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临床试验/NCT04221243
NCT04221243Unknown不适用

Evaluation Of Innovative 3D Printed Space Maintainer Versus Conventional One

Farah Ahmed Barakat2 个研究点 分布在 1 个国家目标入组 30 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
发起方
入组人数
30
试验地点
2
主要终点
introduce a new 3D printed design of an intraoral space maintainer.

研究概览

简要总结

The primary aim of this study is to introduce a new effective and efficient 3D printed design of an intra-oral space maintainer.

The secondary aim of the study is to:

Evaluate the clinical performance of 3D printed space maintainer versus conventional metal band and loop over a period of 6 months regarding their functional , biological aspects and patient satisfaction.

详细描述

And will be conducted as follows:

  • In-Vivo evaluation of the clinical performance of 3D printed space maintainer versus metal band and loop concerning oral hygiene, retention and patient satisfaction.
  • A total of thirty healthy subjects will be selected from the Pediatric Dentistry and Dental Public Health outpatient clinic, Faculty of Dentistry, Ain Shams University. They will be divided using simple randomization in two groups:

Group 1: Children with 3D printed space maintainer (n=15) Group 2: Children with conventional band and loop(n=15)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
6 Years 至 9 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Aged 6-9years' old
  • Premature loss of primary molar or molars in one or more quadrant.
  • Absence of abnormal dental conditions such as cross bite.
  • Sound and healthy buccal and lingual surfaces of abutment teeth.

排除标准

  • Bad oral hygiene
  • Medically Compromised patients.
  • Presence of periapical pathology radiographically.
  • Carious buccal and lingual surfaces of abutment teeth.

结局指标

主要结局

introduce a new 3D printed design of an intraoral space maintainer.

时间窗: 6 months

The function of the new intraoral space maintainer will be assessed whether good retention is obtained or not,by checking whether it fell off the patient's mouth or not .

次要结局

  • compare between the new 3D printed space maintainer versus conventional metal band and loop regarding their biological aspects.(6 months)
  • compare between the new 3D printed space maintainer versus conventional metal band and loop regarding their patient satisfaction.(6 months)

研究者

发起方
Farah Ahmed Barakat
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Farah Ahmed Barakat

Teaching Assistant in British University in Egypt

British University In Egypt

研究点 (2)

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