Ignite Creation Date:
2025-12-24 @ 12:06 PM
Ignite Modification Date:
2026-02-28 @ 8:31 PM
Study NCT ID:
NCT04882761
Status:
COMPLETED
Last Update Posted:
2021-05-12
First Post:
2021-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Socket Shield With Immediate Implant Stability
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2021-02-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-06', 'studyFirstSubmitDate': '2021-02-27', 'studyFirstSubmitQcDate': '2021-05-06', 'lastUpdatePostDateStruct': {'date': '2021-05-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Soft tissue stability', 'timeFrame': '6 months postoperatively', 'description': 'Pink esthetic score'}], 'secondaryOutcomes': [{'measure': 'Bone stability', 'timeFrame': '6 months postoperatively', 'description': 'By Ostell'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Dental Implant']}, 'descriptionModule': {'briefSummary': 'To evaluate socket shield technique either placing implant in direct contact to tooth fragment versus gap created between the tooth and implant.', 'detailedDescription': 'Patients with a non-restorable tooth located in anterior maxillary arch was included in this study, patients were divided into two groups, eight implants per group, both groups had socket shield, group 1 will have implant in direct contact with shield, second group had a gap between dental implant and shield. soft tissue stability, bone width and implant stability was assessed preoperatively, immediate and 6 months postoperative.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with a non-restorable tooth located in anterior maxillary arch (upper right second premolar to upper left second premolar). Tooth to be extracted is endodontically treated and free from periapical infection.\n2. Systemic free patients according to modified Cornell medical index (Brodmank and Erdmann 1949).\n3. Patients with good compliance.\n\nExclusion Criteria:\n\n1. Teeth with current acute periapical infection or sinus tracts.\n2. Heavy smokers and patients with bruxism habits.\n3. Patients with poor oral hygiene or not willing to perform oral hygiene measures.\n4. Vulnerable groups (as pregnant females and decisionally impaired individuals).'}, 'identificationModule': {'nctId': 'NCT04882761', 'briefTitle': 'Socket Shield With Immediate Implant Stability', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Evaluation of Soft Tissue Stability and Labial Plate of Bone of Immediate Implant in Direct Contact Versus Gap With Socket Shield (A Randomized Clinical Study)', 'orgStudyIdInfo': {'id': '13875'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Socket shield in direct contact with dental implant', 'description': 'eight partially extracted sockets where implant (Neobiotech) was placed in direct contact to socket shield', 'interventionNames': ['Device: Dental implant']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Socket shield with gap and xenograft with dental implant', 'description': 'eight partially extracted sockets where a gap was left between implant (Neobiotech) and socket shield', 'interventionNames': ['Device: Dental implant']}], 'interventions': [{'name': 'Dental implant', 'type': 'DEVICE', 'description': 'Comparative', 'armGroupLabels': ['Socket shield in direct contact with dental implant', 'Socket shield with gap and xenograft with dental implant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11566', 'city': 'Cairo', 'state': 'Abbassia', 'country': 'Egypt', 'facility': 'Doaa Khattab', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Doaa Adel-Khattab, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ain Shams University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Doaa Adel Salah Khattab', 'investigatorAffiliation': 'Ain Shams University'}}}}