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临床试验/NCT06412159
NCT06412159已完成不适用

Intra-oral Digital Evaluation of Fit Accuracy for Removable Partial Denture Frameworks Fabricated by Selective Laser Melting Using 2 Different Impression Techniques. Within Subjected Study

Kafrelsheikh University1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2023年1月1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
24
试验地点
1
主要终点
Intra-oral digital Evaluation of fit accuracy for removable partial denture frameworks

研究概览

简要总结

Purpose:Within subject study aim to compare the overall accuracy and fit of different components for mandibular metallic removable partial denture (RPD) frameworks fabricated by selective laser melting using combined analog-digital, and fully digital impression techniques.

Material and methods. Two RPD frameworks were fabricated for each of the 24 participants using each of the 2 techniques of the 24 participants enrolled, were of mandibular Kennedy class I, the first technique was the combined analog-digital workflow had the analog steps include: a physical impression was made using polyvinyl siloxane, stone casts were made, then the stone cast was scanned with a laboratory scanner to generate a digital cast. The 3Shape CAD software was then used to design a digital RPD, which was fabricated from a cobalt-chroumum alloy by selective laser melting. The second technique was fully digital where an intraoral digital scanner was used to make a definitive scan, which was sent to the 3Shape software for digitally designing the RPD framework and subsequent selective laser melting for fabrication. For both frameworks in the same participant, the same design was used for consistency. To assess the accuracy of fit, based on STL data analysis (intra-oral digital superimposition evaluation), a color map was constructed using non metrology software, and overall fit accuracy and the misfit (distance between each framework component and the reference intra-oral scan) were measured at rest, guiding plane and lingual plate areas.

详细描述

Twenty four mandibular bilateral partially edentulous participants aged from 50 to 65 years having mandibular Class I Kennedy classification were selected randomly from the outpatient clinic of the prosthodontic department. The clinical study was explained to the patients and they accept it and an informed consent were signed by all them

For each patient, two different cobalt chromium removable partial denture frameworks were constructed; the first one was fabricated using combined analog-digital workflow (group 1) and the other framework was fabricated using completely digital workflow (group 2) and comparing them through evaluation of:

  1. Over all accuracy
  2. Accuracy of fit of occlusal rests, major connector, Guiding plane/plate relation and retentive terminal of I bar clasp.

Two techniques were used to fabricate 48 RPD frameworks in total. Fabrication of cobalt chromium removable partial denture framework using combined analog-digital workflow (group 1)

The Removable partial denture frameworks for group 1 were fabricated as follow:

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
50 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •mandibular Class I Kennedy classification were selected randomly from the outpatient clinic of the prosthodontic department

排除标准

  • •other classes of removable partial denture maxillary partially edentulous patients

研究组 & 干预措施

selective laser melting removable partial denture frameworks fabricated by conventional technique

Other

selective laser melting removable partial denture frameworks fabricated by conventional technique

干预措施: Selective laser melting framework was fabricated using completely digital workflow (Other)

selective laser melting framework was fabricated using completely digital workflow

Other

selective laser melting framework was fabricated using completely digital workflow

干预措施: Selective laser melting framework was fabricated using completely digital workflow (Other)

结局指标

主要结局

Intra-oral digital Evaluation of fit accuracy for removable partial denture frameworks

时间窗: immediately after insertion of removable partial denture frame work

Intra-oral digital Accuracy of fit evaluation between frame works by using medit compare software to exclude the value of point difference in different area at occlusal rest major connector

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

Nourhan Ahmed Ragheb

associate professor

Kafrelsheikh University

研究点 (1)

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