Relationship of Oral Status to Coronary Artery Disease

August 2, 2019 updated by: Mehtap Bilgin Çetin, Baskent University

Associate Professor

We hypothesized that periodontal disease and edentulism could be a risk for CAD and there might be a relationship between the oral status and the number of main coronary vessels with ≥ 50% stenosis. Therefore, primary goal of this study is to investigate the connection between oral status and the extent of coronary artery disease (CAD), which is diagnosed by angiography.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Subjects were grouped as CAD (+) or CAD (-) based on their coronary angiography outcomes. Participants were included in CAD (+) if they had more than 50% reduction in diameter in one or more major epicardial arteries, whereas patients with less than 50% reduction in epicardial artery diameter were enrolled to CAD (-) group.The extent of CAD was measured by the number of main coronary vessels with more than 50% stenosis and occluded left main coronary artery (LMCA) was also noted.Demographic and socioeconomic backgrounds, brushing and interdental cleaning habits, frequency of dental visits, levels of education and medical histories of participants were carefully recorded. Medical histories mainly included cardiovascular risk factors consisting of age, gender, family history of heart disease and myocardial infarction (MI), smoking habits, current medications, body mass index (BMI), hypertension, diabetes, high density protein (HDL) and CRP levels. BMIs of participants were obtained through dividing weight (in kilograms) by the square of height (in meters). Blood samples were collected before angiography in order to analyze biological parameters. Hospital records were consulted to obtain patient information such as existence of hypertension, hyperlipidemia, and diabetes mellitus. Education levels were evaluated based on the last school the patient had graduated from and categorized as no education, secondary school, high school and university.During the examination, remaining teeth count, plaque index (PI), gingival index (GI), bleeding on probing (BOP) and probing pocket depth (PPD) were analyzed. Periodontal measurements were recorded at four sites around each tooth (mesial, mid-buccal, distal, and mid-lingual) by a periodontal probe excluding third molars. Each patient was evaluated for PI, GI, PPD average scores (whole-mouth) and percent of BOP (+) sites. Oral status was categorized in three groups: Group 1 consisted of periodontally healthy subjects and patients with gingivitis. Patients having periodontitis were involved in group 2 and group 3 included edentulous subjects. Periodontal health was defined as the absence of gingivitis or periodontitis. Gingivitis was defined as BOP score of ≥ 10% and probing depth of ≤ 3mm. Diagnosis of periodontitis is based on multiple clinical and radiographic parameters. If a patient has one or more sites of inflammation (BOP), ≥ 2mm radiographic bone loss and ≥ 4mm probing depth; he/she will be diagnosed for periodontitis.

For radiographic analysis, periapical radiographs were taken from teeth with ≥ 4mm PPD using a hand held intra-oral x-ray system operating at 60kVp, 1.5 mA by Dexcowin DX 3000 with a CCD based sensor Trophy RVG ver. 5.0 . The alveolar bone loss was measured by a personal computer with the Microsoft Windows XP operating system with original software. The site where periodontal ligament terminates at the surface of the root was labeled as the alveolar bone crest. Apart from the third molars, all teeth were examined to measure the interval between cementoenamel junction and interproximal alveolar crest, regarding both mesial and distal aspects of each tooth.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
309

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

who were admitted to Ankara University, Faculty of Medicine, Department of Cardiology and had coronary angiography

Description

Inclusion Criteria:patients who were admitted to Ankara University, Faculty of Medicine, Department of Cardiology and had coronary angiography.

Exclusion Criteria:Participants who needed antibiotic prophylaxis before the dental examination, had periodontal treatment or used antibiotics during the last 6 months were excluded from the study, along with the pregnant women.

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: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
CAD(+) group
Participants were included in CAD (+) if they had more than 50% reduction in diameter in one or more major epicardial arteries,
Other: radiographic evaluations were done
For radiographic analysis, periapical radiographs were taken from teeth with ≥ 4mm PPD using a hand held intra-oral x-ray system operating at 60kVp, 1.5 mA . The alveolar bone loss was measured by a personal computer with the Microsoft Windows XP operating system with original software.
CAD(-) group
patients with less than 50% reduction in epicardial artery diameter were enrolled to CAD (-) group
Other: radiographic evaluations were done
For radiographic analysis, periapical radiographs were taken from teeth with ≥ 4mm PPD using a hand held intra-oral x-ray system operating at 60kVp, 1.5 mA . The alveolar bone loss was measured by a personal computer with the Microsoft Windows XP operating system with original software.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Oral status of patients
Time Frame: Oral status of a patient was defined in 20 minutes.
Oral status was categorized in three groups: Group 1 consisted of periodontally healthy subjects and patients with gingivitis. Patients having periodontitis were involved in group 2 and group 3 included edentulous subjects. Periodontal health was defined as the absence of gingivitis or periodontitis. Gingivitis was defined as BOP score of ≥ 10% and probing depth of ≤ 3mm. Diagnosis of periodontitis is based on multiple clinical and radiographic parameters. If a patient has one or more sites of inflammation (BOP), ≥ 2mm radiographic bone loss and ≥ 4mm probing depth; he/she will be diagnosed for periodontitis
Oral status of a patient was defined in 20 minutes.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
medical histories of participants
Time Frame: Medical data was recorded in 20 minutes
Medical histories mainly included cardiovascular risk factors consisting of age, gender, family history of heart disease and myocardial infarction (MI), smoking habits, current medications, body mass index (BMI), hypertension, diabetes.BMIs of participants were obtained through dividing weight (in kilograms) by the square of height (in meters).Hospital records were consulted to obtain patient information such as existence of hypertension, hyperlipidemia, and diabetes mellitus. If the patient was taking medication for hyperlipidemia, he was noted as a patient with hyperlipidemia.If the patient was taking medication for diabetes, he was noted as a patient with diabetes.If the patient was taking medication for hypertension, he was noted as a patient with hypertension.according to smoking status, patients divided into three groups as never smoked, current smokers, former smokers.
Medical data was recorded in 20 minutes

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Baskent University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ankara University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 12, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 2, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 2, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 6, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 6, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Cetin

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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