Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-26 @ 2:15 AM
Study NCT ID:
NCT04812405
Status:
COMPLETED
Last Update Posted:
2021-03-23
First Post:
2021-03-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Automated Caries Detection Using a 3D Intraoral Scanner. An in Vivo Validation Study.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-03-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-19', 'studyFirstSubmitDate': '2021-03-18', 'studyFirstSubmitQcDate': '2021-03-19', 'lastUpdatePostDateStruct': {'date': '2021-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Agreement of In vivo validation with in vitro caries detection', 'timeFrame': '1 year', 'description': 'To assess the difference in vivo and in vitro the fluorescence emitted of the TRIOS FLUO intraoral scanner from occlusal surface from 3rd molar before and after extraction'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['caries detection', 'in vivo', 'intraoral scanner', 'ICDAS', 'histology'], 'conditions': ['Healthy Patients']}, 'descriptionModule': {'briefSummary': 'This in vivo study with in vitro validation assessed four different algorithms (ALG1-ALG4) implemented in the intraoral scanner system for automated caries detection and classification. 3D scans of the examined teeth were obtained both in vivo and vitro, i.e. before and after tooth extraction, in order to assess any possible differences in the performance of the algorithms at different conditions. The latter could potentially help drawing some conclusions regarding i) the validity of the in vitro studies assessing fluorescence method for caries detection, and ii) the in vivo applicability of in vitro results obtained in the past and the future. Additionally, visual-tactile examination using the ICDAS (ICDAS II) criteria19 was conducted on the same teeth in vivo and histological assessment was used as reference test in vitro.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with permanent molars / premolars,\n* Sound teeth or with caries lesions on the occlusal surfaces.\n\nExclusion Criteria:\n\n* Front teeth / deciduous teeth\n* Teeth with fillings\n* Teeth with broken crown\n* Teeth with extensive lesions on the lateral surfaces.'}, 'identificationModule': {'nctId': 'NCT04812405', 'briefTitle': 'Automated Caries Detection Using a 3D Intraoral Scanner. An in Vivo Validation Study.', 'organization': {'class': 'OTHER', 'fullName': 'National and Kapodistrian University of Athens'}, 'officialTitle': 'Assessment of the Difference of Fluoresce of the TRIOS 4 Intraoral Scanner of the Same Surface at In Vivo and In Vitro Conditions', 'orgStudyIdInfo': {'id': '385'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Teeth', 'description': 'Occlusal examination', 'interventionNames': ['Diagnostic Test: Trios4']}], 'interventions': [{'name': 'Trios4', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['ICDAS'], 'description': 'Examination of occlusal surfaces with 3D scanner and optical criteria', 'armGroupLabels': ['Teeth']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11527', 'city': 'Athens', 'country': 'Greece', 'facility': 'Dentistry', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National and Kapodistrian University of Athens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Rahiotis Chris', 'investigatorAffiliation': 'National and Kapodistrian University of Athens'}}}}