Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-25 @ 9:43 PM
Study NCT ID:
NCT06657651
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-10-28
First Post:
2024-10-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
IMMEDIATE IMPLANT With Different Types of Membranes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-24', 'studyFirstSubmitDate': '2024-10-23', 'studyFirstSubmitQcDate': '2024-10-23', 'lastUpdatePostDateStruct': {'date': '2024-10-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Implant stability', 'timeFrame': '1 year', 'description': 'Osstell will be used to record implant stability at the placement time, 3, 6 and 12 months after surgery.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'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.\n\nPatients' Grouping:\n\nThe patients will be randomly divided into two equal uniform groups each consists of 20 patients:\n\nGroup A:\n\n20 patients with non-restorable mandibular molar tooth will be treated with an immediately placed dental implant in conjunction with a dentin-derived membrane from the extracted tooth.\n\nGroup B:\n\n20 patients with non-restorable mandibular molar tooth will be treated with an immediately placed dental implant in conjunction with extended platelet rich fibrin membrane."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age above 18 years\n* Non-restorable mandibular molar tooth that needs dental extraction \\& guided bone regeneration for immediate implant placement.\n* Acceptable inter-arch space for the future prosthesis.\n* Patient medically free from systemic diseases that absolutely contraindicate implant surgery.\n* Cooperative patient with high motivation and acceptable oral hygiene.\n* Free from history of bruxism / parafunctional habits.\n\nExclusion Criteria:\n\n* Local and / or systemic conditions that interfere with the procedure.\n* Smokers.\n* Pregnancy.\n* Uncooperative patients.\n* Patient had undergone in the past 12 months radiation therapy to the head and neck area.'}, 'identificationModule': {'nctId': 'NCT06657651', 'briefTitle': 'IMMEDIATE IMPLANT With Different Types of Membranes', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Autogenous Dentine Derived Barrier Membrane Versus Extended Platelet Rich Fibrin Membrane in Immediate Implant Placement', 'orgStudyIdInfo': {'id': 'A06030240S'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'immediate implant with dentin-derived membrane', 'interventionNames': ['Procedure: immediate implant placement with dentin-derived membrane']}, {'type': 'EXPERIMENTAL', 'label': 'immediate implant with extended platelet rich fibrin membrane', 'interventionNames': ['Procedure: immediate implant with extended platelet rich fibrin membrane']}], 'interventions': [{'name': 'immediate implant placement with dentin-derived membrane', 'type': 'PROCEDURE', 'description': 'immediate implant placement with dentin-derived membrane and allograft in mandibular molar area', 'armGroupLabels': ['immediate implant with dentin-derived membrane']}, {'name': 'immediate implant with extended platelet rich fibrin membrane', 'type': 'PROCEDURE', 'description': 'immediate implant with extended platelet rich fibrin membrane and allograft in mandibular molar area', 'armGroupLabels': ['immediate implant with extended platelet rich fibrin membrane']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Al Mansurah', 'country': 'Egypt', 'facility': 'Heba Elsheikh', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}