Clinical Trials Directory

Trials / Completed

CompletedNCT04017078

Assessment of Carotid Artery Calcifications

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

Status
Completed
Phase
Study type
Observational
Enrollment
1,101 (actual)
Sponsor
Baskent University · Academic / Other
Sex
All
Age
14 Years – 86 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
OTHERdiagnosis of carotid artery calcification on digital panoramic radiographSuspected 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.

Timeline

Start date
2018-09-01
Primary completion
2018-09-25
Completion
2018-10-01
First posted
2019-07-12
Last updated
2019-07-12

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT04017078. Inclusion in this directory is not an endorsement.