Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-25 @ 9:28 PM
Study NCT ID:
NCT03177356
Status:
UNKNOWN
Last Update Posted:
2017-06-06
First Post:
2017-06-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Implant Placement in Mandibular Molar Xenograft Versus PRF
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': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2017-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-06-05', 'studyFirstSubmitDate': '2017-06-03', 'studyFirstSubmitQcDate': '2017-06-05', 'lastUpdatePostDateStruct': {'date': '2017-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient satisfaction', 'timeFrame': '1 week post operative', 'description': 'evaluation of postoperative complications regarding pain and oedema'}], 'secondaryOutcomes': [{'measure': 'implant stability', 'timeFrame': 'will be measure intraopertively immediately after insertion of the implants and will be measure one more time 6 months after 1st operation at the time of exposure of implants', 'description': 'measurement of implant stability using osstell device'}, {'measure': 'amount of bone gained or lost around the implants', 'timeFrame': '6 months postoperative', 'description': 'two cone beam computed tomography (CBCT) will be taken for the patient, one immediate postoperative and the other 6 months after the operation then the height of bone gained or lost around the implants will be assessed by superimposing the same section in the two CBCTS'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Platelet rich fibrin,xenograft'], 'conditions': ['Edentulous Alveolar Ridge']}, 'descriptionModule': {'briefSummary': '20 recruited patients indicated for immediate implant placement in mandibular molar patients are divided into 2 groups each group contain 15 patients, one group assigned for placement of bovine bone after molar extraction and immediate implant placement, while the other group we use Platelet-rich fibrin as space filling material.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with non-restorable mandibular molars\n2. Both sexes\n\n \\-\n\n Exclusion Criteria:\n * • Heavy smokers more than 20 cigarettes per day.5\n\n * Patients with in sufficient interseptal bone height and width\n\n * Patients with systemic disease that may affect normal healing.\n * Patients with completely resorbed buccal cortical plate.'}, 'identificationModule': {'nctId': 'NCT03177356', 'briefTitle': 'Implant Placement in Mandibular Molar Xenograft Versus PRF', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Immediate Implant Placement With Deproteinized Bovine Bone (Tutogen) Versus Placement of Platelet-rich Fibrin as a Space Filling Material in Mandibular Molars. Randomized Clinical Trial.', 'orgStudyIdInfo': {'id': 'cebc.cairouniversity'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'extraction,implant placement,PRF', 'description': 'Extraction of Mandibular first molar and Implant placement followed by Placement of placement of Platelet rich fibrin as space filling material', 'interventionNames': ['Procedure: extraction,implant placement,PRF']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Exctraction,Implant placement,Bone graft', 'description': 'Extraction of mandibular first molar followed by implant placement and xenogenic bone graft as space filling material', 'interventionNames': ['Procedure: Exctraction,Implant placement,Bone graft']}], 'interventions': [{'name': 'extraction,implant placement,PRF', 'type': 'PROCEDURE', 'description': 'Surgical extraction of mandibular molar using periotome and forceps followed by implant placement in inter-septal bone. Then a blood sample is withdrawn from patient and placed in the centrifuge. Then Platelet-Rich fibrin is placed in the extraction socket as space filling material', 'armGroupLabels': ['extraction,implant placement,PRF']}, {'name': 'Exctraction,Implant placement,Bone graft', 'type': 'PROCEDURE', 'description': 'Surgical extraction of mandibular molar using extraction forceps and periotome followed by implant placement in interseptal bone. De-proteinized bovine bone graft material is placed as space filling material', 'armGroupLabels': ['Exctraction,Implant placement,Bone graft']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'DR.', 'investigatorFullName': 'Ahmed Hussein El Garhy', 'investigatorAffiliation': 'Cairo University'}}}}