Carotid Artery CalcificationNCT04017078
Assessment of Carotid Artery Calcifications
An observational study of Carotid Artery Calcification and Periodontal Diseases, run by Baskent University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 14 to 86 years
- Conditions the study is for
- Carotid Artery Calcification, Periodontal Diseases
- What is being tested?
- diagnosis of carotid artery calcification on digital panoramic radiograph
- How many people
- 1,101 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2018to 1 Oct 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 86 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Baskent University, Faculty of Dentistry, Department of Periodontology
Who may be able to join
- All patients referred to Baskent University, Faculty of Dentistry, Department of Periodontology, during 2016-2018
Who cannot join
- Subjects with the lack of medical data
- DPRs not showing vertebra C3 and C4 were excluded.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Department of Periodontology, Faculty of Dentistry, Baskent University
Ankara, 06790
About this study
Official title: Assessment of Carotid Artery Calcifications on Digital Panoramic Radiographs and Its Relationship wıth Periodontal Condition and Cardiovascular Risk Factors
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.
Read the 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
- Being tested
- diagnosis of carotid artery calcification on digital panoramic radiograph
- Keywords
- carotid artery calcification, panoramic radiography, periodontitis, periodontal disease, systemic diseases
- Medical subject headings
- Periodontal Diseases, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diagnosis of carotid artery calcification on digital panoramic radiographOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients who referred for periodontal therapy | Patients who referred to Baskent University, Faculty of Dentistry, Department of Periodontology, during 2016-2018 Receives: Other: diagnosis of carotid artery calcification on digital panoramic radiograph |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalance of carotid artery calcifications
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.
Measured: The images were evaluated in two months.
Secondary outcomes (5)
The medical data of the patients with and without suspected CACs.
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.
Measured: Medical data was recorded in two months.
Bleeding on probing (BOP)values of the patients with and without suspected CACs.
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.
Measured: BOP values were recorded in two months.
Probing pocket depth (PPD) of the patients with and without suspected CACs.
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.
Measured: PPD values were recorded in two months.
Clinical attachment level (CAL of the patients with and without suspected CACs.
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.
Measured: CAL values were recorded in two months.
Periodontal status of the patients with andwithout suspected CACs.
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.
Measured: Periodontal status was recorded in two months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2019
- Study start1 Sep 2018
- Primary completion25 Sep 2018
- Study completion1 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carotid Artery CalcificationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 1,101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehtap Bilgin Çetin, Baskent University
- Investigators
- Mehtap Bilgin Çetin, DDS,PhD, Principal investigator, Department of Periodontology, Faculty of Dentistry, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04017078
- Sponsor's protocol ID
- MCetin
- Status last verified
- Jul 2019
- First submitted
- 27 Jun 2019
- Last updated
- 12 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32996164
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Carotid Artery Calcifications on Digital Panoramic Radiographs and Its Relationship wıth Periodontal Condition and Cardiovascular Risk Factors
- ClinicalTrials.gov ID
- NCT04017078
- Acronym / sponsor ID
- MCetin
- Conditions
- Carotid Artery Calcification, Periodontal Diseases
- Keywords
- carotid artery calcification, panoramic radiography, periodontitis, periodontal disease, systemic diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,101 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 25 Sep 2018 (actual)
- Study completion
- 1 Oct 2018 (actual)
- First posted
- 12 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who referred for periodontal therapy | – | Other: diagnosis of carotid artery calcification on digital panoramic radiographPatients who referred to Baskent University, Faculty of Dentistry, Department of Periodontology, during 2016-2018 |
Who may qualify
- Ages
- 14 to 86 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Baskent University, Faculty of Dentistry, Department of Periodontology
Key inclusion criteria (1 listed)
- All patients referred to Baskent University, Faculty of Dentistry, Department of Periodontology, during 2016-2018
Key exclusion criteria (2 listed)
- Subjects with the lack of medical data
- DPRs not showing vertebra C3 and C4 were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| diagnosis 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. | Other | Patients who referred for periodontal therapy |
Primary outcome
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.
5 secondary outcomes
The medical data of the patients with and without suspected CACs.
Time frame: Medical data was recorded in two months.
Bleeding on probing (BOP)values of the patients with and without suspected CACs.
Time frame: BOP values were recorded in two months.
Probing pocket depth (PPD) of the patients with and without suspected CACs.
Time frame: PPD values were recorded in two months.
Clinical attachment level (CAL of the patients with and without suspected CACs.
Time frame: CAL values were recorded in two months.
Periodontal status of the patients with andwithout suspected CACs.
Time frame: Periodontal status was recorded in two months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2019.
- Derived from this study: PubMed 32996164Bilgin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mehtap Bilgin Çetin, DDS,PhD principal investigator
Department of Periodontology, Faculty of Dentistry, Baskent University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carotid Artery Calcification and Periodontal Diseases, run by Baskent University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalance of carotid artery calcifications (time frame: The images were evaluated in two months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04017078, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2019.