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临床试验/NCT03354715
NCT03354715Unknown不适用

Patient Satisfaction and Retention of Upper Complete Denture Base Using Rapid Prototyping Versus a Conventional One: Randomized Control Trial

Cairo University2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2017年4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
16
试验地点
2
主要终点
Patient Satisfaction

研究概览

简要总结

Comparing patient satisfaction and retention of upper complete denture fabricated using two different denture base materials, the first fabricated using rapid prototyping method while the second is following conventional methods.

详细描述

Searching for other materials or other fabrication technologies has been one of the goals to help to re-innovate the fabrication of complete dentures , which would greatly influence completely edentulous Patient satisfaction. The introduction of rapid prototyping (RP)Stereo lithography (SLA) technology has many advantage as high accuracy, high mechanical strength, smooth surface finish with close tolerance and fine details printing, but it has some limitation as it is only limited Material, in addition to the high material and equipment cost.

SLA has been used in dental fields like maxillofacial prosthesis , wax pattern fabrication for crown bridge , removable partial denture 19, but still complete denture was reported in a very few reports indicating that RP is not yet successfully applied in Complete denture manufacturing 19-21A randomised trial is therefore needed to asses accurately wether the introduction of rapid prototyping in complete denture fabrication is successful or not in comparison to the conventional technique and to discover the possible challenges in this recent technique and the ways to overcome it.

Retention of complete dentures and patient satisfaction has been reported in many studies22-26. Patients have showed a higher satisfaction, as retention of both maxillary and mandibular complete dentures increased.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (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.
  • Patients who can understand and respond to a written questionnaire in Arabic.
  • Cooperative patients

排除标准

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

研究组 & 干预措施

Rapid prototyping Denture base

Sham Comparator

Complete Denture Using Rapid Prototyping method for fabrication of the complete denture depending on

干预措施: Rapid prototyping Denture base (Device)

Heat Cured Conventional Complete Denture

Sham Comparator

Complete Denture using heat cured Denture base using flasking and deflasking method

干预措施: Heat Cured Conventional Complete Denture (Device)

结局指标

主要结局

Patient Satisfaction

时间窗: 3 month

Patient Satisfaction Questionnaire using likert scale five points represent degree of satisfaction and compare the result to each other

次要结局

  • Retention(3 month)

研究者

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

Omar Mahmoud Youssef

Master Student

Cairo University

研究点 (2)

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