Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00066053
Status:
COMPLETED
Last Update Posted:
2011-08-05
First Post:
2003-08-01
Brief Title:
Periodontitis and Cardiovascular Events or PAVE
Sponsor:
University at Buffalo
Organization:
University at Buffalo
Study Overview
Official Title:
Periodontal Intervention for Cardiac Events A Pilot Trial
Status:
COMPLETED
Status Verified Date:
2007-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine if treating periodontal infections gum problems will lead to fewer heart problems in patients at high risk for cardiovascular disease
Detailed Description:
There is growing evidence of a strong association between infection and atherosclerosis as well as a specific link between periodontal infection gum problems and heart disease Previous studies have established possible effective treatments of periodontal disease These treatments may lead to fewer heart events in persons at high risk for cardiovascular disease In contrast to previous heart disease studies the primary treatment in this project is directed toward infectious agents at periodontal sites This project is a pilot randomized clinical trial to test the feasibility of selecting and refining a periodontal infection treatment and examining the effect of that treatment on future heart events It is a multi-center planning and pilot study involving five investigational centers at the University at Buffalo lead and overall coordinating center University of North Carolina Boston University Kaiser PermanenteOregon Health Science University University of Maryland and a data coordinating center at the University of North Carolina Central microbiology and cytokine laboratories and a biologic specimen bank are also included A team of cardiologists periodontists epidemiologists infectious disease specialists biostatisticians research nurses in periodontics and cardiology and data managers has been assembled to accomplish the research with a careful cost-effective approach The ultimate goal is to develop a definitive randomized clinical trial that will include about 4000 participants from approximately 15 centers across the United States
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01DE013940 | NIH | None | httpsreporternihgovquickSearchU01DE013940 |