Ignite Creation Date:
2025-12-26 @ 11:47 AM
Ignite Modification Date:
2025-12-26 @ 11:47 AM
Study NCT ID:
NCT02660216
Status:
COMPLETED
Last Update Posted:
2021-01-19
First Post:
2016-01-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Modified Minimally Invasive Approach Towards Le Fort I Osteotomy: a Prospective Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007569', 'term': 'Jaw Abnormalities'}], 'ancestors': [{'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D019767', 'term': 'Maxillofacial Abnormalities'}, {'id': 'D019465', 'term': 'Craniofacial Abnormalities'}, {'id': 'D009139', 'term': 'Musculoskeletal Abnormalities'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D018640', 'term': 'Stomatognathic System Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2019-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-15', 'studyFirstSubmitDate': '2016-01-11', 'studyFirstSubmitQcDate': '2016-01-18', 'lastUpdatePostDateStruct': {'date': '2021-01-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-01-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'accuracy of the minimally invasive approach in comparison to conventional approaches, based on 3D virtual CBCT superimposition of planning CBCT and postoperative CBCT', 'timeFrame': 'at 4 weeks postoperative'}], 'secondaryOutcomes': [{'measure': 'Surgical time necessary to complete the procedure', 'timeFrame': 'perioperative'}, {'measure': 'Intraoperative and early postoperative complications', 'timeFrame': 'within 4 weeks postoperative'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['minimally invasive', 'le fort I osteotomy', '3D virtual treatment planning', 'accuracy'], 'conditions': ['Jaw Abnormalities']}, 'descriptionModule': {'briefSummary': 'Nowadays, maxillary Le Fort I osteotomy is a safe and routinely performed procedure. The conventional approach is characterized by a vestibular incision extending from molar-to-molar, associated with a pterygomaxillary disjunction performed with a curved chisel. Adequate mobilization of the maxilla during Le Fort I osteotomy requires an effective separation of the maxillary tuberosity from the pterygoid plates of the sphenoid bone. However, as initially described by Precious (1991) and later by Hernandez-Alfaro (2013), a true pterygomaxillary osteotomy is not necessary to achieve successful disjunction. Furthermore, Hernandez-Alfaro combined his technique of pterygomaxillary disjunction, the so-called "Twist technique", to a minimally invasive protocol, performing the complete Le Fort I osteotomy through a 20 to 30 mm long horizontal vestibular incision. Although promising, the technique remains highly sensitive from a technical standpoint, and its true accuracy has not been comprehensively evaluated.\n\nThe purpose of this study is to present and validate a minimally invasive approach towards Le Fort I osteotomy, using a modified pterygomaxillary (PTM) disjunction technique. The primary outcome is to evaluate the accuracy of the technique using rigid voxel-based registration of the 3D virtual treatment planning and the 4 weeks postoperative CBCT images. Secondary outcomes include the surgical time necessary to complete the procedure and the presence of intraoperative and early postoperative complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All consenting patients requiring a bimaxillary orthognathic procedure as part of their orthodontic-surgical treatment plan, and satisfying the inclusion and exclusion criteria.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients of all ages\n* Patients of all genders\n* A Le Fort I osteotomy is planned, as part of a bimaxillary orthognathic procedure\n* The surgery is planned with 3D Virtual Treatment Planning (Maxilim v. 2.3.0.3.0.)\n* The planning is transferred with 3D CAD/CAM tooth-borne splint and vertical internal bony reference landmarks\n* The maxilla is repositioned first during the surgery (maxilla first sequence)\n\nExclusion Criteria:\n\n* Patients not eligible according to abovementioned criteria\n* Simultaneous extraction of impacted teeth 18 and/or 28\n* Previous maxillary orthognathic surgery\n* Previous Surgical Assisted Rapid Palatal Expansion (SARPE)\n* Syndromic condition, including cleft lip and palate\n* Segmental Le Fort I osteotomy\n* Adjuvant Zygomatic osteotomy\n* Maxillary impaction higher than 3 mm\n* Maxillary advancement greater than 5 mm'}, 'identificationModule': {'nctId': 'NCT02660216', 'acronym': 'MILF-I', 'briefTitle': 'A Modified Minimally Invasive Approach Towards Le Fort I Osteotomy: a Prospective Study', 'organization': {'class': 'OTHER', 'fullName': 'AZ Sint-Jan AV'}, 'orgStudyIdInfo': {'id': 'BO49201525495'}}, 'contactsLocationsModule': {'locations': [{'city': 'Bruges', 'country': 'Belgium', 'facility': 'general hospital Saint-John Bruges', 'geoPoint': {'lat': 51.20892, 'lon': 3.22424}}], 'overallOfficials': [{'name': 'Gwen Swennen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Division of Maxillofacial Surgery, Department of Surgery, General Hospital Saint-John Bruges, Belgium'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AZ Sint-Jan AV', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Maxillofacial Surgeon, MD, LDS, DMD, PhD, FEBOMFS', 'investigatorFullName': 'Gwen Swennen', 'investigatorAffiliation': 'AZ Sint-Jan AV'}}}}