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临床试验/NCT02931968
NCT02931968已完成不适用

A Retrospective Clinical Study Evaluating Full-Arch Monolithic Zirconia Implant Supported Fixed Dental Prosthesis

University of North Carolina, Chapel Hill1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2017年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
22
试验地点
1
主要终点
Percent Incidence of Prosthetic Complications

研究概览

简要总结

This study is designed to recall all patients who have received a full-arch monolithic zirconia implant supported fixed dental prosthesis in the University of North Carolina (UNC) School of Dentistry Graduate Prosthodontic and/or Dental Faculty Practice clinics between January 1, 2008 to September 1, 2015. The main purpose is to evaluate the biological and technical complications associated with this form of prosthetic treatment. Additionally patient centered outcomes will be evaluated.

详细描述

Purpose: A retrospective single-center study to provide scientific data on the clinical performance of full-arch monolithic zirconia implant supported fixed dental prosthesis (MZISFDP).

Participants: Individuals with at least one edentulous dental arch (maxilla/mandible) who were treated in the UNC Graduate Prosthodontic clinic and Dental Faculty Practice between January 1, 2008 to September 1, 2015 with full-arch MZISFDP.

Procedures (methods): This study is designed as a retrospective descriptive study with a single prospective examination of a population of subjects previously restored with full-arch MZISFDPs. An estimated 60 participants will be enrolled in the study. The study includes retrospective data and radiograph collection from dental records as well as data collection from one prospective visit that includes clinical examination, a panoramic radiograph and 2 patient questionnaires.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Percent Incidence of Prosthetic Complications

时间窗: At time of study visit (anywhere from 1-8 years from prosthesis delivery)

Implant and prosthetic survivals are going to be reported by number of occurrence and will be analyzed by using descriptive tabular methods; Prosthetic screw loosening (number of complications calculated by percent), Repair of prosthesis (zirconia fracture)

次要结局

  • Percent Incidence of Biological Complications(At time of study visit (anywhere from 1-8 years from prosthesis delivery))
  • Quantitative measurement of bone level(At time of study visit (anywhere from 1-8 years from prosthesis delivery))
  • Patient self-reported OHIP-14 satisfaction scores(At time of study visit (anywhere from 1-8 years from prosthesis delivery))
  • Patient self-reported QoLFAST-10 scores(At time of study visit (anywhere from 1-8 years from prosthesis delivery))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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