Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 10:46 PM
Study NCT ID:
NCT03447067
Status:
UNKNOWN
Last Update Posted:
2018-02-27
First Post:
2018-02-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Computer Guided Versus Conventional Surgical Removal of Deeply Impacted Mandibular Third Molar With Preservation of External Oblique Ridge
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 18}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-03-28', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2018-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-02-25', 'studyFirstSubmitDate': '2018-02-10', 'studyFirstSubmitQcDate': '2018-02-25', 'lastUpdatePostDateStruct': {'date': '2018-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain', 'timeFrame': 'immediate post operative ,at three day pain change till fourteen day day .', 'description': 'each patient well be asked to rate current and worst pain intensity on visual analogue scale (VAS ) of 0-10 with Zero being no pain and Ten corresponds to the worst pain(pain change during follow up period .'}], 'secondaryOutcomes': [{'measure': 'evaluation of maximum inter incisal opening', 'timeFrame': 'immediate post operative ,at three day inter incisal change till fourteen day .', 'description': 'assessment of MMO will be performed by measuring the distance in mm between the incisal edges of the upper and lower central incisor by using tape graduated method.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Impacted Third Molar Tooth']}, 'descriptionModule': {'briefSummary': 'in patent have deeply impacted lower third molar ,dose computer guided enhance surgical outcome versus conventional surgical remove of wisdom teeth', 'detailedDescription': 'P- Patient with deeply impacted mandibular molar I- Computer guided surgical cutting stent C- Conventional extraction O- Clinical outcome sound radiographic outcomes primary outcome\n\n\\- pain : each patient well be asked to rate current and worst pain intensity on visual analogue scale (VAS ) of 0-10 with Zero being no pain and Ten corresponds to the worst pain.\n\nSecondary outcome\n\n* evaluation of maximum inter incisal opening: assessment of MMO will be performed by measuring the distance in mm between the incisal edges of the upper and lower central incisor by using tape graduated method.\n* evaluation of edema throw use nylon thread.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient with deeply impacted mandibular third molar\n* patients should be free from any systematic disease that affect normal healing\n\nExclusion Criteria:\n\n* -Patient with soft tissue impaction and impaction class A position 1\n* Medical problem that may interfere with the procedures such as bleeding disorder \\& pregnant.\n* Uncooperative patient.'}, 'identificationModule': {'nctId': 'NCT03447067', 'briefTitle': 'Computer Guided Versus Conventional Surgical Removal of Deeply Impacted Mandibular Third Molar With Preservation of External Oblique Ridge', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Computer Guided Versus Conventional Surgical Removal of Deeply Impacted Mandibular Third Molar With Preservation of External Oblique Ridge', 'orgStudyIdInfo': {'id': '171986'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Conventional surgery', 'description': 'comprised 9 patient undergoing surgical removal of deeply impacted mandibular third molar by regular manor.\n\n(Based on :Panorama and CBCT ) technique : 1- flap design 2- bone removal 3- tooth division 4- closure flap (suture)', 'interventionNames': ['Procedure: computer guided surgical', 'Device: CBCT']}, {'type': 'EXPERIMENTAL', 'label': 'computer guided surgery', 'description': 'comprised 9 patient undergoing surgical removal of deeply impacted mandibular third molar using computer guided surgical cutting stent.\n\nBased on (panorama , CBCT and fabricating computer guided stent technique: 1- flap design 2- accurate setting stent in a predesign site 3- bony window removing according to the stent design 4- surgical separation of the teeth with extraction the remaning part . 5- identify the nerve 6- replace the bony window in to original place with stability 7- closure and depridment', 'interventionNames': ['Procedure: Conventional surgery', 'Device: CBCT']}], 'interventions': [{'name': 'computer guided surgical', 'type': 'PROCEDURE', 'description': 'has three cutting guided plane for identify the position of place of the third molar, it have beveled cut for stability after remove the teeth and placing the bony window', 'armGroupLabels': ['Conventional surgery']}, {'name': 'Conventional surgery', 'type': 'PROCEDURE', 'description': 'Low speed motor with surgiacl round burs and surgical fissure for removal a covering bone with decapitation and guttering formation', 'armGroupLabels': ['computer guided surgery']}, {'name': 'CBCT', 'type': 'DEVICE', 'description': 'For measuring the bone removeal', 'armGroupLabels': ['Conventional surgery']}, {'name': 'CBCT', 'type': 'DEVICE', 'description': 'for identifed the nerve', 'armGroupLabels': ['computer guided surgery']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'alaaedein M abu al einain, master', 'role': 'CONTACT', 'email': 'surgeonalaamahmoud@gmail.com', 'phone': '00201011618208'}, {'name': 'Mamdouh S Sayed Ahmed, Professor', 'role': 'CONTACT', 'email': 'dr.mamdouhahmed@hotmail.com', 'phone': '00201222173262'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alaadden Mahmoud Abu Al Enein', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Alaadden Mahmoud Abu Al Enein', 'investigatorAffiliation': 'Cairo University'}}}}