Multicenter Clinical Study on the Efficacy and Esthetic Outcomes of Immediate Implant Placement Using the Socket-Shield Technique Versus Conventional Immediate Implantation in the Anterior Maxillary Esthetic Zone
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 48
- 主要终点
- Thickness of the labial bone plate
研究概览
简要总结
This study plans to enroll no fewer than 48 adult patients who have non-restorable maxillary anterior teeth due to trauma or dental diseases and are candidates for immediate implant placement, meeting the inclusion and exclusion criteria.
详细描述
This is a prospective, multicenter, parallel-group, evaluator-blinded randomized controlled trial.It aims to compare the Socket Shield Technique (SST) with conventional immediate implant placement (IIP) in the maxillary anterior aesthetic zone, evaluating labial bone plate thickness, implant survival/success rates, pink aesthetics, and patient satisfaction to assess their clinical efficacy and aesthetic outcomes.
Eligible participants will provide informed consent and be randomly assigned to groups via center-stratified randomization.
Primary endpoint: Changes in buccal bone plate thickness at the implant shoulder and at 2, 4, and 6 mm apically at 6 months after prosthetic restoration (T3).
Secondary endpoints: Implant survival and success rates; changes in buccal bone volume; changes in soft tissue contour convexity; Pink Esthetic Score (PES); patient satisfaction; operative time, pain levels, and treatment-related parameters.
Safety endpoints: Intraoperative and postoperative adverse events, including infection, bleeding, wound dehiscence, implant loosening, peri-implantitis, shield fragment displacement/exposure/dislodgement, need for reoperation, and other serious adverse events (SAEs).
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)
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
- •Age: 18 to 65 years old;
- •Good general health, able to tolerate oral implant surgery, with no absolute surgical contraindications (ASA I or II);
- •Clinical diagnosis of an unrestorable maxillary anterior tooth, suitable for immediate implant placement; ④ Periodontal tissues are basically healthy, with no obvious active infection in the apical area; ⑤ No obvious root fracture on the labial/buccal side or severe mobility preoperatively; radiographic evaluation confirms that the bone volume in the surgical site meets the requirements of the protocol; ⑥ Willing to accept randomization and standardized follow-up, and has signed the Informed Consent Form; ⑦ Able to provide complete intraoral photographs, CBCT (Cone Beam Computed Tomography) scans, and follow-up data.
排除标准
- •Presence of severe systemic diseases that may affect the surgery or healing, or current use of related medications such as bisphosphonates;
- •Severe periodontal disease or uncontrolled poor oral hygiene;
- •Obvious inflammation in the apical area of the affected tooth, or pathological root resorption; ④ Abnormal occlusal relationship, obvious bruxism, or inability to establish a stable restorative occlusion;
- •Pregnancy or lactation, or unsuitability for radiographic examination; ⑥ History of previous surgery or radiotherapy affecting the bone volume or soft tissues in the target area, which the investigator deems would seriously interfere with the evaluation; ⑦ Expected inability to complete the follow-up, or refusal to comply with the study requirements.
研究组 & 干预措施
the Socket Shield Technique (SST)
the Socket Shield Technique (SST) immediate implant placement
干预措施: the Socket Shield Technique (SST) immediate implant placement (Procedure)
conventional immediate implant placement (IIP)
干预措施: Conventional immediate implant placement (Procedure)
结局指标
主要结局
Thickness of the labial bone plate
时间窗: 6 months after the restoration (T3)
The changes in the thickness of the labial bone plate at the implant shoulder and 2, 4, and 6 mm below
次要结局
- Implant retention and success rate(3, 6,12 ,24 and 36 months after the operaiton)
- Volume change of the labial bone plate(6 months after the crown restoration was completed)
- Change in the contour curvature of soft tissues(6 months after the crown restoration was completed)
- Pink Aesthetic Score (PES)(6 months after the crown restoration was completed)
- Patients' satisfaction degree(On the day after the surgery, the day of crown restoration completion, and 6 months after the restoration was completed)
研究者
Xi Ding
Chief of the Department of Stomatology
First Affiliated Hospital of Wenzhou Medical University