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临床试验/NCT06522217
NCT06522217已完成不适用

Prosthetic Rehabilitation of Lip and Palate Deformaties in Neonates Using Two Different Approaches

Tanta University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2018年2月19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
20
试验地点
1
主要终点
extraoral measurements

研究概览

简要总结

This study was conducted to compare the use of conventional nasoalveolar molding appliances and the use of digitally designed and produced nasoalveolar molding appliances in rehabilitating neonates born with unilateral complete cleft lip and palate.

详细描述

For this prospective study, twenty newborns with non-syndromic complete unilateral cleft lip and palate were referred from the Outpatient Clinics of several pediatric surgeons and obstetricians to the Department of Prosthodontics -Faculty of Dentistry - Tanta University.

Inclusion criteria:

  • Age range from 2-3 weeks after birth.
  • Only the Non-syndromic unilateral cleft lip and palate neonates.
  • Newborn infants without any surgical intervention.

Exclusion criteria:

  • Patients with the life threatening syndromes.
  • Respiratory difficulties are not considered for presurgical treatment.
  • Uncooperative guardians.

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
Double (Participant, Care Provider)

盲法说明

starting 2 conventional then 2 CAD NAM patients

入排标准

年龄范围
2 Weeks 至 4 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Age range from 2-3 weeks after birth.
  • Only the Non-syndromic unilateral cleft lip and palate neonates.
  • Newborn infants without any surgical intervention.

排除标准

  • Patients with the life threatening syndromes.
  • Respiratory difficulties are not considered for presurgical treatment.
  • Uncooperative guardians.

结局指标

主要结局

extraoral measurements

时间窗: 3-4 months

* Nostril height in (mm) * Nasal dome height in (mm) * Columella height in( mm) * Nostril basal width in (mm) * Nostril width in (mm)

intraoral measurements

时间窗: 3 -4 months

measuring 2 points the first is the intersegmental distance in (mm) and the second is the alveolar width in (mm)

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

Rehab Mohamed Abdallah

lecturer of removable and maxillofacial prosthodontics

Tanta University

研究点 (1)

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