- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03042117
Connecting Periodontal and Coronary Artery Disease Via the Inflammatory State of the Body
January 28, 2020 updated by: Texas Tech University Health Sciences Center
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Withdrawn
Conditions
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:
- 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
Exclusion Criteria:
- 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
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- L17-008
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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