Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2025-12-26 @ 3:49 AM
Study NCT ID:
NCT06874218
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-13
First Post:
2025-03-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Digital Analysis of Primary Teeth Crown Dimensions and Clinical Evaluation in a Sample of Egyptian Children
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': 'SCREENING', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Digitally determine crown dimensions of primary teeth in a sample of Egyptian children.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 59}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2027-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-08', 'studyFirstSubmitDate': '2025-03-08', 'studyFirstSubmitQcDate': '2025-03-08', 'lastUpdatePostDateStruct': {'date': '2025-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'crown dimensions of primary teeth in a sample of Egyptian children.', 'timeFrame': 'intra operative', 'description': 'Digitally determine crown dimensions of primary teeth in a sample of Egyptian children using intraoral scanner and Digital measurements of teeth dimensions by Meshmixer analyzing software.'}], 'secondaryOutcomes': [{'measure': 'Clinical evaluation of prefabricated zirconia crowns according to the Egyptian sizes compared with the international standard zirconia crowns sizes for primary upper central incisors.', 'timeFrame': 'intra operative', 'description': 'Clinical evaluation of prefabricated zirconia crowns according to the Egyptian sizes compared with the international standard zirconia crowns sizes for primary upper central incisors by Modified United States Public Health Service (USPHS) criteria, and the gingival state near the primary performed crown will be assessed by using the Silness\\& Loe indices (1964) to record plaque index and gingival index.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Teeth Dimensions', 'Digital Analysis', 'Egyptian Children'], 'conditions': ['Primary Teeth Crown Dimensions in a Sample of Egyptian Children']}, 'descriptionModule': {'briefSummary': 'The aim of this study will be conducted to:\n\n1. Digitally determine crown dimensions of primary teeth in a sample of Egyptian children.\n2. Clinical evaluation of prefabricated zirconia crowns according to the Egyptian sizes compared with the international standard zirconia crowns sizes for primary upper central incisors', 'detailedDescription': 'Currently, there is limited availability of primary tooth crown measurement for Egyptian children. SO, this study aims to digitally determine tooth crown dimensions of primary teeth in a group of Egyptian children and compare prefabricated zirconia crowns according to the Egyptian crown sizes with the international standard zirconia crowns sizes for primary upper central incisors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children having normal fully erupted primary teeth and with no morphological variations.\n* Children with no history of orthodontic or prosthodontic treatment.\n* Children with normal overjet and overbite.\n* Sound interproximal \\& buccal / lingual walls with or without minimal occlusal pits \\& fissure incipient caries.\n* No previous interproximal \\& buccal / lingual restorations.\n* Intact mesial and distal marginal ridge.\n\nExclusion Criteria:\n\n* Children with gross carious lesions.\n* Children with hypo-mineralization, hypoplasia and fracture primary teeth.\n* Children with medical disabilities'}, 'identificationModule': {'nctId': 'NCT06874218', 'acronym': 'Digital Analys', 'briefTitle': 'Digital Analysis of Primary Teeth Crown Dimensions and Clinical Evaluation in a Sample of Egyptian Children', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Digital Analysis of Primary Teeth Crown Dimensions and Clinical Evaluation in a Sample of Egyptian Children', 'orgStudyIdInfo': {'id': 'Digital Analysis of teeth'}, 'secondaryIdInfos': [{'id': 'PED1-252299', 'type': 'REGISTRY', 'domain': 'Research Ethics Committee Faculty of Dentistry'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Primary Teeth Crown Dimensions in a Sample of Egyptian Children', 'description': 'Digitally determine crown dimensions of primary teeth in a sample of Egyptian children', 'interventionNames': ['Device: prefabricated CAD-CAM Zirconia crowns according to Egyptian sizes.']}], 'interventions': [{'name': 'prefabricated CAD-CAM Zirconia crowns according to Egyptian sizes.', 'type': 'DEVICE', 'description': 'compare prefabricated zirconia crowns according to the Egyptian crown sizes with the international standard zirconia crowns sizes for primary upper central incisors', 'armGroupLabels': ['Primary Teeth Crown Dimensions in a Sample of Egyptian Children']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tanta', 'country': 'Egypt', 'facility': 'Tanta university', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'centralContacts': [{'name': 'Reham Abbelwahed Melegy, MD', 'role': 'CONTACT', 'email': 'reham_abdelwahed@dent.tanta.edu.eg', 'phone': '+2 01014602137'}, {'name': 'Amina Mohammed El Hosary, professor', 'role': 'CONTACT', 'email': 'amina.elhosary@dent.tanta.edu.eg', 'phone': '+2 01006816569'}], 'overallOfficials': [{'name': 'Reham Abdelwahed Melegy, MSC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tanta University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'for patient privacy'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant lecture', 'investigatorFullName': 'Reham Abdelwahed Melegy', 'investigatorAffiliation': 'Tanta University'}}}}