Ignite Creation Date:
2025-12-25 @ 5:07 AM
Ignite Modification Date:
2026-03-12 @ 5:05 AM
Study NCT ID:
NCT03852927
Status:
UNKNOWN
Last Update Posted:
2019-02-25
First Post:
2019-02-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Computer Guided Contouring of Craniofacial Fibrous Dysplasia Involving Zygoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077275', 'term': 'Craniofacial Fibrous Dysplasia'}], 'ancestors': [{'id': 'D005357', 'term': 'Fibrous Dysplasia of Bone'}, {'id': 'D010009', 'term': 'Osteochondrodysplasias'}, {'id': 'D001848', 'term': 'Bone Diseases, Developmental'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-01-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-02-22', 'studyFirstSubmitDate': '2019-02-22', 'studyFirstSubmitQcDate': '2019-02-22', 'lastUpdatePostDateStruct': {'date': '2019-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy', 'timeFrame': '1 week after the surgical procedure', 'description': 'Preoperative plane and post-operative 3D CT scan will superimposed, and the difference between the planed and postoperative bone contour will be estimated.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Craniofacial Fibrous Dysplasia']}, 'descriptionModule': {'briefSummary': 'This study will be conducted on patients with monostotic unilateral craniofacial fibrous dysplasia affecting zone I (fronto-orbital, zygomatic, and upper maxillary regions). Computer guided shaving will be performed for all the patients, and the accuracy of this procedure will be assessed.', 'detailedDescription': 'This study will be conducted on patients with monostotic unilateral craniofacial fibrous dysplasia affecting zone I (fronto-orbital, zygomatic, and upper maxillary regions).\n\nI. Preoperative preparation\n\n1. Virtual planning Computed tomography (CT) will be performed for the skull using a multi-slice helical CT machine. Computed tomography DICOM (digital Imaging and Communication in Medicine) files will be imported to the 3D surgical planning software (Mimics 10.0, Materialise NV, Leuven, Belgium). Using the software and through a series of segmentation and simulation processes, area of interest will be virtually selected and separated. Finally, the virtual image of the surgical guide will be reconstructed.\n2. Rapid prototyping Stereolithographic (STL) files of the virtual image will be exported to multi-jet modelling printing machine (InVision Si2, 3D Systems e Rock Hill, SC) and will be fabricated using plastic material (VisiJet SR 200, 3D Systems e Rock Hill, SC).\n\nII. Surgical procedures Area of interest for all patients will be exposed using the hemicoronal, and maxillary intraoral vestibular incisions. The surgical guide(s) will be seated in position on the affected side. Bone removal will be performed through the guide according to the preoperative planning. The bone removal will be then performed to connect the guiding holes using surgical burs. Finally, the incisions will be sutured after soft tissue suspension.\n\nIII. Follow up Postoperative CT will be performed for postoperative assessment. After 1 week patients will be recalled for suture removal and clinical assessment. Then the patients will be recalled 1, 3 months for further assessment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '17 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Monostotic unilateral craniofacial fibrous dysplasia.\n* Facial asymmetry affecting zone I (fronto-orbital, zygomatic, and upper maxillary regions)\n* More than 17 years\n\nExclusion Criteria:\n\n* functional deficits\n* orbital manifestations'}, 'identificationModule': {'nctId': 'NCT03852927', 'briefTitle': 'Computer Guided Contouring of Craniofacial Fibrous Dysplasia Involving Zygoma', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Computer Guided Contouring of Craniofacial Fibrous Dysplasia Involving Zygoma: a Case Series', 'orgStudyIdInfo': {'id': '19-1-20'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Computer guided contouring', 'type': 'PROCEDURE', 'otherNames': ['Computer guided shaving'], 'description': 'Using virtual planing and rapid prototyping a surgical guide will be fabricated, and will be used for bone contouring of the bone lesion.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '11728', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Sherif Ali', 'role': 'CONTACT', 'email': 'sherif.ali@dentistry.cu.edu.eg', 'phone': '+201001932020'}], 'facility': 'Faculty of dentistry, Cairo university', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of oral and maxillofacial surgery', 'investigatorFullName': 'Sherif Ali', 'investigatorAffiliation': 'Cairo University'}}}}