Periodontitis and Cardiovascular Events or "PAVE"
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00066053|
Recruitment Status : Completed
First Posted : August 5, 2003
Last Update Posted : August 5, 2011
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Disease Coronary Heart Disease Myocardial Infarction Cerebrovascular Accident||Procedure: Periodontal Treatment: SRP Procedure: Referral||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||303 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Periodontal Intervention for Cardiac Events: A Pilot Trial|
|Study Start Date :||January 2003|
|Actual Primary Completion Date :||June 2005|
|Actual Study Completion Date :||June 2005|
Experimental: Periodontal Treatment: SRP
Comprehensive scaling & root planing and subgingival tissue removal; fluorides applied as appropriate; oral hygiene instructions.
Procedure: Periodontal Treatment: SRP
Scaling and root planing. Subgingival tissue removal. Fluorides as needed. Oral hygiene instructions. Oral hygiene instructions.
Other Name: Treatment of periodontal infections.
Active Comparator: Community Comparator
Referral to community dentist with copy of x-rays and letter with diagnosis and recomendations for treatment.
- Patient outcomes are hospitalized for myocardial infarction (MI), cardiac revascularization, fatal coronary heart disease, unstable angina, and/or hospitalized ischemic stroke. [ Time Frame: One year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00066053
|United States, New York|
|University at Buffalo|
|Buffalo, New York, United States, 14214|
|Principal Investigator:||Sara G Grossi, DDS, MS||University at Buffalo|
|Principal Investigator:||Thomas E van Dyke, DDS,MS||Goldman School of Dental Medicine, Boston, MA|
|Principal Investigator:||John C Gunsolley, DDS,MS||University of Maryland, Dept. of Periodontics, Baltimore, MD|
|Principal Investigator:||James D Beck, Ph.D||University of NC, School of Dentistry, Chapel Hill, NC|
|Principal Investigator:||Lloyd E Chambless, PhD,||University of NC, Dept. of Biostatistics, Chapel Hill, NC|
|Principal Investigator:||Steven Offenbacher, DDS,PhD,MMSc||University of NC, Comprehensive Cntr. for Inflammatory Diseases, Chapel Hill, NC|
|Principal Investigator:||Theresa Madden, DDS, PhD||Oregon Health and Science University, Portland, OR|
|Principal Investigator:||Gerardo Maupome, PhD||Kaiser-Permanente Center for Health Research, Portland, OR|