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临床试验/NCT06851897
NCT06851897招募中不适用

Comparison of Perforated 3D Printed Metal Fixed Mandibular Retainer Versus Conventional Fixed Bonded Retainer A Randomized Clinical Trial

Mariam Alaa1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2025年2月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
64
试验地点
1
主要终点
Bond Failure

研究概览

简要总结

Although different materials of mandibular fixed retainer were discussed in the literature, there is contradicting evidence regarding the bond failure of Titanium fixed metal retainer, whether immediate or after 12 months. Moreover, insufficient evidence is present regarding 3D metal printed fixed mandibular retainers.

详细描述

In recent years a new possibility is available for dental practitioners: CAD-CAM technology and 3D printing, which find their application in all aspects of orthodontics. Orthodontists are already familiar with several products that use 3D printers (i.e. invisible aligners), also known as additive manufacturing, 3D printing is a technology whereby sequential layers of material are layered on top of one another to form an object23. Two recent articles reported the fabrication of a custom lingual retainer cut from a nickel-titanium block with CAD/CAM technology and a CAD/CAM Zirconium bar as a bonded mandibular fixed retainer.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
15 Years 至 35 Years(Child, Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Patients with properly finished orthodontic treatment.
  • •No sex predilection.
  • •The presence of 4 permanent mandibular incisors and 2 permanent mandibular canines.
  • •No active caries, restorations, fractures, or periodontal disease of previously mentioned teeth
  • •Patients with good oral hygiene.

排除标准

  • •Patients with no need of fixed mandibular retention.
  • •Enamel hypoplasia or hypocalcification of mandibular anterior teeth.
  • •Abnormal morphology of mandibular anterior teeth
  • •Periodontal disease that contraindicates fixed orthodontic retention.
  • •No or poor patient's compliance & bad oral hygiene.
  • •Psychological problems.

研究组 & 干预措施

Conventional fixed retainer

Active Comparator

multistrand or braided metal wire

干预措施: conventional fixed retainer (Other)

Perforated 3D printed metal fixed retainer

Experimental

3D printed wire custom made to each patient after intraoral scanning

干预措施: perforated 3D printed metal fixed retainer (Other)

结局指标

主要结局

Bond Failure

时间窗: immediate up to 12 months

Counting number of teeth debonded immediately after placement of wire up to 12 months

次要结局

未报告次要终点

研究者

发起方
Mariam Alaa
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mariam Alaa

Assistant Lecturer

Cairo University

研究点 (1)

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