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临床试验/NCT04017078
NCT04017078已完成不适用

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

Baskent University1 个研究点 分布在 1 个国家目标入组 1,101 人开始时间: 2018年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,101
试验地点
1
主要终点
prevalance of carotid artery calcifications

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
14 Years 至 86 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

prevalance of carotid artery calcifications

时间窗: 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.

次要结局

  • Clinical attachment level (CAL of the patients with and without suspected CACs.(CAL values were recorded in two months.)
  • Bleeding on probing (BOP)values of the patients with and without suspected CACs.(BOP values were recorded in two months.)
  • Periodontal status of the patients with andwithout suspected CACs.(Periodontal status was recorded in two months.)
  • The medical data of the patients with and without suspected CACs.(Medical data was recorded in two months.)
  • Probing pocket depth (PPD) of the patients with and without suspected CACs.(PPD values were recorded in two months.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mehtap Bilgin Çetin

Assosc.Prof.Ph.D

Baskent University

研究点 (1)

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