Status:
COMPLETED
Impact of Gum Infection on Heart Disease
Lead Sponsor:
Boston University
Collaborating Sponsors:
National Institute of Dental and Craniofacial Research (NIDCR)
Conditions:
Cardiovascular Disease
Periodontal Disease
Eligibility:
All Genders
20+ years
Phase:
NA
Brief Summary
The purpose of this study is to determine the effect of gum infection on parameters of cardio-vascular disease.
Detailed Description
Epidemiological studies indicate that individuals with severe periodontal disease have significantly increased risk for cardiovascular disease. Periodontal disease, a chronic bacterial infection of th...
Eligibility Criteria
Inclusion
- The study seeks to enroll patients with periodontal disease and no other major co-morbidities including cardiovascular disease or other major medical problems.
- In this intervention study, cigarette smokers will be permitted as justified below and randomized in stratified fashion to ensure equal numbers in the two treatment groups.
Exclusion
- Known cardiovascular disease including coronary heart disease, cerebral vascular disease, peripheral vascular disease, valvular heart disease, and congestive heart failure.
- Major coronary risk factors including diabetes mellitus, hypertension, hypercholesterolemia requiring treatment according to the ATP-III guidelines.
- Other major illness including cancer, liver disease, renal disease, pulmonary disease, chronic infectious disease (including HIV and hepatitis C infection), rheumatological disease, hematological disease, or any condition requiring hospitalization or chronic medical therapy.
- Use of antibiotics within three months.
- Use of oral contraceptives or hormone replacement therapy.
- Major psychiatric illness requiring treatment or that might interfere with the ability to understand and cooperate with the protocol.
- Ongoing drug or alcohol abuse.
- Use of sildenafil (Viagra) within 7 days because of the risk of marked hypotension with nitroglycerin administration.
- History of migraine headaches that might be exacerbated by nitroglycerin.
- Use of cholesterol lowering therapy, angiotensin converting enzyme inhibitors (subjects should not be taking these drugs because they will have no history of cardiovascular disease risk factors).
- Antioxidant vitamins (vitamin C or vitamin E) in doses exceeding the Recommended Dietary Allowances (RDA), (60 mg/day and 30 IU/day, respectively).
- Pregnancy, as diagnosed by serum beta-hCG.
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 8 2012
Estimated Enrollment :
174 Patients enrolled
Trial Details
Trial ID
NCT00093236
Start Date
September 1 2004
End Date
December 8 2012
Last Update
April 20 2017
Active Locations (1)
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1
Boston University Medical Campus
Boston, Massachusetts, United States, 02118