Ignite Creation Date:
2025-12-24 @ 4:50 PM
Ignite Modification Date:
2026-01-03 @ 8:16 PM
Study NCT ID:
NCT05409950
Status:
COMPLETED
Last Update Posted:
2022-06-08
First Post:
2022-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Socket Shield Technique With Immediate Implant Placement in the Esthetic Zone
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2021-09-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-04', 'studyFirstSubmitDate': '2022-05-24', 'studyFirstSubmitQcDate': '2022-06-04', 'lastUpdatePostDateStruct': {'date': '2022-06-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Implant stability', 'timeFrame': 'immediate postoperative', 'description': 'Using osstell'}, {'measure': 'Implant stability', 'timeFrame': 'one month post-operative', 'description': 'Using osstell'}, {'measure': 'Implant stability', 'timeFrame': 'three month post-operative', 'description': 'Using osstell'}, {'measure': 'Implant stability', 'timeFrame': 'six month post-operative', 'description': 'Using osstell'}, {'measure': 'Horizontal gap', 'timeFrame': 'immediate postoperative', 'description': 'Using cone-beam computed tomography'}, {'measure': 'Horizontal gap', 'timeFrame': 'six month post-operative', 'description': 'Using cone-beam computed tomography'}, {'measure': 'Vertical bone loss', 'timeFrame': 'immediate postoperative', 'description': 'Using cone-beam computed tomography'}, {'measure': 'Vertical bone loss', 'timeFrame': 'six month post-operative', 'description': 'Using cone-beam computed tomography'}, {'measure': 'Bone density', 'timeFrame': 'immediate postoperative', 'description': 'Using cone-beam computed tomography'}, {'measure': 'Bone density', 'timeFrame': 'six month post-operative', 'description': 'Using cone-beam computed tomography'}, {'measure': 'peri-implant probing depth', 'timeFrame': 'immediate postoperative', 'description': 'using periodontal probe'}, {'measure': 'peri-implant probing depth', 'timeFrame': 'one month post-operative', 'description': 'using periodontal probe'}, {'measure': 'peri-implant probing depth', 'timeFrame': 'three month post-operative', 'description': 'using periodontal probe'}, {'measure': 'peri-implant probing depth', 'timeFrame': 'six month post-operative', 'description': 'using periodontal probe'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Immediate implants, sockets shield technique, esthetic zone'], 'conditions': ['Alveolar Bone Resorption']}, 'descriptionModule': {'briefSummary': 'The study was conducted on 20 immediate implant placement sites in the anterior maxillary region. In the study group, 10 implants were inserted using socket shield technique, while in control group, 10 implants were inserted using conventional immediate placement technique. All patients received immediate and 6 months post-operative CBCT to assess horizontal bone loss, vertical bone loss, and measurement of bone density. Implant stability quotients (ISQs) was measured immediately, 1st, 3rd and 6 months post-operatively.', 'detailedDescription': 'Unrestorable tooth extraction with immediate implant placement is considered one of the best treatment options in restoring the esthetics and function. Extraction socket resorption is considered a challenging procedure when it involves the esthetics zone. The preservation of the entire attachment apparatus for complete preservation of the alveolar ridge makes socket shield technique a promising procedure that helps to maintain anatomy, esthetics and function. Socket shield technique, eliminate the negative consequences of bone resorption of the buccal plate of bone; leading to maintaining hard and soft tissue contours and provides a perfect pleasing esthetic result with good function. It is a highly promising technique in terms of maintaining pink and white esthetics through preservation of the interdental papilla during preparation of the interdental socket shield. It is considered a minimally invasive surgical procedure and offers the advantages of immediate implant placement.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Endodontic or non-endodontic treated un-restorable remaining root/ tooth related to maxillary anterior teeth.\n2. Healthy adult patients \\> 20 years old (ASAI, II) .\n3. Adequate oral hygiene.\n4. Intact periodontal tissues.\n\nExclusion Criteria:\n\n1. Periapical or periodontal active infection involving the teeth/root to be extracted (as excluded by radiographic examination).\n2. Medically compromised patients (ASA III, IV, V).\n3. Patients receiving chemotherapy or radiotherapy.\n4. Heavy smokers,alcohol or drug abuse.\n5. Patients with parafunctional habits such as bruxism, clenching, excessive gum chewing, lip or fingernail biting.'}, 'identificationModule': {'nctId': 'NCT05409950', 'briefTitle': 'Evaluation of Socket Shield Technique With Immediate Implant Placement in the Esthetic Zone', 'organization': {'class': 'NETWORK', 'fullName': 'Egyptian Russian University'}, 'officialTitle': 'Evaluation of Socket Shield Technique With Immediate Implant Placement in the Esthetic Zone', 'orgStudyIdInfo': {'id': 'HR-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Study group: implants were inserted using socket shield technique at the esthetic zone', 'interventionNames': ['Procedure: Immediate implant placement using socket shield technique']}, {'type': 'NO_INTERVENTION', 'label': 'Control group: implants were inserted using conventional immediate technique'}], 'interventions': [{'name': 'Immediate implant placement using socket shield technique', 'type': 'PROCEDURE', 'description': 'Evaluation of socket shield technique with immediate implant placement at the esthetic zone in comparison with the conventional immediate implant placement', 'armGroupLabels': ['Study group: implants were inserted using socket shield technique at the esthetic zone']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ismailia', 'country': 'Egypt', 'facility': 'Suez canal university', 'geoPoint': {'lat': 30.60427, 'lon': 32.27225}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Egyptian Russian University', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}