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

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.

Study Overview

Status

Withdrawn

Intervention / Treatment

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.

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
No Coronary Artery Disease (CAD)
Patients with no known cardiovascular disease.
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.
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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Level of periodontal disease
Time Frame: one day
one day

Secondary Outcome Measures

Outcome Measure
Time Frame
ESR
Time Frame: one day
one day
Myeloperoxidase (MPO)
Time Frame: one day
one day
IgG
Time Frame: one day
one day
hs-CRP
Time Frame: one day
one day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Ami Knox, MBA, Texas Tech University Health Sciences Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 18, 2016

Primary Completion (Actual)

July 13, 2017

Study Completion (Actual)

July 13, 2017

Study Registration Dates

First Submitted

January 26, 2017

First Submitted That Met QC Criteria

February 1, 2017

First Posted (Estimate)

February 3, 2017

Study Record Updates

Last Update Posted (Actual)

January 30, 2020

Last Update Submitted That Met QC Criteria

January 28, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Data will not be shared with other researchers

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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