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临床试验/NCT06047925
NCT06047925已完成不适用

3D-printed Crowns Versus Prefabricated Stainless-Steel Crowns for Intermediate Restoration of Compromised First Permanent Molars (Randomized Controlled Clinical Trial)

Ain Shams University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年6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
40
试验地点
2
主要终点
The clinical performance of 3d printed crowns versus prefabricated SSCs in compromised first permanent molars

研究概览

简要总结

The study will evaluate the clinical performance and both patient and parent satisfaction of 3d printed crowns versus prefabricated Stainless-steel crowns (SSCs) in compromised first permanent molars

详细描述

A total of Forty permanent first mandibular molars in healthy subjects will be selected from the Pediatric Dentistry and Dental Public Health outpatient clinic.

The molars will be randomly assigned equally into two treatment groups group A 3D-printed crowns & group B prefabricated SSCs, removal of caries with a high-speed handpiece then removal of the remaining carious lesion with excavator then glass ionomer restoration will be placed, preparation of SSCs crowns will be done in Group A by reduction of occlusal surface by about 1.5 mm, Proximally, tooth reduction is made through the mesial and distal contact areas, then roundation of line angles. Proper size of crown will be selected. It can also be helpful to measure the dimension of the contralateral tooth. A correctly fitting crown should snap or click at try in. In group B reduction will be performed on the occlusal surface using a flame stone or a wheel stone, to perform occlusal clearance. Reduction will be performed on the mesial, distal, buccal, and lingual surfaces of the tooth Then roundation of the line angles will be performed. Impression for the preparation will be taken using putty and light poly vinyl siloxane material. The preparation will be optically scanned in the lab and the restoration will be digitally designed using computer designing software. The crown will be printed using 3D printer using hybrid resin material. Crown will be checked for proper fit and cemented to the tooth by self-etch adhesive.

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 (Investigator, Outcomes Assessor)

盲法说明

Double (Investigator-outcome Assessor)

入排标准

年龄范围
10 Years 至 13 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children included in the study should conform to the following criteria:
  • Badly broken-down endodontically treated first permanent molar
  • First permanent molar with extensive multi-surface caries.
  • First permanent molar with structural developmental defects such as hypoplasia, Molar-Incisor Hypomineralization (MIH), Amelogenesis Imperfecta, and Dentinogenesis Imperfecta

排除标准

  • Children who are uncooperative needing sedation or general anesthesia.
  • Children who are physically or mentally disabled or having any medical condition that will complicate the treatment.
  • Molars of poor prognosis

研究组 & 干预措施

group A

Experimental

First permanant molar will be prepared to receive 3D printed crown

干预措施: 3D printed crown (Procedure)

group B

Active Comparator

First permanant molar will be prepared to receive SSC

干预措施: stanless steel crown (Procedure)

结局指标

主要结局

The clinical performance of 3d printed crowns versus prefabricated SSCs in compromised first permanent molars

时间窗: 3,6,12 and 18 months

Evaluation of clinical performance of both crowns regarding gingival health (gingival \& plaque index) and Fracture, retention, marginal discoloration and surface texture according to the modified United states Public Health Service (USPHS) criteria. 3,6-12 and 18 months.

次要结局

  • Patient and parent satisfaction.(Immediately ,3,6,12&18 months)

研究者

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

Dina Bassam Mohamed Ahmed

Asisstant lecturer

Ain Shams University

研究点 (2)

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