Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2026-01-15 @ 2:36 PM
Study NCT ID:
NCT03731650
Status:
UNKNOWN
Last Update Posted:
2018-11-06
First Post:
2018-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-grafted Maxillary Sinus Floor Elevation With Simultaneous Implant Placement Using Different Implant Lengths
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2019-08-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-11-03', 'studyFirstSubmitDate': '2018-09-12', 'studyFirstSubmitQcDate': '2018-11-03', 'lastUpdatePostDateStruct': {'date': '2018-11-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'height of gained bone', 'timeFrame': '6 months post operative', 'description': 'two cone beam CT will be done for the patients, one immediate post operative \\& the other 6 months post operative then the amount of gained bone will be assessed by superimposing the same section in the two cone beam CT.'}], 'secondaryOutcomes': [{'measure': 'implant stability', 'timeFrame': 'will be measured intra operative after implant insertion and will be measured once more 6 months post operative after the first operation at the time of implant exposure', 'description': 'measurement of the implant stability using OSSTELL device.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Maxillary Sinus Lift']}, 'descriptionModule': {'briefSummary': 'twenty recruited patients indicated for sinus augmentation and simultaneous implant placement will be divided into two groups (10 in each of the groups).to evaluate \\& compare bone formation \\& implant stability after shneiderian membrane elevation and augmentation with graft less tenting technique with different implant lengths.\n\ngroup one will receive 8mm implant lenght while group two will receive 10mm implants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient with atrophic maxilla \\& pneumatized maxillary sinus with residual bone height at least 4mm of residual ridge\n* both sexes\n\nExclusion Criteria:\n\n* patients with systematic diseases that may affect normal healing\n* sinus pathology\n* heavy smokers more than 20 cigarettes per day'}, 'identificationModule': {'nctId': 'NCT03731650', 'briefTitle': 'Non-grafted Maxillary Sinus Floor Elevation With Simultaneous Implant Placement Using Different Implant Lengths', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Non-grafted Maxillary Sinus Floor Elevation With Simultaneous Implant Placement Using Different Implant Lengths', 'orgStudyIdInfo': {'id': 'aaali.cairo university'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'active comparator', 'interventionNames': ['Procedure: maxillary sinus lift']}, {'type': 'EXPERIMENTAL', 'label': 'placebo', 'interventionNames': ['Procedure: maxillary sinus lift']}], 'interventions': [{'name': 'maxillary sinus lift', 'type': 'PROCEDURE', 'description': 'non grafted maxillary sinus floor augmentation with simultaneous implant placement', 'armGroupLabels': ['active comparator', 'placebo']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'ahmed abdul nasser ali, BDS', 'role': 'CONTACT', 'email': 'ahmedabdulnasserali@gmail.com', 'phone': '00201115905965'}, {'name': 'ahmed abdel rahman mohammed, MDS', 'role': 'CONTACT', 'email': 'airplayer2003@yahoo.com', 'phone': '00201005261204'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Ahmed Abdulnasser', 'investigatorAffiliation': 'Cairo University'}}}}