Comparing Accuracy of Static Navigation Systems and Robotic System in Partially Edentulous in Posterior Area: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 36
- 主要终点
- implant positional accuracy
研究概览
简要总结
The aim of this randomized clinical trial to compare the implant positional accuracy of robotic system-assisted implant surgery with that of static system-assisted implant surgery. Patients will be recruited and randomly assigned to either the robotic surgery group or the static navigation surgery group to evaluate the accuracy of the implants in both groups and to compare patient-reported and physician-reported outcomes of the two approaches.
详细描述
Dental implants have been widely used for replacing the lost natural teeth, with evidence of long-term success and improvement of patients' quality of life. Nevertheless, proper implant position is considered today an essential prerequisite for ensuring successful treatment outcomes, as well as long-term maintenance of the prosthesis and the peri-implant tissue health.Therefore, we plan to conduct this randomized clinical trialto compare the implant positional accuracy of robotic system-assisted implant surgery with that of static system-assisted implant surgery. Patients will be recruited and randomly assigned to either the robotic surgery group or the static navigation surgery group to evaluate the accuracy of the implants in both groups and to compare patient-reported and physician-reported outcomes of the two approaches.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Informed consent form signed voluntarily.
- •Aged at least 18 years.
- •Partial edentulousness in the posterior maxillary or mandibular region (premolar, molar, maximum two in a row).
- •Sufficient bone volume for implant placement without bone augmentation;
- •The minimum number of residual teeth was seven teeth.
- •Good communication with the physician, compliance, ability to follow the physician's advice to maintain oral hygiene.
- •Exclusion criteria:
- •Systemic disease that would interfere with dental implant surgery.
- •Bisphosphonate treatment.
- •Untreated, uncontrolled periodontal disease.
- •Heavy smoker (more than 10 cigarettes per day).
- •Poor oral hygiene.
排除标准
- 未提供
结局指标
主要结局
implant positional accuracy
时间窗: immediately after surgery
The implant placement accuracy was measured by overlapping the planned position of the implant in the preoperative CBCT and its final position assessed through a postoperative CBCT.
次要结局
- Pain perception(immediately after surgery, and 1 to 7 days after surgery.)
- Surgery complication(Immediately and 7 days after surgery)
研究者
Ke Song
Principal Investigator, Clinical Professor
Tongji Hospital