Clinical Performance of an Intraoral Scanner With Integrated Caries Detection
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Performance of the caries detection tool, integrated in intraoral scanning system in terms of sensitivity, specificity and reliability.
研究概览
简要总结
The goal of this study is to evaluate if an intraoral scanning device with an integrated radiation-free caries detection tool (near-infrared light) can detect early tooth decay.
The main questions it aims to answer are:
Can the tool find tooth decay as accurately as traditional visual and X-ray examinations? How reliable is the tool when used by different dentists?
Participants will:
- Have one tooth scheduled for extraction. This tooth and its adjacent teeth need to be examined before the extraction by using the intraoral scanner with the caries detection tool, which takes about 5 extra minutes. Those results will be compared to the standard dental examination, including visual inspection and X-rays.
- Allow investigators to check the extracted tooth and the neighboring teeth directly after extraction to see if any carious lesion is visible.
This study does not involve any drugs or invasive procedures beyond the planned tooth extraction, and participants will not be exposed to extra radiation. The results will help dentists detect tooth decay, which may allow less invasive treatments and better prevention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •All genders, minimum age for participation is 18 years
- •Presence of a tooth, that is already scheduled for extraction (indication for extraction diagnosed during the normal clinical service independently of this study by a qualified dentist)
- •Availability of a radiograph (X-ray) showing the tooth to be extracted along with adjacent teeth
- •Signed informed consent after a comprehensive explanation of the study is available
排除标准
- •participants under the age of 18
- •Addicts or participants with impaired cognitive abilities that do not allow the participant to assess the scope of the study
研究组 & 干预措施
intraoral scan
干预措施: intraoral scan with integrated caries detection tool (Diagnostic Test)
结局指标
主要结局
Performance of the caries detection tool, integrated in intraoral scanning system in terms of sensitivity, specificity and reliability.
时间窗: From the enrollment at four weeks.
次要结局
未报告次要终点
研究者
Albert Mehl
Prof. Dr. Dr.
University of Zurich