The periodontitis and vascular events (PAVE) pilot study: Recruitment, retention, and community care controls

David J. Couper, James D. Beck, Karen L. Falkner, Susan P. Graham, Sara G. Grossi, John C. Gunsolley, Theresa Madden, Gerardo Maupome, Steven Offenbacher, Dawn D. Stewart, Maurizio Trevisan, Thomas E. Van Dyke, Robert J. Genco

Research output: Contribution to journalArticle

28 Scopus citations

Abstract

Background: 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. Methods: 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. Results: 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 Of those who had not withdrawn, 93% completed the 6-month contact.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. Conclusions: 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.

Original languageEnglish (US)
Pages (from-to)80-89
Number of pages10
JournalJournal of periodontology
Volume79
Issue number1
DOIs
StatePublished - Jan 1 2008

Keywords

  • Cardiovascular disease
  • Controlled clinical trial
  • Periodontal disease
  • Pilot study
  • Subgingival scaling

ASJC Scopus subject areas

  • Periodontics

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    Couper, D. J., Beck, J. D., Falkner, K. L., Graham, S. P., Grossi, S. G., Gunsolley, J. C., Madden, T., Maupome, G., Offenbacher, S., Stewart, D. D., Trevisan, M., Van Dyke, T. E., & Genco, R. J. (2008). The periodontitis and vascular events (PAVE) pilot study: Recruitment, retention, and community care controls. Journal of periodontology, 79(1), 80-89. https://doi.org/10.1902/jop.2008.070216