Ignite Creation Date:
2025-12-25 @ 4:30 AM
Ignite Modification Date:
2026-01-04 @ 4:15 PM
Study NCT ID:
NCT03781518
Status:
COMPLETED
Last Update Posted:
2018-12-20
First Post:
2018-11-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mandibular Ridge Splitting Versus Khoury Shell Technique
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D044382', 'term': 'Population Groups'}], 'ancestors': [{'id': 'D003710', 'term': 'Demography'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-18', 'studyFirstSubmitDate': '2018-11-01', 'studyFirstSubmitQcDate': '2018-12-18', 'lastUpdatePostDateStruct': {'date': '2018-12-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Amount of horizontal bone gain (bone width)', 'timeFrame': '4 months', 'description': 'measurement using CBCT'}], 'secondaryOutcomes': [{'measure': 'Soft tissue healing', 'timeFrame': '1 months', 'description': 'Dehiscence or no dehiscence'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Horizontal Augmentation of Atrophic Posterior Mandible']}, 'descriptionModule': {'briefSummary': 'Mandibular ridge splitting with complete separation of the buccal cortical plate versus Khoury shell technique for horizontal augmentation of atrophic posterior mandible'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with atrophic mandible with residual bone width 3 to 4 mm.\n* Both sexes.\n* No intraoral soft and hard tissue pathology\n* No systemic condition that contraindicate implant placement.\n\nExclusion Criteria:\n\n* • Any pathology in the posterior mandible.\n\n * Heavy smokers more than 20 cigarettes per day.\n * Patients with systemic disease that may affect normal healing.\n * Psychiatric problems\n * Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site.'}, 'identificationModule': {'nctId': 'NCT03781518', 'briefTitle': 'Mandibular Ridge Splitting Versus Khoury Shell Technique', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Mandibular Ridge Splitting With Complete Separation of the Buccal Cortical Plate Versus Khoury Shell Technique for Horizontal Augmentation of Atrophic Posterior Mandible', 'orgStudyIdInfo': {'id': '290316'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ridge splitting', 'description': 'Mandibular ridge splitting with complete separation of the buccal cortical plate for horizontal augmentation of atrophic mandible and splinting with screws', 'interventionNames': ['Procedure: ridge splitting in group and khoury shell technique in the other group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'khoury shell technique', 'description': 'bone block is taken from the ramus to augment deficient posterior mandible and splinting with screws', 'interventionNames': ['Procedure: ridge splitting in group and khoury shell technique in the other group']}], 'interventions': [{'name': 'ridge splitting in group and khoury shell technique in the other group', 'type': 'PROCEDURE', 'description': 'Mandibular ridge splitting with complete separation of the buccal cortical plate for horizontal augmentation of atrophic posterior mandible in one group and the other group will receive khoury shell technique by taking bone block from the ramus', 'armGroupLabels': ['khoury shell technique', 'ridge splitting']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12611', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Omnia El- Atawy', 'investigatorAffiliation': 'Cairo University'}}}}