Clinical trial NCT04017078: Assessment of Carotid Artery Calcifications
Official title: Assessment of Carotid Artery Calcifications on Digital Panoramic Radiographs and Its Relationship wıth Periodontal Condition and Cardiovascular Risk Factors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carotid Artery Calcification
Periodontal Diseases
Keywords: carotid artery calcification
panoramic radiography
periodontitis
periodontal disease
systemic diseases
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2019-07-12
Enrollment: 1101
Sex: ALL
Minimum age (years): 14
Maximum age (years): 86
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Baskent University, Faculty of Dentistry, Department of Periodontology

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.

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.

Primary outcomes:
measure: prevalance of carotid artery calcifications
timeFrame: The images were evaluated in two months.
Secondary outcomes:
measure: The medical data of the patients with and without suspected CACs.
timeFrame: Medical data was recorded in two months.
measure: Bleeding on probing (BOP)values of the patients with and without suspected CACs.
timeFrame: BOP values were recorded in two months.
measure: Probing pocket depth (PPD) of the patients with and without suspected CACs.
timeFrame: PPD values were recorded in two months.
measure: Clinical attachment level (CAL of the patients with and without suspected CACs.
timeFrame: CAL values were recorded in two months.
measure: Periodontal status of the patients with andwithout suspected CACs.
timeFrame: Periodontal status was recorded in two months.
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Department of Periodontology, Faculty of Dentistry, Baskent University
Study officials:
affiliation: Department of Periodontology, Faculty of Dentistry, Baskent University
name: Mehtap Bilgin Çetin, DDS,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.