- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07463534
Atlas of Ultrasound Imaging of the Oral Cavity: Characterization and Description of Anatomical Structures (ATLAS-US)
Ultrasound imaging is a non-invasive and non-ionizing technique widely used for the evaluation of soft tissues in many medical specialties. In dentistry and oral medicine, however, ultrasound remains underused compared with conventional imaging methods such as radiography, cone-beam computed tomography (CBCT), or magnetic resonance imaging.
Recent advances in high-frequency ultrasound technology allow improved visualization of intraoral and extraoral soft tissues, including gingival tissues, mucosal structures, salivary glands, vascular structures, and inflammatory changes. Ultrasound imaging may therefore provide complementary diagnostic information in oral medicine.
The purpose of this prospective observational study is to describe and characterize intraoral and extraoral anatomical structures using ultrasound imaging in order to develop a reference atlas of ultrasound images of the oral cavity.
Adult patients attending a routine dental consultation at Tours University Hospital may be invited to participate. Ultrasound imaging will be performed during the clinical visit using an intraoral or extraoral ultrasound probe. The examination will last approximately 10 minutes and will not modify standard clinical care.
Ultrasound images will be anonymized and collected to create a database of normal and pathological oral structures. This database will allow descriptive analysis and classification of ultrasound images and contribute to the development of educational resources and future diagnostic applications in oral medicine and dentistry.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Matthieu RENAUD, Dr
- Phone Number: +33 2.47.47.79.92
- Email: matthieu.renaud@univ-tours.fr
Study Locations
-
-
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Tours, France, 37044
- University Hospital, Tours
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Contact:
- Matthieu RENAUD, Dr
- Phone Number: +33 2.47.47.79.92
- Email: matthieu.renaud@univ-tours.fr
-
Principal Investigator:
- Matthieu RENAUD, Dr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age ≥18 years old
- Patient having a dental consultation at Tours University Hospital
Exclusion Criteria:
- Subject under legal protection
- Pregnant or breastfeeding woman
- Expressed opposition to the processing of their data
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
anatomy of healthy and pathological extraoral and intraoral tissues
Time Frame: Enrollment
|
Description in ultrasound imaging (thickness, depth, location of anatomical elements, architectural organization of tissues).
|
Enrollment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of high-quality images
Time Frame: Through study completion, an average of one year
|
Achievement of a sufficient number of high-quality images for descriptive image analysis.
|
Through study completion, an average of one year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- DR250359 - ATLAS-US
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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