Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2026-02-25 @ 9:46 PM
Study NCT ID:
NCT06789835
Status:
COMPLETED
Last Update Posted:
2025-01-23
First Post:
2024-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Automated Quantification of Dental Plaque
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003773', 'term': 'Dental Plaque'}], 'ancestors': [{'id': 'D003741', 'term': 'Dental Deposits'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-11-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-16', 'studyFirstSubmitDate': '2024-12-19', 'studyFirstSubmitQcDate': '2025-01-16', 'lastUpdatePostDateStruct': {'date': '2025-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Planimetric plaque index', 'timeFrame': '1 day', 'description': 'Plaque area coverage of teeth'}], 'secondaryOutcomes': [{'measure': 'Turesky modification of the Quigley and Hein Plaque Index', 'timeFrame': '1 day', 'description': 'Plaque coverage of teeth'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dental Plaque']}, 'descriptionModule': {'briefSummary': 'The study generates data that contribute to the development and validation of an automated approach to full-mouth quantification of dental plaque, based on fluorescence images and intraoral scans of teeth with disclosed and undisclosed plaque.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nMales and females ≥ 18 years old Presence of at least one tooth Anatomically possible to perform intraoral imaging Subjects need to be able to understand and follow instructions, as well as to read and sign the informed consent form\n\nExclusion Criteria:\n\nHistory of allergies towards any of the ingredients in the disclosing agents Self-reported serious medical conditions'}, 'identificationModule': {'nctId': 'NCT06789835', 'briefTitle': 'Automated Quantification of Dental Plaque', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Automated Quantification of Dental Plaque', 'orgStudyIdInfo': {'id': '109/2023'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Fluorescence imaging of disclosed and undisclosed plaque', 'interventionNames': ['Device: Fluorescence imaging of disclosed and undisclosed plaque']}], 'interventions': [{'name': 'Fluorescence imaging of disclosed and undisclosed plaque', 'type': 'DEVICE', 'description': 'Teeth are imaged using a fluorescence camera/an intraoral scanner before and after plaque disclosure.', 'armGroupLabels': ['Fluorescence imaging of disclosed and undisclosed plaque']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Department of Dentistry and Oral Health, Aarhus University', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}], 'overallOfficials': [{'name': 'Sebastian Schlafer, DDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Aarhus'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Due to general data protection regulations, individual participant data will not be made available publicly. Summary data will be made available upon publication of the results.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'collaborators': [{'name': '3Shape A/S', 'class': 'INDUSTRY'}, {'name': 'National and Kapodistrian University of Athens', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}