Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2026-02-23 @ 8:08 PM
Study NCT ID:
NCT01879969
Status:
COMPLETED
Last Update Posted:
2013-06-19
First Post:
2013-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Computer Assisted Orthognathic Surgery. Facial Asymmetry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005146', 'term': 'Facial Asymmetry'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-18', 'studyFirstSubmitDate': '2013-06-06', 'studyFirstSubmitQcDate': '2013-06-13', 'lastUpdatePostDateStruct': {'date': '2013-06-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in linear measures', 'timeFrame': 'Preoperative (baseline)-Postoperative (up to 1 month)', 'description': 'More specifically were measured: distance from the upper interincisal point to the facial midline; distance from the lower interincisal point to the facial midline; distance between interincisal points; distance from skeletal menton to the facial midline; distance from soft tissue menton to the facial midline;'}, {'measure': 'Change in angular measures', 'timeFrame': 'Preoperative (baseline)- Postoperative (up to one month)', 'description': 'More specifically were measured:distance from the maxillary sagittal plane to the facial mid-sagittal plane; distance from the mandibular sagittal plane to the facial mid-sagittal plane.'}], 'secondaryOutcomes': [{'measure': 'age of patients', 'timeFrame': 'Preoperative (baseline)', 'description': 'age at surgery'}, {'measure': 'Type of surgery needed', 'timeFrame': 'Preoperative (baseline)', 'description': 'How many patients had genioplasty added to the standard bimaxillary surgery plan'}, {'measure': 'sample size', 'timeFrame': 'Preoperative (baseline)', 'description': 'number of patients'}, {'measure': 'gender', 'timeFrame': 'Preoperative (baseline)', 'description': 'male/female'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['computer-assisted orthognathic surgery; facial asymmetry'], 'conditions': ['Facial Asymmetry']}, 'descriptionModule': {'briefSummary': 'The specific aims of the study were to measure and compare the rates of alignment and cant reduction of the dental and facial midlines among the two groups.', 'detailedDescription': 'The purpose of this randomized, controlled, clinical study, was to evaluate the most accurate procedure for orthognathic correction of facial asymmetry. The investigators compared two different methods of surgical planning: classical (esthetic analysis of the face, cephalometric study of the skull in lateral and posteroanterior cephalograms, analysis and surgical simulation of plaster casts mounted in semi-individual articulators, development of a surgical acrylic resin intermediate splint) and digital planning (cone-beam computed tomography, data acquisition, software-assisted virtual surgery -Maxilim; Medicim, Mechelen, Belgium- and CAD/CAM processing of the surgical intermediate splint).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '54 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* facial asymmetry or mandibular deviation (cant of the occlusal plane \\> 3° and/or midline discrepancies \\> 2.5 mm)\n* presence of all central incisors,\n* pre- and postoperative radiographs and plaster casts (group 1)\n* cranial CBCT images (group 2)\n* pre- and postoperative digital photographs.\n\nExclusion Criteria:\n\n* previous trauma involving the hard or soft facial tissues\n* functional deviation of the mandible\n* incomplete records (CBCT, radiographs, casts or digital photographs).'}, 'identificationModule': {'nctId': 'NCT01879969', 'briefTitle': 'Computer Assisted Orthognathic Surgery. Facial Asymmetry', 'organization': {'class': 'OTHER', 'fullName': 'Università degli Studi di Sassari'}, 'orgStudyIdInfo': {'id': 'IDM 06/06/13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'asymmetric patients, classic procedure', 'description': 'random selected', 'interventionNames': ['Procedure: classic procedure of planning']}, {'type': 'EXPERIMENTAL', 'label': 'asymmetric patients, computer assisted', 'description': 'random selected', 'interventionNames': ['Procedure: computer assisted orthognathic planning and surgery of asymmetric patients']}], 'interventions': [{'name': 'classic procedure of planning', 'type': 'PROCEDURE', 'description': 'analysis of pictures, 2D radiographs and aesthetics; model surgery and acrylic splint', 'armGroupLabels': ['asymmetric patients, classic procedure']}, {'name': 'computer assisted orthognathic planning and surgery of asymmetric patients', 'type': 'PROCEDURE', 'otherNames': ['CBCT, data acquisition and processing; virtual surgery and CAD/CAM intermediate splint'], 'armGroupLabels': ['asymmetric patients, computer assisted']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07100', 'city': 'Sassari', 'state': 'SS', 'country': 'Italy', 'facility': 'Maxillofacial Unit, University of Sassari', 'geoPoint': {'lat': 40.72586, 'lon': 8.55552}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Università degli Studi di Sassari', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'DDS, PhD, Assistant Professor', 'investigatorFullName': 'Silvio Mario Meloni', 'investigatorAffiliation': 'Università degli Studi di Sassari'}}}}