Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:47 AM
Study NCT ID:
NCT07396350
Status:
COMPLETED
Last Update Posted:
2026-02-09
First Post:
2026-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IMMEDIATE IMPLANT With Different Types of Membrane
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-02', 'studyFirstSubmitDate': '2026-02-02', 'studyFirstSubmitQcDate': '2026-02-02', 'lastUpdatePostDateStruct': {'date': '2026-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Implant stability', 'timeFrame': '12 months', 'description': 'The implant stability was evaluated immediately postoperatively and after 3, 6, and 12 months. An Osstell Mentor device (Osstell, Savadaled, Sweden; Integration Diagnostics) was utilized to assess implant stability utilizing resonance frequency analysis (RFA). Measurements were made at 90° in four different directions in order to calculate the RFA value. The implant stability quotient (ISQ) was calculated by averaging the results for each implant.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dental implant'], 'conditions': ['Tooth Extraction']}, 'descriptionModule': {'briefSummary': "Forty patients will be selected from the outpatient's clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University for replacement of non-restorable tooth in posterior mandibular area with immediate implants."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Eligibility Criteria:\n\n1. Patients aged 18 years and older.\n2. Non-restorable mandibular molars requiring extraction and GBR for immediate implant placement.\n3. The tooth that required extraction showed no clinical or radiographic signs of acute infection.\n4. There was at least 5 mm of available bone between the superior border of the inferior alveolar canal and the root apex.\n5. At least 8 mm inter-arch space for the prosthesis.\n6. Patients were free of systemic conditions that absolutely contraindicate implant insertion.\n7. Patients with good oral hygiene.\n8. Patients capable of adhering to the mandated follow-up appointments.\n\nExclusion Criteria:\n\n1. Tobacco Smokers.\n2. Pregnancy.\n3. Patients with a history of radiation to the head and neck.\n4. Bruxism and parafunctional habits'}, 'identificationModule': {'nctId': 'NCT07396350', 'briefTitle': 'IMMEDIATE IMPLANT With Different Types of Membrane', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Autogenous Dentine Derived Barrier Membrane Versus Extended Platelet Rich Fibrin Membrane in Immediate Implant Placement in Posterior Mandible: a 2 Year Follow up', 'orgStudyIdInfo': {'id': 'R.26.01.96'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'immediate implant with dentin-derived membrane', 'interventionNames': ['Procedure: immediate implant with dentin-derived barrier membrane']}, {'type': 'EXPERIMENTAL', 'label': 'immediate implant with extended platelet rich fibrin membrane', 'interventionNames': ['Procedure: immediate implant with eprf membrane']}], 'interventions': [{'name': 'immediate implant with dentin-derived barrier membrane', 'type': 'PROCEDURE', 'description': 'immediate implant with dentin-derived barrier membrane with allograft covering any peri-implant defect and jumping gap.', 'armGroupLabels': ['immediate implant with dentin-derived membrane']}, {'name': 'immediate implant with eprf membrane', 'type': 'PROCEDURE', 'description': 'immediate implant with eprf membrane with allograft covering any peri-implant defect and jumping gap.', 'armGroupLabels': ['immediate implant with extended platelet rich fibrin membrane']}]}, 'contactsLocationsModule': {'locations': [{'zip': '002', 'city': 'Al Mansurah', 'country': 'Egypt', 'facility': 'Mansoura university', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}