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

NCT03042117 | Withdrawn

• 1 other identifier: L17-008
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Periodontal Diseases; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• Level of periodontal disease

  one day

Secondary Outcomes (4)

• ESR

  one day

• Myeloperoxidase (MPO)

  one day

• IgG

  one day

• hs-CRP

  one day

Study Arms (3)

No Coronary Artery Disease (CAD)

Patients with no known cardiovascular disease.

Other: periodontal probing

CAD without Myocardial Infarction (MI)

Patients with cardiovascular disease without a myocardial infarction.

Other: periodontal probing

CAD with MI

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

Other: periodontal probing

Interventions

periodontal probing 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; CAD without Myocardial Infarction (MI); No Coronary Artery Disease (CAD)

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients from ages 18-89 years who are being seen in the Center for Cardiovascular Health at TTUHSC and at Dr. Johnson's dental clinic who meet the inclusion criteria, and who will consent to participating in the study. There will be between 25 to 35 patients in each group.

You may qualify if:

• Patients with known CAD with previous MI, OR
• Patients without known CAD
• Ages 18-89 years
• Patients who have dental implants with a recorded patient history of how the teeth were lost
• Patients with at least one tooth in each of the four quadrants of the mouth
• Able to obtain all necessary pocket measurements and blood samples needed for the study

You may not qualify if:

• Patients with a known history of rheumatoid arthritis
• Patients with a known history of lupus
• Patients currently under the care of a rheumatologist
• Patients who have had a MI in the two weeks prior to entering the study
• Patients with a previous history of coronary artery bypass graft
• Current smokers and tobacco users
• Patients on disease-modifying agents for rheumatoid arthritis (methotrexate)10. Patients who have undergone chemotherapy in the past five years
• Patients who currently use steroids or immunosuppressive agents

Sponsors & Collaborators

• Texas Tech University Health Sciences Center: lead

MeSH Terms

Conditions

Periodontal Diseases; Cardiovascular Diseases

Interventions

Periodontal Index

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Health Surveys; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Dentistry; Periodontics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Dentistry

Study Officials

• Ami Knox, MBA

  Texas Tech University Health Sciences Center

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2017
• First Posted: February 3, 2017
• Study Start: October 18, 2016
• Primary Completion: July 13, 2017
• Study Completion: July 13, 2017
• Last Updated: January 30, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share