跳至主要内容
临床试验/NCT05296291
NCT05296291招募中不适用

RCT Study of Posterior Implant Supported Bridges Made of Various Prosthetic Materials

Branemarkkliniken2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
2
主要终点
Complication rate

研究概览

简要总结

In recent years, zirconia-based implant-supported bridge designs have begun to be used more and more as an alternative to metal ceramic bridges. Another new material that has been introduced in the clinic is the high translucent monolithic zirconia, which has only been investigated a few follow-up studies with short follow up duration.

The aim being to evaluate the clinical outcome of implant-anchored posterior bridges, made from

  1. high-translucent monolithic zirconia,
  2. zirconia ceramic with porcelain and
  3. metal ceramics. The hypothesis is that high-translucent monolithic zirconia has lower rate of complications since surface porcelain veneering is not required.

A total of 60 research subjects will be included in the study. Patients in need of a permanent implant-supported bridge, located posterior of the canine in the upper or lower jaw will be asked for participation. Each subject will be treated according to standard treatment protocols with implants from Nobel Biocare, the Branemark implant system and then be randomly assigned to obtain one of the following three type of bridges.

20 research subjects will be included in each of the three study arms. The prosthetic treatment will be carried out according to standard clinic protocol.

All research subjects will be evaluated after 1, 3, 5 years. X-rays and photos will be taken at the installation of the bridges and after 1 and 5 years of follow-up or more frequent, depending on individual indication of the patient and the associated standard clinical care protocol.

Personal data, implant survival, marginal bone loss and biological and technical complications related to the implants will be recorded. Survival of the bridge, technical and biological complication related to the bridge will also be recorded

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

入选标准

  • edentulous behind the canine in the maxilla or mandible
  • older than 18 years

排除标准

  • younger than 18 years
  • active periodontitis

结局指标

主要结局

Complication rate

时间窗: From placement of prosthetic Bridge until last follow-up of the study after 5 years

次要结局

未报告次要终点

研究者

发起方
Branemarkkliniken
申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验