Ignite Creation Date:
2025-12-24 @ 12:00 PM
Ignite Modification Date:
2025-12-24 @ 12:00 PM
Study NCT ID:
NCT05047861
Status:
UNKNOWN
Last Update Posted:
2021-09-17
First Post:
2021-09-06
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Implant Placement in the Preserved Socket Using Socket Shield Technique With Autogenous Dentin Graft Versus Preserved Socket Using Socket Shield With Alloplast
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D057893', 'term': 'Immediate Dental Implant Loading'}], 'ancestors': [{'id': 'D003758', 'term': 'Dental Implantation, Endosseous'}, {'id': 'D003757', 'term': 'Dental Implantation'}, {'id': 'D013516', 'term': 'Oral Surgical Procedures, Preprosthetic'}, {'id': 'D019647', 'term': 'Oral Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019919', 'term': 'Prosthesis Implantation'}, {'id': 'D003813', 'term': 'Dentistry'}, {'id': 'D011476', 'term': 'Prosthodontics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 8}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-14', 'studyFirstSubmitDate': '2021-09-06', 'studyFirstSubmitQcDate': '2021-09-14', 'lastUpdatePostDateStruct': {'date': '2021-09-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in implant stability', 'timeFrame': 'immeditely and at 3 months', 'description': 'it will be measured using Osstell ISQ, or Implant Stability Quotient, is a scale from 1 to 100 and is a measure of the stability of an implant.\n\nHigh stability means \\>70 ISQ, between 60-69 is medium stability and \\< 60 ISQ is considered as low stability.'}, {'measure': 'change in bone density', 'timeFrame': 'at baseline and 3 months', 'description': 'it will be measured using CBCT'}, {'measure': 'change in bone height', 'timeFrame': 'at baseline and 3 months', 'description': 'it will be measured using CBCT'}, {'measure': 'change in Labio/Bucco-Palatal width', 'timeFrame': 'at baseline and 3 months', 'description': 'it will be measured using CBCT'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Teeth Extraction', 'Tooth Socket']}, 'descriptionModule': {'briefSummary': 'Alveolar bone resorption and labial bone plate reduction follow teeth extraction due to the deficiency of blood supply, derived from the loss of periodontal ligaments, and hence the socket shield technique with Bone graft was introduced to preserve the periodontal ligaments related perfusion and preserve socket dimensions for new bone formation.\n\nThis study aims to compare implants placed in two differently preserved sockets, the first one preserved using Socket Shield technique with Autogenous Dentin Graft while the other socket preserved using socket shield technique with Alloplastic bone graft material'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* One or more of non-restorable (fractured or decayed) tooth/teeth in the upper aesthetic regions (incisors, premolars).\n* Intact labial/buccal periodontal tissues.\n* Sufficient bone volume to allow placement of an implant.\n* Non-Smoker\n* Ability to read and sign an informed consent form\n\nExclusion Criteria:\n\n* A medical history that contraindicates oral surgical treatment (uncontrolled/untreated diabetes mellitus, immunocompromised status,current radio/chemotherapy of the oral and maxillofacial region, treatment with oral and/or intravenous amino-bisphosponates).\n* Untreated periodontal disease. \\[15,18\\]\n* Vertical root fractures on the buccal aspect. \\[26\\]\n* Tooth /teeth with horizontal fractures below bone level. \\[26\\]\n* Tooth /teeth with external or internal resorptions.'}, 'identificationModule': {'nctId': 'NCT05047861', 'briefTitle': 'Implant Placement in the Preserved Socket Using Socket Shield Technique With Autogenous Dentin Graft Versus Preserved Socket Using Socket Shield With Alloplast', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'Evaluation of Implant Placement in Preserved Socket Using Socket Shield Technique With Autogenous Dentin Graft Versus Preserved Socket Using Socket Shield With Alloplast (Controlled Clinical and Radiographic Study)', 'orgStudyIdInfo': {'id': 'Socket shield_2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study group', 'description': 'patients will receive the implant in the previously preserved socket using Socket shield technique with Alloplastic graft material', 'interventionNames': ['Procedure: socket shield technique with autogenous dentin graft']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'patients will receive the implant in the previously preserved socket shield with Autogenous dentin graft', 'interventionNames': ['Procedure: socket shield technique with alloplast graft']}], 'interventions': [{'name': 'socket shield technique with autogenous dentin graft', 'type': 'PROCEDURE', 'description': 'The crown of the hopeless tooth will be decoronated with a chamfer diamond bur and a large-head round diamond bur under copious irrigation, until the bone crest level.\n\nThe root will then be sectioned along the long axis into buccal and palatal halves with a long shank fissure bur.\n\nThe lingual root fragment will be carefully retrieved using microperiotome. The remaining buccal root fragment will be thinned and concaved slightly with a long shank fissure bur. The thickness of the buccal root fragment should be at least 1.5 mm to ensure resistance to fracture and resorption.\n\nThe coronal part of this shield will be beveled to make a lingual slope for a better emergence profile with a large head round diamond bur.\n\nThe socket shield will be checked for immobility so the implant could be inserted palatally into the socket shield.\n\nAfter the final preparation of the socket shield, Graft will be placed using autogenous dentin graft from the discarded palatal part of the tooth', 'armGroupLabels': ['Study group']}, {'name': 'socket shield technique with alloplast graft', 'type': 'PROCEDURE', 'description': 'The crown of the hopeless tooth will be decoronated with a chamfer diamond bur and a large-head round diamond bur under copious irrigation, until the bone crest level.\n\nThe root will then be sectioned along the long axis into buccal and palatal halves with a long shank fissure bur.\n\nThe lingual root fragment will be carefully retrieved using microperiotome. The remaining buccal root fragment will be thinned and concaved slightly with a long shank fissure bur. The thickness of the buccal root fragment should be at least 1.5 mm to ensure resistance to fracture and resorption.\n\nThe coronal part of this shield will be beveled to make a lingual slope for a better emergence profile with a large head round diamond bur.\n\nThe socket shield will be checked for immobility so the implant could be inserted palatally into the socket shield.\n\nAfter final preparation of socket shield, Graft will be placed Alloplast graft', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00203', 'city': 'Alexandria', 'state': 'Azarita', 'country': 'Egypt', 'facility': 'Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hams Hamed Abdelrahman', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer of DPH and Clinical statistician', 'investigatorFullName': 'Hams Hamed Abdelrahman', 'investigatorAffiliation': 'Alexandria University'}}}}