Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2025-12-26 @ 2:44 AM
Study NCT ID:
NCT04893902
Status:
UNKNOWN
Last Update Posted:
2021-05-20
First Post:
2021-05-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Digital VS. Conventional Ear Impression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'control clinical rial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 8}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-05-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2021-05-17', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-05-14', 'studyFirstSubmitDate': '2021-05-14', 'studyFirstSubmitQcDate': '2021-05-14', 'lastUpdatePostDateStruct': {'date': '2021-05-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'total deviation between Conventional auricular impression and two types of digital impression', 'timeFrame': '1 day'}], 'secondaryOutcomes': [{'measure': 'total deviation between two types of digital impression', 'timeFrame': '1 day'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ear impression -Ear scanning-intraoral scanner-scannin marker-ear prosthesis'], 'conditions': ['Patient Loss His Ear and Need Auricular Prosthesis']}, 'referencesModule': {'references': [{'pmid': '36117136', 'type': 'DERIVED', 'citation': 'Dohiem MM, Emam NS, Abdallah MF, Abdelaziz MS. Accuracy of digital auricular impression using intraoral scanner versus conventional impression technique for ear rehabilitation: A controlled clinical trial. J Plast Reconstr Aesthet Surg. 2022 Nov;75(11):4254-4263. doi: 10.1016/j.bjps.2022.08.002. Epub 2022 Aug 5.'}]}, 'descriptionModule': {'briefSummary': 'What is known:\n\nEar impressions are made in conventional manner by impression materials which may affect the accuracy of the obtained data and consume time and effort .\n\nWhat this study adds:\n\nPredesigned ear markers facilitate ear scanning using an intraoral scanner that decreases the probability of in-accuracies using the conventional manner with less time and effort', 'detailedDescription': 'Prosthodontic maxillofacial rehabilitation of acquired or congenital ear defects is considered a challenging procedure. This clinical trial introduces a novel approach for digital scanning of the unaffected contralateral ear using an intraoral scanner in comparison to the conventional impression techniques. CAD/CAM is a very promising design and fabrication of an auricular prosthesis for patients with unilateral ear defects.\n\nPurpose: This study aims to compare digital impression technique using an intra-oral digital scanner IOSfor the unaffected ear with markers /without markers versus traditional techniques with hydro colloidal impression materials.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* any normal patient\n\nExclusion criteria:\n\n* no exclusion criteria'}, 'identificationModule': {'nctId': 'NCT04893902', 'briefTitle': 'Digital VS. Conventional Ear Impression', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Zagazig University'}, 'officialTitle': 'An Innovative Approach for Auricular Rehabilitation Using Two Types Digital Impression Versus Conventional Techniques:', 'orgStudyIdInfo': {'id': 'dohiem md'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'conventional ear impression', 'interventionNames': ['Device: medit intra oral scanner']}, {'type': 'EXPERIMENTAL', 'label': 'digital auricular impression without marker using intra oral scanner', 'interventionNames': ['Device: medit intra oral scanner']}, {'type': 'EXPERIMENTAL', 'label': 'digital auricular impression with marker using intra oral scanner', 'interventionNames': ['Device: medit intra oral scanner']}], 'interventions': [{'name': 'medit intra oral scanner', 'type': 'DEVICE', 'description': 'ear scanning with intra oral scanner', 'armGroupLabels': ['conventional ear impression', 'digital auricular impression with marker using intra oral scanner', 'digital auricular impression without marker using intra oral scanner']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11742', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mohamed M dohiem, lecturer', 'role': 'CONTACT', 'email': 'mdohiem@zu.edu.eg', 'phone': '00201002411965'}], 'facility': 'Mohamed Mahmoud dohiem', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Mohamed M dohiem, lecturer', 'role': 'CONTACT', 'email': 'mdohiem@zu.edu.eg', 'phone': '01002411965'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mohamed Mahmoud Dohiem', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'lecture prosthetic department zagazig university egypt', 'investigatorFullName': 'Mohamed Mahmoud Dohiem', 'investigatorAffiliation': 'Zagazig University'}}}}