Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:11 AM
Study NCT ID:
NCT06211205
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-18
First Post:
2023-12-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of a Customized 3D Printed Nostril Retainer Combined With Taping Vs.Taping Only on Enhancing the Nasolabial Esthetics and Maxillary Arch Dimensions in Infants With Unilateral Complete Cleft Lip and Palate.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002971', 'term': 'Cleft Lip'}], 'ancestors': [{'id': 'D008047', 'term': 'Lip Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D009056', 'term': 'Mouth 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': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-01-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-08', 'studyFirstSubmitDate': '2023-12-24', 'studyFirstSubmitQcDate': '2024-01-08', 'lastUpdatePostDateStruct': {'date': '2024-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Nasolabial esthetics', 'timeFrame': '3 months', 'description': 'Nasal basal width, Collumella Length, Defetcted Nostril width and height, Interlabial gap will be measured in mm at 2 time points to evaluate the effect of the intervention.\n\nThis will be performed on a 3D scan for the infants and through calibrated photographs'}], 'secondaryOutcomes': [{'measure': 'Maxillary arch changes', 'timeFrame': '3 months', 'description': 'Interalveolar gap will be measured in mm through an intraoral scan for the infants at 2 time points'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cleft Lip and Palate']}, 'descriptionModule': {'briefSummary': 'Lip taping was proven as simple, handy technique of PSIO for alveolar molding yielding enhanced maxillary arch dimensions in UCCLP infants.\n\nThe approach behind this study is to combine this simple step with a digitally designed 3D printed customized nasal molding device to enhance the naslolabial esthetics and maxillary arch dimensions in infants with unilateral complete cleft lip and palate, employing full digital workflow.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '30 Days', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Infants with age range from 1-30 days.\n2. Unilateral complete cleft lip and palate\n3. Medically free subjects.\n4. Both males and females.\n\nExclusion Criteria:\n\n1. Patients older than 30 days.\n2. Syndromic patients with other defects in addition to cleft lip and palate.\n3. Patients with bilateral cleft lip and palate.\n4. Incomplete cleft lip.\n5. Patient with previous surgical lip repair or adhesion.\n6. Patients with previous presurgical infant orthopedic treatment.\n7. Medically compromised patients.'}, 'identificationModule': {'nctId': 'NCT06211205', 'briefTitle': 'Effectiveness of a Customized 3D Printed Nostril Retainer Combined With Taping Vs.Taping Only on Enhancing the Nasolabial Esthetics and Maxillary Arch Dimensions in Infants With Unilateral Complete Cleft Lip and Palate.', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effectiveness of a Customized 3D Printed Nostril Retainer Combined With Taping Vs. Taping Only on Enhancing the Nasolabial Esthetics and Maxillary Arch Dimensions in Infants With Unilateral Complete Cleft Lip and Palate: A Randomized Clinical Trial.', 'orgStudyIdInfo': {'id': 'NCT26091993123'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Customized nostril retainer combined with lip taping', 'interventionNames': ['Device: Customized 3D printed nostril retainer combined with lip taping']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lip taping', 'interventionNames': ['Procedure: Lip taping']}], 'interventions': [{'name': 'Customized 3D printed nostril retainer combined with lip taping', 'type': 'DEVICE', 'description': 'the infants will receive a customised nostril retainer appliance to enhance the nasal esthetics combined with lip tape to approximate the labial and alveolar segments', 'armGroupLabels': ['Customized nostril retainer combined with lip taping']}, {'name': 'Lip taping', 'type': 'PROCEDURE', 'description': 'the infants will receive lip tape to approximate the labial and alveolar segments', 'armGroupLabels': ['Lip taping']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'contacts': [{'name': 'Hana A Adawy', 'role': 'CONTACT', 'email': 'hana_adel@dentistry.cu.edu.eg', 'phone': '+01002061202'}], 'facility': 'Department of Orthodontics, Faculty of Dentistry, Cairo university', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Hana A Adawy', 'role': 'CONTACT', 'email': 'hana_adel@dentistry.cu.edu.eg', 'phone': '+201002061202'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Hana Adawy, Principal Investigator', 'investigatorFullName': 'Hana Adel Adawy', 'investigatorAffiliation': 'Cairo University'}}}}