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临床试验/NCT06895915
NCT06895915尚未招募不适用

Accuracy of Immediate Implant Placement Using Robotic System Versus Dynamic Navigation System in Anterior Maxillae: A Random Controlled Clinical Trial

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2026年6月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
24
试验地点
1
主要终点
Implant positional 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 in immediate implant placement compared to free hand procedure. On the basis of dynamic navigation, robotic system uses the robotic arm to replace the manual process of implant bed preparation and implant placement, therefore improving the accuracy of implant placement theoretically. The goal of this randomized controlled trial is to compare the positional implant accuracy, the surgical time, and patient satisfaction between dynamic navigation and robotic assisted immediate implant placement in maxillae. Subjects will be randomized to either group based on the allocation. The accuracy of placement will be assessed evaluating the difference between the planned and the actual position using a follow-up CBCT scan taken at the end of the surgery. Subjects will be followed up for one year to assess both patient reported and professional outcomes.

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 in immediate implant placement compared to free hand procedure. However, dynamic navigation faces the following deficiencies in immediate implant placement. Firstly, it has a steep learning curve. Secondly, the rigid palatal bone wall of the socket will force the direction of drill deviating buccally. On the basis of dynamic navigation, robotic system uses the robotic arm to replace the manual process of implant bed preparation and implant placement, therefore improving the accuracy of implant placement theoretically. The goal of this randomized controlled trial is to compare the positional implant accuracy, the surgical time, and patient satisfaction between dynamic navigation and robotic assisted immediate implant placement in maxillae. Subjects will be randomized to either treatment modalities based on the plan. The accuracy of placement will be assessed evaluating the difference between the planned and the actual position using a follow-up scan taken at the end of the surgery. Subjects will be followed up for one year to assess the professional outcomes.

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

入选标准

  • a. ≥18 years old and in good health; b. One or more maxillary incisors that cannot be retained due to non-periodontitis; c. The buccal bone plate is intact; d. No acute infection; e. The extraction socket have at least 3-5 mm apical bone.

排除标准

  • a. General contraindications of oral implant surgery (such as immunodeficiency, long-term use of corticosteroids); b. Treatments or diseases that may affect bone tissue metabolism (for example, taking bisphosphonates or receiving local radiotherapy); c. Periodontitis history or uncontrolled periodontitis. Bleeding of probing (BOP) positive site ≥ 10%, or probing depth (PD) ≥ 4mm; d. Heavy smokers or previous heavy smoking history (quit smoking time <5 years or> 20 cigarettes per day); e. Refuse to participate in this trial.

研究组 & 干预措施

Robotic Surgery

Experimental

Immediate implant placement assisted by robotic surgery

干预措施: dynamic navigation surgery (Procedure)

Dynamic navigation

Sham Comparator

Immediate implant placement assisted by dynamic navigation

干预措施: robotic surgery (Procedure)

结局指标

主要结局

Implant positional accuracy

时间窗: immediately after surgery

Implant accuracy will be measured as discrepancy between the digital plan and the actual position of the implant. (Global deviation at platform and apex, Angular deviation)

次要结局

  • Surgery time(intraoperative)
  • Pain perception(7 days after surgery)
  • Surgeon preference(Immediately after surgery)
  • Soft tissue changes(immediately after crown delivery)

研究者

发起方
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
申办方类型
Other
责任方
Principal Investigator
主要研究者

shichong Qiao

Research Fellow

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

研究点 (1)

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