The periodontitis and vascular events (PAVE) pilot study: Adverse events

James D. Beck, David J. Couper, 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

52 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)90-96
Number of pages7
JournalJournal of Periodontology
Volume79
Issue number1
DOIs
StatePublished - Jan 2008

Fingerprint

Periodontitis
Blood Vessels
Periodontal Diseases
Cardiovascular Diseases
Root Planing
Specimen Handling
Therapeutics
Dental Care
Laboratory Animals
Ambulatory Care
Group Psychotherapy
Random Allocation
Secondary Prevention
Telephone
Multicenter Studies
Heart Diseases
Tooth
Control Groups
Population

Keywords

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

ASJC Scopus subject areas

  • Dentistry(all)

Cite this

Beck, J. D., Couper, D. J., Falkner, K. L., Graham, S. P., Grossi, S. G., Gunsolley, J. C., ... Genco, R. J. (2008). The periodontitis and vascular events (PAVE) pilot study: Adverse events. Journal of Periodontology, 79(1), 90-96. https://doi.org/10.1902/jop.2008.070223

The periodontitis and vascular events (PAVE) pilot study : Adverse events. / 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.

In: Journal of Periodontology, Vol. 79, No. 1, 01.2008, p. 90-96.

Research output: Contribution to journalArticle

Beck, JD, Couper, DJ, Falkner, KL, Graham, SP, Grossi, SG, Gunsolley, JC, Madden, T, Maupome, G, Offenbacher, S, Stewart, DD, Trevisan, M, Van Dyke, TE & Genco, RJ 2008, 'The periodontitis and vascular events (PAVE) pilot study: Adverse events', Journal of Periodontology, vol. 79, no. 1, pp. 90-96. https://doi.org/10.1902/jop.2008.070223
Beck JD, Couper DJ, Falkner KL, Graham SP, Grossi SG, Gunsolley JC et al. The periodontitis and vascular events (PAVE) pilot study: Adverse events. Journal of Periodontology. 2008 Jan;79(1):90-96. https://doi.org/10.1902/jop.2008.070223
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. / The periodontitis and vascular events (PAVE) pilot study : Adverse events. In: Journal of Periodontology. 2008 ; Vol. 79, No. 1. pp. 90-96.
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