Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-27 @ 11:02 PM
Study NCT ID:
NCT06292234
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-19
First Post:
2024-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient Specific Implant Versus Miniplates for Advancement of Hypoplastic Maxilla
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': ['PARTICIPANT'], 'maskingDescription': 'single blinded clinical trial'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel randomized controlled trial with 1:1 allocation ratio and superiority framework'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-17', 'studyFirstSubmitDate': '2024-02-25', 'studyFirstSubmitQcDate': '2024-03-02', 'lastUpdatePostDateStruct': {'date': '2024-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Distraction effectiveness', 'timeFrame': 'immediate postoperative, 4 months postoperatively, 10 months postoperatively', 'description': 'Amount of distraction using Lateral Cephalometry \\& FBCT measured in millimeters (mm)'}], 'secondaryOutcomes': [{'measure': 'Velopharyngeal insufficiency', 'timeFrame': 'Preoperative , 4 months postoperatively, 10 months postoperatively', 'description': 'Scoring from 0 to 4; 0: Normal, 1: minimal, 2: mild, 3: moderate, 4: sever using endoscopy'}, {'measure': 'Speech', 'timeFrame': 'preoperative, 4 months postoperatively, and 10 months postoperatively', 'description': 'Nasometry Speech assessment; 1=absent, 2=mild, 3=mild to moderate, 4=moderate, 5=moderate to severe and 6=severe.'}, {'measure': 'Operative time', 'timeFrame': 'Immediate postoperative', 'description': 'Measuring the time of the procedures in minutes'}, {'measure': 'Wound dehiscence', 'timeFrame': 'immediate postoperative till 4 months postoperatively', 'description': 'Clinical assessment of presence or absence of wound dehiscence (Binary: Yes or No)'}, {'measure': 'Infection', 'timeFrame': 'immediate postoperative till 4 months postoperatively', 'description': 'Clinical assessment of presence or absence of infection (Binary: Yes or No)'}, {'measure': 'Nerve affection', 'timeFrame': 'immediate postoperative till 4 months postoperatively', 'description': 'Clinical assessment of presence or absence of nerve affection (Binary: Yes or No)'}, {'measure': 'Screw loosening', 'timeFrame': 'immediate postoperative till 4 months postoperatively', 'description': 'Clinical assessment of presence or absence of screw loosening (Binary: Yes or No)'}, {'measure': 'Overall complications', 'timeFrame': 'immediate postoperative, 4 months postoperatively and 10 months postoperatively', 'description': 'Clinical assessment of presence or absence of complications (Binary: Yes or No)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cleft Lip and Palate']}, 'descriptionModule': {'briefSummary': 'Distraction osteogenesis is the treatment of choice in management of severe maxillary anteroposterior deficiency allowing for a progressive bone generation and simultaneous expansion of the surrounding scarred soft tissue \\& better long-term stability \\& less relapse rate.', 'detailedDescription': 'Maxillary distraction using rigid external distraction device (RED) with skeletal anchorage in cleft lip and palate overcomes the disadvantages of tooth brone RED \\& showed reliable advancement \\& reasonable relapse rate in the short \\& long-term follow up \\& most importantly it solved somehow counterclockwise rotation of maxilla but still it can occur. Positioning of plates in relation to center of resistance of maxilla to adjust vector of distraction can be done now by using Virtual surgical planning (VSP) \\& fabrication of patient specific implants (PSI) to overcome problems encountered with use of conventional miniplates during distraction process. Limited data in literature with no randomized clinical trials were done to assess distraction effectiveness using PSI in RED with skeletal anchorage and its effect on velopharyngeal insufficiency (VPI) \\& speech. Based on that data, the research will compare distraction effectiveness, VPI \\& speech between using either PSI implants or miniplates for distraction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Non growing cleft patients, age range (18-30 years)\n2. Unilateral or bilateral cleft patients\n3. Anteroposterior deficiency (1.5-2.5 cm)\n4. No sex predilection\n\nExclusion Criteria:\n\n1. Syndromic patients.\n2. bone metabolism \\& systemic diseases.'}, 'identificationModule': {'nctId': 'NCT06292234', 'briefTitle': 'Patient Specific Implant Versus Miniplates for Advancement of Hypoplastic Maxilla', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'External Distraction Using Patient Specific Implant Versus Miniplates for Advancement of Hypoplastic Maxilla in Non-growing Cleft Patients', 'orgStudyIdInfo': {'id': 'OMFS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'patient specific implants', 'description': 'Custom made designed implants', 'interventionNames': ['Device: PSI']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'miniplates', 'description': 'Over the counter miniplates', 'interventionNames': ['Device: Conventional miniplates']}], 'interventions': [{'name': 'PSI', 'type': 'DEVICE', 'description': 'Fabrication of PSI implants using virtual surgical planning', 'armGroupLabels': ['patient specific implants']}, {'name': 'Conventional miniplates', 'type': 'DEVICE', 'description': 'Ready made miniplates', 'armGroupLabels': ['miniplates']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator, Phd candidate, Department of Oral & Maxillofacial Surgery, Faculty of Dentistry', 'investigatorFullName': 'Hagar Mahmoud Ahmed Mohamed', 'investigatorAffiliation': 'Cairo University'}}}}