Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-31 @ 2:16 PM
Study NCT ID:
NCT06838533
Status:
COMPLETED
Last Update Posted:
2025-02-27
First Post:
2025-02-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient Specific PEEK Versus Titanium Patient Specific Plates in The Fixation of Computer-Guided Advancement Genioplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000013', 'term': 'Congenital Abnormalities'}], 'ancestors': [{'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-03-01', 'size': 84835, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2025-02-12T03:39', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-25', 'studyFirstSubmitDate': '2025-02-12', 'studyFirstSubmitQcDate': '2025-02-17', 'lastUpdatePostDateStruct': {'date': '2025-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stability of PEEK vs Titanium plates', 'timeFrame': '6 months follow up', 'description': 'Radiographic linear discrepancy in mm (Horizontal and vertical) between Pogonion and Menton position in immediate and 6 months postoperative'}], 'secondaryOutcomes': [{'measure': 'Patient satisfaction', 'timeFrame': '6 months', 'description': 'Number from 1 to 5 of a 5-point Likert scale (1 very dissatisfied is minimal to 5 very satisfied is maximum)'}, {'measure': 'Cost of patient specific plated (PEEK and titanium)', 'timeFrame': '6 months', 'description': 'Number in Egyptian pound'}, {'measure': 'Soft tissue healing', 'timeFrame': '6 months', 'description': 'Binary answer (yes if happened or no if not happened) of clinical examination (Infection, soft tissue dehiscence and plate exposure)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Genioplasty', 'PEEK', 'Mandible deformity'], 'conditions': ['Mandible; Deformity']}, 'descriptionModule': {'briefSummary': 'Evaluation of polyetheretherketone (PEEK) versus titanium patient specific plates in the fixation of computer-guided advancement genioplasty.', 'detailedDescription': 'Aim: Comparison between polyetheretherketone (PEEK) and titanium patient specific plates in the fixation of computer-guided advancement genioplasty.\n\nPatients and Methods: This study included fourteen patients indicated for advancement genioplasty. Patients were assigned randomly into one of two equal groups. Group A (Control group) included seven patients who were treated by computer guided advancement genioplasty using patient specific titanium plates and Group B(Study group) involved seven patients who were treated by computer guided advancement genioplasty using patient specific PEEK plates.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '17 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who are indicated to advancement genioplasty.\n* Patients with completed growth.\n* Physically and psychologically able to tolerate surgical procedures.\n\nExclusion Criteria:\n\n* Presence of any medical conditions that contraindicate the surgical procedure.\n* Any medical condition that compromises the healing and surgical outcome.'}, 'identificationModule': {'nctId': 'NCT06838533', 'acronym': 'PEEK', 'briefTitle': 'Patient Specific PEEK Versus Titanium Patient Specific Plates in The Fixation of Computer-Guided Advancement Genioplasty', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Faculty of Dental Medicine for Girls'}, 'officialTitle': 'Patient Specific Polyetheretherketone (PEEK) Miniplates Versus Titanium Genioplasty Plates in The Fixation of Computer-Guided Advancement Genioplasty', 'orgStudyIdInfo': {'id': 'ORSUR-108-2-L'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PEEK plates in Computer guided advancement genioplasty', 'description': 'Study group', 'interventionNames': ['Procedure: computer guided advancement genioplasty']}, {'type': 'EXPERIMENTAL', 'label': 'Titanium plates in Computer guided advancement genioplasty', 'description': 'Control group', 'interventionNames': ['Procedure: computer guided advancement genioplasty']}], 'interventions': [{'name': 'computer guided advancement genioplasty', 'type': 'PROCEDURE', 'description': 'PEEK vs Titanium patient specific plates', 'armGroupLabels': ['PEEK plates in Computer guided advancement genioplasty', 'Titanium plates in Computer guided advancement genioplasty']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12345', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Dina mohamed abdelwahab', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Nahed Adly, consultant', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assistant professor at faaculty of dentistry AlAzhar university'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Faculty of Dental Medicine for Girls', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dina Mohamed Mohamed Abdelwahab', 'investigatorAffiliation': 'Faculty of Dental Medicine for Girls'}}}}