跳至主要内容
临床试验/NCT04543292
NCT04543292已完成不适用

Clinical Evaluation of Polytetrafluoroethylene (PTFE, MATFILL) for the Sealing of Prosthetic Chimneys.

Fundación Eduardo Anitua2 个研究点 分布在 1 个国家目标入组 4 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
已完成
发起方
入组人数
4
试验地点
2
主要终点
Integrity of screw head

研究概览

简要总结

Dental implant supported screwed prosthetic rehabilitations are associated to several advantages, as a minimal occlusal spaced and easier hygiene and maintenance. In this sense, screwed rehabilitations have been associated with lower frequency of biological and technical complications. Nevertheless, the screwing process results in the formation of a prosthetic chimney that requieres an appropriate sealing protocol. This protocol needs to include a material for the protection of the screw head. Nowadays, there is a lack of materials for this intended use with marketing authorisation. Several materials have been tested in the bibliography including PTFE, although there are not high quality studies. In this context, this clinical investigation aims to evaluate the efficacy and safety os a PTFE-based product (MAFILL) for the sealing of prosthetic chimneys and the protection of the screw head.

研究设计

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

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age > 18 years old
  • Clinical need for the placement of a implant-supported dental prosthesis
  • Clinical need for the filling of the prosthetic chimney
  • Signing informed consent

排除标准

  • Inability of follow-up

结局指标

主要结局

Integrity of screw head

时间窗: 6 weeks

Integrity of the screw head observed in photographs

次要结局

  • Occurrence of prosthetic complications(6 weeks)
  • Occurrence of biological complications(6 weeks)

研究者

发起方
Fundación Eduardo Anitua
申办方类型
Other
责任方
Sponsor

研究点 (2)

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