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The Periodontitis and Vascular Events (PAVE) pilot study: recruitment, retention, and community care controls
- Source :
- Journal of periodontology. 79(1)
- Publication Year :
- 2008
-
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 Of those who had not withdrawn, 93% completed the 6-month contact.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.
- Subjects :
- Male
medicine.medical_specialty
Randomization
Population
Pilot Projects
Disease
Coronary Artery Disease
Oral hygiene
law.invention
Root Planing
Coronary artery disease
Randomized controlled trial
law
Risk Factors
Internal medicine
Medicine
Humans
Community Health Services
education
Dental Care
Periodontitis
Aged
education.field_of_study
business.industry
Patient Selection
Smoking
Middle Aged
medicine.disease
Oral Hygiene
Control Groups
Clinical trial
Treatment Outcome
Research Design
Sample Size
Physical therapy
Periodontics
Dental Scaling
Feasibility Studies
Patient Compliance
Female
business
Follow-Up Studies
Subjects
Details
- ISSN :
- 00223492
- Volume :
- 79
- Issue :
- 1
- Database :
- OpenAIRE
- Journal :
- Journal of periodontology
- Accession number :
- edsair.doi.dedup.....a5f6af4fa6f3456d8bf10d273181f1e5