Dynamic Guided Implant Surgery VS Static Guided Surgery. A Pilot Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Implant placement accuracy at the vertical plane.
研究概览
简要总结
This study aims to evaluate if dynamic-guided surgery is an accurate system for placing dental implants.
Researchers will assess the dental implant accuracy of the dynamic guided system compared to the static pilot guide.
Participants will:
- Receive implant treatment that will be placed by a dynamic or static pilot drill guided system.
- Receive post-operative radiological exam for comparative (on the same appointment).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 盲法
- Single (Investigator)
盲法说明
Due to the nature of the treatment, it is impossible to mask the treatment from the participant and the care provider. However, the data for analysis will be masked to the investigator responsible for assessing the accuracy of each implant placement system.
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years or older,
- •ASA type 1 or 2,
- •Full mouth plaque scores up to 25% (O'LEARY TJ. The plaque control record 1972;43:38), -Partially edentulous with at least one missing tooth
- •Having a bone crest of at least 10mm in length and 6mm in width.
排除标准
- •medical conditions contraindicating surgery,
- •untreated periodontal disease or caries
- •the need for bone augmentation
- •acute local infections
- •history of head/neck radiation.
结局指标
主要结局
Implant placement accuracy at the vertical plane.
时间窗: The data for the assessment is collected during the same appointment as the implant placement and requires an additional 20 minutes.
Implant placement accuracy compared with the implant planning. Expressed in mm.
Implant placement accuracy at the implant platform level
时间窗: The data for the assessment is collected during the same appointment as the implant placement and requires an additional 20 minutes.
Implant placement accuracy compared with the implant planning. Expressed in mm.
Implant placement accuracy at the implant apex level
时间窗: The data for the assessment is collected during the same appointment as the implant placement and requires an additional 20 minutes.
Implant placement accuracy compared with the implant planning. Expressed in mm.
Implant placement accuracy at an angular evel
时间窗: The data for the assessment is collected during the same appointment as the implant placement and requires an additional 20 minutes.
Implant placement accuracy compared with the implant planning. Expressed in degrees.
次要结局
未报告次要终点
研究者
Jordi Marquès Guasch
Jordi marques Guasch
Universitat Internacional de Catalunya