants were randomized to receive periodontal therapy provided by the study or community dental care. Follow-up telephone calls and clinic visits were planned to alternate at 3-month intervals after randomization, with all participants followed until at least the 6-month clinic visit. Participants were followed for adverse events and periodontal and cardiovascular outcomes.
A total of 303 participants were randomized. Recruitment that involved active participation of a cardiologist with responsibility for the patients worked best among the strategies used. Of those who had not withdrawn, 93% completed the 6-month contact. During follow-up, 11% of the 152 subjects in the community dental care group reported receiving periodontal therapy outside of the study.
If appropriate recruitment strategies are used, this pilot study demonstrated that it is feasible to conduct a secondary prevention trial of periodontal therapy in patients who have had coronary heart disease. If a community dental care group is used, sample size estimation needs to take into account that a non-trivial proportion of participants in this group may receive periodontal therapy outside of the study.

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    • "In response, multi-center trials have begun. One multi-center trial is the Periodontitis and Vascular Events study, which randomly assigned patients to periodontal therapy or community dental care, but found no difference in outcomes in their pilot study (Couper et al., 2008; Beck et al., 2008). Although this pilot was not designed to be long enough nor large enough for an adequate estimate of treatment effects, another potential reason for this finding is that periodontal therapy was received by at least 11% of the control group. "
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