Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2026-01-07 @ 10:10 AM
Study NCT ID:
NCT04824456
Status:
UNKNOWN
Last Update Posted:
2021-04-01
First Post:
2020-11-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neurosensory Assesment After Using Separators Vs Chisels in Bilateral Sagittal Split Mandibular Osteotomy. RCT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Patient with skeletal malocclusion, class II or class III that is indicated for bilateral sagittal split osteotomy.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2019-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-27', 'studyFirstSubmitDate': '2020-11-23', 'studyFirstSubmitQcDate': '2021-03-27', 'lastUpdatePostDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'neurosensory disturbance of the inferior alveolar nerve.', 'timeFrame': '1 year', 'description': 'use Von Frey filaments to test sensory function of the lower lip and two point discrimination test (blunt and sharp ) also to assess the sensory function'}], 'secondaryOutcomes': [{'measure': 'Incidence of bad split', 'timeFrame': '1 year', 'description': 'if bad split in the mandible occur during the operation it will be reported'}, {'measure': 'post operative edema ,', 'timeFrame': '1 year', 'description': 'preoperative measure from the tragus to mid of the chin by cm then the measure is repeated to count the amount of edema'}, {'measure': 'post operative pain', 'timeFrame': '1 year', 'description': 'by visual analogue scale from 0 to 10 and the patient choose the number'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['to Assess Neurosensory Function of Inferior Alveolar Nerve After BSSO']}, 'descriptionModule': {'briefSummary': 'The bilateral sagittal split Ramus osteotomy (BSSRO) was introduced by Trauner and Obwegeser. Since then, many modifications of this procedure have been reported, leading to a less difficult and more predictable procedure for correcting mandibular anomalies. persistent post-operative neurosensory disturbances of the inferior alveolar nerve are still one of the major complications of this operation. The incidence has decreased over the years due to improved techniques and the use of different instruments. However, most recent series still report postoperative persistent hypesthesia of the inferior alveolar nerve in more than 10% of the patients up to 48%.\n\nThere are no reports on the influence of other surgical variables on the persisting post-operative hypesthesia. Several methods have been reported for evaluating neurosensory disturbances of the inferior alveolar nerve. One of the simplest methods reported is tactile evaluation based on subjective sensation reported by the patients. Many authors have used this method in their evaluation of post-operative hypesthesia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'IInclusion criteria:\n\n1. Patient with skeletal malocclusion, class II or class III that is indicated for bilateral sagittal split osteotomy.\n2. Adults \\>18 years.\n3. Systemically healthy.\n\nExclusion criteria:\n\n1. Patients not indicated for orthognathic surgery.\n2. Severe systemic disease.\n3. Have a medical condition associated with systemic neuropathy (e.g. diabetes)\n4. Patients whom cannot tolerate follow up intervals. (affect accuracy of study results)\n5. Are unwilling to sign informed consent.'}, 'identificationModule': {'nctId': 'NCT04824456', 'briefTitle': 'Neurosensory Assesment After Using Separators Vs Chisels in Bilateral Sagittal Split Mandibular Osteotomy. RCT', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Evaluation of Neurosensory Disturbance After Using Separators Vs Chisels in Bilateral Sagittal Split Mandibular Osteotomy. RCT', 'orgStudyIdInfo': {'id': '15460'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'bilateral sagittal split osteotomy using chisels.', 'description': 'The final split is completed with Smith forceps and flag separators', 'interventionNames': ['Procedure: bilateral sagittal split osteotomy using separators.']}], 'interventions': [{'name': 'bilateral sagittal split osteotomy using separators.', 'type': 'PROCEDURE', 'description': 'The final split is completed with a thin osteotomes, splitting the entire ascending ramus from the anterior to the posterior border of the ramus.', 'armGroupLabels': ['bilateral sagittal split osteotomy using chisels.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12345', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Faculty of Dentistry', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer', 'investigatorFullName': 'Hisham Mohammed Abdllfattah', 'investigatorAffiliation': 'Cairo University'}}}}