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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Pink Esthetic Score (PES)
研究概览
简要总结
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.
详细描述
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.
This 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.
Forty-two patients requiring extraction of a single non-restorable tooth in the esthetic zone will be randomly allocated into two groups:
Test group: Immediate implant placement with socket shield technique and immediate restoration.
Control group: Early implant placement following soft tissue healing with contour augmentation.
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 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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18 years or older
- •Patients presenting with a single non-restorable tooth in the esthetic zone indicated for extraction and implant replacement
- •Presence of a thin buccal bone plate (<1 mm)
- •Adequate bone volume to allow implant placement in a prosthetically ideal position
- •Intact socket walls following tooth extraction
- •Ability to achieve primary implant stability ≥35 Ncm at the time of implant placement
- •Patients willing to participate in the study and able to provide written informed consent
排除标准
- •History of systemic diseases that may affect bone healing
- •Use of medications that may influence bone metabolism (e.g., bisphosphonates)
- •Smoking within the past 5 years
- •Presence of acute infection at the surgical site or adjacent teeth
- •Teeth with vertical or subcrestal horizontal root fractures on the buccal aspect
- •Presence of internal or external root resorption
- •Severe periodontal destruction at the implant site
研究组 & 干预措施
Immediate Implant Placement and Immediate Restoration with the Socket Shield Tech
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.
干预措施: Socket Shield (Procedure)
Early Type II Implant placement with Contour augmentation with Xenograft
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.
干预措施: Early Implant Placement (Procedure)
结局指标
主要结局
Pink Esthetic Score (PES)
时间窗: 12 months after implant restoration
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.
次要结局
- Peri-implant Mid-facial Mucosal Recession(12 months after implant placement)
- Horizontal Radiographic Peri-implant Bone Changes(12 months after implant Restoration)
- Vertical Radiographic Peri-implant Bone Changes(12 months after implant Restoration)
- Patient Satisfaction(12 months after implant restoration)