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

NCT ID: NCT03042117

Last Updated: 2020-01-30

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-10-18
• Study Completion Date: 2017-07-13

Brief 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.

Detailed 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.

Conditions

Periodontal Diseases; Cardiovascular Diseases

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

No Coronary Artery Disease (CAD)

Patients with no known cardiovascular disease.

periodontal probing

Intervention Type: OTHER

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

CAD without Myocardial Infarction (MI)

Patients with cardiovascular disease without a myocardial infarction.

periodontal probing

Intervention Type: OTHER

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

CAD with MI

Patients with cardiovascular disease with previous history of a myocardial infarction.

periodontal probing

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Texas Tech University Health Sciences Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ami Knox, MBA

Role: STUDY_DIRECTOR

Texas Tech University Health Sciences Center

Other Identifiers

L17-008

Identifier Type: -

Identifier Source: org_study_id