Impact of Gum Infection on Heart Disease

Completed · Not applicable

Conditions studied: Cardiovascular Disease, Periodontal Disease

In brief

The purpose of this study is to determine the effect of gum infection on parameters of cardio-vascular disease.

Key facts

Study ID

NCT00093236

Run by

Boston University

People needed

174

Starts

2004-09-01

Expected to finish

2012-12-08

Last updated by the study team

2017-04-20

Who can join

Age: 20 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Boston University Medical Campus — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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