Condition or disease |
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Carotid Stenosis |
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 |
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 |
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 |
Inclusion Criteria:
Exclusion Criteria:
France | |
Rennes University Hospital | |
Rennes, France, 35033 |
Principal Investigator: | Guy CATHELINEAU | Rennes University Hospital |
Tracking Information | |||||
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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 |
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
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Original Primary Outcome Measures | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures |
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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. |
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Study Type | Observational | ||||
Study Design | Observational Model: Case-Only Time Perspective: Retrospective |
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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. |
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Recruitment Information | |||||
Recruitment Status | Completed | ||||
Actual Enrollment |
401 | ||||
Original Estimated Enrollment |
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:
Exclusion Criteria:
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Sex/Gender |
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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 |
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IPD Sharing Statement | Not Provided | ||||
Responsible Party | Rennes University Hospital | ||||
Study Sponsor | Rennes University Hospital | ||||
Collaborators | Not Provided | ||||
Investigators |
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PRS Account | Rennes University Hospital | ||||
Verification Date | September 2019 |