Assessment of Carotid Artery Calcifications

July 10, 2019 updated by: Mehtap Bilgin Çetin, Baskent University

Assessment of Carotid Artery Calcifications on Digital Panoramic Radiographs and Its Relationship wıth Periodontal Condition and Cardiovascular Risk Factors

The aim of the study was to determine retrospectively the presence of carotid artery calcification (CAC) detected on digital panoramic radiographs (DPRs) and correlate the finding of such calcifications with gender, smoking status, medical history and periodontal status.The authors hypothesized that more CACs could observed in DPRs of individuals with periodontitis and CACs may correlate with the various risk factors included age, gender, smoking status, medical history.DPRs, periodontal status, medical (hypertension, diabetes, hyperlipidemia, cardiovascular disease) and smoking stories of 1101 patients (576 males, 525 females) were evaluated. The patients were divided into two groups as CAC detected in dental DPRs [CAC(+)] and those who were not [CAC (-)]. Periodontal status categorized as gingivitis, periodontitis and gingivitis with reduced periodontium.

Study Overview

Detailed Description

The first aim of the study was to determine retrospectively the presence of CACs detected on digital panoramic radiographs (DPRs) and second to correlate the finding of such calcifications with gender, smoking status, medical history and periodontal status. The authors hypothesized that more CACs could observed in DPRs of individuals with periodontitis and CACs may correlate with the various risk factors included age, gender, smoking status, medical history.

DPRs, periodontal status and medical stories of 1101 patients (576 males, 525 females) referred to Baskent University, Faculty of Dentistry, Department of Periodontology, during 2016-2018 were evaluated in this retrospective, cross-sectional study. This study was approved by Baskent University Institutional Review Board and supported by Baskent University Research Fund. All study procedures were performed in accordance with the Declaration of Helsinki and Research Committee Regulations.

Medical histories included gender, age, hypertension, diabetes, cardiovascular diseases, hyperlipidemia and smoking status. All data were obtained from the hospital records of the patients. Periodontal status of the participants also were determined based on hospital records.

All digital panoramic images were acquired using the same machine , with the following exposure parameters: 64-66 kVp; 6-9 mA; and 10 s. An observer with 7 years of experience at the Dentomaxillofacial Radiology department of the investigator's university evaluated the images on 2 different dates and 30 days apart by using the ClearCanvas program on an LED monitor under low light. Suspected CACs findings were defined as one or more radiopaque mass adjacent to the cervical vertebrae at or below the intervertebral space between C3 and C4 on the DPR .18 The CAC's were scored as present (+) or absent (-) by the dentomaxillofacial radiologist.Statistical analysis Whether the distributions of continuous variables were normally or not being determined by Kolmogorov Smirnov test. Levene test was used for the evaluation of homogeneity of variances. While, categorical data were shown as number of cases and percentages, otherwise, descriptive statistics for continuous variables were expressed as mean ± SD or median (min-max) percentiles, where applicable.

While, the mean differences between groups were compared by Student's t test, otherwise, Mann Whitney U test was applied for comparisons of not normally distributed data. Categorical data were analyzed by Continuity Corrected Chi-square or Fisher's Exact test, where appropriate.

Determining the best predictor(s) which effect on the existence of carotid artery calcification was evaluated by Multiple Logistic Regression Analysis. Any variable whose univariable test had a p value <0.25 was accepted as a candidate for the multivariable model along with all variables of known clinical importance. Odds ratios, 95% confidence intervals and Wald statistic for each independent variable were also calculated.Data analysis was performed by using IBM SPSS Statistics version 17.0 software. p value less than 0.05 was considered as statistically significant.

Study Type

Observational

Enrollment (Actual)

1101

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Ankara, Turkey, 06790
        • Department of Periodontology, Faculty of Dentistry, Baskent University

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

14 years to 86 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Baskent University, Faculty of Dentistry, Department of Periodontology

Description

Inclusion Criteria:

  • All patients referred to Baskent University, Faculty of Dentistry, Department of Periodontology, during 2016-2018

Exclusion Criteria:

  • Subjects with the lack of medical data
  • DPRs not showing vertebra C3 and C4 were excluded.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients who referred for periodontal therapy
Patients who referred to Baskent University, Faculty of Dentistry, Department of Periodontology, during 2016-2018
Suspected carotid arty calcifications findings were defined as one or more radiopaque mass adjacent to the cervical vertebrae at or below the intervertebral space between C3 and C4 on the DPR.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
prevalance of carotid artery calcifications
Time Frame: The images were evaluated in two months.
Suspected CACs findings were defined as one or more radiopaque mass adjacent to the cervical vertebrae at or below the intervertebral space between C3 and C4 on the DPR.The CAC's were scored as present (+) or absent (-) by the dentomaxillofacial radiologist.
The images were evaluated in two months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The medical data of the patients with and without suspected CACs.
Time Frame: Medical data was recorded in two months.
All medical data were obtained from the hospital records.if the patient was taking medication for hypertension, he was noted as a hypertensive patient. if the patient was taking medication for diabetes, he was noted as a patient with diabetes.If the patient was taking medication for hyperlipidemia, he was noted as a patient with hyperlipidemia.according to smoking status patients divided into three groups as never smoked, current smokers, former smokers.
Medical data was recorded in two months.
Bleeding on probing (BOP)values of the patients with and without suspected CACs.
Time Frame: BOP values were recorded in two months.
On periodontal examination, bleeding on probing (BOP) were evaluated in each patient. All periodontal measurements were recorded at six sites around each tooth by a periodontal probe excluding third molar.
BOP values were recorded in two months.
Probing pocket depth (PPD) of the patients with and without suspected CACs.
Time Frame: PPD values were recorded in two months.
Probing pocket depth (PPD = distance between gingival margin and bottom of the periodontal pocket)were evaluated in each patient. All periodontal measurements were recorded at six sites around each tooth by a periodontal probe excluding third molar.
PPD values were recorded in two months.
Clinical attachment level (CAL of the patients with and without suspected CACs.
Time Frame: CAL values were recorded in two months.
Clinical attachment level (CAL = distance between the cemento-enamel junction and bottom of the periodontal pocket)were evaluated in each patient. All periodontal measurements were recorded at six sites around each tooth by a periodontal probe excluding third molar.
CAL values were recorded in two months.
Periodontal status of the patients with andwithout suspected CACs.
Time Frame: Periodontal status was recorded in two months.
Periodontal status was categorized as gingivitis, reduced periodontium with gingivitis and periodontitis. When no clinical attachment loss and/or recession, probing depths 3 mm or less, BOP ≥ %10 of sites were present, the diagnosis was gingivitis. If gingival inflammation was noted with clinical attachment loss and/or recession, probing depths ≤ 3 mm, BOP ≥ %10 of sites, the patient was diagnosed as reduced periodontium with gingivitis. The patients who had interdental CAL at ≥ 2 non-adjacent teeth or buccal or oral CAL ≥ 3 mm with probing depths >3 mm at ≥ 2 teeth and BOP ≥ %10 of sites were diagnosed as periodontitis.
Periodontal status was recorded in two months.

Collaborators and Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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)

September 1, 2018

Primary Completion (Actual)

September 25, 2018

Study Completion (Actual)

October 1, 2018

Study Registration Dates

First Submitted

June 27, 2019

First Submitted That Met QC Criteria

July 10, 2019

First Posted (Actual)

July 12, 2019

Study Record Updates

Last Update Posted (Actual)

July 12, 2019

Last Update Submitted That Met QC Criteria

July 10, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

Clinical Trials on Periodontal Diseases

3
Subscribe