Socket Shield Technique for Immediate and Delayed Implant Placement: A 6-Year Clinical Tria
- Conditions
- Alveolar Ridge PreservationImplant Dentistry
- Registration Number
- NCT07171866
- Lead Sponsor
- Soaad Tolba Mohammed Tolba Badawi
- Brief Summary
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.
SST 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.
This randomized clinical trial enrolled patients who needed single-tooth implants in the esthetic zone. Participants were randomly assigned to one of two groups:
Immediate SST group: the implant was placed at the same time the socket shield was prepared.
Delayed SST group: implant placement was performed six months after socket shield preparation.
Over a 6-year follow-up period, both groups were evaluated for:
Changes in ridge width and bone height using CBCT imaging. Esthetic outcomes using the Pink Esthetic Score (PES). Patient satisfaction through a structured questionnaire.
The goal is to determine whether SST offers reliable long-term outcomes in either immediate or delayed implant placement scenarios, supporting its broader clinical use.
- Detailed Description
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.
Study Design:
Parallel-arm, randomized controlled trial Conducted at the Faculty of Dentistry, Mansoura University Sample: 25 patients needing single-tooth replacement
Groups:
Immediate SST: implant placed at time of shield preparation Delayed SST: implant placed after 6-month healing
Primary Outcome:
Ridge 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.
Secondary Outcomes:
Buccal/Palatal Bone Height Implant Stability Pink Esthetic Score Patient Satisfaction
Serial 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.
This 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
- Patients requiring single-tooth replacement in the anterior maxilla (esthetic zone)
- Age between 18-65 years
- Good systemic health
- Demonstrated good oral hygiene
- Presence of an intact buccal plate
- Class I or II sagittal root position
- Sufficient apical bone volume and quality for implant placement
- Willingness and ability to comply with study protocol and follow-up schedule
- Signed informed consent
- Presence of acute infection at the extraction site (e.g., abscess)
- Vertical root fracture or advanced periodontitis with buccal plate loss
- Uncontrolled systemic disease (e.g., diabetes, osteoporosis)
- Parafunctional habits (e.g., bruxism, clenching)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Horizontal Ridge Width Change at 1, 2, 4, and 6 mm Apical to the Implant Platform Immediately after implant placement (baseline), 1 year, and 6 years post-placement 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.
Unit of Measure: → Millimeters (mm) Safety Issue: → No
- Secondary Outcome Measures
Name Time Method Buccal and Palatal Bone Height Change Immediately after implant placement (baseline), 1 year, and 6 years post-placement 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.
Unit of Measure: → Millimeters (mm) Safety Issue: → NoImplant Stability Quotient (ISQ) Immediately after implant placement, loading time and 1-year post-placement Implant stability was assessed using a resonance frequency analysis device (Osstell ISQ). Buccolingual and mesiodistal values were averaged to calculate ISQ.
Unit of Measure:
→ ISQ Units
Safety Issue:
→ NoPink Esthetic Score (PES) At implant loading, 1 year, and 6 years post-placement 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.
Unit of Measure: → Score (0-10) Safety Issue: → NoPatient Satisfaction (VAS Score) At implant loading, 1 year, and 6 years post-placement Satisfaction was measured using a 100 mm visual analog scale (VAS) on three dimensions: overall experience, expectations, and esthetics. Scores were converted into percentages.
Unit of Measure: → VAS (%) Safety Issue: → No
Trial Locations
- Locations (1)
Faculty of Dentistry, Mansoura University
🇪🇬Al Mansurah, Dakahlia Governorate, Egypt
Faculty of Dentistry, Mansoura University🇪🇬Al Mansurah, Dakahlia Governorate, Egypt