Ignite Creation Date:
2025-12-24 @ 4:51 PM
Ignite Modification Date:
2025-12-27 @ 12:18 PM
Study NCT ID:
NCT06829550
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-11-06
First Post:
2025-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
3D Scanning as an Advanced Tool for Identifying Tooth Lesions in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014077', 'term': 'Tooth Erosion'}, {'id': 'D009050', 'term': 'Fluorosis, Dental'}, {'id': 'D003731', 'term': 'Dental Caries'}, {'id': 'D057085', 'term': 'Tooth Wear'}], 'ancestors': [{'id': 'D017001', 'term': 'Tooth Demineralization'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D000094603', 'term': 'Dental Enamel Hypomineralization'}, {'id': 'D000094602', 'term': 'Developmental Defects of Enamel'}, {'id': 'D014071', 'term': 'Tooth Abnormalities'}, {'id': 'D018640', 'term': 'Stomatognathic System Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-11-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-05', 'studyFirstSubmitDate': '2025-02-05', 'studyFirstSubmitQcDate': '2025-02-14', 'lastUpdatePostDateStruct': {'date': '2025-11-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate caries using intraoral digital scanning', 'timeFrame': 'Evaluation will occur during the single 1 day visit', 'description': 'Dental caries - detection of caries lesions in primary teeth comparing the use of intraoral digital 3D scanning (imaging) to a traditional clinical exam'}, {'measure': 'Evaluate Erosive tooth wear using digital scanning', 'timeFrame': 'Evaluation will occur during the single 1 day visit', 'description': 'Erosive Tooth Wear - detection of erosive tooth wear patterns in primary teeth comparing the use of intraoral digital 3D scanning (imaging) with a traditional clinical erosion tooth wear exam'}, {'measure': 'Evaluate fluorosis using intraoral digital scanning', 'timeFrame': 'Evaluation will occur during the single 1 day visit', 'description': 'Fluorosis: - detection of fluorosis in primary teeth comparing the use of intraoral digital 3D scanning (imaging) with a traditional clinical fluorosis exam'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['scanning for dental problems', 'computer-assisted image processing', 'tooth wear', 'dental fluorosis', 'intraoral scanner', 'dental caries', 'dental decay', 'tooth erosion'], 'conditions': ['Dental Caries in Children', 'Tooth Erosion', 'Fluorosis, Dental', 'Dental Caries']}, 'descriptionModule': {'briefSummary': 'This study focuses on assessing dental caries, erosive tooth wear, and fluorosis in primary teeth using a 3D intraoral digital scanner. The investigator will validate findings using three key indices: ICDAS (for caries), BEWE (for erosive wear), and TF (for fluorosis). Teeth will be cleaned and examined visually using dental tools and light. After visual checks, teeth will be scanned with a 3D intraoral scanner. Children aged 3-12 years with fully erupted primary teeth, seeking dental treatment at the Department of Pediatric Dentistry, Indiana University School of Dentistry.\n\nThe visual examination and digital scanning will be performed just once and during the dental appointment at the clinic of Pediatric Dentistry following the protocols used in the clinical routine. It is expected to complete the visual examination and the digital scanning in 30 minutes.', 'detailedDescription': 'Experimental design: This study is based on information obtained in a pilot study in the framework of a "validation study" previously to an in vivo study. Investigators will be trained in 3 different indices to register and grade the lesions to obtain reproducible data. International caries detection and assessment system (ICDAS - Pitts et al., 2013), Basic Erosive Wear Examination (BEWE - Schlueter et al., 2020), and TF index (Thylstrup \\& Fejerskov, 1978) will be used for detection of caries lesions, erosive tooth wear, and dental fluorosis, respectively.\n\nPatient recruitment: The research protocol was approved by the Institutional Review Board (# 24373). After IRB approval and previous to any intervention, a signed informed consent form will be obtained from the legal guardians of each child. Children aged between 3 and 12 years old, presenting any fully erupted primary teeth, searching for dental treatment at the Department of Pediatric Dentistry, Indiana University School of Dentistry will be included in this study.\n\nVisual examination: Before visual examination, teeth will be cleaned using a bristle brush, prophylaxis paste and mirror, washed, and carefully air dried. Isolator will be used to control the saliva during the prophy. For the index detection using the visual examination of the different indices on each tooth\'s, the primary upper and lower incisors, canines and molars will be dried with compressed air, and each tooth\'s buccal, palatal/lingual, and occlusal surfaces will be examined visually using adequate dental instruments for each index. A headlight or overhead/dental unit light will be directly over the teeth. The diagnosis of caries lesions, erosive tooth wear, and dental fluorosis will be carried out separately. ICDAS, BEWE, and TF systems will be registered and graded the lesions according to table 1. Once the visual examination is completed, the data will be stored to be compared with intraoral scanner later.\n\nDigital scanning: After completing the visual examination, the investigators will be calibrated using 3Shape TRIOS 4 intraoral scanner and 3Shape Unite software for data processing according to the manufacturer\'s instructions. The primary teeth\'s buccal, palatal/lingual, and occlusal surfaces will be scanned with a 3D intraoral scanner (IOS) (TRIOS 4; 3Shape A/S, Copenhagen, Denmark) and register with a number. There will be no headlight or overhead/dental unit light directly over the teeth to be scanned. Subsequently, using the 3Shape Unite software, each tooth will be analyzed separately on all its surfaces (as with the visual examination, the ICDAS, BEWE, and TF, indices will be detected) by using the 3Shape software and an entire screen of a 15.5" Dell laptop. Following, the 3D image will be magnified until only lesion can be seen and each surface will be observed systematically for each index.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '3 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nChildren aged between 3 and 12 years old, presenting at least one fully erupted primary tooth.\n\nExclusion Criteria:\n\n* Unerupted primary teeth.\n* Restored teeth.\n* Children under 3 or older than 12 years old.\n* Children using medication.'}, 'identificationModule': {'nctId': 'NCT06829550', 'briefTitle': '3D Scanning as an Advanced Tool for Identifying Tooth Lesions in Children', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': '3D Scanning as an Advanced Tool for Identifying Tooth Lesions in Children', 'orgStudyIdInfo': {'id': '24373'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'direct- visual examination and indirect- 3D digital scanning', 'description': 'Two diagnostic methods (direct- visual examination and indirect- 3D digital scanning) will be conducted for each participant (n=30), comparing their effectiveness in detecting dental caries, erosive tooth wear, and fluorosis.', 'interventionNames': ['Diagnostic Test: indirect- 3D digital scanning']}], 'interventions': [{'name': 'indirect- 3D digital scanning', 'type': 'DIAGNOSTIC_TEST', 'description': 'examination for dental caries, erosive tooth wear and dental fluorosis using direct assessment (visual) and indirect assessment (digital scanning)', 'armGroupLabels': ['direct- visual examination and indirect- 3D digital scanning']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University School of Dentistry (IUSD)', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}], 'overallOfficials': [{'name': 'Aline Castilho, DDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indiana Unviersity'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indiana University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Aline Rogeria Freire de Castilho', 'investigatorAffiliation': 'Indiana University'}}}}