Accuracy and Primary Stability of Straight and Tapered Implants Placed Into Fresh Extraction Sockets Using Dynamic Navigation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Accuracy
研究概览
简要总结
Prosthetic-driven immediate implant placement for optimal aesthetic restoration has been increasing in demand during the last decades but requires higher accuracy. Dynamic navigation has been a reported better implant positioning. There are two main choices of implant macrogeometry: straight and tapered implants. One feature of implant design that may influence implants' accuracy is the taper of the implant body. However, their exact role is still needed to be investigated further. Besides, implant macrogeometry may influence primary stability, which is a prerequisite in achieving osseointegration. Therefore, we designed a randomized controlled clinical trial study to verify the clinical efficacy of the implant macrogeometry by comparing straight implants with tapered implants in immediate implant placement using dynamic navigation.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years old and in good health;
- •The maxillary incisor that cannot be retained due to non-periodontitis;
- •The buccal bone plate is complete;
- •No acute infection;
- •The extraction socket have at least 3-5 mm apical bone.
排除标准
- •General contraindications of oral implant surgery (such as immunodeficiency, long-term use of corticosteroids);
- •Treatments or diseases that may affect bone tissue metabolism (for example, taking bisphosphonates or receiving local radiotherapy);
- •Periodontitis history or uncontrolled periodontitis. Bleeding of probing (BOP) positive site ≥ 10%, or probing depth (PD) ≥ 4mm;
- •Heavy smokers or previous heavy smoking history (quit smoking time <5 years or> 20 cigarettes per day);
- •Refuse to participate in this trial.
结局指标
主要结局
Accuracy
时间窗: one week
mm
次要结局
- Insetion torque value, ITV(surgery day)
- Implant Stability Quotient, ISQ(surgery day)
研究者
Junyu Shi
Principal Investigator
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University