Assessment of Carotid Artery Calcifications

NCT ID: NCT04017078

Last Updated: 2019-07-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1101 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-09-01
• Study Completion Date: 2018-10-01

Brief Summary

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.

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.

Conditions

Carotid Artery Calcification; Periodontal Diseases

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Patients who referred for periodontal therapy

Patients who referred to Baskent University, Faculty of Dentistry, Department of Periodontology, during 2016-2018

diagnosis of carotid artery calcification on digital panoramic radiograph

Intervention Type: OTHER

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.

Interventions

diagnosis of carotid artery calcification on digital panoramic radiograph

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 86 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baskent University

OTHER

Sponsor Role: lead

Responsible Party

Mehtap Bilgin Çetin

Assosc.Prof.Ph.D

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mehtap Bilgin Çetin, DDS,PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Periodontology, Faculty of Dentistry, Baskent University

Locations

Department of Periodontology, Faculty of Dentistry, Baskent University

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Bilgin Cetin M, Sezgin Y, Nisanci Yilmaz MN, Koseoglu Secgin C. Assessment of carotid artery calcifications on digital panoramic radiographs and their relationship with periodontal condition and cardiovascular risk factors. Int Dent J. 2020 Sep 29;71(2):160-6. doi: 10.1111/idj.12618. Online ahead of print.

Reference Type: DERIVED

PMID: 32996164 (View on PubMed)

Other Identifiers

MCetin

Identifier Type: -

Identifier Source: org_study_id