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Assessment of Carotid Artery Calcifications

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ClinicalTrials.gov Identifier: NCT04017078
Recruitment Status : Completed
First Posted : July 12, 2019
Last Update Posted : July 12, 2019
Sponsor:
Information provided by (Responsible Party):
Mehtap Bilgin Çetin, Baskent University

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.

Condition or disease Intervention/treatment
Carotid Artery Calcification Periodontal Diseases Other: diagnosis of carotid artery calcification on digital panoramic radiograph

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.


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Study Type : Observational
Actual Enrollment : 1101 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Assessment of Carotid Artery Calcifications on Digital Panoramic Radiographs and Its Relationship wıth Periodontal Condition and Cardiovascular Risk Factors
Actual Study Start Date : September 1, 2018
Actual Primary Completion Date : September 25, 2018
Actual Study Completion Date : October 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Minerals X-Rays

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
Other: 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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.



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Ages Eligible for Study:   14 Years to 86 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Baskent University, Faculty of Dentistry, Department of Periodontology
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04017078


Locations
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Turkey
Department of Periodontology, Faculty of Dentistry, Baskent University
Ankara, Turkey, 06790
Sponsors and Collaborators
Baskent University
Investigators
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Principal Investigator: Mehtap Bilgin Çetin, DDS,PhD Department of Periodontology, Faculty of Dentistry, Baskent University

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Responsible Party: Mehtap Bilgin Çetin, Assosc.Prof.Ph.D, Baskent University
ClinicalTrials.gov Identifier: NCT04017078     History of Changes
Other Study ID Numbers: MCetin
First Posted: July 12, 2019    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mehtap Bilgin Çetin, Baskent University:
carotid artery calcification
panoramic radiography
periodontitis
periodontal disease
systemic diseases

Additional relevant MeSH terms:
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Periodontal Diseases
Carotid Artery Diseases
Arteriosclerosis
Calcinosis
Mouth Diseases
Stomatognathic Diseases
Calcium Metabolism Disorders
Metabolic Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases