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临床试验/NCT03685513
NCT03685513Unknown不适用

One Year Clinical Evaluation of Milled BioHPP Polyetheretherketone (PEEK)-Based Versus Metal Ceramic Single Crowns

Cairo University0 个研究点目标入组 46 人开始时间: 2019年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
46
主要终点
Fracture

研究概览

简要总结

Although the metal-ceramic system is still widely used to fabricate crowns and fixed partial dentures and is considered as the standard treatment in dentistry, aesthetic concerns have stimulated the development of new dental tooth-colored systems as PEEK.

BioHPP PEEK is 20% ceramic reinforced, semicrystalline, thermoplastic and radiolucent polymer for extreme durability especially for frameworks for fixed and removable dental prostheses. It has many advantages as low density, light weight, shock absorber, biocompatible and venerable with composite resin.

The aim of this study is to evaluate the clinical performance of milled BioHPP PEEK-based single crowns and compare them to metal-based single crowns.

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
Double (Participant, Outcomes Assessor)

盲法说明

Double blind

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • From 18-50 years old, be able to read and sign the informed consent document.
  • Have no active periodontal or pulpal diseases, have teeth with good restorations
  • Psychologically and physically able to withstand conventional dental procedures
  • Patients with teeth problems indicated for single posterior crowns:
  • Badly decayed teeth
  • Teeth restored with large filling restorations
  • Endodontically treated teeth
  • Malformed teeth
  • Malposed teeth (Tilted, over-erupted, rotated, etc.)
  • Spacing between posterior teeth
  • Able to return for follow-up examinations and evaluation

排除标准

  • Patient less than 18 or more than 50 years
  • Patient with active resistant periodontal diseases
  • Patients with poor oral hygiene and uncooperative patients
  • Pregnant women
  • Patients in the growth stage with partially erupted teeth
  • Psychiatric problems or unrealistic expectations
  • Lack of opposing dentition in the area of interest

结局指标

主要结局

Fracture

时间窗: 1 year

Measured using modified USPHS criteria

次要结局

  • Marginal adaptation(1 year)

研究者

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

Abdelrahman Soliman Elsayed Badran

Resident, Fixed Prosthodontics Department, Faculty of Dentistry

Cairo University

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