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临床试验/NCT05317182
NCT05317182已完成不适用

"Comparative Study of the Accuracy of Dental Contacts of an Occlusal Splint Made According to Conventional or Digital Techniques Using GeoMagic®."

Universitat Internacional de Catalunya1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年2月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Volumetric changes assessed in Root Mean Square (RMS)

研究概览

简要总结

To compare the accuracy of the occlusal splints made by conventional impression and milled with the splint made by intraoral scanner and milled.

详细描述

Forty participants received two different occlusal devices from two different workflows (fully conventional and fully digital). Every splint was scanned before and after the occlusal adjustments in order to compare the volumetric changes. Furthermore, the scans were compared in a software Geomagic® Control X calculates and measures the distance from every surface point from the initial dataset (occlusal devices before adjustment) to the final dataset (occlusal device after adjustment).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients between 18 to 70 years old.
  • Patients who maintain until first molar in both arches.
  • Patients who need occlusal splints due to bruxism.

排除标准

  • Pregnant patients.
  • Patients with removable prostheses.
  • Patients with fixed prostheses between six to six in both arches.
  • Patients with partial edentulism, do not maintain until first molar in both arches.
  • Patients with Temporomandibular Disorders (TMD): articular noises, pain on palpation, limited opening.

研究组 & 干预措施

Analogic-Analogic

Active Comparator

Occlusal splints made by conventional impression and conventional fabrication.

干预措施: Occlusal Splints Analogic-Analogic (Other)

Analogic-Digital

Active Comparator

Occlusal splints made by conventional impression and digital design and fabrication.

干预措施: Occlusal Splints Analogic-Digital (Other)

Digital-Digital

Active Comparator

Occlusal splints performed by intra-oral scanner and digital design and fabrication.

干预措施: Occlusal Splints Digital-Digital (Other)

结局指标

主要结局

Volumetric changes assessed in Root Mean Square (RMS)

时间窗: 1 week

The software of automatically graphical comparisons called Geomagic® Control X (Geomagic Inc., 3D Systems Inc., USA) will be used to calculate the accuracy by measuring the distance (positive or negative) from every surface point from the initial dataset (occlusal devices before adjustment) to the final dataset (occlusal device after adjustment). This approach will give us the mean of the simple arithmetic difference.

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

Alvaro Blasi

Principal investigator

Universitat Internacional de Catalunya

研究点 (1)

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