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临床试验/NCT05032170
NCT05032170已完成不适用

In Vivo Accuracy of Two Intraoral Scanning Systems in Detecting Two Inter-foraminal Implants in the Edentulous Mandible.

University Hospital Heidelberg1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2022年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
16
试验地点
1
主要终点
Effect of intraoral scanner on scanning accuracy

研究概览

简要总结

Today, tooth- or implant-supported single crowns and short-span fixed partial dentures can be fabricated on the basis of an intraoral scan, but the scanning accuracy decreases with increasing length of the jaw section to be captured. An accurate scan is also made more difficult by edentulous jaw sections, as these provide the scanner with few landmarks for proper three-dimensional image composition.

With respect to both edentulous and edentulous patients with dental implants, the currently available literature does not provide a firm basis for deciding whether such patients can already be scanned with sufficient accuracy. It is considered problematic in this context that the findings on digital impression accuracy, regardless of whether teeth or implants have been scanned, are based almost exclusively on the results of in vitro studies. Conclusions about the accuracy of intraoral scanners under clinical conditions with moving patients and limited accessibility to the structures to be imaged, especially in the presence of blood, saliva or sulcus fluid, are extremely limited based on these data.

Therefore, the aim of this study is to determine the clinical scanning accuracy of two current intraoral scanning systems for the three-dimensional acquisition of the position of two interforaminal dental implants in the edentulous mandible. The influence of artificial landmarks to achieve increased scan accuracy will also be tested.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants who had received a mandibular overdenture supported by two implants with either Locator attachments or a Dodler bar attachment following an immediate loading protocol as part of a randomized controlled trial [Kappel S, Giannakopoulos NN, Eberhard L, Rammelsberg P, Eiffler C. Immediate Loading of Dental Implants in Edentulous Mandibles by Use of Locator® Attachments or Dolder® Bars: Two-Year Results from a Prospective Randomized Clinical Study. Clin Implant Dent Relat Res. 2016 Aug;18(4):752-
  • doi: 10.1111/cid.
  • Epub 2015 May
  • PMID: 25950679.] and for whom intact working casts with laboratory implant analogs representing the reference implant positions were available.
  • Participant is legally capable
  • Signed informed consent form available

排除标准

  • Participant not contactable
  • Participant not willing to participate
  • New overdenture or dolder bar attachment based on a working cast other than that used for immediate loading
  • No intact working casts available
  • Diagnosed epilepsy
  • Pregnancy and lactation
  • Local or systemic acute or chronic (also in the past) general medical diseases and conditions, which contradict a participation in the study and or expose the patient to a higher risk in case of a study participation
  • Known allergies or intolerances to the materials used in the study.
  • Lack of compliance

结局指标

主要结局

Effect of intraoral scanner on scanning accuracy

时间窗: through study completion, an average of 2 hours

Accuracy will be given as trueness and precision according to ISO 20896-1:2019 Dentistry - Digital impression devices - Part 1: Methods for assessing accuracy. Implant distance deviations will be measured in \[µm\] and implant angle deviations in \[°\].

次要结局

  • Effect of implant attachment on scanning accuracy in [µm] and [°](through study completion, an average of 2 hours)
  • Effect of artificial landmarks on scanning accuracy(through study completion, an average of 2 hours)
  • Effect of intraoral scanner/use of artificial landmarks on intraoral scanning process/quality of the 3D dataset by a study investigator on the basis of qualitative criteria (see description)(through study completion, an average of 2 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Wolfgang Bömicke

Principal Investigator

University Hospital Heidelberg

研究点 (1)

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