跳至主要内容
临床试验/NCT04970095
NCT04970095Unknown不适用

Evaluation of Alt-RAMEC by EDO With Facemask in Patients With Cleft Lip and Palate (UCLP) Using Cone Beam Computed Tomography (CBCT)

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
change in 3D dimension of skull after and before expansion

研究概览

简要总结

Evaluate the treatment outcome of Alternate Rapid Maxillary Expansion and Constriction Alt-RAMEC 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.Clefts patient 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 by Maxillary Expander with Differential Opening (EDO) with alternate rapid maxillary expansion and constriction (Alt-RAMEC) , which is opened by opening the expansion device by 1 mm per day for a week, then closing the device at a rate of 1 mm per day in the second week and so on alternately for 7 consecutive weeks after the completion of the expansion, the facemask device will be used to protraction of maxilla the measurement and difference before and after treatment will be assessment 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

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

排除标准

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

结局指标

主要结局

change in 3D dimension of skull after and before expansion

时间窗: six month

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

sarah salah khalil Abdelaal

Principal Investigator

Faculty of Dental Medicine for Girls

研究点 (2)

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