NCT05837780Enrolling By Invitation不适用
Three Dimensional Evaluation of Maxillary Arch Changes After Using Two Different Construction Techniques of Nasoalveolar Molding Devices in Unilateral Cleft Lip and Palate Patients (Randomized Controlled Trial)
Minia University1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2023年1月3日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Alveolar cleft width
研究概览
简要总结
This study includes Three Dimensional Evaluation of Maxillary Arch Changes After Using Two Different Construction Techniques of Nasoalveolar Molding Devices in Unilateral Cleft Lip and Palate Patients (Randomized Controlled Trial) Null hypothesis: there is no difference between using conventionally constructed nasoalveolar molding device and using digitally constructed nasoalveolar molding device
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, Outcomes Assessor)
入排标准
- 年龄范围
- 7 Days 至 1 Month（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Good general health without any systematic disease, disability or other syndromes Non syndromatic unilateral cleft lip and palate Both genders Age less than one month Parents willing to participate in the study and sign informed consent
排除标准
- •Patients exhibiting systemic disease, disability or other syndrome, parents denying participating in the study or not given their informed consent
结局指标
主要结局
Alveolar cleft width
时间窗: 3 months
measurement of width between two alveolar segments
次要结局
未报告次要终点
研究者
Amany Alaa Abd el Aziz
assistant Lecturer of prosthodontics
Minia University
研究点 (1)
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