Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-25 @ 2:32 AM
Study NCT ID:
NCT05261334
Status:
UNKNOWN
Last Update Posted:
2022-03-25
First Post:
2022-01-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Socket Shield Technique Versus Early Implant Placement With Contour Augmentation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001862', 'term': 'Bone Resorption'}], 'ancestors': [{'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-03-31', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2023-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-11', 'studyFirstSubmitDate': '2022-01-28', 'studyFirstSubmitQcDate': '2022-02-26', 'lastUpdatePostDateStruct': {'date': '2022-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'facial bone thickness', 'timeFrame': '12 months', 'description': 'using superimposed CBCT images'}], 'secondaryOutcomes': [{'measure': 'facial bone height changes', 'timeFrame': '12 months', 'description': 'using superimposed CBCT images'}, {'measure': 'Soft tissue height changes', 'timeFrame': '12 months', 'description': 'using superimposed intraoral scans'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bone Loss', 'Bone Resorption']}, 'descriptionModule': {'briefSummary': 'comparing socket shield technique with early implant placement with contour augmentation in preserving the bone contour', 'detailedDescription': 'comparing immediate implant placement with socket shield technique and final crown after 3 months with extraction and after 4 to 8 weeks implant placement with contour bone augmentation then after 3 to 4 months final crown delivery'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Non-restorable maxillary teeth in the esthetic zone\n2. Intact adjacent teeth\n3. Adequate palatal and apical bone that allows achieving implant primary stability.\n4. Type I socket\n5. ≥18 years\n6. ≤ 60 years\n7. Systemically healthy patients\n\nExclusion Criteria:\n\n1. Extraction sockets with acute or chronic infection or with adjacent infected teeth\n2. Heavy Smokers \\> than 10 cigarettes daily\n3. Cancer patients undergoing radiotherapy or chemotherapy during or within the last 6 months.\n4. Unmotivated patients to maintain adequate oral hygiene to follow up.\n5. Patients with physical disabilities that could affect follow up.'}, 'identificationModule': {'nctId': 'NCT05261334', 'briefTitle': 'Socket Shield Technique Versus Early Implant Placement With Contour Augmentation', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Socket Shielding in Immediate Versus Early Implant Placement With Contour Augmentation of Fresh Extraction Sockets in the Esthetic Zone. A Randomized Pilot Clinical Study.', 'orgStudyIdInfo': {'id': 'sst versus contour aug'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'socket shield technique', 'description': 'immediate implant placement with socket shield technique', 'interventionNames': ['Procedure: contour augmentation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'contour augmentation', 'description': 'early implant placement with contour bone augmentation', 'interventionNames': ['Procedure: contour augmentation']}], 'interventions': [{'name': 'contour augmentation', 'type': 'PROCEDURE', 'description': 'early implant placement with contour bone augmentation', 'armGroupLabels': ['contour augmentation', 'socket shield technique']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11553', 'city': 'Cairo', 'country': 'Egypt', 'contacts': [{'name': 'iman abdelwahab radi, PHD', 'role': 'CONTACT', 'email': 'iman.abdelwahab@dentistry.cu.edu.eg', 'phone': '01001539613', 'phoneExt': '002'}, {'name': 'Amir alaa Elawady, BDS', 'role': 'CONTACT', 'email': 'Amir112093@miuegypt.edu.eg', 'phone': '01020205791'}], 'facility': 'Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Iman Abd-ElWahab Radi, PhD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor of Prosthodontics, Faculty of Dentistry, Cairo University', 'investigatorFullName': 'Iman Abd-ElWahab Radi, PhD', 'investigatorAffiliation': 'Cairo University'}}}}