Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2026-04-17 @ 8:14 PM
Study NCT ID:
NCT06251960
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-26
First Post:
2024-02-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Demineralized Dentin Graft in Preservation of Post-Extraction Sites Associated With Delayed Implant Placement
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': 30}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-24', 'studyFirstSubmitDate': '2024-02-01', 'studyFirstSubmitQcDate': '2024-02-01', 'lastUpdatePostDateStruct': {'date': '2024-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Histomorphometric evaluation:', 'timeFrame': '4 monhs', 'description': "After 4 months of socket preservation and just before implant placement, a trephine bur will be used to collect a core of bone from the preserved socket. Bone will be examined histologically to evaluate the quality and quantity of the formed bone.\n\nBriefly, the specimens were fixed with 4% paraformaldehyde in 0.1M PBS (pH 7.4) and decalcified in 0.5M EDTA (pH 7.8). After decalcification, each specimen will be processed and embedded in paraffin, and transverse serial sections of 5 μm thickness will be prepared. The sections will be stained with hematoxylin and eosin (H\\&E), Masson's Trichrome (MT) (Cat # HT15, Sigma Aldrich) and immunohistochemical staining with osteocalcin antibody polyclonal osteocalcin (OCN);diagnostic biosystems), histological examination will be carried out using an Olympus BX-51 optical microscope (Olympus Co., Tokyo, Japan)."}, {'measure': 'Histomorphometric analysis', 'timeFrame': '4 months', 'description': 'Microscopic images of the surgical sites will be taken by randomly selecting four areas of the center portion of the defect at 100× magnification. Then, using 16 images of each group, the ratio of newly formed bone to the entire defect area in the slide images will be calculated in trichrome and osteocalcin-stained images using the Intel® Core I7® based computer using VideoTest Morphology® software (Russia) with a specific built-in routine for % area, measurement.'}, {'measure': 'Bone density:', 'timeFrame': '12 months', 'description': 'Bone density will be evaluated using Cone Beam Computed Tomography (CBCT) that will be made immediately after socket preservation, at 4 months after preservation (just before implant placement), and after 12 months from implant loading.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Socket Preservation']}, 'descriptionModule': {'briefSummary': 'Thirty patients will be selected from outpatient clinic of the Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University seeking for extraction of non-restorable mandibular posterior teeth For the 1st group: the socket will be grafted with completely demineralized dentin graft after 3 days of extraction, followed by delayed implant placement after 4 months.\n\nFor the 2nd group: the socket will be grafted with partially demineralized dentin graft in in the same day of extraction, followed by delayed implant placement after 4 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient medically free from systemic diseases.\n* Patient with good oral hygiene.\n* Age above 18 years.\n* Presence of non-restorable mandibular premolar tooth due to caries, root resorption, roots fracture, etc.\n* No acute infection is present.\n* No history of bruxism.\n* Patients prepared to comply with the follow-up and maintenance program.\n\nExclusion Criteria:\n\n* Patients with systemic diseases that interfere with dental implant insertion.\n* Pregnancy.\n* Immunocompromised patients.\n* Existence of non-treated generalized progressive periodontitis.'}, 'identificationModule': {'nctId': 'NCT06251960', 'briefTitle': 'Demineralized Dentin Graft in Preservation of Post-Extraction Sites Associated With Delayed Implant Placement', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Comparison of Autogenous Completely Demineralized Dentin Graft Versus Partially Demineralized Dentin Graft Used in Preservation of Post-Extraction Sites Associated With Delayed Implant Placement', 'orgStudyIdInfo': {'id': 'A01012023OS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'socket preservation with completely demineralized dentin graft.', 'interventionNames': ['Procedure: socket preservation with completely demineralized dentin graft']}, {'type': 'EXPERIMENTAL', 'label': 'socket preservation with partially demineralized dentin graft.', 'interventionNames': ['Procedure: socket preservation with partially demineralized dentin graft']}], 'interventions': [{'name': 'socket preservation with completely demineralized dentin graft', 'type': 'PROCEDURE', 'description': 'socket preservation with completely demineralized dentin graft followed by delayed implant placement after 4 months', 'armGroupLabels': ['socket preservation with completely demineralized dentin graft.']}, {'name': 'socket preservation with partially demineralized dentin graft', 'type': 'PROCEDURE', 'description': 'socket preservation with completely demineralized dentin graft followed by delayed implant placement after 4 months', 'armGroupLabels': ['socket preservation with partially demineralized dentin graft.']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Al Mansurah', 'country': 'Egypt', 'facility': 'Heba Elsheikh', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}