Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 2:09 PM
Study NCT ID:
NCT07416851
Status:
COMPLETED
Last Update Posted:
2026-02-18
First Post:
2026-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Computer-Assisted Removal of Supernumerary Teeth vs Freehand Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014096', 'term': 'Tooth, Supernumerary'}], 'ancestors': [{'id': 'D014071', 'term': 'Tooth Abnormalities'}, {'id': 'D018640', 'term': 'Stomatognathic System Abnormalities'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-01-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-13', 'studyFirstSubmitDate': '2026-01-29', 'studyFirstSubmitQcDate': '2026-02-13', 'lastUpdatePostDateStruct': {'date': '2026-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'operation time', 'timeFrame': 'intraoperative using a stopwatch measuring time in minutes', 'description': 'time from starting of the incision till exposure of the impacted supernumerary'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['computer aided'], 'conditions': ['Supernumerary Teeth']}, 'descriptionModule': {'briefSummary': 'While CBCT imaging enables the surgeon to precisely map the position of impacted supernumerary teeth relative to neighboring structures, traditional extraction methods for impacted supernumerary teeth can involve extensive bone removal and soft tissue dissection, increasing operative time and trauma. Computer-assisted surgery and the use of 3D-printing technology offer a paradigm shift by leveraging advanced imaging and manufacturing technologies to guide surgical procedures with high accuracy and with and minimally invasive alveolar surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '7 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy children\n\nExclusion Criteria:\n\n* systemic conditions contraindicates surgery'}, 'identificationModule': {'nctId': 'NCT07416851', 'briefTitle': 'Computer-Assisted Removal of Supernumerary Teeth vs Freehand Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Kafrelsheikh University'}, 'officialTitle': 'Computer-Assisted Removal of Supernumerary Teeth vs Freehand Surgery : A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'KFSIRB200-854'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'computer guide', 'interventionNames': ['Procedure: extraction']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'free hand', 'interventionNames': ['Procedure: extraction of impaction']}], 'interventions': [{'name': 'extraction', 'type': 'PROCEDURE', 'description': 'extraction of impaction', 'armGroupLabels': ['computer guide']}, {'name': 'extraction of impaction', 'type': 'PROCEDURE', 'description': 'extraction of impaction', 'armGroupLabels': ['free hand']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alexandria', 'country': 'Egypt', 'facility': 'Kafrelsheikh', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kafrelsheikh University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Mohamed Farouk Mekky', 'investigatorAffiliation': 'Kafrelsheikh University'}}}}