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临床试验/NCT04653519
NCT04653519Unknown不适用

Accuracy and Reproducibility of Virtually Guided Minimally Invasive Tooth Preparations Using Reverse Engineering (Controlled Clinical Trial)

Alexandria University1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2020年9月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
10
试验地点
1
主要终点
Evaluation of the virtually guided tooth preparation accuracy

研究概览

简要总结

The aim of the study is to assess and reproduce standardized virtually guided minimally invasive tooth preparations using digitally designed occlusal template, compared to its reference virtual preparation using a computer aided 3-dimensional (3-D) analysis, and to investigate the effect of these preparations on absolute marginal discrepancy of 3 unit monolithic translucent zirconia FPD using a computer aided 3-D analysis.

详细描述

Ten patients with missing mandibular first molar will receive a three-unit full contour monolithic zirconia FPD. Each patient case will receive two modes of preparation as in the previous in-vitro study: virtually guided tooth preparation using occlusal resin template to assist the intraoral preparation and the reference virtual tooth preparation. Each participant's preparation will be evaluated using diagnostic dental software and will be compared to a reference digital virtual preparation using 3-D mesh processing reverse engineering metrology software.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients with a missing lower first mandibular molar.
  • •Good oral hygiene with no signs of periapical pathology or periodontal disease (periodontal screening index 0-1) and with compliance to perform strict oral hygiene measures.
  • •Well-aligned abutment teeth with similar mesio-distal (M-D) and bucco-lingual (B- L) dimensions; (2nd premolar: M-D 7.8 mm ±1, B-L 8.7 mm ±1), (2nd molar: M-D 10.73±1, B-L 10.5 mm ±1).
  • •Abutment teeth with an adequate occluso-gingival height where (2nd premolar: 8.4 mm ±1, 2nd molar 7mm ±1), and adequate edentulous span length (9.5 mm±1); for an appropriate connector area of at least 9 mm.
  • •Absence of parafunctional habits (clinching, bruxism).

排除标准

  • •Bad oral hygiene.
  • •Advanced periodontitis, gingivitis, or recession.
  • •Abutments with subgingival restorations, root caries.
  • •Parafunctional habits.
  • •Undergoing orthodontic treatment.
  • •Obvious dentition malalignment.

研究组 & 干预措施

Virtually guided minimally invasive preparation

Experimental

干预措施: Virtually guided minimally invasive preparation (Device)

结局指标

主要结局

Evaluation of the virtually guided tooth preparation accuracy

时间窗: 1 month

Each scan data of virtually guided preparations will be uploaded to a 3D mesh processing reverse engineering software, then superimposed against the reference virtual preparation using the software's best fit matching algorithm tool. Superimposed 3D data files will be sectioned into 5 different 2D planes: buccolingual, mesiodistal, transverse occlusal, transverse middle, and transverse gingival. Differences will be assessed both qualitatively and quantitively to measure deviations. Quantitative assessment will be expressed with a sign: (+) indicating external deviation or (-) indicating internal deviation. The deviation (+ or -) will be numerically described with mean and standard deviation. Qualitative assessment will be through a color-coded mapping of superimposed images where discrepancies between each test specimen and reference file will be expressed with yellow range of color lines indicating external deviations and cyan range of color lines indicating internal deviations

3-D Evaluation of absolute marginal discrepancy using reverse engineering

时间窗: 1 month

Four scans will be performed using a calibrated laboratory scanner: each 3D printed master cast with 2 preparations designs, external \& intaglio surfaces of monolithic zirconia 3-unit FPDs, monolithic zirconia 3-unit FPDs after it has been seated on each preparation design. The 3D point clouds of all 4 scans will be obtained in STL format. The 3D data of the FPD retainers will be registered to the data obtained from the external surface of the crown using registration module in reverse engineering software. The 3D data of the virtual seating of the intaglio \& external surfaces on the preparations will be obtained \& margins of the FPD retainers \& preparations will be extracted. The software's construct cross-sectional cloud circular command to divide the preparation evenly into curves. Every curve will intersect with the outer edge of the ceramic retainer \& margin design of the preparation at 2 points. Distance between these 2 points will be recorded (absolute marginal discrepancy)

次要结局

未报告次要终点

研究者

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

yara attia

Assistant Lecturer of Fixed Prosthodontics

Fayoum University

研究点 (1)

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