Ignite Creation Date:
2025-12-24 @ 2:07 PM
Ignite Modification Date:
2026-01-02 @ 1:40 PM
Study NCT ID:
NCT06881095
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-03-18
First Post:
2025-03-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immediate Dental Implant Installation With and Without Socket Shield Technique in Aesthetic Zone
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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'non restorable anterior teeth with thin labial plate of bone'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-03-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-06-16', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-15', 'studyFirstSubmitDate': '2025-03-11', 'studyFirstSubmitQcDate': '2025-03-15', 'lastUpdatePostDateStruct': {'date': '2025-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'labial bone thickness', 'timeFrame': '6 months', 'description': '1\\. labial bone thickness measuring thickness of labial bone labial to the implant by (CBCT) Cone beam computed tomography'}, {'measure': 'marginal bone loss', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'bone density around dental implant', 'timeFrame': '6 months', 'description': 'bone density around dental implant by Cone beam computed tomography'}, {'measure': 'implant secondary stability', 'timeFrame': '6 months', 'description': 'Secondary implant stability: will be recorded just after uncovery using Resonance frequency analysis (RFA) device \\* (Osstell).'}, {'measure': 'implant success', 'timeFrame': '6 months', 'description': 'absence of infection, fistula formation or implant mobility'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['socket shield technique', 'partial extraction therapy', 'immediate dental implant'], 'conditions': ['Immediate Dental Implants', 'Thin Labial Plate of Bone Pre-extraction', 'Hopeless Tooth in Esthetic Zone']}, 'descriptionModule': {'briefSummary': '20 patients with non-restorable anterior teeth underwent extraction with immediate implant installation using either the immediate implant with socket shield technique or the conventional immediate dental implant.\n\nthe socket shield technique group (study group): 10 patients will have immediate implant placement with the socket shield technique.\n\n* conventional immediate dental implant technique (control group): 10 patients will have immediate implant placement with conventional technique.', 'detailedDescription': "20 patients with non-restorable anterior teeth underwent extraction with immediate implant installation randomized to two groups immediate dental implant with the socket shield technique group (study group): 10 patients will have immediate implant placement with socket shield technique.\n\n* conventional immediate dental implant technique (control group): 10 patients will have immediate implant placement with conventional technique without socket shield technique.\n\npreparation of shield: the root will be sectioned in a mesio-distal direction along its long axis, sectioning divided the tooth root into one facial third and two palatal thirds, Periotomes will then be inserted between the palatal root section and the alveolar socket wall to sever the PDL and this section of root was then carefully delivered so as not to disturb the facial root section, the remaining root section was then reduced coronally to 1 mm above the alveolar crest.\n\nThe tooth socket's palatal wall and apex will be then curetted to remove any tissue or infective remnants and the root section was checked for immobility with a sharp probe.\n\nAfter completion of the previous steps, the tooth root here will be known as the socket- shield (SS). An osteotomy was then sequentially prepared according to manufacturer instructions and a suitable implant then inserted palatal to the SS."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- 1. Non restorable maxillary anterior teeth without periapical pathology that may affect the success of dental implants.\n\n2\\. Interarch space enough for prosthetic rehabilitation. 3. Presence of posterior teeth or prosthesis that maintain occlusal bite. 4. Adult patients. 5. Good oral hygiene.\n\nExclusion Criteria:\n\n\\- 1. Edentulous anterior maxillary region. 2. Bad oral hygiene. 3. Patients with any relevant systemic diseases that affect soft tissue or bone healing.\n\n4\\. Patients with parafunctional habits (bruxism and clenching). 5. Uncooperative patients. 6. Heavy smokers.'}, 'identificationModule': {'nctId': 'NCT06881095', 'acronym': 'socket shield', 'briefTitle': 'Immediate Dental Implant Installation With and Without Socket Shield Technique in Aesthetic Zone', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Immediate Dental Implant Installation With and Without Socket Shield Technique in Aesthetic Zone', 'orgStudyIdInfo': {'id': 'islam123'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'socket shield technique group (study group)', 'description': "the socket shield technique group (study group): 10 patients will have immediate implant placement with socket shield technique.\n\n* conventional immediate dental implant technique (control group): 10 patients will have immediate implant placement with conventional technique without socket shield technique.\n\npreparation of shield: the root will be sectioned in a mesio-distal direction along its long axis, sectioning divided the tooth root into one facial third and two palatal thirds, Periotomes will then be inserted between the palatal root section and the alveolar socket wall to sever the PDL and this section of root was then carefully delivered so as not to disturb the facial root section, the remaining root section was then reduced coronally to 1 mm above the alveolar crest.\n\nThe tooth socket's palatal wall and apex will be then curetted to remove any tissue or infective remnants and the root section was checked for immobility with a sharp probe.\n\nAfter completion of th", 'interventionNames': ['Procedure: socket shield technique group (study group)']}, {'type': 'EXPERIMENTAL', 'label': 'conventional immediate implant without socket shield technique(control group)', 'description': 'conventional immediate implant without socket shield technique:\n\n• After administration of local anesthesia, atraumatic tooth extraction by extraction forceps and Periotomes, an osteotomy was then sequentially prepared according to manufacturer instructions and a suitable implant then inserted and placement of cover screw. However, the soft tissue contour formed after healing may need some modification prior to impression taking. Suturing around the healing abutment, suture will be removed one week post surgically and then healing abutment and final prosthetic loading will be done after 4-6 months.', 'interventionNames': ['Procedure: conventional immediate implant without socket shield technique']}], 'interventions': [{'name': 'socket shield technique group (study group)', 'type': 'PROCEDURE', 'otherNames': ['partial extraction therapy'], 'description': "immediate implant installation with socket shield technique: After administration of local anesthesia, the root will be sectioned in a mesio-distal direction along its long axis, sectioning divided the tooth root into one facial third and two palatal thirds.\n\nPeriotomes will then be inserted between the palatal root section and the alveolar socket wall to sever the PDL and this section of root was then carefully delivered so as not to disturb the facial root section, the remaining root section was then reduced coronally to 1 mm above the alveolar crest.\n\nThe tooth socket's palatal wall and apex will be then curetted to remove any tissue or infective remnants, and the root section was checked for immobility with a sharp probe.\n\nAfter completion of the previous steps, the tooth root here will be known as the socket- shield (SS). An osteotomy was then sequentially prepared according to manufacturer", 'armGroupLabels': ['socket shield technique group (study group)']}, {'name': 'conventional immediate implant without socket shield technique', 'type': 'PROCEDURE', 'description': '• After administration of local anesthesia, atraumatic tooth extraction by extraction forceps and Periotomes, an osteotomy was then sequentially prepared according to manufacturer instructions and a suitable implant then inserted and placement of cover screw. However, the soft tissue contour formed after healing may need some modification prior to impression taking. Suturing around the healing abutment, suture will be removed one week post surgically and then healing abutment and final prosthetic loading will be done after 4-6 months.', 'armGroupLabels': ['conventional immediate implant without socket shield technique(control group)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3111', 'city': 'Tanta', 'country': 'Egypt', 'facility': 'Faculty of Dentistry', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'overallOfficials': [{'name': 'islam ahmed abo elela, master study', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'faculty of dentistry tanta university'}, {'name': 'Ibrahim mohammed nowair, professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'faculty of dentistry tanta university'}, {'name': 'Rafic ramadan bedir, professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'faculty of dentistry tanta university'}, {'name': 'Wesam Hamed Elsaadany, lecturer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'faculty of dentistry tanta university'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'master degree( Principal Investigator)', 'investigatorFullName': 'Islam Ahmed Elsayed', 'investigatorAffiliation': 'Tanta University'}}}}