The Periodontitis and Vascular Events (PAVE) pilot study: adverse events.
BACKGROUND
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.


METHODS
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.


RESULTS
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.


CONCLUSIONS
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.
Beck
James D
JD
Department of Dental Ecology, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, USA. james_beck@unc.edu
Couper
David J
DJ
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
D000038:Abscess / Q000209:etiology; D003153:Community Health Services; D017714:Community-Acquired Infections / Q000209:etiology; D003324:Coronary Artery Disease / Q000097:blood / Q000150:complications / Q000517:prevention & control*; D003729:Dental Care; D003774:Dental Plaque Index; D012534:Dental Scaling; D003863:Depression / Q000209:etiology; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D005883:Gingival Crevicular Fluid / Q000737:chemistry; D006801:Humans; D006973:Hypertension / Q000209:etiology; D008297:Male; D008875:Middle Aged; D009910:Oral Hygiene; D010518:Periodontitis / Q000097:blood / Q000150:complications / Q000517:prevention & control*; D010865:Pilot Projects; D011014:Pneumonia / Q000209:etiology; D016745:Root Planing; D013357:Subgingival Curettage; D014076:Tooth Diseases / Q000209:etiology; D016896:Treatment Outcome