The Periodontitis and Vascular Events (PAVE) Pilot Study: Recruitment, Retention, and Community Care Controls

Department of Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill, NC 27514, USA.
Journal of Periodontology (Impact Factor: 2.71). 02/2008; 79(1):80-9. DOI: 10.1902/jop.2008.070216
Source: PubMed


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.
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.
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 Of those who had not withdrawn, 93% completed the 6-month contact.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.
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.

Download full-text


Available from: Gerardo Maupomé, Aug 31, 2015
  • Source
    • "In response, multi-center trials have begun. One multi-center trial is the Periodontitis and Vascular Events study, which randomly assigned patients to periodontal therapy or community dental care, but found no difference in outcomes in their pilot study (Couper et al., 2008; Beck et al., 2008). Although this pilot was not designed to be long enough nor large enough for an adequate estimate of treatment effects, another potential reason for this finding is that periodontal therapy was received by at least 11% of the control group. "
    [Show abstract] [Hide abstract]
    ABSTRACT: Studies show a relationship between oral inflammatory processes and cardiovascular risk factors, suggesting that dental care may reduce the risk of cardiovascular disease (CVD) events. However, due to the differences between men and women in the development and presentation of CVD, such effects may vary by sex. We use a valid set of instrumental variables to evaluate these issues and include a test of essential heterogeneity. CVD events include new occurrences of heart attack (including death from heart attack), stroke (including death from stroke), angina, and congestive heart failure. Controls include age, race, education, marital status, foreign birthplace, and cardiovascular risk factors (health status, body mass index, alcohol use, smoking status, diabetes status, high-blood-pressure status, physical activity, and depression). Our analysis finds no evidence of essential heterogeneity. We find the minimum average treatment effect for women to be -0.01, but find no treatment effect for men. This suggests that women who receive dental care may reduce their risk of future CVD events by at least one-third. The findings may only apply to married middle-aged and older individuals as the data set is only representative for this group.
    Full-text · Article · Oct 2011 · Health Economics
  • Source
    • "Randomized controlled trials, using populations at higher risk for future cardiovascular events, with more severe periodontal disease might enlighten us as regards several unresolved issues on the association between periodontitis and CAD. To implement such a project, close collaboration of cardiologists and periodontologists is imperative and the design of future studies should appropriately assess the extent of the exposure variable [16] [42]. "
    [Show abstract] [Hide abstract]
    ABSTRACT: Periodontitis is a bacterially-induced, localized chronic inflammatory disease destroying both the connective tissue and the supporting bone of the teeth. In the general population, severe forms of the disease demonstrate a prevalence of almost 5%, whereas initial epidemiological evidence suggests an association between periodontitis and coronary artery disease (CAD). Both the infectious nature of periodontitis and the yet etiologically unconfirmed infectious hypothesis of CAD, question their potential association. Ephemeral bacteremia, systemic inflammation and immune-pathological reactions constitute a triad of mechanisms supporting a cross-talk between periodontal and vascular damage. To which extent each of these periodontitis-mediated components contribute to vascular damage still remains uncertain. More than twenty years from the initial epidemiological association, the positive weight of evidence remains still alive but rather debated, because of both the presence of many uncontrolled confounding factors and the different assessment of periodontal disease. From the clinical point of view, advising periodontal prevention or treatment targeting on the prevention of CAD it is unjustified. By contrast, oral hygiene including periodontal health might contribute to the overall well-being and healthy lifestyle and hence as might at least partially contribute to cardiovascular prevention.
    Full-text · Article · Jan 2011 · American Journal of Cardiovascular Disease
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: 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. 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. 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. 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.
    Full-text · Article · Feb 2008 · Journal of Periodontology
Show more