In Vivo Accuracy of Digital Intraoral Scans/Optical Impression Systems for the Production of Full-Arch Impressions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Accuracy measurement of digital impressions performed with optical impression systems are primary endpoints
研究概览
简要总结
For several decades now, modern procedures have allowed dentists to capture your teeth using digital cameras. This digital procedure is increasingly replacing traditional impressions with a viscous mass that hardens in the mouth.
In the following study, the investigators want to find out whether the accuracy of these modern methods is comparable to the classic impression technique.
Three conventional impressions are taken for this purpose, and multiple digital impressions are also taken with each of the intraoral scanners. The impressions are then compared with each other. This allows the accuracy of the different intraoral scanners to be determined.
详细描述
In summary, this study intends to address the need for comprehensive in vivo research on the accuracy of intraoral impression methods, especially in the context of modern digital technologies. By comparing various digital and conventional methods, this research will offer valuable information to guide dental practitioners in choosing the most precise and reliable techniques for their clinical applications.
The following study design is planned:
The study is non-randomised. The study setup is monocentric. At the beginning of the session, 3 conventional impression each of the upper and lower jaw is taken. After 8 hours the impression is moulded by a dental technician with a SuperHard plaster (type 4).After 48 hours of setting time the plaster-model is scanned with a lab scanner (inEos X5, Dentsply Sirona) to generate a .stl-file that is comparable to the following digital impressions.
This is followed by 6 digital impressions of the upper and lower jaw and the associated bite registration in habitual occlusion, divided between two experienced practitioners (3 upper, 3 lower jaw scans, 3 bite registrations per practitioner) with the 8 different intra oral scanners. In total, 6 conventional (3 upper, 3 lower jaw impressions), 48 digital impressions and 48 bite registration are taken. If it is not possible to take all the impressions in one session, a new conventional impression is taken at the start of each new session, so that a daily updated reference model is always available. Minimizing bias is achieved, by using the intra oral scanners according to the manufacturers instructions.
The number of scans was calculated as part of a power analysis based on previous study results and should therefore be meaningful.
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
- 否
入选标准
- •All genders, minimum age for participation is 18 years
- •Good general health and healthy dental conditions (gaps with a maximum of 1 missing tooth are permitted)
- •Written consent after informed consent discussion 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
- •participants suffering from periodontitis (pathological tooth mobility could falsify the study results)
- •Maximal mouth opening less than 3.5 cm
- •participants who wear large reconstructive works and/or have a free-end situation from at least the 2nd premolar
研究组 & 干预措施
Comparison conventional impression vs. digital impression
The investigators would like to investigate the accuracy of various intraoral scanning systems. For this a conventional impression is taken from all patients to generate a reference model, which is then compared to full-arch impressions from various digital intraoral scanning systems.
The examination is carried out in the same way for all participants.
干预措施: impression of the teeth (Diagnostic Test)
结局指标
主要结局
Accuracy measurement of digital impressions performed with optical impression systems are primary endpoints
时间窗: It is intended that all impressions take place within half a day, the accuracy measurement should be carried out within 6 weeks.
The accuracy of the intraoral scanners (primary endpoint) is analyzed on the basis of precision and trueness. The unit of measure used is the same (μm). The trueness of each test group is assessed by superimposing each scan with the reference model data set. The precision is calculated as the mean difference between all superimpositions within one test group.
次要结局
未报告次要终点