Ignite Creation Date:
2025-12-24 @ 1:59 PM
Ignite Modification Date:
2026-01-03 @ 8:39 PM
Study NCT ID:
NCT04197895
Status:
UNKNOWN
Last Update Posted:
2019-12-13
First Post:
2019-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical and Radiographic Evaluation of Advanced Platelet Rich Fibrin in the Preservation of Alveolar Ridge Following Atraumatic Tooth Extraction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2020-12-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-12-11', 'studyFirstSubmitDate': '2019-12-11', 'studyFirstSubmitQcDate': '2019-12-11', 'lastUpdatePostDateStruct': {'date': '2019-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mesial and distal height of extraction site', 'timeFrame': '2 months', 'description': 'digital radiograph'}], 'secondaryOutcomes': [{'measure': 'soft tissue thickness', 'timeFrame': '2 months', 'description': 'will be evaluated by endo file with rubber stopper and digital caliper'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Socket Preservation']}, 'descriptionModule': {'briefSummary': 'compare the effect of application of A-PRF in socket preservation after atraumatic tooth extraction and natural healing regarding to bone remodeling . Null hypotheis, after atraumatic extraction, socket with advanced PRF has no difference with socket with blood clot in primary outcome'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The inclusion criteria are as follow :\n\n * patients with an unremarkable medical history\n * subjects with at least one site bordered by minimum of one tooth.\n * Nonsmoker\n * Teeth with root fracture, teeth with failed endodontic therapy or advanced caries\n * Intact extraction socket with no dehiscence or fenestration.\n * The buccolingual thickness of the buccal plate of bone in surgical area is 1 mm or more\n\nExclusion Criteria:\n\n* Patients with systemic diseases.\n* Patients with presence or history of osteonecrosis of the jaws, with use of bisphosphonates, exposure to head and neck radiation, chemotherapy.\n* patients with large distinct pre-apical pathology'}, 'identificationModule': {'nctId': 'NCT04197895', 'briefTitle': 'Clinical and Radiographic Evaluation of Advanced Platelet Rich Fibrin in the Preservation of Alveolar Ridge Following Atraumatic Tooth Extraction', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Clinical and Radiographic Evaluation of Advanced Platelet Rich Fibrin in the Preservation of Alveolar Ridge Following Atraumatic Tooth Extraction: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'nana2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'test group', 'description': 'Socket preservation with APRF', 'interventionNames': ['Procedure: Socket preservation with APRF']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control group', 'description': 'natural healing', 'interventionNames': ['Procedure: natural healing']}], 'interventions': [{'name': 'Socket preservation with APRF', 'type': 'PROCEDURE', 'description': 'Socket preservation with APRF , A-PRF membranes were implanted into the extraction socket following tooth extraction. One entire A-PRF membrane would be placed at the base of the extraction socket and another A-PRF membrane will cover the extraction site then suturing will be done .Venous blood will be collected via venipuncture of the forearm with a butterfly needle into at least 10 mL sterile glass vacuum tube. The blood sample will be immediately centrifuged at 1,300 rpm (200 x g) for 8 minutes', 'armGroupLabels': ['test group']}, {'name': 'natural healing', 'type': 'PROCEDURE', 'description': 'after atraumatic extraction , the socket will be left for natural healing after suturing', 'armGroupLabels': ['control group']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nahed Gamal Saleh Abdelaal', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'dentist', 'investigatorFullName': 'Nahed Gamal Saleh Abdelaal', 'investigatorAffiliation': 'Cairo University'}}}}