Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 1:09 PM
Study NCT ID:
NCT07463534
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-20
First Post:
2026-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Atlas of Ultrasound Imaging of the Oral Cavity: Characterization and Description of Anatomical Structures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-17', 'studyFirstSubmitDate': '2026-03-05', 'studyFirstSubmitQcDate': '2026-03-05', 'lastUpdatePostDateStruct': {'date': '2026-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'anatomy of healthy and pathological extraoral and intraoral tissues', 'timeFrame': 'Enrollment', 'description': 'Description in ultrasound imaging (thickness, depth, location of anatomical elements, architectural organization of tissues).'}], 'secondaryOutcomes': [{'measure': 'Number of high-quality images', 'timeFrame': 'Through study completion, an average of one year', 'description': 'Achievement of a sufficient number of high-quality images for descriptive image analysis.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ultrasound imaging', 'oral cavity'], 'conditions': ['Dental Consultation']}, 'descriptionModule': {'briefSummary': '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.\n\nRecent 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.\n\nThe 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.\n\nAdult 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.\n\nUltrasound 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patient having a dental consultation at Tours University Hospital', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years old\n* Patient having a dental consultation at Tours University Hospital\n\nExclusion Criteria:\n\n* Subject under legal protection\n* Pregnant or breastfeeding woman\n* Expressed opposition to the processing of their data'}, 'identificationModule': {'nctId': 'NCT07463534', 'acronym': 'ATLAS-US', 'briefTitle': 'Atlas of Ultrasound Imaging of the Oral Cavity: Characterization and Description of Anatomical Structures', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Tours'}, 'officialTitle': 'Atlas of Ultrasound Imaging of the Oral Cavity: Characterization and Description of Anatomical Structures', 'orgStudyIdInfo': {'id': 'DR250359 - ATLAS-US'}}, 'contactsLocationsModule': {'locations': [{'zip': '37044', 'city': 'Tours', 'country': 'France', 'contacts': [{'name': 'Matthieu RENAUD, Dr', 'role': 'CONTACT', 'email': 'matthieu.renaud@univ-tours.fr', 'phone': '2.47.47.79.92', 'phoneExt': '+33'}, {'name': 'Matthieu RENAUD, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'university hospital, Tours', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}], 'centralContacts': [{'name': 'Matthieu RENAUD, Dr', 'role': 'CONTACT', 'email': 'matthieu.renaud@univ-tours.fr', 'phone': '2.47.47.79.92', 'phoneExt': '+33'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Tours', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}