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临床试验/NCT06456879
NCT06456879已完成不适用

Clinical Performance and Convenience of Three Types of Crowns as Esthetic Alternatives to Stainless Steel Crowns for Primary Molars

Mansoura University4 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年2月5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
80
试验地点
4
主要终点
the gingival index

研究概览

简要总结

This study will be conducted to assess the clinical performance and convenience of three types of crowns as esthetic alternatives to stainless steel crown for primary molars:

  • The prefabricated commercially available zirconia crowns (NuSmile®) (NZC).
  • The locally manufactured zirconia crowns created via Computer-Aided Design/Computer-Aided Manufacturing (CAD/CAM) system (CCZC).
  • The locally manufactured hybrid ceramic crowns created via Computer-Aided Design/Computer-Aided Manufacturing (CAD/CAM) system (CCHC).

详细描述

Eighty lower second primary molars will be divided into 4 groups:

  • Group 1(n=20): receive 3M™ ESPE™ Stainless Steel crowns for Primary Molars.
  • Group 2 (n=20): receive the prefabricated commercially available zirconia crowns (NuSmile®) (NZC).
  • Group 3 (n=20): receive the locally manufactured zirconia crowns created via (CAD/CAM) system (CCZC).
  • Group 4 (n=20): receive the locally manufactured hybrid ceramic crowns created via (CAD/CAM) system (CCHC).

Clinical and radiographic examination of the primary molar will be conducted to ensure compliance with the study criteria. Oral health instructions will be given to the child and parents then the application of local anesthesia.

  1. Stainless steel crowns:

Reduction of occlusal surface by about 1.5 mm using a flame shaped diamond bur to produce a uniform occlusal reduction. Proximal reduction using a long and tapered diamond bur to allow the probe to pass through the contact area. An appropriate size will be selected according to mesiodistal width of the prepared tooth and a trial fit will be carried out before cementation. The crown should remain no more than 1 mm subgingivally.(21) 2. Zirconia and hybrid ceramic 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
Single (Investigator)

入排标准

年龄范围
4 Years 至 8 Years(Child)
性别
Female
接受健康志愿者

入选标准

  • Children between 4-8 years old.
  • Definitely positive or positive behavior according to Frankl behavior rating scale.
  • The lower second primary molar with one or more indications for crown restoration.

排除标准

  • The child does not have occlusal problems or periodontal diseases
  • The child does not take medications that lead to symptoms of periodontal diseases.

结局指标

主要结局

the gingival index

时间窗: 12 months

0 = normal gingiva 1. = mild inflammation 2. = moderate inflammation 3. = severe inflammation

Crown retention

时间窗: 12 months

0 = present. 1 = absent.

Crown integrity

时间窗: 12 months

0 = intact. 1. = crack present. 2. = fracture present. 3. = crown lost.

Plaque Index

时间窗: 12 months

0 = no plaque 1= film at the gingival margin and adjacent tooth 2 = moderate accumulation of plaque 3 = abundance of plaque.

Color stability

时间窗: 12 months

0 = Unchanged. 1. = Minor deviation from original. 2. = Unacceptable discoloration.

次要结局

  • wear of opposing natural teeth.(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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