跳至主要内容
临床试验/NCT06658366
NCT06658366
已完成
不适用

In Vivo Accuracy of Digital Intraoral Scans/Optical Impression Systems for the Production of Full-Arch Impressions

University of Zurich1 个研究点 分布在 1 个国家目标入组 10 人2024年10月28日

概览

阶段
不适用
干预措施
impression of the teeth
疾病 / 适应症
Full-arch Impression
发起方
University of Zurich
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
状态
已完成
最后更新
3个月前

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. The selection of scanners represents a heterogeneous selection of devices currently on the market. The scanners come from different price categories and use different optical measuring principles. The precision measurement is carried out by comparing the impressions within and between the tested groups (precision and trueness respectively). For that, the scans will be exported to STL \& PLY format (depending on the scanning device) and imported into evaluation programs (Dentexion, Dentexion and Control X, Geomagic). The evaluation process follows the ISO 5725-1 criteria. After superimposition of the mesh surfaces according to the best-fit alignment, the distances will be measured point-to-point using the signed nearest neighbor method and sorted into a histogram. From that, the distance measure for each pairwise surface superimposition will be calculated from the (90%-10%)/2 percentile value.

注册库
clinicaltrials.gov
开始日期
2024年10月28日
结束日期
2025年4月30日
最后更新
3个月前
研究类型
Interventional
研究设计
Single Group
性别
All

研究者

责任方
Sponsor

入排标准

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

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.

研究点 (1)

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