Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2025-12-25 @ 3:14 PM
Study NCT ID:
NCT06653868
Status:
RECRUITING
Last Update Posted:
2024-10-22
First Post:
2024-10-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Grafting of the Peri-implant Bony Defects Around Immediate Implants Using Xenogenic Versus Alloplastic Sticky Grafts: Randomized Controlled Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016301', 'term': 'Alveolar Bone Loss'}], 'ancestors': [{'id': 'D001862', 'term': 'Bone Resorption'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D055093', 'term': 'Periodontal Atrophy'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015921', 'term': 'Dental Implants'}], 'ancestors': [{'id': 'D003764', 'term': 'Dental Materials'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D017266', 'term': 'Dental Prosthesis'}, {'id': 'D011476', 'term': 'Prosthodontics'}, {'id': 'D003813', 'term': 'Dentistry'}, {'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2026-03-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-21', 'studyFirstSubmitDate': '2024-10-21', 'studyFirstSubmitQcDate': '2024-10-21', 'lastUpdatePostDateStruct': {'date': '2024-10-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'bone changes', 'timeFrame': '6 months', 'description': 'superimposition'}], 'secondaryOutcomes': [{'measure': 'pink esthetic score', 'timeFrame': '6 months', 'description': 'soft tissue esthetics'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bone Loss, Alveolar']}, 'descriptionModule': {'briefSummary': 'In patients with a single non restorable tooth, does filling the peri-implant buccal gap with alloplastic sticky grafts result comparable results compared to xenogenic sticky grafts?', 'detailedDescription': 'The buccal aspect of the dental implant has great importance, especially in the aesthetic zone, because the buccal bone is very thin especially in the anterior maxilla and its resorption can result in recession of the soft tissue. A gap occurs in immediately placed implant due to discrepancy between the dimensions of the extraction socket and the implant. Augmentation of the buccal gap decreases the amount of buccal bone resorption and soft tissue recession . Filling the peri-implant defects has been widely discussed to prevent further bone loss. The use of biologic materials such as platelet rich fibrin can enhance the quality of alloplastic bone grafts to give comparable effect when compared to xenogenic grafts.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with healthy systemic condition (Mazzotti et al., 2023).\n2. Age from 20-50 years old\n3. Patients must be free of any systemic disease which could influence the surgical procedure.\n4. Tooth involved in the esthetic zone.\n5. Sufficient hard and soft tissue volume in vertical and buccolingual direction\n6. Natural teeth adjacent to the involved tooth will be required to be free from infection.\n7. Controlled oral hygiene.\n8. Indication for tooth extraction included (Degidi et al., 2012);\n\n * Endodontic failures\n * Untreatable caries\n * Non- restorable teeth\n * Vertical root fracture\n * Remaining roots\n\nExclusion Criteria:\n\n\\- 1.Pregnant females 2.Smokers (Khuller, 2009) 3.Unmotivated and uncooperative patients with poor oral hygiene 4.Patients with habits that may compromise the longevity and affect the result of the study as alcoholism or parafunctional habits.\n\n5.Presence of acute dento-alveolar infection.'}, 'identificationModule': {'nctId': 'NCT06653868', 'briefTitle': 'Grafting of the Peri-implant Bony Defects Around Immediate Implants Using Xenogenic Versus Alloplastic Sticky Grafts: Randomized Controlled Clinical Trial', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Grafting of the Peri-implant Bony Defects Around Immediate Implants Using Xenogenic Versus Alloplastic Sticky Grafts: Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'per631'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'immediate implant placement surgery with filling the gap distance with alloplastic sticky graft', 'description': 'immediate implant placement surgery with filling the gap distance with injectable platelet rich fibrin combined with alloplast.', 'interventionNames': ['Procedure: dental implant with bone augmentation']}, {'type': 'EXPERIMENTAL', 'label': 'immediate implant placement surgery with filling the gap distance with xenogenic sticky bone', 'description': 'immediate implant placement surgery with filling the gap distance with injectable platelet rich fibrin combined with xenograft.', 'interventionNames': ['Procedure: dental implant with bone augmentation']}], 'interventions': [{'name': 'dental implant with bone augmentation', 'type': 'PROCEDURE', 'otherNames': ['gap distance augmentation'], 'description': 'gap distance augmentation with bone graft', 'armGroupLabels': ['immediate implant placement surgery with filling the gap distance with alloplastic sticky graft', 'immediate implant placement surgery with filling the gap distance with xenogenic sticky bone']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'bassant mohye, phd candidate', 'role': 'CONTACT', 'email': 'bassant_mohye@hotmail.com', 'phone': '01006744545'}], 'facility': 'Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'bassant mohye, phd candidate', 'role': 'CONTACT', 'email': 'bassant_mohye@hotmail.com', 'phone': '01006744545'}, {'name': 'cairo university', 'role': 'CONTACT', 'email': 'rec@dentistry.cu.edu.eg', 'phone': '0223646375'}], 'facility': 'Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'bassant mohye', 'investigatorFullName': 'bassant mohye', 'investigatorAffiliation': 'Cairo University'}}}}