Ignite Creation Date:
2025-12-25 @ 2:05 AM
Ignite Modification Date:
2025-12-26 @ 12:30 AM
Study NCT ID:
NCT03536260
Status:
UNKNOWN
Last Update Posted:
2018-05-24
First Post:
2018-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Marginal Bone Loss After Immediate Implant Placement in Maxillary Esthetic Zone With Nanobone Versus Xenograft
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016254', 'term': 'Mutagenesis, Insertional'}, {'id': 'D014183', 'term': 'Transplantation, Heterologous'}], 'ancestors': [{'id': 'D015202', 'term': 'Protein Engineering'}, {'id': 'D005818', 'term': 'Genetic Engineering'}, {'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D009154', 'term': 'Mutation'}, {'id': 'D014644', 'term': 'Genetic Variation'}, {'id': 'D055614', 'term': 'Genetic Phenomena'}, {'id': 'D016296', 'term': 'Mutagenesis'}, {'id': 'D014180', 'term': 'Transplantation'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2018-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-05-14', 'studyFirstSubmitDate': '2018-04-05', 'studyFirstSubmitQcDate': '2018-05-14', 'lastUpdatePostDateStruct': {'date': '2018-05-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement of Crestal Bone Loss in grafted socket', 'timeFrame': '3 months after implant placement'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Implant Placement in Maxillary Esthetic Zone']}, 'descriptionModule': {'briefSummary': 'Immediate implant placement has a success rate from 94-100 % . After tooth extraction there is a loss in the horizontal and vertical dimension by about 3-6 mm and 1-2 mm respectively and alveolar crest resorption of about 44% especially through 6 months after extraction.\n\nAfter immediate implant placement there is usually a void between the implant and the socket walls which is called jumping distance or gap which may heal spontaneously or need bone graft to bridge the space. If the gap is 1-2 mm it may heal spontaneously more than that this will need bone graft. There is no evidence that the graft impairs osseointegration Development of artificial bone has increasingly progressed in the last few years. Nanobone "nanocrystalline hydroxyapatite embedded in a porous silica gel matrix bone graft is introduced which has osseoconductive and biomimetic properties .the sub-micron modification in the bone substitute will enhance osteogenic property. It bind to the bone by stimulation of osteoblast activity and enhance growth factors which improve bone healing and provide more strength and stability to the implant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients with badly broken teeth in upper esthetic zone indicated for extraction, presence of at least 4 mm of bone beyond the root apex to guarantee implant primary stability, implant placement within the alveoli confines.\n* Both sexes.\n* No intraoral soft and hard tissue pathology.\n* No systemic condition that contraindicate implant placement.\n\nExclusion Criteria:\n\n* Presence of fenestrations or dehiscence of the residual bony Walls after extraction.\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': 'NCT03536260', 'briefTitle': 'Evaluation of Marginal Bone Loss After Immediate Implant Placement in Maxillary Esthetic Zone With Nanobone Versus Xenograft', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Evaluation of Marginal Bone Loss After Immediate Implant Placement in Maxillary Esthetic Zone With Nanobone Versus Xenograft (Randomized Clinical Trial)', 'orgStudyIdInfo': {'id': 'FarahatMBL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Immediate implant with Xenograft', 'interventionNames': ['Device: Implant with Xenograft']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Immediate implant with Nanobone', 'interventionNames': ['Device: Implant with NanoBone graft']}], 'interventions': [{'name': 'Implant with NanoBone graft', 'type': 'DEVICE', 'description': 'Using of NanoBone graft to fill the gap in the socket after immediate implant placement', 'armGroupLabels': ['Immediate implant with Nanobone']}, {'name': 'Implant with Xenograft', 'type': 'DEVICE', 'description': 'Using of Xenograft to fill the gap in the socket after immediate implant placement', 'armGroupLabels': ['Immediate implant with Xenograft']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Faculty of Dentistry , Cairo university', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Abdullah Mohammed Farahat', 'investigatorAffiliation': 'Cairo University'}}}}