NCT04045808

Brief 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. 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
309

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2009

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 12, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2011

Completed
8.5 years until next milestone

First Submitted

Initial submission to the registry

August 2, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 6, 2019

Completed
Last Updated

August 6, 2019

Status Verified

August 1, 2019

Enrollment Period

1.7 years

First QC Date

August 2, 2019

Last Update Submit

August 2, 2019

Conditions

Keywords

coronary angiographycoronary artery diseaseedentulismperiodontitisperiodontal disease

Outcome Measures

Primary Outcomes (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

    Oral status of a patient was defined in 20 minutes.

Secondary Outcomes (1)

  • medical histories of participants

    Medical data was recorded in 20 minutes

Study Arms (2)

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

CAD(-) group

patients with less than 50% reduction in epicardial artery diameter were enrolled to CAD (-) group

Other: radiographic evaluations were done

Interventions

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(+) groupCAD(-) group

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Coronary Artery DiseasePeriodontal DiseasesPeriodontitis

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesMouth DiseasesStomatognathic Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD,DDS

Study Record Dates

First Submitted

August 2, 2019

First Posted

August 6, 2019

Study Start

April 12, 2009

Primary Completion

January 1, 2011

Study Completion

February 2, 2011

Last Updated

August 6, 2019

Record last verified: 2019-08