The Effect of a Newly Designed Presurgical Orthopedic Appliance on Maxillary Arch Dimensions in Infants With Bilateral Cleft Lip and Palate: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Arch dimension (experimental group and control group)
研究概览
简要总结
A randomized clinical trial to compare the effectiveness of newly designed active type of presurgical orthopedic appliances on maxillary arch dimensions in infants with bilateral cleft lip and palate.
详细描述
It is a multicenter randomized clinical trial with two parallel arms. The patients will be randomly divided into two groups, group one: a passive orthopedic appliance will be used, and group two a new designed active orthopedic appliance will be used. Impressions will be taken before starting the treatment (T1) and at the end of treatment (T2) three months later. The effectiveness of the two appliances will be assessed and measured on digital models of the maxillary arch before and after the treatment.
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
- 5 Days 至 2 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy new born infants with complete bilateral cleft lip, alveolus and palate.
- •Non-syndromic.
- •Non-operated cases.
排除标准
- •Infants with systemic syndromes. 2.Facial deformities.
结局指标
主要结局
Arch dimension (experimental group and control group)
时间窗: T1 before starting any treatment and T2 After treatment before surgical repair (average 3 months)
Evaluation of the efficiency of a newly designed presurgical infant orthopedic for bilateral cleft lip and palate patients by measuring the maxillary arch dimension at the beginning and end of treatment in both experimental and control group.
次要结局
- Parents Perception and experience(T1 before starting any treatment and T2 After treatment before surgical repair (average 3 months))
- Linear measurement (experimental group and control group)(T1 before starting any treatment and T2 After treatment before surgical repair (average 3 months))
- Angular measurement (experimental group and control group)(T1 before starting any treatment and T2 After treatment before surgical repair (average 3 months))
- Vertical measurement (experimental group and control group)(T1 before starting any treatment and T2 After treatment before surgical repair (average 3 months))
研究者
Mushriq F. Abid
Professor
University of Baghdad