跳至主要内容
临床试验/NCT02681250
NCT02681250Unknown不适用

A Randomized Controlled Clinical Trial of Dental Implants in Titanium-zirconium Alloy

Vastra Gotaland Region2 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2015年2月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
96
试验地点
2
主要终点
Change in bone loss measured on X-ray (mm)

研究概览

简要总结

A Randomized controlled Clinical trial which aim is to investigate the clinical outcome of dental implants in titanium-zirconium alloy compared to traditional titan-4 implants. The hypothesis is set to no difference in the clinical outcome for the two types of implants. Preliminary estimation of 96 patients needed. A pilot study will provide us with further data in order to more accurately specify the sample number."

详细描述

Background

Implants have been used for the purpose of replacing lost teeth since the 1960s. Since then, the treatment of edentulism with dental implants has been implemented in a large scale. The main reason for this is that research has shown that treatment with implants are very predictable in terms of implant survival. The accumulated knowledge, as seen from 15 and 20 year follow-ups, has been based on prerequisites that are not always followed today. One of them is that the implants used in the aforementioned studies are manufactured in titanium that has good rigidity and is used as the main implant material today. In addition, the studies have examined implants with a turned surface. This standard revised in the mid 1990s when a series of studies showed increased and accelerated osseous ingrowth of implants with a moderate raw surface that had been achieved by blasting. The related biological events describing this process have been described in detail in the literature.

Today, other materials are being explored as an alternative to the well documented implant material titanium with a focus on finding a material with higher stiffness combined with equivalent biological characteristics. A stiffer material theoretically gives possibilities for implants installations without bone augmentation in cases with reduced bone volumes.

An alternative implant material which has reached the clinic is titanium-zirconium alloy. It has been shown to have an increased rigidity in comparison with titanium and comparable biological characteristics but the documentation consists mainly of animal studies and short term clinical follow-up in the form of case-series. Since it has been demonstrated that the choice of implant material may influence osseointegration, it is necessary to evaluate the implants made of titanium-zirconium in a clinical controlled study with long-term follow-up in which the emphasis is put on the clinical outcome.

Aims

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
Single (Participant)

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients in need for implant treatment

排除标准

  • 未提供

结局指标

主要结局

Change in bone loss measured on X-ray (mm)

时间窗: Baseline and 1 year

次要结局

  • Change in amount of Clinical Mucosa (mm)(Baseline and 1 year)
  • Change in bleeding on probing (Yes/No)(Baseline and 1 year)
  • Change in Pocket depth (mm)(Baseline and 1 year)
  • Change in Prosthetic Complications (Yes/No)(Baseline and 1 year)

研究者

发起方
Vastra Gotaland Region
申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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