Ignite Creation Date:
2025-12-24 @ 7:18 PM
Ignite Modification Date:
2025-12-29 @ 1:42 PM
Study NCT ID:
NCT04434703
Status:
UNKNOWN
Last Update Posted:
2021-01-29
First Post:
2020-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Alveolar Ridge Preservation Following Tooth Extraction Using Advanced Platelet Rich Fibrin (A-PRF) Versus Platelet Rich Fibrin (PRF)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001777', 'term': 'Blood Coagulation'}], 'ancestors': [{'id': 'D006487', 'term': 'Hemostasis'}, {'id': 'D001790', 'term': 'Blood Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2021-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-28', 'studyFirstSubmitDate': '2020-06-13', 'studyFirstSubmitQcDate': '2020-06-13', 'lastUpdatePostDateStruct': {'date': '2021-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in bucco-lingual dimensions', 'timeFrame': '6 months', 'description': 'clinical measurement using bone caliper in mm numerical'}], 'secondaryOutcomes': [{'measure': 'change in alveolar bone height', 'timeFrame': '6 months', 'description': 'radiographic measurement using CBCT in mm numerical'}, {'measure': 'bone dentistry', 'timeFrame': '6 months', 'description': 'radiographic measurement using CBCT'}, {'measure': 'soft tissue healing', 'timeFrame': '6 months', 'description': 'clinical measurement using landr et al index (healing index) in numerical'}, {'measure': 'postoperative pain scores', 'timeFrame': '2 weeks', 'description': 'clinical measurement using VAS scale in numerical where No pain (0-4 mm) - mild pain (5-44 mm) -moderate pain (45-74 mm), and severe pain (75- 100 mm).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alveolar Bone Resorption']}, 'descriptionModule': {'briefSummary': 'the aim of this study is clinically and radiographically evaluate the use of advance platelet rich fibrin (A-PRF) versus platelet rich fibrin (PRF) in preservation of alveolar ridge following tooth extraction', 'detailedDescription': 'systemically healthy patients who have at least one non-restorable tooth in the upper inter-bicuspid region and are not seeking immediate or early implant treatment will be allocated in this study after performing nonsurgical periodontal therapy and preoperative periapical therapy to evaluate and improve the condition of the periodontal tissues.\n\nAnesthesia will be given then flapless atraumatic extraction using periotomes followed by forceps after luxation. For all groups, the socket will be debrided using curette then\n\n* group A, the socket will be filled with A.PRF\n* group B the socket will be filled with PRF.\n* group C no bio-additive will be added.\n* Criss cross horizontal mattress suture will be applied to close the extraction wound.\n\nPRF and A-PRF preparation :\n\n10 ml of blood will be drawn from each patient by vein puncture of the antecubital vein.\n\n* Plateletr ich fibrin (PRF) is 3000 rpm and 10 minutes without addition of anticoagulant\n* Advanced platelet rich fibrin (A-PRF) is 1300 rpm and 8 minutes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with at least one non restorable tooth in upper inter-bicuspid region.\n* Stable periodontal condition with no acute periapical infection.\n* Systematically healthy conditions.\n* Cooperative patients.\n* Intact buccal plate of bone.\n\nExclusion Criteria:\n\n* Smokers.\n* Patients seeking immediate or early implants.\n* Pregnant females.\n* Bone diseases.\n* Drugs and diseases that may affect platelet count or function.'}, 'identificationModule': {'nctId': 'NCT04434703', 'briefTitle': 'Alveolar Ridge Preservation Following Tooth Extraction Using Advanced Platelet Rich Fibrin (A-PRF) Versus Platelet Rich Fibrin (PRF)', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Alveolar Ridge Preservation Following Tooth Extraction Using Advanced Platelet Rich Fibrin (A-PRF) Versus Platelet Rich Fibrin (PRF) A Randomized Clinical Trail :Comparative Study', 'orgStudyIdInfo': {'id': '6-3-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Platelet rich fibrin (PRF)', 'description': "Platelet rich fibrin is the secoond generation of platelet concentrates which is an autogenous biomaterial that is prepared from the patient's own blood", 'interventionNames': ['Procedure: Platelet rich fibrin (PRF)']}, {'type': 'EXPERIMENTAL', 'label': 'Advanced platelet rich fibrin (A-PRF)', 'description': 'Advanced platelet rich fibrin is the last modification of PRF which is expected to contain a relatively greater number of white blood cellsand growth factors', 'interventionNames': ['Procedure: Advanced platelet rich fibrin (A-PRF)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'blood clot', 'description': 'normal healing of the wound without adding any biomaterial', 'interventionNames': ['Procedure: blood clot']}], 'interventions': [{'name': 'Platelet rich fibrin (PRF)', 'type': 'PROCEDURE', 'description': "following atraumatic extraction of the tooth using periotomes , 10 ml of patient's blood will be drawn by vein puncture of the antecubital vein and prepared in a centrifuge at 3000 rpm for 10 minutes then criss horizontal mattress suture will be applied to close the extraction wound", 'armGroupLabels': ['Platelet rich fibrin (PRF)']}, {'name': 'Advanced platelet rich fibrin (A-PRF)', 'type': 'PROCEDURE', 'description': "following atraumatic extraction of the tooth using periotomes , 10 ml of patient's blood will be drawn by vein puncture of the antecubital vein and prepared in a centrifuge at 1300 rpm for 8 minutes then criss horizontal mattress suture will be applied to close the extraction wound", 'armGroupLabels': ['Advanced platelet rich fibrin (A-PRF)']}, {'name': 'blood clot', 'type': 'PROCEDURE', 'description': 'following atraumatic extraction of the tooth using periotomes, no bio-addative will be added and criss horizontal mattress suture will be applied to close the extraction wound', 'armGroupLabels': ['blood clot']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11865', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'School of dentistry , Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': "it will include participant's contacts ( name, age , phone number , address ,medical and dental history , periodontal condition) ,periodontal chart and preoperative radiograph"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Reem Mahmoud AbdAlhameed AbuBasha', 'investigatorAffiliation': 'Cairo University'}}}}