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出境医 / 临床实验 / Carotid Region Calcifications and Orthopantomogram (ADCACO)

Carotid Region Calcifications and Orthopantomogram (ADCACO)

Study Description
Brief Summary:
Observational study.

Condition or disease
Carotid Stenosis

Detailed Description:

The orthopantomogram or dental panoramic is a routine screening examination in dental practice. It is defined as a two-dimensional, inexpensive examination that provides an overview of bone and dental structures, temporomandibular joints, nasal cavities and maxillary sinuses. While the dentist's attention is focused primarily on dento-maxillary structures, careful examination of the dentist may reveal radiopaque images in the submandibular region, which Friedlander calls the Carotid Artery Territory and defines as the projection region of the common carotid artery, the carotid bifurcation and the internal carotid artery. Calcifications observed at this level can be of two types: anatomical and pathological. Among the so-called pathological calcifications are the calcifications of the carotid artery which are described in the literature as irregular, appearing as vertical, heterogeneous, uni- or bilateral lines and located at the angle of the mandible opposite C3-C4. A table was proposed by Pornprasertsuk-Damrongsri in 2006 allowing the differential diagnosis of these calcifications of the carotid artery with other types of calcifications based on an exhaustive a priori analysis of the literature.

The radiopacities identified as carotid calcifications are in fact calcifications that appear on a prior thickening of the vascular wall of a carotid artery corresponding to an atheroma plaque. This atheroma plaque can generate occlusions (such as embolism or stenosis).

In addition, some studies have shown a correlation between the detection of carotid artery calcifications from the orthopantomogram and the presence of Doppler stenosis. Currently the Doppler is the gold standard test for diagnosing carotid stenosis.

Romano-sousa in its 2009 study shows a strong correlation between the detection of carotid calcifications on the orthopantomogram and Doppler images: calcifications are observed on both the orthopantomogram and Doppler in 59.4% of cases. Almog (2002) finds 50% stenosis (>50%) in analyzed sides with calcifications; compared to 21% in sides where there is no calcification.

In 1998, Friedlander concluded that dentists could have a role in preventing cardiovascular events by screening carotid artery calcifications on the orthopantomogram, and included this analysis of the orthopantomogram in a public health approach that would reduce mortality and morbidity from ischemic stroke, as well as the costs associated with lost productivity, hospitalization and rehabilitation. Indeed, stroke is the third leading cause of death in developed countries and a major cause of serious morbidity.

It therefore seems interesting to be able to detect asymptomatic carotid stenosis in order to implement an appropriate diagnostic and therapeutic strategy. On the other hand, the accidental discovery of carotid artery calcifications on an orthopantomogram indicates a general arterial abnormality. It may therefore be interesting to detect possible calcifications of the carotid artery in middle-aged patients with no cardiovascular history or risk factors for cardiovascular events.

On the other hand, some authors mention a link between the presence of calcifications of the carotid artery and the existence of periodontal disease. Indeed, both are linked to an inflammatory phenomenon. The investigators will therefore try to see if this relationship exists in the investigator's population.

Study Design
Layout table for study information
Study Type : Observational
Actual Enrollment : 401 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Attitude of the Dentist to the Detection of Calcification of the Carotid Region on an Orthopantomogram
Actual Study Start Date : May 6, 2019
Actual Primary Completion Date : July 10, 2019
Actual Study Completion Date : July 10, 2019
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. Presence or absence of calcifications of the carotid area [ Time Frame: During the realization of the orthopantomogram (between 1 September 2018 and 31 December 2018) ]
    Calcifications of the carotid as recorded on the orthopantomogram of the patient


Secondary Outcome Measures :
  1. Presence or absence of a cardiovascular pathology [ Time Frame: During the consultation at the Dental Care Centre (between 1 September 2018 and 31 December 2018) ]
    Cardiovascular pathology as recorded on the medical record of the patient.

  2. Presence or absence of moderate to severe alveolysis [ Time Frame: During the consultation at the Dental Care Centre (between 1 September 2018 and 31 December 2018) ]
    Periodontal disease as recorded during the consultation at the dental centre


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients over 18 years of age who presented themselves at the Dental Care Centre of the Rennes University Hospital between 1 September 2018 and 31 December 2018
Criteria

Inclusion Criteria:

  • Adult patient (18 years of age or older) attending the dental care centre at the Rennes University Hospital;
  • Who had an orthopantomogram radiological examination at the Rennes Dental Care Centre between 1 September 2018 and 31 December 2018;
  • Having agreed to the use of its data for teaching or publication purposes.

Exclusion Criteria:

  • Orthopantomogram not usable, not allowing to visualize the sub-mandibular region (due to poor patient positioning);
  • Persons of full age who are subject to legal protection (protection of justice, guardianship, guardianship), persons deprived of their liberty.
Contacts and Locations

Locations
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France
Rennes University Hospital
Rennes, France, 35033
Sponsors and Collaborators
Rennes University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Guy CATHELINEAU Rennes University Hospital
Tracking Information
First Submitted Date April 30, 2019
First Posted Date May 3, 2019
Last Update Posted Date September 4, 2019
Actual Study Start Date May 6, 2019
Actual Primary Completion Date July 10, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 2, 2019)
Presence or absence of calcifications of the carotid area [ Time Frame: During the realization of the orthopantomogram (between 1 September 2018 and 31 December 2018) ]
Calcifications of the carotid as recorded on the orthopantomogram of the patient
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 2, 2019)
  • Presence or absence of a cardiovascular pathology [ Time Frame: During the consultation at the Dental Care Centre (between 1 September 2018 and 31 December 2018) ]
    Cardiovascular pathology as recorded on the medical record of the patient.
  • Presence or absence of moderate to severe alveolysis [ Time Frame: During the consultation at the Dental Care Centre (between 1 September 2018 and 31 December 2018) ]
    Periodontal disease as recorded during the consultation at the dental centre
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Carotid Region Calcifications and Orthopantomogram
Official Title Attitude of the Dentist to the Detection of Calcification of the Carotid Region on an Orthopantomogram
Brief Summary Observational study.
Detailed Description

The orthopantomogram or dental panoramic is a routine screening examination in dental practice. It is defined as a two-dimensional, inexpensive examination that provides an overview of bone and dental structures, temporomandibular joints, nasal cavities and maxillary sinuses. While the dentist's attention is focused primarily on dento-maxillary structures, careful examination of the dentist may reveal radiopaque images in the submandibular region, which Friedlander calls the Carotid Artery Territory and defines as the projection region of the common carotid artery, the carotid bifurcation and the internal carotid artery. Calcifications observed at this level can be of two types: anatomical and pathological. Among the so-called pathological calcifications are the calcifications of the carotid artery which are described in the literature as irregular, appearing as vertical, heterogeneous, uni- or bilateral lines and located at the angle of the mandible opposite C3-C4. A table was proposed by Pornprasertsuk-Damrongsri in 2006 allowing the differential diagnosis of these calcifications of the carotid artery with other types of calcifications based on an exhaustive a priori analysis of the literature.

The radiopacities identified as carotid calcifications are in fact calcifications that appear on a prior thickening of the vascular wall of a carotid artery corresponding to an atheroma plaque. This atheroma plaque can generate occlusions (such as embolism or stenosis).

In addition, some studies have shown a correlation between the detection of carotid artery calcifications from the orthopantomogram and the presence of Doppler stenosis. Currently the Doppler is the gold standard test for diagnosing carotid stenosis.

Romano-sousa in its 2009 study shows a strong correlation between the detection of carotid calcifications on the orthopantomogram and Doppler images: calcifications are observed on both the orthopantomogram and Doppler in 59.4% of cases. Almog (2002) finds 50% stenosis (>50%) in analyzed sides with calcifications; compared to 21% in sides where there is no calcification.

In 1998, Friedlander concluded that dentists could have a role in preventing cardiovascular events by screening carotid artery calcifications on the orthopantomogram, and included this analysis of the orthopantomogram in a public health approach that would reduce mortality and morbidity from ischemic stroke, as well as the costs associated with lost productivity, hospitalization and rehabilitation. Indeed, stroke is the third leading cause of death in developed countries and a major cause of serious morbidity.

It therefore seems interesting to be able to detect asymptomatic carotid stenosis in order to implement an appropriate diagnostic and therapeutic strategy. On the other hand, the accidental discovery of carotid artery calcifications on an orthopantomogram indicates a general arterial abnormality. It may therefore be interesting to detect possible calcifications of the carotid artery in middle-aged patients with no cardiovascular history or risk factors for cardiovascular events.

On the other hand, some authors mention a link between the presence of calcifications of the carotid artery and the existence of periodontal disease. Indeed, both are linked to an inflammatory phenomenon. The investigators will therefore try to see if this relationship exists in the investigator's population.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients over 18 years of age who presented themselves at the Dental Care Centre of the Rennes University Hospital between 1 September 2018 and 31 December 2018
Condition Carotid Stenosis
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 3, 2019)
401
Original Estimated Enrollment
 (submitted: May 2, 2019)
387
Actual Study Completion Date July 10, 2019
Actual Primary Completion Date July 10, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Adult patient (18 years of age or older) attending the dental care centre at the Rennes University Hospital;
  • Who had an orthopantomogram radiological examination at the Rennes Dental Care Centre between 1 September 2018 and 31 December 2018;
  • Having agreed to the use of its data for teaching or publication purposes.

Exclusion Criteria:

  • Orthopantomogram not usable, not allowing to visualize the sub-mandibular region (due to poor patient positioning);
  • Persons of full age who are subject to legal protection (protection of justice, guardianship, guardianship), persons deprived of their liberty.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03936881
Other Study ID Numbers 35RC19_30024_ADCACO
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Rennes University Hospital
Study Sponsor Rennes University Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Guy CATHELINEAU Rennes University Hospital
PRS Account Rennes University Hospital
Verification Date September 2019

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