Ignite Creation Date:
2025-12-24 @ 6:43 PM
Ignite Modification Date:
2026-01-03 @ 11:30 PM
Study NCT ID:
NCT03661957
Status:
UNKNOWN
Last Update Posted:
2018-09-07
First Post:
2018-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non Grafted Maxillary Sinus Floor Elevation With Implant Placement Versus the Use of Short Endosseous 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': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2019-04', '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': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'primary stability', 'timeFrame': '6 months', 'description': 'measuring primary stability using osstel'}], 'secondaryOutcomes': [{'measure': 'marginal bone loss', 'timeFrame': '6 months', 'description': 'measuring marginal bone loss using cone beam ct'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Primary Stability of Implants', 'Marginal Bone Loss']}, 'descriptionModule': {'briefSummary': 'Assessment the need for sinus floor elevation when restoring atrophic posterior maxilla or it will be enough to use of short implant'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with partially edentulous in the posterior area of the maxilla, with a residual ridge that allowed insertion of ≤8 mm length implants.\n* Both sexes.\n* No intraoral soft and hard tissue pathology\n* No systemic condition that contraindicate implant placement.\n\nExclusion Criteria:\n\n* Sinus pathology.\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\n* Immunodeficiency pathology, bruxism, stress situation (socially or professionally), emotional instability, and unrealistic aesthetic demands.'}, 'identificationModule': {'nctId': 'NCT03661957', 'briefTitle': 'Non Grafted Maxillary Sinus Floor Elevation With Implant Placement Versus the Use of Short Endosseous Implants', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Non Grafted Maxillary Sinus Floor Elevation With Simultaneous Implant Placement Versus the Use of Short Endosseous Implants', 'orgStudyIdInfo': {'id': 'cairo university 99'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Non grafted maxillary sinus floor elevation with implant pacem', 'interventionNames': ['Procedure: Non grafted maxillary sinus floor elevation with simultaneous implant placement']}, {'type': 'EXPERIMENTAL', 'label': 'using short dental implants for posterior atrophic maxilla', 'interventionNames': ['Procedure: using short dental implants for posterior atrophic maxilla']}], 'interventions': [{'name': 'Non grafted maxillary sinus floor elevation with simultaneous implant placement', 'type': 'PROCEDURE', 'description': 'lateral window for sinus elevation ,membrane elevation ,implant placement , membrane for window closure', 'armGroupLabels': ['Non grafted maxillary sinus floor elevation with implant pacem']}, {'name': 'using short dental implants for posterior atrophic maxilla', 'type': 'PROCEDURE', 'description': 'placement of short dental implant with bone height below 8mm', 'armGroupLabels': ['using short dental implants for posterior atrophic maxilla']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'ahmed maher mansour, BDS', 'role': 'CONTACT', 'email': 'a7mad.maher10@gmail.com', 'phone': '00201092955447'}], 'facility': 'Ahmed Maher Mansour', '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': 'Ahmed Maher Mansour', 'investigatorAffiliation': 'Cairo University'}}}}