title: 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.
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 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.
authors.affiliation: Department of Periodontology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
authors.forename: Steven
authors.initials: S
authors.lastname: Offenbacher
authors.forename: James D
authors.initials: JD
authors.lastname: Beck
authors.forename: Kevin
authors.initials: K
authors.lastname: Moss
authors.forename: Luisito
authors.initials: L
authors.lastname: Mendoza
authors.forename: David W
authors.initials: DW
authors.lastname: Paquette
authors.forename: David A
authors.initials: DA
authors.lastname: Barrow
authors.forename: David J
authors.initials: DJ
authors.lastname: Couper
authors.forename: Dawn D
authors.initials: DD
authors.lastname: Stewart
authors.forename: Karen L
authors.initials: KL
authors.lastname: Falkner
authors.forename: Susan P
authors.initials: SP
authors.lastname: Graham
authors.forename: Sara
authors.initials: S
authors.lastname: Grossi
authors.forename: John C
authors.initials: JC
authors.lastname: Gunsolley
authors.forename: Theresa
authors.initials: T
authors.lastname: Madden
authors.forename: Gerardo
authors.initials: G
authors.lastname: Maupome
authors.forename: Maurizio
authors.initials: M
authors.lastname: Trevisan
authors.forename: Thomas E
authors.initials: TE
authors.lastname: Van Dyke
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Genco
mesh_terms: 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
chemical_list: D053583:Interleukin-1beta; D002097:C-Reactive Protein