Results from the Periodontitis and Vascular Events (PAVE) study: A pilot multicentered, randomized, controlled trial to study effects of periodontal therapy in a secondary prevention model of cardiovascular disease

Steven Offenbacher, James D. Beck, Kevin Moss, Luisito Mendoza, David W. Paquette, David A. Barrow, David J. Couper, Dawn D. Stewart, Karen L. Falkner, Susan P. Graham, Sara Grossi, John C. Gunsolley, Theresa Madden, Gerardo Maupome, Maurizio Trevisan, Thomas E. Van Dyke, Robert J. Genco

Research output: Contribution to journalArticle

142 Citations (Scopus)

Abstract

Background: In the Periodontitis and Vascular Events (PAVE) pilot study, periodontal therapy was provided as an intervention in a secondary cardiac event prevention model through five coordinated cardiac-dental centers. Methods: Subjects were randomized to either community care or protocol provided scaling and root planing to evaluate effects on periodontal status and systemic levels of high-sensitivity C-reactive protein (hs-CRP). Results: After 6 months, there was a significant reduction inmean probing depth and extent of 4- or 5-mm pockets. However, there were no significant differences in attachment levels, bleeding upon probing, or extent of subgingival calculus comparing subjects assigned to protocol therapy (n = 151) to those assigned to community care (n = 152). Using intent-to-treat analyses, there was no significant effect on serumhs-CRP levels at 6 months. However, 48% of the subjects randomized to community care received preventive or periodontal treatments. Secondary analyses demonstrated that consideration of any preventive or periodontal care (i.e., any treatment) compared to no treatment showed a significant reduction in the percentage of people with elevated hs-CRP (values >3 mg/l) at 6 months. However, obesity nullified the periodontal treatment effects on hs-CRP reduction. The adjusted odds ratio for hs-CRP levels >3 mg/l at 6 months for any treatment versus no treatment among non-obese individuals was 0.26 (95% confidence interval: 0.09 to 0.72), adjusting for smoking, marital status, and gender. Conclusion: This pilot study demonstrated the critical role of considering obesity as well as rigorous preventive and periodontal care in trials designed to reduce cardiovascular risk.

Original languageEnglish (US)
Pages (from-to)190-201
Number of pages12
JournalJournal of Periodontology
Volume80
Issue number2
DOIs
StatePublished - Feb 2009

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Periodontitis
Secondary Prevention
Blood Vessels
Cardiovascular Diseases
Randomized Controlled Trials
C-Reactive Protein
Preventive Medicine
Therapeutics
Obesity
Root Planing
Calculi
Marital Status
Tooth
Smoking
Odds Ratio
Confidence Intervals
Hemorrhage

Keywords

  • C-reactive protein
  • Cardiovascular diseases
  • Controlled clinical trial
  • Obesity
  • Periodontitis
  • Prevention

ASJC Scopus subject areas

  • Periodontics

Cite this

Results from the Periodontitis and Vascular Events (PAVE) study : A pilot multicentered, randomized, controlled trial to study effects of periodontal therapy in a secondary prevention model of cardiovascular disease. / Offenbacher, Steven; Beck, James D.; Moss, Kevin; Mendoza, Luisito; Paquette, David W.; Barrow, David A.; Couper, David J.; Stewart, Dawn D.; Falkner, Karen L.; Graham, Susan P.; Grossi, Sara; Gunsolley, John C.; Madden, Theresa; Maupome, Gerardo; Trevisan, Maurizio; Van Dyke, Thomas E.; Genco, Robert J.

In: Journal of Periodontology, Vol. 80, No. 2, 02.2009, p. 190-201.

Research output: Contribution to journalArticle

Offenbacher, S, Beck, JD, Moss, K, Mendoza, L, Paquette, DW, Barrow, DA, Couper, DJ, Stewart, DD, Falkner, KL, Graham, SP, Grossi, S, Gunsolley, JC, Madden, T, Maupome, G, Trevisan, M, Van Dyke, TE & Genco, RJ 2009, 'Results from the Periodontitis and Vascular Events (PAVE) study: A pilot multicentered, randomized, controlled trial to study effects of periodontal therapy in a secondary prevention model of cardiovascular disease', Journal of Periodontology, vol. 80, no. 2, pp. 190-201. https://doi.org/10.1902/jop.2009.080007
Offenbacher, Steven ; Beck, James D. ; Moss, Kevin ; Mendoza, Luisito ; Paquette, David W. ; Barrow, David A. ; Couper, David J. ; Stewart, Dawn D. ; Falkner, Karen L. ; Graham, Susan P. ; Grossi, Sara ; Gunsolley, John C. ; Madden, Theresa ; Maupome, Gerardo ; Trevisan, Maurizio ; Van Dyke, Thomas E. ; Genco, Robert J. / Results from the Periodontitis and Vascular Events (PAVE) study : A pilot multicentered, randomized, controlled trial to study effects of periodontal therapy in a secondary prevention model of cardiovascular disease. In: Journal of Periodontology. 2009 ; Vol. 80, No. 2. pp. 190-201.
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abstract = "Background: In the Periodontitis and Vascular Events (PAVE) pilot study, periodontal therapy was provided as an intervention in a secondary cardiac event prevention model through five coordinated cardiac-dental centers. Methods: Subjects were randomized to either community care or protocol provided scaling and root planing to evaluate effects on periodontal status and systemic levels of high-sensitivity C-reactive protein (hs-CRP). Results: After 6 months, there was a significant reduction inmean probing depth and extent of 4- or 5-mm pockets. However, there were no significant differences in attachment levels, bleeding upon probing, or extent of subgingival calculus comparing subjects assigned to protocol therapy (n = 151) to those assigned to community care (n = 152). Using intent-to-treat analyses, there was no significant effect on serumhs-CRP levels at 6 months. However, 48{\%} of the subjects randomized to community care received preventive or periodontal treatments. Secondary analyses demonstrated that consideration of any preventive or periodontal care (i.e., any treatment) compared to no treatment showed a significant reduction in the percentage of people with elevated hs-CRP (values >3 mg/l) at 6 months. However, obesity nullified the periodontal treatment effects on hs-CRP reduction. The adjusted odds ratio for hs-CRP levels >3 mg/l at 6 months for any treatment versus no treatment among non-obese individuals was 0.26 (95{\%} confidence interval: 0.09 to 0.72), adjusting for smoking, marital status, and gender. Conclusion: This pilot study demonstrated the critical role of considering obesity as well as rigorous preventive and periodontal care in trials designed to reduce cardiovascular risk.",
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author = "Steven Offenbacher and Beck, {James D.} and Kevin Moss and Luisito Mendoza and Paquette, {David W.} and Barrow, {David A.} and Couper, {David J.} and Stewart, {Dawn D.} and Falkner, {Karen L.} and Graham, {Susan P.} and Sara Grossi and Gunsolley, {John C.} and Theresa Madden and Gerardo Maupome and Maurizio Trevisan and {Van Dyke}, {Thomas E.} and Genco, {Robert J.}",
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AU - Beck, James D.

AU - Moss, Kevin

AU - Mendoza, Luisito

AU - Paquette, David W.

AU - Barrow, David A.

AU - Couper, David J.

AU - Stewart, Dawn D.

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AU - Graham, Susan P.

AU - Grossi, Sara

AU - Gunsolley, John C.

AU - Madden, Theresa

AU - Maupome, Gerardo

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AU - Genco, Robert J.

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N2 - Background: In the Periodontitis and Vascular Events (PAVE) pilot study, periodontal therapy was provided as an intervention in a secondary cardiac event prevention model through five coordinated cardiac-dental centers. Methods: Subjects were randomized to either community care or protocol provided scaling and root planing to evaluate effects on periodontal status and systemic levels of high-sensitivity C-reactive protein (hs-CRP). Results: After 6 months, there was a significant reduction inmean probing depth and extent of 4- or 5-mm pockets. However, there were no significant differences in attachment levels, bleeding upon probing, or extent of subgingival calculus comparing subjects assigned to protocol therapy (n = 151) to those assigned to community care (n = 152). Using intent-to-treat analyses, there was no significant effect on serumhs-CRP levels at 6 months. However, 48% of the subjects randomized to community care received preventive or periodontal treatments. Secondary analyses demonstrated that consideration of any preventive or periodontal care (i.e., any treatment) compared to no treatment showed a significant reduction in the percentage of people with elevated hs-CRP (values >3 mg/l) at 6 months. However, obesity nullified the periodontal treatment effects on hs-CRP reduction. The adjusted odds ratio for hs-CRP levels >3 mg/l at 6 months for any treatment versus no treatment among non-obese individuals was 0.26 (95% confidence interval: 0.09 to 0.72), adjusting for smoking, marital status, and gender. Conclusion: This pilot study demonstrated the critical role of considering obesity as well as rigorous preventive and periodontal care in trials designed to reduce cardiovascular risk.

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