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临床试验/NCT05049694
NCT05049694已完成不适用

Clinical and Radiographic Performance of Preformed Zirconia Crowns and Stainless-Steel Crowns in Permanent First Molars: 18-Month Results of a Prospective, Randomized Trial

Hacettepe University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Number of zirconia and stainless steel crowns that showed successful retention over two years

研究概览

简要总结

The purpose of this study is to evaluate and compare the clinical and radiographic performance of zirconia and stainless steel crowns on permanent molar

详细描述

Zirconia and stainless steel crowns will be placed on at least two permanent molars, in a split mouth design. 100 patients will be included in the study. The teeth will be randomized into two groups according to the crown type.

Group 1: Zirconia crown 2: Stainless steel crown. Plaque index, gingival index, crown retention, presence of restoration failure, gingival margin extension and pulpal health of the teeth will be clinically evaluated at baseline and 1., 6., 12., 18., 24. months. The restorations will be evaluated radiographically at 6., 12. and 18. months. Intra-oral photos will be taken directly after treatment and at control appointments.

The data will be analysed statistically using Fisher's Exact Test and pearson's chi-square test; and Log-rank and the Kaplan-Meier will be used to estimate survival percentages.

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
6 Years 至 13 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients and parent of the patients who accept to participate and sign the informed consent
  • Patients who have at least two permanent molars with caries that require crown restoration
  • Patients that have good cooperation to the procedure

排除标准

  • Patients and parent of the patients who don't accept to participate and sign the informed consent
  • Teeth that doesn't have opposing permanent molars
  • Patients who have bruxism or deep-bite
  • Patient who are allergic to nickel

结局指标

主要结局

Number of zirconia and stainless steel crowns that showed successful retention over two years

时间窗: 2 years

Long-term clinical success of zirconia and stainless steel crowns placed on permanent molars

次要结局

未报告次要终点

研究者

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

Zafer Cavit Cehreli, DDS, PhD

Prof.Dr.

Hacettepe University

研究点 (2)

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