Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2026-01-01 @ 7:25 PM
Study NCT ID:
NCT07171866
Status:
COMPLETED
Last Update Posted:
2025-09-17
First Post:
2025-09-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Socket Shield Technique for Immediate and Delayed Implant Placement: A 6-Year Clinical Tria
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The radiographic outcomes assessor was blinded to group allocation. No other masking was implemented due to the surgical nature of the intervention.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants were randomized into two parallel groups: one receiving immediate implant placement and the other delayed placement following the SST. Each group followed the assigned intervention protocol throughout the study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-11', 'studyFirstSubmitDate': '2025-09-06', 'studyFirstSubmitQcDate': '2025-09-06', 'lastUpdatePostDateStruct': {'date': '2025-09-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Horizontal Ridge Width Change at 1, 2, 4, and 6 mm Apical to the Implant Platform', 'timeFrame': 'Immediately after implant placement (baseline), 1 year, and 6 years post-placement', 'description': 'Ridge width was measured at 1 mm, 2 mm, 4 mm, and 6 mm apical to the implant platform using standardized CBCT scans. Superimposed scans were aligned using the Fusion module of OnDemand3D™ software. Changes in horizontal ridge width were calculated by subtracting baseline values from those at 1 year and 6 years to assess dimensional stability over time.\n\nUnit of Measure: → Millimeters (mm) Safety Issue: → No'}], 'secondaryOutcomes': [{'measure': 'Buccal and Palatal Bone Height Change', 'timeFrame': 'Immediately after implant placement (baseline), 1 year, and 6 years post-placement', 'description': 'Bone height was measured from the implant apex to the most coronal point of the buccal and palatal bone crest using CBCT. Changes were calculated at each follow-up relative to baseline.\n\nUnit of Measure: → Millimeters (mm) Safety Issue: → No'}, {'measure': 'Implant Stability Quotient (ISQ)', 'timeFrame': 'Immediately after implant placement, loading time and 1-year post-placement', 'description': 'Implant stability was assessed using a resonance frequency analysis device (Osstell ISQ). Buccolingual and mesiodistal values were averaged to calculate ISQ.\n\nUnit of Measure:\n\n→ ISQ Units\n\nSafety Issue:\n\n→ No'}, {'measure': 'Pink Esthetic Score (PES)', 'timeFrame': 'At implant loading, 1 year, and 6 years post-placement', 'description': 'The esthetic outcome was assessed using the PES, evaluating five parameters each scored from 0-2. Total PES ranges from 0-10, with ≥6 considered clinically acceptable.\n\nUnit of Measure: → Score (0-10) Safety Issue: → No'}, {'measure': 'Patient Satisfaction (VAS Score)', 'timeFrame': 'At implant loading, 1 year, and 6 years post-placement', 'description': 'Satisfaction was measured using a 100 mm visual analog scale (VAS) on three dimensions: overall experience, expectations, and esthetics. Scores were converted into percentages.\n\nUnit of Measure: → VAS (%) Safety Issue: → No'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Socket Shield Technique', 'Immediate Implant Placement', 'Delayed Implant Placement', 'CBCT', 'Ridge Width Change', 'Pink Esthetic Score', 'Alveolar Ridge Preservation', 'Long-term Implant Outcomes'], 'conditions': ['Alveolar Ridge Preservation', 'Implant Dentistry']}, 'descriptionModule': {'briefSummary': 'This study investigates the long-term performance of the Socket Shield Technique (SST) for preserving the bone and soft tissue around dental implants when used with two different timing protocols: immediate versus delayed implant placement.\n\nSST is a surgical technique where a thin portion of the tooth root (the buccal shield) is intentionally retained to support the facial bone and gum tissues after tooth extraction. While SST is known to enhance esthetics and preserve bone in the short term, little evidence exists on its long-term effectiveness in different clinical scenarios.\n\nThis randomized clinical trial enrolled patients who needed single-tooth implants in the esthetic zone. Participants were randomly assigned to one of two groups:\n\nImmediate SST group: the implant was placed at the same time the socket shield was prepared.\n\nDelayed SST group: implant placement was performed six months after socket shield preparation.\n\nOver a 6-year follow-up period, both groups were evaluated for:\n\nChanges in ridge width and bone height using CBCT imaging. Esthetic outcomes using the Pink Esthetic Score (PES). Patient satisfaction through a structured questionnaire.\n\nThe goal is to determine whether SST offers reliable long-term outcomes in either immediate or delayed implant placement scenarios, supporting its broader clinical use.', 'detailedDescription': 'This randomized controlled clinical trial was conducted to compare the long-term clinical, radiographic, esthetic, and patient-reported outcomes of the SST when used with either immediate or delayed implant placement in the anterior maxilla.\n\nStudy Design:\n\nParallel-arm, randomized controlled trial Conducted at the Faculty of Dentistry, Mansoura University Sample: 25 patients needing single-tooth replacement\n\nGroups:\n\nImmediate SST: implant placed at time of shield preparation Delayed SST: implant placed after 6-month healing\n\nPrimary Outcome:\n\nRidge Width Change: measured at 1 mm, 2 mm, 4 mm, and 6 mm apical to the implant platform using standardized CBCT imaging at baseline, 1 year, and 6 years.\n\nSecondary Outcomes:\n\nBuccal/Palatal Bone Height Implant Stability Pink Esthetic Score Patient Satisfaction\n\nSerial CBCT scans were superimposed using the Fusion module of OnDemand3D software for precise assessment. All clinical assessments were performed by calibrated, blinded examiners. Statistical analysis was performed using SPSS, with significance set at p \\< 0.05.\n\nThis study provides one of the first long-term comparative evaluations of SST in different implant placement protocols, offering evidence to support its clinical reliability over a 6-year period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients requiring single-tooth replacement in the anterior maxilla (esthetic zone)\n* Age between 18-65 years\n* Good systemic health\n* Demonstrated good oral hygiene\n* Presence of an intact buccal plate\n* Class I or II sagittal root position\n* Sufficient apical bone volume and quality for implant placement\n* Willingness and ability to comply with study protocol and follow-up schedule\n* Signed informed consent\n\nExclusion Criteria:\n\n* Presence of acute infection at the extraction site (e.g., abscess)\n* Vertical root fracture or advanced periodontitis with buccal plate loss\n* Uncontrolled systemic disease (e.g., diabetes, osteoporosis)\n* Parafunctional habits (e.g., bruxism, clenching)'}, 'identificationModule': {'nctId': 'NCT07171866', 'acronym': 'SST', 'briefTitle': 'Socket Shield Technique for Immediate and Delayed Implant Placement: A 6-Year Clinical Tria', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'From Esthetics to Function: Can Socket Shield Technique Prove Long-term Effectiveness Either With Immediate or Delayed Implant Placement Protocols? A 6-Year Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'R.25.09.21'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Immediate Implant Placement with SST', 'description': 'Participants received the SST with immediate implant placement performed at the time of extraction.', 'interventionNames': ['Procedure: Immediate Implant Placement with SST']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Delayed Implant Placement with SST', 'description': 'Participants received the SST with delayed implant placement, performed 6 months after extraction and shield preparation.', 'interventionNames': ['Procedure: Delayed Implant Placement with SST']}], 'interventions': [{'name': 'Immediate Implant Placement with SST', 'type': 'PROCEDURE', 'description': 'Participants underwent extraction and socket shield preparation, followed by immediate implant placement in the esthetic maxillary zone. The implant was inserted at the same surgical session using a flapless or minimally invasive approach. CBCT was used to guide planning and assess ridge dimensions. Healing and follow-up assessments were conducted at 1 year and 6 years post-placement.', 'armGroupLabels': ['Immediate Implant Placement with SST']}, {'name': 'Delayed Implant Placement with SST', 'type': 'PROCEDURE', 'description': 'Participants underwent extraction and socket shield preparation. Implant placement was delayed for 6 months to allow soft and hard tissue healing. The implant was placed after verifying shield stability and ridge preservation via CBCT. Follow-up assessments were conducted at 1 year and 6 years post-placement.', 'armGroupLabels': ['Delayed Implant Placement with SST']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35511', 'city': 'Al Mansurah', 'state': 'Dakahlia Governorate', 'country': 'Egypt', 'facility': 'Faculty of Dentistry, Mansoura University', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'overallOfficials': [{'name': 'Soaad Tolba Badawy, Lecturer, Oral Surgery, MU', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of dentistry, Mansoura university'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The individual participant data will not be shared due to privacy considerations, and limitations in participant consent regarding external data sharing.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Soaad Tolba Mohammed Tolba Badawi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Oral and Maxillofacial Surgery, Faculty of Dentistry, Mansoura University', 'investigatorFullName': 'Soaad Tolba Mohammed Tolba Badawi', 'investigatorAffiliation': 'Mansoura University'}}}}