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临床试验/NCT04479046
NCT04479046已完成不适用

Evaluating the Efficiency of Newly Designed Prefabricated PMMA Crowns for Restoring Primary Teeth in Comparison to Stainless Steel and Zirconia Crowns

Ain Shams University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2018年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Crown survival

研究概览

简要总结

Evaluation of PMMA pediatric crowns

详细描述

The aim of the present study is to evaluate the PMMA crowns regarding the following aspects:

I. Clinical evaluation of PMMA crowns regarding wear of opposing teeth when compared to zirconia crowns and stainless steel crowns after 6 months, and 12 months.

II. Color stability of PMMA crowns and zirconia crowns after 6 months, and 12 months.

III. Gingival health of restored teeth after 6 months, and 12 months. IV. Patient's satisfaction regarding the appearance and clinical performance of PMMA crowns when compared to stainless steel crowns and zirconia crowns through a given questionnaire.

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
5 Years 至 8 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Children included in the study should conform to the following criteria:
  • •Aged 5-8 years old
  • •Medically free
  • •Patient should suffer from extensively decayed primary lower second molar that will undergo pulpotomy.
  • •The anticipated exfoliation date of the selected primary teeth has to be more than 12 months from the date of the study start.

排除标准

  • •Children with the following criteria will be totally excluded from the study:
  • •Children who are extremely uncooperative and difficult to manage.
  • •Children suffering from any medical conditions that can't be managed in the clinic.
  • •Teeth with decay extending beneath the free gingival margin.
  • •Teeth that were grossly broken down, that cannot be restored.
  • •Presence of uncontrolled bleeding.
  • •Clinical or radiographic evidence of non-vitality such as presence of an abscess or a sinus, obvious discoloration, and premature hypermobility.

研究组 & 干预措施

Stainless steel crowns

Active Comparator

3M ESPE

干预措施: PMMA crowns (Other)

Zirconia crowns

Experimental

Nu Smile

干预措施: PMMA crowns (Other)

PMMA crowns

Experimental

Dental Direkt

干预措施: PMMA crowns (Other)

结局指标

主要结局

Crown survival

时间窗: 6 months

Fracture

Gingival health

时间窗: 6 months

Plaque index

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

Nada Aboushady

Assistant Lecturer

Ain Shams University

研究点 (1)

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