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临床试验/NCT03507179
NCT03507179Unknown不适用

Retention of Complete Denture Using Rapid Prototyping Versus a Conventional Complete Denture: Cross Over Randomized Control Trial

Cairo University0 个研究点目标入组 2 人开始时间: 2018年5月4日最近更新:
适应症

试验速览

阶段
不适用
入组人数
2
主要终点
retention

研究概览

简要总结

Nineteen patients will be selected from the clinic following the inclusion and exclusion criteria. Each one of them will receive two dentures. The first denture will be a conventional complete denture while the second denture will be a complete denture made by Rapid prototyping method.

For both groups, a preliminary impression will be made & after pouring the primary impression, self-cured acrylic resin trial denture bases with a wax rim will be constructed on the primary casts for the upper & lower arches for a jaw relation record. A facebow record will be used to mount the upper cast, while the lower cast will be mounted using a centric relation record. Setting of artificial teeth will be performed, then the denture will be tried in patient's mouth. Functional impression will be taken during the try in stage which.

For the first denture, the functional impression will be poured in normal way to obtain the master cast. Then Processing will be done in normal way and the denture will be finished and polished and delivered to the patient.

But for the second denture construction CBCT scanning of the try in with the functional impression will be done to obtain STL file then denture base manufacturing will be done by 3D printing.

For group A and group B Retention will be measured for the upper denture immediately, with a wash out period one month between the two dentures.

详细描述

Heat processed denture base is the treatment of choice for most of edentulous patients and it is considered as the golden standard and the main comparator for the new techniques. But using Heat Cured Acrylic resin would require many laboratory steps which introduce several errors . Meanwhile, the introduction of rapid prototyping method with high accuracy which eliminates some of the laboratory steps was the reason for choosing it to compare it with the conventional method.

研究设计

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

入排标准

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

入选标准

  • Age ranging from 40-70 years.
  • Cooperative patients.
  • male or female patients

排除标准

  • Pathological changes of residual ridges.
  • Patients with any systemic diseases.
  • Patients with xerostomia.
  • Patients with flabby and flat ridges.
  • Patients with allergy to resins.
  • Patient with sever undercuts, or irregular bony exostosis. -

结局指标

主要结局

retention

时间窗: immediately after denture construction

We will Determine the geographic center for upper denture base to measure retention then A loop will be attached to each denture base at the position of geographic center using clear self cure acrylic resin and the retention will be measured by applying the forces perpendicular to the denture using Digital Force Meter Each base will be tested 3 times and the average will be calculated. Then the loop will be removed and the denture will finished and polish. Retention will be measured immediately after denture insertion.

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

lina khalaf

teaching assistant

Cairo University

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