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临床试验/NCT04025697
NCT04025697Unknown不适用

Complete Denture Tooth Movement in Digital Light Processing Versus Conventional Fabrication Techniques: A Randomized Controlled Trial

Cairo University0 个研究点目标入组 14 人开始时间: 2019年10月1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
14
主要终点
The amount of tooth movement

研究概览

简要总结

The purposes of this study are to compare the denture tooth movement, the amount of occlusal adjustment needed and the chairside time required for CAD-CAM and conventional dentures.

PICOT Format:

P: completely edentulous patients. I: Complete denture fabricated by digital light processing method. C: Complete denture fabricated by the conventional method.

O:

Primary Outcome: Denture tooth movement

Secondary outcomes:

  • Amount of occlusal adjustments needed
  • Chairside time T: Three months with a wash-up period of 2 weeks

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Health Services Research
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Age ranging from 40-70 years.
  • •Cooperative patients with no history of psychological diseases.
  • •Completely edentulous patients with types I, II and III mandibles according to McGarry et al.

排除标准

  • •Pathological changes of residual ridges
  • •Patients with xerostomia.
  • •Patients with flabby ridges.
  • •Temporomandibular disorders and neuromuscular disorders e.g. Parkinson's disease

研究组 & 干预措施

Conventional CD

Placebo Comparator

A conventional Complete denture will be constructed and the amount of denture tooth movement will be measured

干预措施: Complete Denture (Other)

Rapid Prototyped Denture

Active Comparator

A digital light processed denture will be constructed and the amount of tooth movement will be measured

干预措施: Rapid prototyped denture (Other)

结局指标

主要结局

The amount of tooth movement

时间窗: 8 months

The amount of tooth movement will be measured immediately after denture construction using the Geomagic surface matching software (Geomagic Control 2014; 3D Systems Inc.) Laser scan images of the denture obtained both after trial setup of teeth and of the final denture after being hydrated for 24 hours. Those images will be transferred into STL files that will then be superimposed using the global registration function of the software by finding 10,000 points in common between both pre and pot processing STL files. Measurements will be made at different points using the software and colour surface maps will be created using the 3D comparison function to display the amount and direction of tooth movement

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

Shaymaa Belety

Assistant Lecturer

Cairo University

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