Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 1:33 AM
Study NCT ID:
NCT07365657
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-26
First Post:
2026-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Finite Element Modelling of Le Fort I Osteotomy Fixation : PSI vs Miniplates
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008310', 'term': 'Malocclusion'}], 'ancestors': [{'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-01-23', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-16', 'studyFirstSubmitDate': '2026-01-16', 'studyFirstSubmitQcDate': '2026-01-16', 'lastUpdatePostDateStruct': {'date': '2026-01-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plate stress levels', 'timeFrame': 'At the inclusion', 'description': 'assessed by FORGE software'}], 'secondaryOutcomes': [{'measure': 'Stress on bone', 'timeFrame': 'At the inclusion', 'description': 'Mechanical stress in mecanics is measured in Pa (Pascal)'}, {'measure': 'Maxillary displacement', 'timeFrame': 'At the inclusion', 'description': 'Displacement levels in mecanics is measured in millimeters or micrometers.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Malocclusion']}, 'descriptionModule': {'briefSummary': 'This study aimed to evaluate the biomechanical performance of patient-specific versus conventional fixation for Le Fort I osteotomy using subject-specific finite element models derived from real surgical plans. Two distinct clinical scenarios-a minor advancement without impaction and a moderate advancement with posterior impaction-were analyzed to determine how surgical movements influence implant stress, bone stress, and maxillary micromotion. By combining surgical planning with validated computational modeling, this work provides clinically relevant insight to optimize PSI design and guide fixation strategy selection in orthognathic surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '2 patients : one with type II maloclusion, one with type III maloclusion who previously undergone orthognathic surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient operated on By Pr SAVOLDELLI.\n* Patient undergoing patient-specific orthognathic surgery.\n* Access to numerical (digital) planning.\n\nExclusion Criteria:\n\n* Previous maxillo-facial trauma.\n* Facial cleft.'}, 'identificationModule': {'nctId': 'NCT07365657', 'briefTitle': 'Finite Element Modelling of Le Fort I Osteotomy Fixation : PSI vs Miniplates', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nice'}, 'officialTitle': 'Subject-specific Finite Element Modelling of Le Fort I Osteotomy Fixation : Patient-specific Implants vs Miniplates', 'orgStudyIdInfo': {'id': '26IUFC01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Type II maloclusion', 'description': '2 patients : one with type II maloclusion, one with type III maloclusion who previously undergone orthognathic surgery', 'interventionNames': ['Other: In silico orthognathic surgery with customized implants digital only on 3D scanners']}, {'label': 'Type III maloclusion', 'description': '2 patients : one with type II maloclusion, one with type III maloclusion who previously undergone orthognathic surgery', 'interventionNames': ['Other: In silico orthognathic surgery with customized implants digital only on 3D scanners']}], 'interventions': [{'name': 'In silico orthognathic surgery with customized implants digital only on 3D scanners', 'type': 'OTHER', 'description': '2 patients : one with type II maloclusion, one with type III maloclusion who previously undergone orthognathic surgery', 'armGroupLabels': ['Type II maloclusion', 'Type III maloclusion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06000', 'city': 'Nice', 'state': 'Alpes Maritimes', 'country': 'France', 'facility': 'CHU Nice', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}], 'centralContacts': [{'name': 'Olina Rios', 'role': 'CONTACT', 'email': 'rios.o@chu-nice.fr', 'phone': '0788454522', 'phoneExt': '+ 33'}, {'name': 'Charles +33 SAVOLDELL', 'role': 'CONTACT', 'email': 'savoldelli.c@chu-nice.fr', 'phone': '33648275014', 'phoneExt': '+33'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nice', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}