NCT04017078

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,101

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2018

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2018

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2019

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 12, 2019

Completed
Last Updated

July 12, 2019

Status Verified

July 1, 2019

Enrollment Period

24 days

First QC Date

June 27, 2019

Last Update Submit

July 10, 2019

Conditions

Keywords

carotid artery calcificationpanoramic radiographyperiodontitisperiodontal diseasesystemic diseases

Outcome Measures

Primary Outcomes (1)

  • 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.

    The images were evaluated in two months.

Secondary Outcomes (5)

  • The medical data of the patients with and without suspected CACs.

    Medical data was recorded in two months.

  • Bleeding on probing (BOP)values of the patients with and without suspected CACs.

    BOP values were recorded in two months.

  • Probing pocket depth (PPD) of the patients with and without suspected CACs.

    PPD values were recorded in two months.

  • Clinical attachment level (CAL of the patients with and without suspected CACs.

    CAL values were recorded in two months.

  • Periodontal status of the patients with andwithout suspected CACs.

    Periodontal status was recorded in two months.

Study Arms (1)

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

Interventions

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.

Patients who referred for periodontal therapy

Eligibility Criteria

Age14 Years - 86 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Baskent University, Faculty of Dentistry, Department of Periodontology

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Periodontology, Faculty of Dentistry, Baskent University

Ankara, 06790, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Periodontal DiseasesPeriodontitis

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Study Officials

  • Mehtap Bilgin Çetin, DDS,PhD

    Department of Periodontology, Faculty of Dentistry, Baskent University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assosc.Prof.Ph.D

Study Record Dates

First Submitted

June 27, 2019

First Posted

July 12, 2019

Study Start

September 1, 2018

Primary Completion

September 25, 2018

Study Completion

October 1, 2018

Last Updated

July 12, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations