PRECISION OF SURGICAL GUIDES FOR PLACEMENT OF EXTRA-LARGE DENTAL IMPLANTS. A PILOT STUDY
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Accuracy of Surgical Guides in implant placement
研究概览
简要总结
The use of zygomatic implants is a technique that is becoming more and more widespread in daily clinical practice, however, few professionals feel safe and confident in performing this type of procedure. We therefore believe that a line of research focused on simplifying this technique will have an extraordinary impact on the safety of both patients and surgeons. Currently, new surgical guides have emerged that guarantee greater precision in the placement of zygomatic implants. However, no comparative clinical studies have yet been performed to evaluate the degree of accuracy of guided implant placement compared to the conventional freehand technique.
详细描述
The primary objective of the study is to study the accuracy of the use of guided surgical splints compared to traditional freehand zygomatic implant placement.
The secondary objectives are:
- To compare the magnitude of variations depending on implant length by superimposing postoperative CT scans using 3DSlicer® (http://www.slicer.org) and exocad® software.
- To compare the magnitude of the variations depending on the location of the implant by superimposing postoperative and postoperative CT scans using 3DSlicer® (http://www.slicer.org) and exocad® software.
- To assess the clinical relevance of cogomatic implant placement using guided surgical splinting on pain parameters and surgical time.
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 (Participant, Outcomes Assessor)
盲法说明
blind
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18-80 years of age, patients who sign the informed consent form and patients who consent to undergo preoperative and postoperative orthopantomography and CT scans.
排除标准
- •Smoking (more than 10 cigarettes per day).
- •Alcoholism (more than 25g/day in women and more than 40g/day in men according to WHO criteria),
- •Oncological treatment (history of treatment in the last 6 months or current treatment with chemotherapy or radiotherapy).
- •History of head and neck radiotherapy.
- •Allergic to anesthetics or antibiotics.
研究组 & 干预措施
Guide Surgery Arm
Use of Surgical Guide
干预措施: Surgical Guide (Procedure)
Control
Hand Free Implant Placement
干预措施: Surgical Guide (Procedure)
结局指标
主要结局
Accuracy of Surgical Guides in implant placement
时间窗: 12 months
Accuracy of Surgical Guides in terms of Radiological differences in implant placement. The primary outcome is to measure the differences existing between implant planificación and final implant placement. First, a computed tomography (CT) scan will be performed to plan the placement of the zygomatic implants. Once the implants have been placed in both groups, another CT scan will be performed to evaluate the following parameters using 3DSlicer® software (http://www.slicer.org). Three-dimensional lateral apical implant deviation and three-dimensional lateral neck implant deviation respect to the original digital planning will be evaluated by superimposing images. 3D lateral deviations will be measured in mm in relation with original planning. Also deviations in degrees between the original planning and the final placements will be evaluated.
次要结局
未报告次要终点
研究者
Jesús Torres García Denche
Associate Profesor
Universidad Complutense de Madrid