Ignite Creation Date:
2025-12-25 @ 2:14 AM
Ignite Modification Date:
2025-12-26 @ 12:43 AM
Study NCT ID:
NCT05929560
Status:
COMPLETED
Last Update Posted:
2023-07-03
First Post:
2023-06-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Digital Impression in Neonates
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Paired design "Same patients receive conventional impression and digital"'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-25', 'studyFirstSubmitDate': '2023-06-25', 'studyFirstSubmitQcDate': '2023-06-25', 'lastUpdatePostDateStruct': {'date': '2023-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Deviation of linear measurments', 'timeFrame': 'up to 1 month', 'description': 'The stone models obtained from conventional methods and 3D printed models obtained from the intraoral scanning were measured directly three times using an Vernier Fowler Calipers (WESTport Corporation, NY.),'}], 'secondaryOutcomes': [{'measure': "Assessment of gaurdian' perception and experience", 'timeFrame': 'up to 1 month', 'description': "The assessment of mothers' perception and experience regarding Pre-surgical infant orthopedics (PSIO) was executed using 16 validated preformed question.\n\nA questionnaire assess parents' satisfaction concerning PSIO"}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Unilateral Complete Cleft Lip and Palate']}, 'descriptionModule': {'briefSummary': 'The goal of this \\[clinical trial\\] is to \\[explore the attitudes of guardians with different educational background regarding the technique of impression registration as well as the compliance to using feeding appliances \\] in \\[neonates\\].\n\nResearchers will compare \\[conventional impression technique to digital impression\\]'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '28 Days', 'minimumAge': '1 Day', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with unilateral complete cleft lip and palate\n* neonates\n\nExclusion Criteria:\n\n* infants and children\n* bilateral cleft lip and palatal\n* incomplete cleft lip'}, 'identificationModule': {'nctId': 'NCT05929560', 'briefTitle': 'Digital Impression in Neonates', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'Diagnostic Evaluation and Guardian Assessment of Using Digital Impression in Neonates Versus the Conventional Techniques.', 'orgStudyIdInfo': {'id': 'Digital_impression_neonates_23'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional impression', 'interventionNames': ['Other: Conventional impression']}, {'type': 'EXPERIMENTAL', 'label': 'Digital impression', 'interventionNames': ['Other: Digital impression']}], 'interventions': [{'name': 'Conventional impression', 'type': 'OTHER', 'description': 'Palatal impressions obtained using an irreversible hydrocolloid impression material', 'armGroupLabels': ['Conventional impression']}, {'name': 'Digital impression', 'type': 'OTHER', 'description': 'after obtaining stone models from conventional impression material, stone models were scanned using the I700 (Medit) scanner and Patients were directly scanned intraorally using an intraoral 3D scanner Subsequently, the printed 3D model scan data of the seven patients were then used for standard triangulated language (STL)', 'armGroupLabels': ['Digital impression']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alexandria', 'country': 'Egypt', 'facility': 'Alexandria Faculty of Dentistry', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexandria University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer of DPH and Clinical statistician', 'investigatorFullName': 'Hams Hamed Abdelrahman', 'investigatorAffiliation': 'Alexandria University'}}}}