Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 1:22 PM
Study NCT ID:
NCT07319494
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-01-06
First Post:
2025-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Advanced PRF vs PRF for Gap Filling in Immediate Implants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D056690', 'term': 'Prolactin-Releasing Hormone'}], 'ancestors': [{'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-10-15', 'size': 210967, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-12-20T12:30', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-02-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-20', 'studyFirstSubmitDate': '2025-11-30', 'studyFirstSubmitQcDate': '2025-12-20', 'lastUpdatePostDateStruct': {'date': '2026-01-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical evaluation', 'timeFrame': '6 month', 'description': 'Implant stability will be measured by resonance frequency analysis (RFA) values expressed as implant stability quotient (ISQ) unit at 6 months post-operative'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Immediate dental implant placement and socket healing'], 'conditions': ['Comparison of Advanced Platelet-Rich Fibrin Versus Platelet-Rich Fibrin as a Gap-filling Material']}, 'descriptionModule': {'briefSummary': 'Study type: Clinical Trial\n\nGoal:\n\nThe goal of this clinical trial is to learn if Advanced Platelet-Rich Fibrin (A-PRF) versus traditional Platelet-Rich Fibrin (PRF) can improve bone healing and soft tissue outcomes in patients undergoing immediate dental implant placement.\n\nMain questions it aims to answer:\n\nDoes A-PRF provide greater buccal bone preservation compared to PRF after immediate implant placement?\n\nDoes A-PRF improve soft tissue healing and reduce postoperative complications compared to PRF?\n\nComparison group:\n\nResearchers will compare A-PRF to PRF as a gap-filling material in immediate implants to see if A-PRF results in better bone and soft tissue outcomes.\n\nParticipants will:\n\nUndergo tooth extraction followed by immediate implant placement\n\nReceive either A-PRF or PRF as the gap-filling material in the implant site\n\nHave CBCT scans at baseline and 6 months to measure bone thickness\n\nHave clinical assessments of soft tissue healing and implant stability\n\nAttend follow-up visits at 1 week, 1 month, 3 months, and 6 months post-surgery'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The selected patients has a badly decayed mandibular posterior teeth which are indicated for extraction due to dental causes (periapical abscess, trauma or caries) not periodontal as diagnosed by periapical x-ray.\n* Healthy patients who are classified according to the American Society of Anesthesiologists (ASA)(2022) physical status classification as class I.\n* Patient age ≥ 20 years old.\n* Surgical site with sufficient for implant placement.\n* Sufficient interocclusal space for prosthesis.\n* Good oral hygiene.\n* Patients have thick biotype.\n* Patients have socket class I.\n\nExclusion Criteria:\n\n* Active periodontal diseases and periapical lesions not chronic infections.\n* Patients have parafunctional\n* History of alcohol or drug dependency, psychological factor that might affect the surgical or prosthodontic treatment.\n* Smoking.\n* Pregnant patients.\n* Patients who are not willing to complete the study.'}, 'identificationModule': {'nctId': 'NCT07319494', 'acronym': 'A-PRF vs PRF', 'briefTitle': 'Advanced PRF vs PRF for Gap Filling in Immediate Implants', 'organization': {'class': 'OTHER', 'fullName': 'Beni-Suef University'}, 'officialTitle': 'Comparison of Advanced Platelet Rich Fibrin Versus Platelet Rich Fibrin as a Gap Filling Material in Immediate Implant Placement', 'orgStudyIdInfo': {'id': 'DU:024111959'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PRF Group', 'description': 'Participants in this arm will undergo tooth extraction followed by immediate implant placement. The extraction socket will be filled with traditional Platelet-Rich Fibrin (PRF) as the gap-filling material.', 'interventionNames': ['Procedure: Immediate dental implant and PRF']}, {'type': 'EXPERIMENTAL', 'label': 'A-PRF Group', 'description': 'Participants in this arm will undergo tooth extraction followed by immediate implant placement. The extraction socket will be filled with Advanced Platelet-Rich Fibrin (A-PRF) as the gap-filling material.', 'interventionNames': ['Procedure: Immediate Dental Implant and A-PRF']}], 'interventions': [{'name': 'Immediate Dental Implant and A-PRF', 'type': 'PROCEDURE', 'description': 'Arm 1: Advanced Platelet-Rich Fibrin (A-PRF) Participants will have a tooth extracted, the socket cleaned, and A-PRF prepared from their blood placed in the socket as a gap-filling material before immediate implant placement. Follow-up visits will assess bone and soft tissue healing and implant stability.', 'armGroupLabels': ['A-PRF Group']}, {'name': 'Immediate dental implant and PRF', 'type': 'PROCEDURE', 'description': 'Arm 2: Platelet-Rich Fibrin (PRF) Participants will have a tooth extracted, the socket cleaned, and traditional PRF prepared from their blood placed in the socket as a gap-filling material before immediate implant placement. Follow-up visits will assess bone and soft tissue healing and implant stability.', 'armGroupLabels': ['PRF Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35516', 'city': 'Al Mansurah', 'country': 'Egypt', 'facility': 'Delta University For Science And Technology', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beni-Suef University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Eman Magdy Ahmed', 'investigatorAffiliation': 'Beni-Suef University'}}}}