Accuracy and Primary Stability in Immediate Implant Placement Using Dynamic Navigation or Freehand
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 24
- 试验地点
- 3
- 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 reported better implant positioning. However, dynamic navigation's application to immediate implant placement has not been studied, and its exact role is still needed to be investigated further. Besides, implant insertion angle may influence primary stability, which is a prerequisite in achieving osseointegration, while dynamic navigation can precisely control angle and position. Therefore, the investigators designed a randomized controlled clinical trial study to verify the clinical efficacy of dynamic navigation and freehand in immediate implant placement. Patients will then be followed up one year after delivery of the crown to assess additional parameters.
详细描述
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 reported better implant positioning. However, dynamic navigation's application to immediate implant placement has not been studied, and its exact role is still needed to be investigated further. Besides, implant insertion angle may influence primary stability, which is a prerequisite in achieving osseointegration, while dynamic navigation can precisely control angle and position. Therefore, the investigators designed a randomized controlled clinical trial study to verify the clinical efficacy of dynamic navigation and freehand in immediate implant placement. Patients will then be followed up one year after delivery of the crown to assess additional parameters.
These will include the assessment of soft tissue inflammation, cytokine concentrations, microbiome, stability of the buccal bone plate.
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
- 是
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: before surgery to after surgery one week
Taking cone-beam computed tomography (CBCT). The deviation between the planned implant and the actual implant were measured by Computer Assisted Dental Implant Precision System (Dcarer, Suzhou, China) as follows: (1) At least four feature points (like tooth cusps or bone pits) were selected in preoperative and postoperative CBCT for rough registration. (2) Feature surface circles in preoperative CBCT were selected, and then a mathematical algorithm displayed a similar feature surface circle in postoperative CBCT. The algorithm registered thousands of points in these two circles via conventional iso-surface thresholding technology. The software calculated registration error automatically. (3) Finally, the planned and actual implant were identified, and the deviation would be automatically calculated.
Peri-implant soft tissue health
时间窗: 12-months follow-up after delivery of crown
Assessment of tissue health according to the definition of the 2017 International Classification. Berglundh et al.
次要结局
- Implant microbiome(12-months follow-up after delivery of crown)
- Patient satisfaction(12-months follow-up after delivery of crown)
- Esthetic appearance of the dental crown(12-months follow-up after delivery of the crown)
- Peri-implant sulcus fluid Inflammation(12-months follow-up after delivery of crown)
- Buccal bone changes(12-months follow-up after delivery of crown)
- 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