Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2026-02-25 @ 8:48 PM
Study NCT ID:
NCT03661658
Status:
UNKNOWN
Last Update Posted:
2018-09-07
First Post:
2018-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Inferior Alveolar Nerve Lateralization With Simultaneous Implant Placement Versus the Use of Short Dental Implants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 8}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2019-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-09-05', 'studyFirstSubmitDate': '2018-09-02', 'studyFirstSubmitQcDate': '2018-09-05', 'lastUpdatePostDateStruct': {'date': '2018-09-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary stability', 'timeFrame': '3 months', 'description': 'measuring the primary stability using the osstel'}], 'secondaryOutcomes': [{'measure': 'Marginal bone loss', 'timeFrame': '3 months', 'description': 'measuring the marginal bone loss by using CBCT'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Primary Stability of the Implants', 'Marginal Bone Loss']}, 'descriptionModule': {'briefSummary': 'Assess the long term stability of short dental implants in comparison to standard implants inserted simultaneously with inferior alveolar nerve lateralization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients with edentulous posterior mandible.\n* Both sexes.\n* No intraoral soft and hard tissue pathology.\n* No systemic condition that contraindicate implant placement.\n* Residual alveolar bone width longer than 6 mm height (7-9 mm).\n\nExclusion Criteria:\n\n* Presence of fenestrations or dehiscence of the residual ridge.\n* Heavy smokers more than 20 cigarettes per day .(24)\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': 'NCT03661658', 'briefTitle': 'Inferior Alveolar Nerve Lateralization With Simultaneous Implant Placement Versus the Use of Short Dental Implants', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Inferior Alveolar Nerve Lateralization With Simultaneous Implant Placement Versus the Use of Short Dental Implants', 'orgStudyIdInfo': {'id': 'cairo university 8'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Inferior alveolar nerve lateralization with implant placement', 'interventionNames': ['Procedure: Inferior alveolar nerve lateralization with simultaneous implant placement']}, {'type': 'EXPERIMENTAL', 'label': 'Using short dental implant with atrophic mandible', 'interventionNames': ['Procedure: Using short dental implant']}], 'interventions': [{'name': 'Using short dental implant', 'type': 'PROCEDURE', 'description': 'Using short dental implant for patients with atrophic posterior mandible.', 'armGroupLabels': ['Using short dental implant with atrophic mandible']}, {'name': 'Inferior alveolar nerve lateralization with simultaneous implant placement', 'type': 'PROCEDURE', 'description': 'Inferior alveolar nerve lateralization with simultaneous implant placement in atrophic posterior mandible.', 'armGroupLabels': ['Inferior alveolar nerve lateralization with implant placement']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ehab Ahmed Shams, PDS', 'role': 'CONTACT', 'email': 'ehab_ahmed_206@hotmail.com', 'phone': '00201005233925'}], 'facility': 'Ehab Ahmed Shams', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'dentist-Master student', 'investigatorFullName': 'Ehab Ahmed Shams', 'investigatorAffiliation': 'Cairo University'}}}}