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临床试验/NCT01188226
NCT01188226终止不适用

Evaluation of Wear Characteristics of Nano-Hybrid Denture Teeth

University of California, Los Angeles2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2010年8月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
10
试验地点
2
主要终点
Location of Posterior Denture Tooth Wear

研究概览

简要总结

The majority of teeth utilized in the fabrication of conventional complete dentures are made of acrylic resins. These acrylic teeth provide increased bond strength to the denture base and are much easier to adjust for correct denture occlusion compared to teeth made of harder materials, such as porcelain. However, the acrylic teeth will wear faster than the porcelain teeth, leading to alterations in how the teeth contact each other if the denture is not replaced periodically (typically every 5-8 years). With the increase in biting and chewing forces that can be achieved during function with dentures supported by dental implants, the rate of tooth wear may be increased, leading to more frequent need for replacement of the prosthesis. Acrylic teeth made of nano hybrid composite material (NHC) potentially offer greater wear resistance and aesthetic characteristics. The NHC teeth employ a wide range of fillers, including highly cross-linked organic macrofillers, high-density inorganic microfillers and silanized silica based nanofillers. The macrofillers are, to a large part, responsible for the adequate strength and color-stability of the teeth, whereas the microfillers improve the wear resistance. The nanofillers offer fundamentally different optical behaviour from those of larger fillers, improving light reflection without lowering the translucency. This offers additional opportunities in the development of composite teeth, which have to exhibit lifelike aesthetics and translucency. These teeth made of nano-particles and hybrid composites can be made with two different techniques, one where the materials are pressed together and another using an injection technique. The injection method has been found to have better aesthetic results, but resistance to wear in clinical use has not been established.

The purpose of this study is to evaluate the wear characteristics of new resin denture teeth (nano particles - hybrid composite) made by an injection technique. Twenty-four edentulous subjects will be enrolled who have completed implant placement for mandibular implant overdentures opposing a maxillary complete denture or implant overdenture, or patients that have previously received these dentures and are interested in having new dentures. Both maxillary and mandibular dentures will be fabricated using injection molded nano-hybrid composite denture teeth. The wear of denture teeth will be evaluated using stereophotographic recordings at baseline, 6, 12, 18 and 24 months after denture treatment.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Being treated at UCLA School of Dentistry clinics with implant-assisted mandibular overdentures and conventional maxillary complete dentures or implant overdentures
  • Previously treated at UCLA School of Dentistry clinics with implant-assisted mandibular overdentures and conventional maxillary complete dentures or implant overdentures and desires new dentures
  • Have healthy, normal soft and hard oral tissues

排除标准

  • Oral and medical conditions which would interfere with follow-up evaluations over a two-year period after denture treatment completion
  • Abnormal oral soft or hard tissues that prevents conventional denture fabrication
  • Impaired dexterity the prevents proper oral hygiene
  • Allergy to denture base materials
  • Severe parafunction based on current condition of existing dentures
  • Any limitation in mouth opening or closing
  • Severe TMD symptoms
  • Employees (and their immediate families) of the UCLA School of Dentistry

结局指标

主要结局

Location of Posterior Denture Tooth Wear

时间窗: 24 months after denture completion

Clinical evaluation of posterior wear location (right, left, equal)

次要结局

  • Denture Teeth Esthetics(24 months after denture completion)
  • Amount of Denture Teeth Plaque(24 months after denture completion)
  • Denture Teeth Calculus(24 months after denture completion)

研究者

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

Neal Garrett

Principal Investigator

University of California, Los Angeles

研究点 (2)

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