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Coronary Artery DiseaseNCT04045808

Relationship of Oral Status to Coronary Artery Disease

An observational study of Coronary Artery Disease and Periodontal Diseases, run by Baskent University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 30 to 80 years
Conditions the study is for
Coronary Artery Disease, Periodontal Diseases
What is being tested?
radiographic evaluations were done
Type of treatment
Pill or oral medicine
How many people
309 participants
Where
No sites listed yet
Study dates
12 Apr 2009to 2 Feb 2011
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 80 years
  • All sexes
  • Adult, Older adult

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

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.

About this study

Official title: 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.

Read the 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.

Being tested
radiographic evaluations were done
Keywords
coronary angiography, coronary artery disease, edentulism, periodontitis, periodontal disease
Medical subject headings
Coronary Artery Disease, Periodontal Diseases, Periodontitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • radiographic evaluations were doneOther

    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.

Study groups in NCT04045808
Study groupRoleWhat they receive
CAD(+) groupParticipants were included in CAD (+) if they had more than 50% reduction in diameter in one or more major epicardial arteries,
Receives: Other: radiographic evaluations were done
CAD(-) grouppatients with less than 50% reduction in epicardial artery diameter were enrolled to CAD (-) group
Receives: Other: radiographic evaluations were done

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Oral status of patients

    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

    Measured: Oral status of a patient was defined in 20 minutes.

Secondary outcomes (1)
  1. medical histories of participants

    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.

    Measured: Medical data was recorded in 20 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2019
  2. Study start12 Apr 2009
  3. Primary completion1 Jan 2011
  4. Study completion2 Feb 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
309 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04045808
Sponsor's protocol ID
Cetin
Status last verified
Aug 2019
First submitted
2 Aug 2019
Last updated
6 Aug 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease and Periodontal Diseases, run by Baskent University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Oral status of patients (time frame: Oral status of a patient was defined in 20 minutes.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2019; AzTrials last refreshed its copy on 8 Nov 2026.

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