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.
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 in mean 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 serum hs-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.


CONCLUSIONS
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.
Offenbacher
Steven
S
Department of Periodontology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Beck
James D
JD
Moss
Kevin
K
Mendoza
Luisito
L
Paquette
David W
DW
Barrow
David A
DA
Couper
David J
DJ
Stewart
Dawn D
DD
Falkner
Karen L
KL
Graham
Susan P
SP
Grossi
Sara
S
Gunsolley
John C
JC
Madden
Theresa
T
Maupome
Gerardo
G
Trevisan
Maurizio
M
Van Dyke
Thomas E
TE
Genco
Robert J
RJ
D002097:C-Reactive Protein / Q000032:analysis*; D002318:Cardiovascular Diseases / Q000097:blood / Q000209:etiology / Q000517:prevention & control*; D003153:Community Health Services; D012534:Dental Scaling; D015987:Effect Modifier, Epidemiologic; D005260:Female; D005883:Gingival Crevicular Fluid / Q000737:chemistry; D006801:Humans; D053583:Interleukin-1beta / Q000032:analysis; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000097:blood / Q000150:complications*; D017063:Outcome Assessment, Health Care; D010518:Periodontitis / Q000097:blood / Q000150:complications / Q000628:therapy*; D010865:Pilot Projects; D055502:Secondary Prevention
D053583:Interleukin-1beta; D002097:C-Reactive Protein