Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2025-12-27 @ 10:47 PM
Study NCT ID:
NCT07082634
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-24
First Post:
2025-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immediate Implant Placement Using the Socket Shield Technique in Maxillary Esthetic Zone
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 8}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-23', 'studyFirstSubmitDate': '2025-07-15', 'studyFirstSubmitQcDate': '2025-07-23', 'lastUpdatePostDateStruct': {'date': '2025-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in pain scores', 'timeFrame': 'baseline, 7, 14, and 21 days', 'description': 'Pain will be evaluated, using visual analogue scale (VAS) as follows:\n\n(0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe) (Figure 1)'}, {'measure': 'Change in implant stability', 'timeFrame': 'baseline and 6 months', 'description': 'The base line primary Implant Stability Quotient (ISQ) will be measured at the time of implant placement, while the secondary stability quotient will be measured after 6months during the prosthetic phase preparation.'}], 'secondaryOutcomes': [{'measure': 'Change in post operative healing', 'timeFrame': 'baseline, 7, 14, and 21 days', 'description': 'The wound healing will be assessed based on Landry Wound Healing Index. The Landry Index uses a numerical score based on the assessment of four given parameters (Erythema., Edema, Wound Margin Adaptation, and Presence of Exudate). Each parameter is given a score depending on its severity, and the total score determine an overall evaluation of wound healing'}, {'measure': 'change in crestal alveolar process width', 'timeFrame': 'baseline and 6 months', 'description': "The width of the crestal alveolar process will be assessed by determination of the dimensional changes of Bucco-palatal ridge in the 6 months' scan. Measurements will be taken from the preoperative records and compared to those taken in the 6 month ones."}, {'measure': 'change in labial bone thickness', 'timeFrame': 'baseline and 6 months', 'description': 'the assessment of the thickness labial plate of bone in the scan performed after 6 months and comparing it with the preoperative CBCT scans.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Socket Shield Technique', 'Maxillary Esthetic Zone']}, 'descriptionModule': {'briefSummary': 'Immediate implant placement in the esthetic zone is an approach that helps preserve soft and hard tissue architecture. However, post extraction bone resorption is still a significant challenge. The socket shield technique (SST) has emerged as a promising way for preserving the buccal plate, potentially improving implant stability and reducing radiographic bone loss. The aim of the present study is to evaluate the clinical and radiographic outcomes of the socket shield technique in the maxillary esthetic zone by assessing implant stability, radiographic bone loss as well as esthetic outcome over a specified follow-up period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a non-restorable maxillary tooth in the aesthetic zone indicated for extraction and subsequent immediate implant placement.\n* Patients with extraction socket Type I.\n* A good standard of oral hygiene.\n\nExclusion Criteria:\n\n* Patients with extraction socket Type II or III, with defect in the buccal plate.\n* Absence of at least 2 mm bone apical to the extraction socket, necessary to obtain adequate primary stability for the implant assessed by pre-operative radiographic evaluation.\n* The presence of any local factor that may interfere with extraction as tooth ankylosis.\n* Patients with deciduous teeth.\n* Patients with bruxism\n* Heavy smokers.\n* Systemic conditions that are considered as a contraindication for placement of implant or those that may interfere with wound healing and immunocompromised conditions and uncontrolled autoimmune diseases.\n* History of oral or intravenous bisphosphonate therapy or any treatments with other medications that may interfere with bone metabolism within the past 12 months.\n* Patients receiving radiotherapy or chemotheraphy.\n* Patient with active infection or chronic infection with severe bone loss.'}, 'identificationModule': {'nctId': 'NCT07082634', 'briefTitle': 'Immediate Implant Placement Using the Socket Shield Technique in Maxillary Esthetic Zone', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'Evaluation of Immediate Implant Placement Using the Socket Shield Technique in Maxillary Esthetic Zone (Clinical and Radiographic Study)', 'orgStudyIdInfo': {'id': '2025-H-0176-D-M-0796'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Socket shield and immediate implant', 'interventionNames': ['Procedure: Socket shield concept and immediate implant placement']}], 'interventions': [{'name': 'Socket shield concept and immediate implant placement', 'type': 'PROCEDURE', 'description': 'Tooth Sectioning: The tooth will be sectioned mesiodistally using a fissure bur, preserving the buccal segment.\n\nPalatal fragment extraction: carefully after sectioning the tooth , the palatal fragment is luxated and extracted with the most important factor is taking care of the buccal part not to become loose , the extraction is done using a periotome to be minimally invasive and to preserve the bone from major damage.\n\nShield Preparation: The buccal fragment is reduced to bone level using a round bur, a beveled edge is created using a diamond football bur, and the shield is thinned to maintain structural integrity.\n\nImplant Site Preparation: Sequential osteotomy performed under copious irrigation, ensuring primary stability.\n\nImplant Placement: A Megagen implant is inserted', 'armGroupLabels': ['Socket shield and immediate implant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11-5020', 'city': 'Beirut', 'country': 'Lebanon', 'contacts': [{'name': 'Mohamed M Issa, BDS', 'role': 'CONTACT', 'email': 'mohamadmarwanissa@gmail.com', 'phone': '+961 76 476 204'}, {'name': 'Mohamed Issa, BDS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Beirut Arab University', 'geoPoint': {'lat': 33.89332, 'lon': 35.50157}}], 'centralContacts': [{'name': 'Mohamed M Issa, BDS', 'role': 'CONTACT', 'email': 'mohamadmarwanissa@gmail.com', 'phone': '+961 76 476 204'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hams Hamed Abdelrahman', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Dental Public Health and biostatistical consultanat', 'investigatorFullName': 'Hams Hamed Abdelrahman', 'investigatorAffiliation': 'Alexandria University'}}}}