Cardiovascular Disease Clinical Trial
Official title:
Systemic Endothelial Consequences of Periodontal Disease
Verified date | April 2017 |
Source | Boston University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine the effect of gum infection on parameters of cardio-vascular disease.
Status | Completed |
Enrollment | 174 |
Est. completion date | December 8, 2012 |
Est. primary completion date | April 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years and older |
Eligibility |
Inclusion Criteria: 1. The study seeks to enroll patients with periodontal disease and no other major co-morbidities including cardiovascular disease or other major medical problems. 2. 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 Criteria: 1. Known cardiovascular disease including coronary heart disease, cerebral vascular disease, peripheral vascular disease, valvular heart disease, and congestive heart failure. 2. Major coronary risk factors including diabetes mellitus, hypertension, hypercholesterolemia requiring treatment according to the ATP-III guidelines. 3. 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. 4. Use of antibiotics within three months. 5. Use of oral contraceptives or hormone replacement therapy. 6. Major psychiatric illness requiring treatment or that might interfere with the ability to understand and cooperate with the protocol. 7. Ongoing drug or alcohol abuse. 8. Use of sildenafil (Viagra) within 7 days because of the risk of marked hypotension with nitroglycerin administration. 9. History of migraine headaches that might be exacerbated by nitroglycerin. 10. 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). 11. Antioxidant vitamins (vitamin C or vitamin E) in doses exceeding the Recommended Dietary Allowances (RDA), (60 mg/day and 30 IU/day, respectively). 12. Pregnancy, as diagnosed by serum beta-hCG. |
Country | Name | City | State |
---|---|---|---|
United States | Boston University Medical Campus | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Boston University | National Institute of Dental and Craniofacial Research (NIDCR) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Periodontal disease progression | Three weeks after initiation of the study, they will return and be re-evaluated for the need for periodontal surgery. If indicated, they will then receive definitive periodontal surgery over the next 4 weeks. At the 12-week time point, periodontal surgery will be reevaluated and further therapy provided as needed and make repeated visits as needed to achieve periodontal health. During this period, the Usual Hygiene Group will return for oral hygiene visits at the 3 and 12-week time points. After a 12-week period (24 week time point) to allow healing and resolution of a systemic inflammatory state, patients will return for follow-up measurements of periodontal parameters, vascular function and inflammation. | 3 wks, 12 wks, and 24 weeks |
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