Connecting Periodontal and Coronary Artery Disease Via the Inflammatory State of the Body

Cardiovascular Diseases Clinical Trial

Official title:

Connecting Periodontal and Coronary Artery Disease Via the Inflammatory State of the Body

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03042117
• Other study ID #: L17-008
• Status: Withdrawn
• Start date: October 18, 2016
• Est. completion date: July 13, 2017

Study information

• Verified date: January 2020
• Source: Texas Tech University Health Sciences Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Cardiovascular disease is one of the leading causes of death in the United States and the world. Many interventions relating to prevention have been emphasized as more risk factors for this devastating disease are discovered. Periodontal disease is known to have a close association with cardiovascular disease, but its role as a risk factor is still not well understood. Inflammation is a driving force in both of these diseases, creating a potential bridge between the two. Specifically, periodontal disease can cause an inflammatory reaction in the body, which may predispose or even directly contribute to atheroma formation in the coronary arteries. In this study, the investigators will study the link between the inflammatory state of the body and will search for a correlation with levels of coronary artery disease and periodontal disease. Inflammatory markers such as high-sensitivity C-reactive protein (hs-CRP), erythrocyte sedimentation rate (ESR), and immunoglobulin G (IgG) levels in the patient's blood will be analyzed and correlated to clinical attachment loss measured via pocket depth measurement, the distance from the gingival margin to the base of the pocket. A definitive link between these disease processes will allow preventive measures to be taken earlier to prevent this lifelong disease.

Description:

Dental probes will be used to probe depth of gum recession in subjects with and without a history of cardiac events. Venous blood samples will also be collected from all subjects for measurement of sedimentation rate, myeloperoxidase, and IgG levels. Statistical analysis will then be done, in attempt to identify a difference in gum recession depth and/or serum inflammatory markers among those with and without prior cardiac events.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 13, 2017
• Est. primary completion date: July 13, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

Inclusion Criteria:

1. Patients with known CAD with previous MI, OR

2. Patients without known CAD

3. Ages 18-89 years

4. Patients who have dental implants with a recorded patient history of how the teeth were lost

5. Patients with at least one tooth in each of the four quadrants of the mouth

6. Able to obtain all necessary pocket measurements and blood samples needed for the study

Exclusion Criteria:

1. Patients with a known history of rheumatoid arthritis

2. Patients with a known history of lupus

3. Patients currently under the care of a rheumatologist

4. Patients who have had a MI in the two weeks prior to entering the study

5. Patients with a previous history of coronary artery bypass graft

6. Current smokers and tobacco users

7. Patients on disease-modifying agents for rheumatoid arthritis (methotrexate)10. Patients who have undergone chemotherapy in the past five years

8. Patients who currently use steroids or immunosuppressive agents

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Periodontal Diseases

Intervention

Other:
• periodontal probing
A periodontal probe will be inserted between the tooth and the gum in the gingival sulcus and a measurement of the pocket depth will be measured by a trained dentist in all subjects

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Texas Tech University Health Sciences Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of periodontal disease		one day
Secondary	ESR		one day
Secondary	Myeloperoxidase (MPO)		one day
Secondary	IgG		one day
Secondary	hs-CRP		one day