Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-26 @ 2:30 AM
Study NCT ID:
NCT05334602
Status:
COMPLETED
Last Update Posted:
2022-04-19
First Post:
2022-04-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Use of Dermal Fat Graft as a Barrier Membrane
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'double blinded'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized clinical trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-12', 'studyFirstSubmitDate': '2022-04-12', 'studyFirstSubmitQcDate': '2022-04-12', 'lastUpdatePostDateStruct': {'date': '2022-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of oronasal fistula', 'timeFrame': '6 months', 'description': 'assessment of incidence of recurrence of oronasal fistual after the surgical procedure clinically'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Alveolar cleft grafting'], 'conditions': ['Unilateral Cleft Lip']}, 'descriptionModule': {'briefSummary': 'a study conducted to assess the use of dermal fat graft use as barrier membrane over grafted bone', 'detailedDescription': 'The study has two group in which the study will have in addition to the conventional bone grafting addition of dermal fat graft to protect the bone. The control will have just normal graft\n\nThe results are assessed using computed tomography to assess the quality of the grafted bone.\n\nThe Chisquare test was used to asses the results significance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '13 Years', 'minimumAge': '9 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients having age range of 8-14ys who performed for 2ry alveolar cleft grafting at the CCC using adipose fat graft in conjunction with ACBG Boys or girls. Unilateral or bilateral cleft alveolus. Accepts Healthy Volunteers has not been entered.\n\nExclusion Criteria:\n\nYounger patients requiring 1ry grafting. Older patients requiring 3ry grafting.'}, 'identificationModule': {'nctId': 'NCT05334602', 'briefTitle': 'The Effect of Use of Dermal Fat Graft as a Barrier Membrane', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'The Effect of Use of Dermal Fat Graft as a Barrier Membrane in Unilateral Alveolar Cleft Grafting. (A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '4.12.2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'study group', 'description': 'Dermal fat graft is added over the grafted bone in the alveolar cleft to protect the bone from resorption', 'interventionNames': ['Procedure: Addition of dermal fat graft as protection over bone graft']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'Conventional procedure of alveolar cleft grafting'}], 'interventions': [{'name': 'Addition of dermal fat graft as protection over bone graft', 'type': 'PROCEDURE', 'description': 'A barrier membrane', 'armGroupLabels': ['study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11757', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Ain shams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Marwa EL Kassaby', 'role': 'STUDY_CHAIR', 'affiliation': 'Ain Shams University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'RCT conducted to assess the effect of adding fat over bone graft in order to protect the bone from resorption'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principle investigator', 'investigatorFullName': 'Yasser Mohamed Nabil Ahmed Khirat El Hadidi', 'investigatorAffiliation': 'Ain Shams University'}}}}