The Periodontitis and Vascular Events (PAVE) pilot study: recruitment, retention, and community care controls.
ABSTRACT 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 Of those who had not withdrawn, 93% completed the 6-month contact.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.
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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.Health Economics 10/2011; 20(10):1241-56. DOI:10.1002/hec.1667 · 2.14 Impact Factor
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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.01/2011; 1(1):76-83.
- European Heart Journal Supplements 04/2010; 12(suppl_B):3-12. DOI:10.1093/eurheartj/suq003 · 5.64 Impact Factor