Ignite Creation Date:
2025-12-25 @ 2:48 AM
Ignite Modification Date:
2025-12-31 @ 12:50 PM
Study NCT ID:
NCT07108933
Status:
COMPLETED
Last Update Posted:
2025-08-07
First Post:
2025-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Scheduled Autologous PRP Guided Injection in the Maxillary Bony Defects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'No masking'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Randomized Clinical Trial (RCT)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-04-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-31', 'studyFirstSubmitDate': '2025-07-31', 'studyFirstSubmitQcDate': '2025-07-31', 'lastUpdatePostDateStruct': {'date': '2025-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Volume of the injected bony defect', 'timeFrame': 'after 3 months', 'description': 'the volume of the injected bony defect is measured by Cone beam computed tomography in millimeters cubic.'}], 'secondaryOutcomes': [{'measure': 'Bone density at the injected site', 'timeFrame': 'after 3 months', 'description': 'the density of bone formed at the injected site is measured by Cone beam computed tomography in Hounsfield unit.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Platelet-rich plasma, scheduled injection, healing process'], 'conditions': ['Bony Defect']}, 'descriptionModule': {'briefSummary': 'Scheduled autologous platelet-rich plasma guided injection is done in critical-sized maxillary bony defects after surgical excision of non- malignant lesions.', 'detailedDescription': 'The study aims to detect the effect of scheduled autologous platelet-rich plasma- guided injection in the healing process of critical-sized maxillary bony defects after surgical removal of non-malignant lesions by using bone volumetric analysis and density measuring with cone beam computed tomography.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 18-65 years (adults within a specific age range).\n\nDiagnosis: Non-malignant maxillary bony defects (e.g., benign tumors or cysts).\n\nHealth: Generally healthy participants who can tolerate surgery.\n\nPlatelet Function: No platelet disorders or blood-related conditions.\n\nWillingness: Informed consent and ability to follow the protocol.\n\nNo Use of Blood Thinners: No current use of anticoagulants like aspirin.\n\nExclusion Criteria:\n\n* Age: Children (under 18) and elderly (over 75).\n\nMalignant Lesions: Participants with cancer or pre-cancerous conditions.\n\nSystemic Illness: Severe conditions (e.g., uncontrolled diabetes, autoimmune disorders).\n\nPlatelet Disorders: Low platelet count or bleeding disorders (e.g., hemophilia).\n\nInfections: Active infections or inflammatory conditions (e.g., periodontal disease).\n\nPregnancy: Women who are pregnant or breastfeeding.\n\nRecent Surgery/Trauma: Recent maxillary surgery or trauma.\n\nUncontrolled Medications: Use of blood thinners, NSAIDs, or immunosuppressive drugs.\n\nNon-compliance: Unwillingness or inability to follow-up with the protocol.\n\nSubstance Abuse: Active drug or alcohol abuse.'}, 'identificationModule': {'nctId': 'NCT07108933', 'briefTitle': 'Scheduled Autologous PRP Guided Injection in the Maxillary Bony Defects', 'organization': {'class': 'OTHER', 'fullName': 'Horus University'}, 'officialTitle': 'Effect of Scheduled Autologous Platelet-rich Plasma Guided Injection in the Healing Process of Critical-sized Maxillary Bony Defects After Surgical Excision of Non- Malignant Lesions: A Prospective Randomized Clinical Trial.', 'orgStudyIdInfo': {'id': 'PRP in maxillary bone defects'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Injection', 'description': 'Scheduled injection of autologous platelet-rich plasma', 'interventionNames': ['Biological: Autologous platelet-rich plasma']}], 'interventions': [{'name': 'Autologous platelet-rich plasma', 'type': 'BIOLOGICAL', 'otherNames': ['PRP'], 'description': 'Guided injection of PRP in bony cavities of maxilla after surgical excision of non-malignant tumors.', 'armGroupLabels': ['Injection']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aswān', 'country': 'Egypt', 'facility': 'Dental clinics of Aswan University Hospital', 'geoPoint': {'lat': 24.09082, 'lon': 32.89942}}], 'overallOfficials': [{'name': 'Eman Abdel Salam, Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Head of department of Oral Surgery'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Horus University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Eman Abdel Salam Yousef', 'investigatorAffiliation': 'Horus University'}}}}