The Periodontitis and Vascular Events (PAVE) pilot study: recruitment, retention, and community care controls.
BACKGROUND
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.


METHODS
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.


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 Of those who had not withdrawn, 93% completed the 6-month contact.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


CONCLUSIONS
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.
Couper
David J
DJ
Department of Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill, NC 27514, USA.
Beck
James D
JD
Falkner
Karen L
KL
Graham
Susan P
SP
Grossi
Sara G
SG
Gunsolley
John C
JC
Madden
Theresa
T
Maupome
Gerardo
G
Offenbacher
Steven
S
Stewart
Dawn D
DD
Trevisan
Maurizio
M
Van Dyke
Thomas E
TE
Genco
Robert J
RJ
D000368:Aged; D003153:Community Health Services; D035061:Control Groups; D003324:Coronary Artery Disease / Q000150:complications / Q000517:prevention & control*; D003729:Dental Care; D012534:Dental Scaling; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009910:Oral Hygiene; D010349:Patient Compliance; D018579:Patient Selection; D010518:Periodontitis / Q000150:complications / Q000517:prevention & control*; D010865:Pilot Projects; D012107:Research Design; D012307:Risk Factors; D016745:Root Planing; D018401:Sample Size; D012907:Smoking; D016896:Treatment Outcome