Effectiveness of Two Methods of Lip Taping as a Presurgical Orthopedic in Infants With Bilateral Cleft Lip and Palate: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Assessment of maxillary arch dimension change
研究概览
简要总结
A randomized clinical trial to compare the effectiveness of two methods of lip taping as a 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 with conventional steri strip, and group two will receive a passive orthopedic appliance with a custom-made tape consist of steri strip and orthodontic elastic. Impressions will be taken before starting the treatment (T1) and at the end of treatment (T2) three months later. The effectiveness of the two methods of taping 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
- 1 Day 至 1 Month（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Non-Syndromic infants with complete bilateral cleft lip and palate.
- •Both sexes.
- •Age range from 1-30 day
排除标准
- •Infants with systemic syndromes.
- •infants with unilateral cleft
- •infants whom parents refuse to consent.
结局指标
主要结局
Assessment of maxillary arch dimension change
时间窗: T1 before starting any treatment and T2 After treatment before surgical repair (average 3 months)]
To evaluate the effect of the lip taping as a presurgical orthopedic on the maxillary arch dimensions for infants with bilateral cleft using two different types of medical taping.
次要结局
- Assessment of Angular measurement change(T1 before starting any treatment and T2 After treatment before surgical repair (average 3 months)])
- Assessment of Parents Perception and experience(T1 before starting any treatment and T2 After treatment before surgical repair (average 3 months)])
- Assessment of Linear measurement change(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