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临床试验/NCT06146153
NCT06146153已完成不适用

Impact of Various Palatal Vault Configurations of Edentulous Arches on Scan Accuracy. An Invivo Clinical Study

October University for Modern Sciences and Arts1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Trueness

研究概览

简要总结

the aim of this study is to compare the influence of different palatal vault configurations on the accuracy and scan speed of IO scans in cases of completely edentulous arches. The null hypothesis is that there is no difference in scanning time, and trueness and precision of IO scans between class I, II and III palatal vault configurations.

详细描述

A reference model will be created for each of the three groups with different palatal vault configurations. PVS material (DMG Silagum, Germany) will be used for impressions in a one-step process by an experienced operator, and type IV plaster (Heraeus, Germany) will be used to produce the models. These models will then bedigitized by an experienced operator using an extraoral scanner (Trios 3; 3Shape, Copenhagen, Denmark). The STL scan file of the maxillary model will be imported into CAD software (Meshmixer; Autodesk, San Rafael, CA, USA) to generate a reference file. Reference markers will then be added to the digital files to aid the superimposition process during digital subtraction operations.For intraoral scans, the entire maxilla of each patient will be digitally captured using an intraoral scanner (TRIOS POD, 3Shape, Copenhagen, Denmark).According to ISO standards, specifically ISO 5725-1, the accuracy of digital impressions obtained with intraoral scanners (IOS) will be evaluated according to two main parameters: trueness and precision.

研究设计

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

入排标准

年龄范围
50 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Full tooth loss in the maxilla;
  • Absence of infectious diseases;
  • Systemic good health;
  • Age between 50 and 75 years;
  • Willingness to cooperate throughout the data collection process

排除标准

  • Exclusion criteria included:
  • Presence of any remaining teeth;
  • Inability to comprehend the study's objectives and procedures;
  • Palatal defect or lesion;
  • Postoperative scarring on the palate;
  • Limitations in mouth opening.

结局指标

主要结局

Trueness

时间窗: 15 days

Trueness is the degree of agreement between the digital impression and the reference scan. To assess trueness, we will measure the deviation between the reference and scanned files

次要结局

  • precision(15 days)

研究者

发起方
October University for Modern Sciences and Arts
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dina ElAwady

Associate professor

October University for Modern Sciences and Arts

研究点 (1)

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