Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 11:05 AM
Study NCT ID:
NCT07412535
Status:
COMPLETED
Last Update Posted:
2026-02-17
First Post:
2026-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Extended Platelet Rich Fibrin or Hyaluronate Enriched Xenografts for Horizontal Ridge Augmentation Via Subperiosteal Tunneling
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2025-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-11', 'studyFirstSubmitDate': '2026-01-14', 'studyFirstSubmitQcDate': '2026-02-11', 'lastUpdatePostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'horizontal bone gain measurement', 'timeFrame': '6months, 12 months', 'description': 'CBCT will be used to measure horizontal bone width of the surgical site (in mm) at 3 points: at level of the crest, 2 mm and 6mm apical to the crest.'}], 'secondaryOutcomes': [{'measure': 'bone density measurement', 'timeFrame': '6 months, 12 months', 'description': 'Bone density will be assessed in HU by CBCT by using on demand 3D program'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dental Implant']}, 'descriptionModule': {'briefSummary': 'Extended platelet rich fibrin or hyaluronate enriched xenografts will be used for horizontal maxillary ridge augmentation via subperiosteal tunneling to allow placement of dental implants six months later.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* a maxillary anterior or premolar narrow ridge (width 3-6 mm), and adequate bone height (\\>8 mm), seeking horizontal augmentation \\& dental implant rehabilitation\n\nExclusion Criteria:\n\n* systemic contraindications to surgery, local infection, untreated periodontal disease, heavy smoking, or pregnancy.'}, 'identificationModule': {'nctId': 'NCT07412535', 'acronym': 'E-PRF', 'briefTitle': 'Extended Platelet Rich Fibrin or Hyaluronate Enriched Xenografts for Horizontal Ridge Augmentation Via Subperiosteal Tunneling', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Extended Platelet Rich Fibrin or Hyaluronate Enriched Xenografts for Horizontal Ridge Augmentation Via Subperiosteal Tunneling', 'orgStudyIdInfo': {'id': 'R.25.12.94'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Hyaluronate Group', 'description': 'Horizontal maxillary augmentation via subperiosteal tunneling using bovine bone and hyaluronate', 'interventionNames': ['Combination Product: bovine bone mixed with hyaluronate']}, {'type': 'EXPERIMENTAL', 'label': 'Extended Platelet Rich Fibrin Group', 'description': 'horizontal maxillary augmentation via subperiosteal tunneling using bovine bone and extended platelet rich fibrin', 'interventionNames': ['Combination Product: bovine bone mixed with E-PEF']}], 'interventions': [{'name': 'bovine bone mixed with hyaluronate', 'type': 'COMBINATION_PRODUCT', 'description': 'cerabone plus will be inserted as a graft material via subperiosteal tunneling of thin maxilla', 'armGroupLabels': ['Hyaluronate Group']}, {'name': 'bovine bone mixed with E-PEF', 'type': 'COMBINATION_PRODUCT', 'description': 'bovine bone mixed with E-PEF will be inserted as a graft material via subperiosteal tunneling of thin maxilla', 'armGroupLabels': ['Extended Platelet Rich Fibrin Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35516', 'city': 'Al Mansurah', 'state': 'Egypt', 'country': 'Egypt', 'facility': 'Mansoura University, Faculty of Dentistry', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant professor of oral and maxillofacial surgery', 'investigatorFullName': 'Noha Ahmed Mansour', 'investigatorAffiliation': 'Mansoura University'}}}}