Dynamic Navigation-Assisted Dental Implant Placement: A Randomised Controlled Clinical Trial Comparing Accuracy With the Freehand
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 主要终点
- Change between the planned and placed implant positions
研究概览
简要总结
Placement of dental implants via the freehand approach may result in damage to the surrounding critical anatomy of undiscordant prosthetic position. A real-time navigational stereotaxic surgical instrument (navigation) may help to alleviate these undesired outcomes in the freehand approach.
All patients received implants in the right and left the side of their upper jaws via the random use of the navigation or the freehand approach. Positional deviations between the planned and placed implants were measured on a final tomographic image matched to the baseline.
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 (Investigator)
盲法说明
Investigation of the post-op images included anonymized patient names providing unbiased analysis.
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
- •men and women aged >18 years.
- •Patients approving to participate in the trial and giving written consent
- •must be able to open his/her mouth
排除标准
- •Hemodynamically significant mitral valve stenosis
- •Prosthetic heart valve (annuloplasty with or without prosthetic ring, commissurotomy and/or valvuloplasty are permitted)
- •Planned cardioversion (electrical or pharmacological)
- •Transient atrial fibrillation caused by a reversible disorder (e.g., thyrotoxicosis, pulmonary embolism, recent surgery, myocardial infacrtion)
- •Known presence of atrial myxoma or left ventricular thrombus
- •Active endocarditis
研究组 & 干预措施
Dynamic Navigation
Dental implant surgery via dynamic navigation assistance
干预措施: Dynamic Navigation Assisted Implant Surgery (Device)
Freehand
Dental implant surgery via conventional freehand
干预措施: Freehand Implant Surgery (Procedure)
结局指标
主要结局
Change between the planned and placed implant positions
时间窗: 12 weeks
Deviations between the planned and placed implants will be measured by matching the pre- and post-op tomographic images.
次要结局
- Damage to the surrounding critical anatomy(1 day (On the day of surgery).)
研究者
Volkan Arisan
Dr. Volkan Arısan
Istanbul University