Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-25 @ 9:21 PM
Study NCT ID:
NCT07104656
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-05
First Post:
2025-07-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluate How Use of an Inferior Border Saw While Making the Inferior Border Osteotomy During Sagittal Ramus Osteotomy Using the Low and Short Medial Osteotomy Modification Technique Affects the Lingual Fracture Pattern of the Mandible
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-04', 'studyFirstSubmitDate': '2025-07-29', 'studyFirstSubmitQcDate': '2025-08-04', 'lastUpdatePostDateStruct': {'date': '2025-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Medial Cortex Fracture Pattern', 'timeFrame': '5 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mandibular', 'osteotomy'], 'conditions': ['Mandibular Surgery']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate if use of an inferior border saw while making the inferior border osteotomy is associated with the medial cortex fracture pattern.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* patient's having mandible surgery\n\nExclusion Criteria:\n\n* Severe dentofacial deformity secondary to a syndromic diagnosis"}, 'identificationModule': {'nctId': 'NCT07104656', 'briefTitle': 'Evaluate How Use of an Inferior Border Saw While Making the Inferior Border Osteotomy During Sagittal Ramus Osteotomy Using the Low and Short Medial Osteotomy Modification Technique Affects the Lingual Fracture Pattern of the Mandible', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'Evaluate How Use of an Inferior Border Saw While Making the Inferior Border Osteotomy During Sagittal Ramus Osteotomy Using the Low and Short Medial Osteotomy Modification Technique Affects the Lingual Fracture Pattern of the Mandible', 'orgStudyIdInfo': {'id': 'IRB-300014869'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Participants receiving jaw surgery', 'description': 'Participants receiving jaw surgery', 'interventionNames': ['Procedure: Inferior Osteotomy made by border saw', 'Procedure: Inferior Osteotomy made with reciprocating saw']}], 'interventions': [{'name': 'Inferior Osteotomy made by border saw', 'type': 'PROCEDURE', 'description': 'Inferior border saw used to make the inferior border osteotomy', 'armGroupLabels': ['Participants receiving jaw surgery']}, {'name': 'Inferior Osteotomy made with reciprocating saw', 'type': 'PROCEDURE', 'description': 'reciprocating saw used to make the inferior osteotomy', 'armGroupLabels': ['Participants receiving jaw surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'contacts': [{'name': 'Brian Kinard', 'role': 'CONTACT', 'email': 'briankinard@uabmc.edu', 'phone': '205-934-4507'}, {'name': 'Brian Kinard', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}], 'centralContacts': [{'name': 'Brian Kinard', 'role': 'CONTACT', 'email': 'briankinard@uabmc.edu', 'phone': '205-934-4507'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Brian Kinard', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}