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临床试验/NCT01816425
NCT01816425Unknown不适用

Comparison Between Cobalt-chromium Partial Dentures and Thermoplastic Partial Dentures: Random Clinical Trial

University of Sao Paulo2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2012年2月最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
试验地点
2
主要终点
Comparison between thermoplastic partial denture and CoCr partial dentures

研究概览

简要总结

The cobalt-chromium (CoCr) partial denture has been made for a long period. It respects biomechanical principles, providing harmony between mechanical and biological activities. The fundamental principles of biomechanics applied in the manufacture of steel structure are: retention, reciprocity, attachment and stability. To get the proper planning, we need to assess the dental support system, with its qualitative and quantitative values. But conventional dentures has a inherent problem which is the metallic elements apparent and in some cases the stiffness of the component support elements that generates stress.

The Thermoplastic partial dentures increase aesthetics in replacement of metal structures in oral rehabilitation. So many treatments are being done in everyday practice without a defined concept on various aspects of its construction and oral applicability.

This trial aims to assess the basic parameters of both dentures in: nutrition, speech therapy, chewing force, chewing efficiency and quality of life.

60 years old or older patients who require removable prosthesis. These will be randomly selected for the fabrication and installation of removable partial dentures (Gold Standard - control group - CoCr partial denture) and thermoplastic partial denture(experimental group).

Before beginning the work, selected patients will make some preliminary tests such as controlling the individual condition, they are:

  • three questionnaires:
  • instrument for assessing quality of life related to oral health, GOHAI - General Oral Health Assessment Index of Atchinson & Dolan
  • instrument for assessing the social and economic profile of ABEP (Brazilian Association of Research Companies) CCEB 2011;
  • Instrument for assessing cognitive condition MINI-MENTAL;
  • Speech evaluation
  • Nutritional assessment;
  • Evaluation of masticatory efficiency and
  • Chewing strength. After preliminary assessments patients will be subjected to treatments for manufacture of partial dentures. After the installation (end of the technical construction of the dentures) and the adjustments appointment the tests will be repeated and in successive control periods of 3 months, 6 months, 12 months, 18 months and 24 months respectively, when the tests will do again now to see if there was a change in the initial condition.

研究设计

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

入排标准

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

入选标准

  • 60 years old or older patient with partial edentulous jaws with indication of removable partial denture

排除标准

  • patient younger than 60 years patient with edentulous mouth

结局指标

主要结局

Comparison between thermoplastic partial denture and CoCr partial dentures

时间窗: 24 months

the tests result of the thermoplastic partial denture will be compared with the tests result of the CoCr partial dentures, the hypothesis is that thermoplastic partial denture are similar to CoCr partial dentures

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

Érico Castaldin Fraga Moreira

Master of Science

University of Sao Paulo

研究点 (2)

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