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临床试验/NCT04331977
NCT04331977已完成不适用

Effectiveness of Two Rapid Maxillary Expanders (Quadhelix vs Hyrax) in Improving the Transverse Skeletal and Dental Dimensions in Patients With Cleft Lip and Palate: A Randomized Clinical Trial

Cairo University2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2020年7月2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
24
试验地点
2
主要终点
Maxillary Expansion

研究概览

简要总结

This randomized controlled trial is designed to compare between quadlelix appliance vs hyrax expander regrading the their effectiveness in maxillary expansion in patients with cleft.

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 (Outcomes Assessor)

入排标准

年龄范围
6 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Mixed dentition stage;
  • Both males and females;
  • Lip repair performed between 3 and 6 months of age and palate repair performed between 12 and 24 months of age;
  • Presence of maxillary constriction and posterior crossbite and need for maxillary expansion previous to the secondary bone graft;
  • Permanent first maxillary molars present;
  • Good periodontal health;
  • No previous orthodontic treatment; and

排除标准

  • Presence of a syndrome in companion with the present cleft defect.
  • Previous secondary alveolar bone grafting.
  • Taking medications affecting growth.

结局指标

主要结局

Maxillary Expansion

时间窗: 6 months

Amount of Maxillary Expansion to be measured as distances (mm) on CBCTs and dental models.

次要结局

未报告次要终点

研究者

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

Mohamed Abd El-Ghafour

Lecturer of Orthodontics

Cairo University

研究点 (2)

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