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临床试验/NCT05121584
NCT05121584Unknown不适用

Evaluation of Two Different Types of Zirconia Crowns Used in Carious Primary Anterior Teeth

Arig Samir Abdelmonem Shawky1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2020年11月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
25
试验地点
1
主要终点
Crown retention

研究概览

简要总结

Evaluation of two different types of zirconia crowns ( Kinder Krown , Nusmile crown) used in carious primary anterior teeth

详细描述

Assess the clinical and radiographic evaluation of Kinder Krowns and Nusmile crowns in restoring carious primary canines And compare between the two crowns used

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
7 Years 至 10 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Children age ranging from 7 to 10 years
  • •Deep carious primary upper canines
  • •The tooth need pulpal treatment
  • •The tooth need a crown restoration
  • •The tooth not submerged
  • •The tooth is not mobile

排除标准

  • •Children with bruxism or deep bite
  • •Children with especial need
  • •Presence of pathological root resorption in preoperative x-ray
  • •Presence of tooth wear (abrasion/attrition) on the opposing teeth

研究组 & 干预措施

Kinder Krown

Experimental

Anterior primary teeth which restored by a Kinder Krown zirconia crown as a final restoration

干预措施: Placement of an anterior crown restoration as a final restoration (Procedure)

NuSmile

Active Comparator

Anterior primary teeth which restored by a NuSmile zirconia crown as a final restoration

干预措施: Placement of an anterior crown restoration as a final restoration (Procedure)

结局指标

主要结局

Crown retention

时间窗: 12 months

Change in the following clinical assessment measure between baseline and 12 months using the scale below A=Intact B=Chipped/small but noticeable areas of loss of material C=Large loss of material D=Complete loss of crown

Opposing tooth wear

时间窗: 12 months

Binary (Yes/No)

Gingival health

时间窗: 12 months

Change in the following clinical assessment measure between baseline and 12 months using the scale below A=No inflammation B=Mild inflammation C=Moderate inflammation D=Marked inflammation

Immediate color match

时间窗: 12 months

A=No noticeable difference from adjacent teeth B=Slight shade mismatch C=Obvious shade mismatch

Gingival index (Loe and Silness)

时间窗: 12 months

Change in the following clinical assessment measure between baseline and 12 months using the scale below 0=Normal gingiva(natural colour pink gingiva no inflammation) 1=Mild inflammation(slight changes in colour,slight edema,no bleeding on probing) 2=Moderate inflammation(redness, edema and glazing, bleeding upon probing 3=Severe inflammation(marked redness and edema/ulceration/tendency to bleed spontaneously

Crown margins

时间窗: 12 months

Change in the following clinical assessment measure between baseline and 12 months using the scale below A=Continuous with the contour of the crown, nice adaptation B=Slight overhang or under contour present C=Large defects noted D=Restoration missing

Child/parent satisfaction

时间窗: 12 months

Binary(Yes/No)

Pathological external/internal root resorption

时间窗: 12 months

Binary(Present/Absent)

Periapical radiolucency

时间窗: 12 months

Binary(Present/Absent)

次要结局

未报告次要终点

研究者

发起方
Arig Samir Abdelmonem Shawky
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Arig Samir Abdelmonem Shawky

B.D.S

Tanta University

研究点 (1)

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