Carotid StenosisADCACONCT03936881
Carotid Region Calcifications and Orthopantomogram
An observational study of Carotid Stenosis, run by Rennes University Hospital at 1 site in France.
Trial summary
Observational study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Stenosis
- How many people
- 401 participants
- Where
- 1 siteFrance
- Study dates
- 6 May 2019to 10 Jul 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Attitude of the Dentist to the Detection of Calcification of the Carotid Region on an Orthopantomogram
Observational study.
Read the 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.
- Conditions
- Carotid Stenosis
- Medical subject headings
- Carotid Stenosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence or absence of calcifications of the carotid area
Calcifications of the carotid as recorded on the orthopantomogram of the patient
Measured: During the realization of the orthopantomogram (between 1 September 2018 and 31 December 2018)
Secondary outcomes (2)
Presence or absence of a cardiovascular pathology
Cardiovascular pathology as recorded on the medical record of the patient.
Measured: During the consultation at the Dental Care Centre (between 1 September 2018 and 31 December 2018)
Presence or absence of moderate to severe alveolysis
Periodontal disease as recorded during the consultation at the dental centre
Measured: During the consultation at the Dental Care Centre (between 1 September 2018 and 31 December 2018)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2019
- Study start6 May 2019
- Primary completion10 Jul 2019
- Study completion10 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid StenosisStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 401 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guy CATHELINEAU, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03936881
- Sponsor's protocol ID
- 35RC19_30024_ADCACO
- Acronym
- ADCACO
- Status last verified
- Sep 2019
- First submitted
- 30 Apr 2019
- Last updated
- 4 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Attitude of the Dentist to the Detection of Calcification of the Carotid Region on an Orthopantomogram
- ClinicalTrials.gov ID
- NCT03936881
- Acronym / sponsor ID
- ADCACO / 35RC19_30024_ADCACO
- Conditions
- Carotid Stenosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 401 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 6 May 2019 (actual)
- Primary completion
- 10 Jul 2019 (actual)
- Study completion
- 10 Jul 2019 (actual)
- First posted
- 3 May 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.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
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)
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)
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 4 Sep 2019.
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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.
Guy CATHELINEAU principal investigator
Rennes University Hospital
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 Stenosis, run by Rennes University Hospital at 1 site in France.
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 3 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 4 Sep 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 France. 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?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Sep 2019.