Ignite Creation Date:
2025-12-24 @ 1:30 PM
Ignite Modification Date:
2026-02-28 @ 4:57 AM
Study NCT ID:
NCT03265795
Status:
UNKNOWN
Last Update Posted:
2017-08-30
First Post:
2017-08-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validity of PEEK PSI Containing Autogenous Bone Graft for Maxillary Reconstruction Following Lesion Enucleation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 8}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2018-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-08-29', 'studyFirstSubmitDate': '2017-08-27', 'studyFirstSubmitQcDate': '2017-08-27', 'lastUpdatePostDateStruct': {'date': '2017-08-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'oral health related quality of life', 'timeFrame': '4 months', 'description': 'OHIP-49 questionaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Maxillary Cyst']}, 'referencesModule': {'references': [{'pmid': '12409759', 'type': 'BACKGROUND', 'citation': 'Gellrich NC, Schramm A, Hammer B, Rojas S, Cufi D, Lagreze W, Schmelzeisen R. Computer-assisted secondary reconstruction of unilateral posttraumatic orbital deformity. Plast Reconstr Surg. 2002 Nov;110(6):1417-29. doi: 10.1097/01.PRS.0000029807.35391.E5.'}, {'pmid': '16327572', 'type': 'BACKGROUND', 'citation': 'Eckardt A, Swennen GR. Virtual planning of composite mandibular reconstruction with free fibula bone graft. J Craniofac Surg. 2005 Nov;16(6):1137-40. doi: 10.1097/01.scs.0000186306.32042.96.'}, {'pmid': '20642821', 'type': 'BACKGROUND', 'citation': 'Lethaus B, Kessler P, Boeckman R, Poort LJ, Tolba R. Reconstruction of a maxillary defect with a fibula graft and titanium mesh using CAD/CAM techniques. Head Face Med. 2010 Jul 19;6:16. doi: 10.1186/1746-160X-6-16.'}]}, 'descriptionModule': {'briefSummary': 'Surgical ablation of large maxillary cysts usually results in considerable hard and soft tissue deficits that ultimately affect the final esthetic and functional outcomes. Reconstruction of such defects; whether primarily or secondarily; offers much better long-term outcomes. However, primary bony reconstruction becomes potentially complicated in many cases of such large cysts encroaching or involving the maxillary sinus where a communication with the maxillary sinus lining may be unavoidable.\n\nReconstruction of such defects can be accomplished using either vascularized or; more commonly; non-vascularized autogenous bone grafts. Different bone substitutes remain to be another viable option. The simultaneous use of titanium meshes provides physical three-dimensional support for the bone graft contained within as well as the overlying soft tissues. However, the drawbacks of titanium meshes in such defects remain to be mainly the difficulty in adequately shaping the mesh and the lack of proper isolation of the mesh contents from the maxillary sinus cavity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age of patients from 15 to 60 years old.\n2. Patients with unilateral maxillary lesion encroaching maxillary sinus.\n3. Dentulous or edentulous patients.\n4. Patients should be free from any systemic disease that may affect normal healing of bone and predictable outcome.\n\nExclusion Criteria:\n\n1. Patients with systemic diseases as history of radiation therapy or chemotherapy, hematological disorders, neuromotor disorders and autoimmune diseases (may affect normal healing).\n2. Patients with bilateral maxillary lesions.\n3. Children under 15 years old.'}, 'identificationModule': {'nctId': 'NCT03265795', 'briefTitle': 'Validity of PEEK PSI Containing Autogenous Bone Graft for Maxillary Reconstruction Following Lesion Enucleation', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Validity of PEEK PSI Containing Autogenous Bone Graft for Maxillary Reconstruction Following Lesion Enucleation', 'orgStudyIdInfo': {'id': 'maxillary reconstruction'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PEEK patient specific implant', 'description': 'this PEEK (poly ether ether ketone) Patient Specific Implant containing autogenous bone graft is used in reconstruction of the bone and the original volume of maxillary sinus accurately (in terms of clinical and radiographic parameters).', 'interventionNames': ['Device: Poly Ether Ether Ketone PSI (patient specific implant).']}], 'interventions': [{'name': 'Poly Ether Ether Ketone PSI (patient specific implant).', 'type': 'DEVICE', 'description': 'reconstruction of the bone and the original volume of maxillary sinus accurately (in terms of clinical and radiographic parameters).', 'armGroupLabels': ['PEEK patient specific implant']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mohamed Zain, DDS', 'role': 'CONTACT', 'email': 'm_zain_89@hotmail.com', 'phone': '00201003363809'}, {'name': 'Maha Hakam', 'role': 'CONTACT'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'internal resident at oral and maxillofacial department', 'investigatorFullName': 'Mohammed Zain', 'investigatorAffiliation': 'Cairo University'}}}}