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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Horizontal Ridge Width Change at 1, 2, 4, and 6 mm Apical to the Implant Platform
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The radiographic outcomes assessor was blinded to group allocation. No other masking was implemented due to the surgical nature of the intervention.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Immediate Implant Placement with SST
Participants received the SST with immediate implant placement performed at the time of extraction.
干预措施: Immediate Implant Placement with SST (Procedure)
Delayed Implant Placement with SST
Participants received the SST with delayed implant placement, performed 6 months after extraction and shield preparation.
干预措施: Delayed Implant Placement with SST (Procedure)
结局指标
主要结局
Horizontal Ridge Width Change at 1, 2, 4, and 6 mm Apical to the Implant Platform
时间窗: 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
次要结局
- Buccal and Palatal Bone Height Change(Immediately after implant placement (baseline), 1 year, and 6 years post-placement)
- Implant Stability Quotient (ISQ)(Immediately after implant placement, loading time and 1-year post-placement)
- Pink Esthetic Score (PES)(At implant loading, 1 year, and 6 years post-placement)
- Patient Satisfaction (VAS Score)(At implant loading, 1 year, and 6 years post-placement)
研究者
Soaad Tolba Mohammed Tolba Badawi
Lecturer of Oral and Maxillofacial Surgery, Faculty of Dentistry, Mansoura University
Mansoura University