Accuracy of Dynamic Navigation System on Zygomatic Implant Placement: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 8
- 试验地点
- 1
- 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 zygomatic implant placement in partially or total edentulous patients in the upper jaw compared with the conventional freehand method.
详细描述
The present study is a prospective randomized clinical trial.
Each patient enrolled in this trial will be randomly allocated to on group (Navigation group (test group) or Freehand group (control group)). Preoperative virtual planification of zygomatic an conventional implants on a prerequired cone beam computed tomography (CBCT) with radiographic markers (tooth if possible or micro implants if not possible) will be performed for each patient.
The patient will be randomly allocated in one group just before the surgery, and the surgical procedure will be performed according the surgery protocol of each group. 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 European Conformity (CE) 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
- Double (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
- •Partial or total edentulous maxilla
- •Large bone atrophy that avoids possible conventional implant placement
- •Over 18 years old patients
排除标准
- •Patients with facial bone disease that contraindicates conventional or zygomatic implants placement.
- •Systemic or local conditions that contraindicates oral surgery.
研究组 & 干预措施
Navigation group
Zygomatic implant placement by dynamic computer assisted surgery system.
干预措施: Freehand zygomatic implant placement (Device)
Freehand group
Zygomatic implant placement by Freehand, without any guidance.
干预措施: Freehand zygomatic implant placement (Device)
结局指标
主要结局
Platform 3D deviation
时间窗: 1 month
Global deviation at the platform of the zygomatic 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).
Angular deviation
时间窗: 1 month
Angular deviation between the virtual planed position of the implant and the final implant position. Measured in degrees
Apex 3D deviation
时间窗: 1 month
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).
次要结局
- Patient-reported outcome measures questionnaire(One week post operative)
- Time of surgery(24 hours)
- Complications(6 months)
研究者
Adrià Jorba García
DDS
University of Barcelona