Accuracy and Patient-Reported Outcome Measures (PROMs) of a Dynamic Navigation System in Implantology: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Platform 3D deviation
研究概览
简要总结
This study consists in a randomized controlled trial which objective is to assess the accuracy of a dynamic navigation system in dental implant placement in partially edentulous patients compared with the conventional freehand method.
详细描述
This is a prospective randomized clinical trial.
Each patient enrolled in this trial will be randomly allocated to one group ( Navigation group or Freehand groups). Preoperative virtual planification of dental implants on a pre-acquired cone beam computed tomography (CBCT) will be performed for each patient using the same system.
During the surgical phase, depending on which group is allocated the patient one surgical approach or other will be used. Then after the surgical procedure a PROMs questionnaire will be asked to the patients.
Finally a postoperative CBCT will be performed and overlapped with the preoperative CBCT (with the implants planification) and implant position deviations between the planned and final position will be measured.
The study devices are CE- (Conformité Européenne, meaning European Conformity) marked products and used within their intended use.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Patient will be unaware of which group since during the surgical procedure patient eyes' will be covered.
Outcome assessor won't take part of the clinical process and will be blinded regarding which group is allocated each patient.
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
- •Partially edentulous patients that requires at least the placement of one dental implant
- •Healthy patients ASA I and II (American Society of Anesthesiologists classification)
- •Over 18 years old patients
排除标准
- •Totally edentulous patients
- •Systemic or local conditions that contraindicates dental implant surgery
- •Patients with less than 3 teeth in the jaw.
结局指标
主要结局
Platform 3D deviation
时间窗: 3 months post operative
global deviation at the platform of the dental implant between the virtual planned position and the final position of the dental implant measured in the 3 axes of the space (3D deviation). Measured in millimeters (mm).
Platform 2D deviation
时间窗: 3 months post operative
Lateral deviation at the platform of the dental implant between the virtual planned position and the final position of the dental implant measured in 2 axes of the space (x and y, 2D deviation). Measured in millimeters (mm).
Angular deviation
时间窗: 3 months post operative
angular deviation between the virtual planed position of the implant and the final implant position. Measured in degrees
Apex 3D deviation
时间窗: 3 months post operative
global deviation at the apex of the dental implant between the virtual planned position and the final position of the dental implant measured in the 3 axes of the space (3D deviation). Measured in millimeters (mm).
Apex depth deviation
时间窗: 3 months post operative
Depth deviation of the apex of the dental implant between the virtual planned position and the final position of the dental implant in the Z-axis. Measured in millimeters (mm).
次要结局
- Patient-reported outcome measures (PROMs) questionnaire(One week post operative.)
研究者
Rui Figueiredo
Associate Professor. PhD, MD, DDS
University of Barcelona