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临床试验/NCT04997083
NCT04997083Unknown不适用

Evaluation of the Treatment Outcome of Cleft Palate Patients Treated With Differential Opening Expander With Slow Protocol and Face Mask

Faculty of Dental Medicine for Girls2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2021年7月15日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
10
试验地点
2
主要终点
Changes in 3 dimensions of skull before and after expansion

研究概览

简要总结

Evaluate the treatment outcome of slow maxillary expansion protocol on patients with cleft lip and palate, using a differential opening expander and face mask which will be measured and recorded by cone beam computed tomography (CBCT).

详细描述

Cleft lip and palate are among the most common deformities in children. Cleft patients are usually having orofacial problems as missing or unerupted permanent teeth, alveolar bone defect, speech difficulty. Patients with cleft lip and palate (CLP) commonly have maxillary arch constriction (maxillary hypoplasia) and Class III malocclusions due to deficient of maxillary growth. The upper jaw of patients with cleft palate will be expanded using maxillary Expander with Differential Opening (EDO) which has two screws; one anterior and one posterior. This will be done with slow expansion protocol, which is one 1/4 turn three times weekly. Petit facemask will be used to protract the retracted maxilla. The differences in measurements between before and after treatment will be assessed by cone beam computed tomography (CBCT).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • All patient age ranges from 8 to 12 years.
  • Patients of both sexes.
  • Cleft lip and palate patients.
  • All the cases showed maxillary arch constriction and deficiency.
  • All patients had maxillary permanent first molars.
  • Primary lip adhesion and palatal closure.

排除标准

  • Patients had received any surgical assisted rapid maxillary expansion or maxillary protraction of fixed orthodontics before.
  • Maxillary dentition unsuitable to bond the expander (less than two dental units beside permanent first molar).
  • Absent maxillary permanent first molars.
  • Uncooperative patients/parents.

结局指标

主要结局

Changes in 3 dimensions of skull before and after expansion

时间窗: Six months

Full skull Cone Beam Computerized Tomography

次要结局

未报告次要终点

研究者

发起方
Faculty of Dental Medicine for Girls
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Amira Helmy Abdulsattar Eldawy

Principal Investigator

Faculty of Dental Medicine for Girls

研究点 (2)

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