Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2026-01-02 @ 12:16 PM
Study NCT ID:
NCT03184857
Status:
COMPLETED
Last Update Posted:
2024-04-02
First Post:
2017-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Open Maxillary Sinus Augmentation Using Different Types of Bone Particles
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': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-29', 'studyFirstSubmitDate': '2017-06-09', 'studyFirstSubmitQcDate': '2017-06-09', 'lastUpdatePostDateStruct': {'date': '2024-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'histomorphometric analysis', 'timeFrame': '6 months', 'description': 'histomorphometric analysis to measure new bone percent formation and residual bone graft percent'}], 'secondaryOutcomes': [{'measure': 'new height of bone gained', 'timeFrame': '6 months', 'description': 'CBCT 6 months postoperative to measure the new height of bone'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['maxillary sinus', 'augmentation', 'bovine bone', 'Nano hydroxy appatite'], 'conditions': ['Maxillary Sinus Augmentation']}, 'referencesModule': {'references': [{'pmid': '39478644', 'type': 'DERIVED', 'citation': 'Nour M, Shawky M, Abaas RA, Hakam M, Atef M. Two Stage Sinus Lifting Using Nanohydroxyapatite Particles Versus Deproteinized Bovine Bone: Randomized Clinical Trial. Clin Implant Dent Relat Res. 2025 Feb;27(1):e13410. doi: 10.1111/cid.13410. Epub 2024 Oct 31.'}]}, 'descriptionModule': {'briefSummary': 'Two stage sinus lifting using Nano hydroxyapatite particles \\[Nanostreams\\] versus Deprotenized bovine bone \\[Tutogen\\] : Randomized clinical trial.\n\ncomparing between Height of new bone formation, Bone area percent( Histomorphometric)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\-\n\nExclusion Criteria:\n\n* sinus pathology\n* heavy smokers\n* patients with systemic disease uncontrolled'}, 'identificationModule': {'nctId': 'NCT03184857', 'briefTitle': 'Open Maxillary Sinus Augmentation Using Different Types of Bone Particles', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Two Stage Sinus Lifting Using Nano Hydroxyapatite Particles [Nanostreams] Versus Deprotenized Bovine Bone [Tutogen] : Randomized Clinical Trial.', 'orgStudyIdInfo': {'id': 'Cebc.cairouniversity - 1025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'two stage sinus lifting using bovine bone particles', 'description': 'Open maxillary sinus lifting will be done with sinus augmentation using bovine bone particles', 'interventionNames': ['Procedure: open maxillary sinus lifting']}, {'type': 'EXPERIMENTAL', 'label': 'two sage sinus lifting using Nano HA bone particles', 'description': 'Open maxillary sinus lifting will be done with sinus augmentation using Nano HA bone particles', 'interventionNames': ['Procedure: open maxillary sinus lifting']}], 'interventions': [{'name': 'open maxillary sinus lifting', 'type': 'PROCEDURE', 'description': 'biopsy of the region 6 months later', 'armGroupLabels': ['two sage sinus lifting using Nano HA bone particles', 'two stage sinus lifting using bovine bone particles']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11437', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Mahmoud Ahmed Nour Eldeen', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principle investigator', 'investigatorFullName': 'Mahmoud Ahmed Nour-El deen', 'investigatorAffiliation': 'Cairo University'}}}}