Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-30 @ 2:44 AM
Study NCT ID:
NCT07468760
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-13
First Post:
2026-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Peri-Implant Hard and Soft Tissue Changes After Immediate Implant Placement With Socket Shield and Immediate Restoration Versus Early Implant Placement in the Esthetic Zone
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The present study is a single-blinded randomized clinical trial. Due to the nature of the surgical interventions, neither the operator performing the procedure nor the participants can be blinded to the treatment allocation. However, the outcome assessor responsible for evaluating the clinical photographs, digital scans, and radiographic measurements will be blinded to group allocation. In addition, the statistician performing the data analysis will also be blinded to the treatment groups to minimize assessment bias.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study is a single-center, prospective, randomized parallel two-arm clinical trial. A total of 42 patients requiring extraction of a single non-restorable tooth in the esthetic zone will be randomly assigned in a 1:1 ratio to either the test group or the control group using a computer-generated randomization list. The test group will receive immediate implant placement with the socket shield technique and immediate restoration, while the control group will receive early type II implant placement following a healing period of 4-8 weeks with contour augmentation. Outcome assessors and the statistician will be blinded to the treatment allocation. Participants will be followed for 12 months to evaluate peri-implant hard and soft tissue changes and esthetic outcomes.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 42}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-09', 'studyFirstSubmitDate': '2026-03-09', 'studyFirstSubmitQcDate': '2026-03-09', 'lastUpdatePostDateStruct': {'date': '2026-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pink Esthetic Score (PES)', 'timeFrame': '12 months after implant restoration', 'description': 'Evaluation of peri-implant soft tissue esthetic outcome using the Pink Esthetic Score, which assesses seven parameters including mesial papilla, distal papilla, soft tissue level, soft tissue contour, alveolar process deficiency, soft tissue color, and texture around the implant restoration. Each parameter is scored from 0 to 2, with a maximum score of 14 indicating optimal esthetic outcome.'}], 'secondaryOutcomes': [{'measure': 'Peri-implant Mid-facial Mucosal Recession', 'timeFrame': '12 months after implant placement', 'description': 'Measurement of vertical changes in the mid-facial peri-implant mucosal level. Digital intraoral scans obtained at baseline and during follow-up will be superimposed using digital analysis software to quantify the vertical displacement of the facial mucosal zenith relative to the baseline position.'}, {'measure': 'Horizontal Radiographic Peri-implant Bone Changes', 'timeFrame': '12 months after implant Restoration', 'description': 'Assessment of horizontal dimensional changes of the buccal peri-implant bone using cone beam computed tomography (CBCT). The horizontal distance between the implant surface and the outer surface of the buccal bone plate will be measured at the mid-buccal aspect 1 mm apical to the buccal bone crest. Measurements obtained immediately after implant placement will be compared with those obtained at follow-up to determine peri-implant bone remodeling.'}, {'measure': 'Vertical Radiographic Peri-implant Bone Changes', 'timeFrame': '12 months after implant Restoration', 'description': 'Assessment of vertical dimensional changes of the buccal peri-implant bone using cone beam computed tomography (CBCT). The vertical distance between the implant platform and the buccal alveolar crest at the mid-buccal aspect of the implant will be measured. Measurements obtained immediately after implant placement will be compared with those obtained at follow-up to determine vertical peri-implant bone remodeling.'}, {'measure': 'Patient Satisfaction', 'timeFrame': '12 months after implant restoration', 'description': 'Patient-reported satisfaction with the implant treatment will be assessed using a Visual Analog Scale (VAS) questionnaire evaluating esthetics and functional outcomes of the implant-supported restoration. The VAS ranges from 0 to 10, where higher scores indicate greater patient satisfaction.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Socket Shield Technique', 'Immediate Implant Placement', 'Early Implant Placement', 'Pink Esthetic Score', 'Partial Extraction Therapy', 'Buccal Bone Remodeling'], 'conditions': ['Tooth Loss in the Anterior Maxilla', 'Alveolar Bone Resorption', 'Partial Edentulism of the Maxilla']}, 'descriptionModule': {'briefSummary': 'This randomized controlled clinical trial aims to compare peri-implant hard and soft tissue dimensional changes following immediate implant placement with the socket shield technique and immediate restoration versus early type II implant placement with contour graft in the esthetic zone. The primary outcome is the Pink Esthetic Score (PES), while secondary outcomes include mid-facial mucosal recession, radiographic vertical and horizontal buccal bone remodeling, and patient satisfaction after 12 months.', 'detailedDescription': 'Immediate implant placement is widely used for replacing non-restorable teeth in the esthetic zone. However, post-extraction remodeling of the buccal bone plate can lead to soft tissue recession and compromised esthetic outcomes. The socket shield technique has been proposed as a partial extraction therapy designed to preserve the buccal root fragment and maintain the facial bone and gingival architecture.\n\nThis single-center, prospective randomized controlled clinical trial aims to evaluate the effectiveness of the socket shield technique with immediate implant placement and immediate restoration compared with early type II implant placement with contour augmentation.\n\nForty-two patients requiring extraction of a single non-restorable tooth in the esthetic zone will be randomly allocated into two groups:\n\nTest group: Immediate implant placement with socket shield technique and immediate restoration.\n\nControl group: Early implant placement following soft tissue healing with contour augmentation.\n\nClinical, radiographic, and patient-reported outcomes will be assessed over a 12-month follow-up period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adults aged 18 years or older\n2. Patients presenting with a single non-restorable tooth in the esthetic zone indicated for extraction and implant replacement\n3. Presence of a thin buccal bone plate (\\<1 mm)\n4. Adequate bone volume to allow implant placement in a prosthetically ideal position\n5. Intact socket walls following tooth extraction\n6. Ability to achieve primary implant stability ≥35 Ncm at the time of implant placement\n7. Patients willing to participate in the study and able to provide written informed consent\n\nExclusion Criteria:\n\n1. History of systemic diseases that may affect bone healing\n2. Use of medications that may influence bone metabolism (e.g., bisphosphonates)\n3. Smoking within the past 5 years\n4. Presence of acute infection at the surgical site or adjacent teeth\n5. Teeth with vertical or subcrestal horizontal root fractures on the buccal aspect\n6. Presence of internal or external root resorption\n7. Severe periodontal destruction at the implant site'}, 'identificationModule': {'nctId': 'NCT07468760', 'briefTitle': 'Peri-Implant Hard and Soft Tissue Changes After Immediate Implant Placement With Socket Shield and Immediate Restoration Versus Early Implant Placement in the Esthetic Zone', 'organization': {'class': 'OTHER', 'fullName': 'Gulf Medical University'}, 'officialTitle': 'Evaluation of Peri-implant Hard And Soft Tissues Changes Between Immediate Implant Placement With Socket Shield Technique and Immediate Restoration Versus Early Type II Implant Placement in The Esthetic Zone - A Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'IRB-COD-STD-87-Feb-2025'}, 'secondaryIdInfos': [{'id': 'IRB-COD-STD-87-Feb-2025', 'type': 'OTHER', 'domain': 'Gulf Medical University'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Immediate Implant Placement and Immediate Restoration with the Socket Shield Tech', 'description': 'Participants allocated to this experimental group will undergo immediate implant placement following partial extraction therapy using the socket shield technique. After decoronation and preparation of the buccal root fragment, the implant osteotomy will be created palatal to the retained root fragment to achieve correct prosthetic positioning. The gap between the implant and the root fragment will be filled with deproteinized bovine bone mineral, and an immediate provisional restoration will be placed using a PMMA temporary crown. Final implant-supported restoration will be delivered after approximately 3 months. Participants will be followed for 12 months to evaluate peri-implant hard and soft tissue changes and esthetic outcomes.', 'interventionNames': ['Procedure: Socket Shield']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Early Type II Implant placement with Contour augmentation with Xenograft', 'description': 'Participants assigned to this active comparator group will undergo atraumatic extraction of the non-restorable tooth followed by early type II implant placement after a healing period of approximately 4-8 weeks. During implant surgery, a full-thickness flap will be elevated and the implant will be placed in the ideal prosthetic position. Contour augmentation will be performed using autogenous bone chips and deproteinized bovine bone mineral particles, which will be covered with a collagen membrane. After approximately 3 months of healing, the implant will be restored with a definitive implant-supported prosthetic restoration. Participants will be followed for 12 months to assess peri-implant hard and soft tissue changes and esthetic outcomes.', 'interventionNames': ['Procedure: Early Implant Placement']}], 'interventions': [{'name': 'Socket Shield', 'type': 'PROCEDURE', 'otherNames': ['Partial Extraction Therapy'], 'description': 'mmediate implant placement following partial extraction therapy using the socket shield technique. After decoronation and preparation of the buccal root fragment, the implant osteotomy will be created palatal to the retained root fragment to achieve correct prosthetic positioning. The gap between the implant and the root fragment will be filled with deproteinized bovine bone mineral, and an immediate provisional restoration will be placed using a PMMA temporary crown. Final implant-supported restoration will be delivered after approximately 3 months', 'armGroupLabels': ['Immediate Implant Placement and Immediate Restoration with the Socket Shield Tech']}, {'name': 'Early Implant Placement', 'type': 'PROCEDURE', 'otherNames': ['Type II Implant Placement'], 'description': 'atraumatic extraction of the non-restorable tooth followed by early type II implant placement after a healing period of approximately 4-8 weeks. During implant surgery, a full-thickness flap will be elevated and the implant will be placed in the ideal prosthetic position. Contour augmentation will be performed using autogenous bone chips and deproteinized bovine bone mineral particles, which will be covered with a collagen membrane. After approximately 3 months of healing, the implant will be restored with a definitive implant-supported prosthetic restoration', 'armGroupLabels': ['Early Type II Implant placement with Contour augmentation with Xenograft']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4184', 'city': 'Ajman', 'country': 'United Arab Emirates', 'contacts': [{'name': 'Mohamed Atef Sayed, Ph.D.', 'role': 'CONTACT', 'email': 'dr.mohamedatef@gmu.ac.ae', 'phone': '+971581069908', 'phoneExt': '1441'}, {'name': 'Mohamed Atef Sayed, Ph.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Moheb Silwadi, M.D.S', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Gulf Medical University', 'geoPoint': {'lat': 25.40177, 'lon': 55.47878}}], 'centralContacts': [{'name': 'Mohamed Atef Sayed, Ph.D', 'role': 'CONTACT', 'email': 'dr.mohamedatef@gmu.ac.ae', 'phone': '+971581069908', 'phoneExt': '1441'}], 'overallOfficials': [{'name': 'Mohamed Atef Sayed, Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Assistant Professor of Periodontics'}, {'name': 'Moheb Silwadi, M.D.S', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gulf Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gulf Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}