Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2026-01-01 @ 6:44 AM
Study NCT ID:
NCT06863051
Status:
RECRUITING
Last Update Posted:
2025-08-01
First Post:
2025-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Albumin Platelet-Rich Fibrin or Leucocyte- Platelet-Rich Fibrin on Immediate Implant
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': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-02-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-30', 'studyFirstSubmitDate': '2025-02-27', 'studyFirstSubmitQcDate': '2025-03-04', 'lastUpdatePostDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vertical peri-implant bone level', 'timeFrame': 'Immediate Post-Operative and 6 months after surgery', 'description': 'the distance between implant platform to the most coronal bone-implant contact'}, {'measure': 'Keratinized tissue Width', 'timeFrame': 'Immediate Post-Operative and 6 months after surgery', 'description': 'Width of Keratinized tissue before and after surgery'}, {'measure': 'Crestal bone level', 'timeFrame': 'Immediate Post-Operative and 6 months after surgery', 'description': 'distance between implant platform and bone crest'}], 'secondaryOutcomes': [{'measure': 'Implant Stability', 'timeFrame': 'Immediate Post-Operative and 6 months after surgery', 'description': 'by Smart peg'}, {'measure': 'Bucco-lingual bone width', 'timeFrame': 'Immediate Post-Operative and 6 months after surgery', 'description': "it's measured with a line coinciding with implant platform"}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Implant', 'PRF', 'Albumin'], 'conditions': ['Immediate Implant Placement']}, 'descriptionModule': {'briefSummary': 'The objective of this study will be to compare between Immediate Implant grafted with xenograft and Alb-PRF gel versus xenograft with L-PRF.', 'detailedDescription': 'The objective of this study will be to compare between xenograft with Alb-PRF gel and xenograft with L-PRF ( L-PRF Block ) in the aspects of :\n\n* Peri-implant vertical defect depth.\n* Crestal bone level.\n* Bucco-lingual bone width.\n* Keratinized tissue width'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': '1. Inclusion criteria\n\n * The presence of non-restorable mandibular molar.\n * Patient 18-45 years old\n * Intact buccal and lingual walls\n * Good oral hygiene.\n * Prescence of sufficient restorative space.\n * Jumping gap more than 2 mm.\n2. Exclusion criteria\n\n * Proximity of anatomical structures\n * Acute localized infection (suppuration at the surgical field)\n * Patients on chemotherapy or radiotherapy.\n * Patients who have systemic disorders (diseases) {diabetes mellitus, autoimmune disease, …etc},\n * Pregnant patients.\n * Smoking and Alcohols.\n * Presence of periapical pathology affecting the neighboring teeth.'}, 'identificationModule': {'nctId': 'NCT06863051', 'briefTitle': 'Effect of Albumin Platelet-Rich Fibrin or Leucocyte- Platelet-Rich Fibrin on Immediate Implant', 'organization': {'class': 'OTHER', 'fullName': 'Kafrelsheikh University'}, 'officialTitle': 'Clinical and Radiographic Evaluation of Xenograft With Albumin Platelet-Rich Fibrin or Leucocyte- Platelet-Rich Fibrin on Immediate Implant Placement in Mandibular Molar Extraction Sites: Randomized Clinical Trial.', 'orgStudyIdInfo': {'id': 'KFSIRB200-531'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Albumin-PRF group', 'description': 'Immediate Implant Placement in lower molar region, Grafted with Xenograft and Albumin PRF Gel', 'interventionNames': ['Procedure: Immediate Implant Placement and Alb-PRF']}, {'type': 'EXPERIMENTAL', 'label': 'L-PRF group', 'description': 'Immediate Implant Placement in lower molar region, Grafted with Xenograft and L-PRF ( L-PRF Block )', 'interventionNames': ['Procedure: Immediate Implant Placement and L-PRF']}], 'interventions': [{'name': 'Immediate Implant Placement and Alb-PRF', 'type': 'PROCEDURE', 'description': 'Immediate Implant Placement in lower molar region, Grafted with Xenograft and Albumin PRF Gel', 'armGroupLabels': ['Albumin-PRF group']}, {'name': 'Immediate Implant Placement and L-PRF', 'type': 'PROCEDURE', 'description': 'Immediate Implant Placement in lower molar region, Grafted with Xenograft and L-PRF', 'armGroupLabels': ['L-PRF group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kafr ash Shaykh', 'state': 'Kafrelsheikh', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Enas Ahmed Elgendy, Dean of Faculty of Dentistry', 'role': 'CONTACT', 'email': 'enas_ahmed@den.kfs.edu', 'phone': '0201003508797'}, {'name': 'Enas Ahmed Elgendy, Dean of Faculty of Dentistry', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kafrelsheikh University, Faculty of Dentistry', 'geoPoint': {'lat': 31.11174, 'lon': 30.93991}}], 'centralContacts': [{'name': 'Mostafa Mohamed Fayed, Demonstrator of Periodontology', 'role': 'CONTACT', 'email': 'mostafa.mohamed@den.kfs.edu.eg', 'phone': '0201004668099'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kafrelsheikh University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Demonstrator of Periodontology', 'investigatorFullName': 'Mostafa Fayed', 'investigatorAffiliation': 'Kafrelsheikh University'}}}}