Parent's Satisfaction and Evaluation of Postsurgical Outcomes in Unilateral Cleft Lip / Palate Newly Born Infants With / Without Vacuum Formed Nasoalveolar Molding Aligners : A Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 14
- 主要终点
- Parents' satisfaction
研究概览
简要总结
Newborns with unilateral cleft lip/ palate will be treated pre-surgically by Vacuum formed aligners in order to evaluate its effect on Nasoalveolar complex.
详细描述
newborns with unilateral cleft lip/ palate will be allocated into two groups: treatment group will receive Vacuum formed aligners while control group will not receive Vacuum formed aligners.
the follow-up period will be 3 months till surgical lip closure. the assessment will be through a questionnaire for the parents' satisfaction outcome, standardized photographs for measurement of nasal changes and interlabial gap outcome and digital maxillary models for the maxillary dimension change outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 Week 至 3 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Non-syndromic Infants with complete unilateral cleft lip and palate
- •Infants less than 3 months of age
- •Males and females.
- •Infants with displaced alveolus
- •Patients whose parents provided written consent for the study.
排除标准
- •Patients above 3 months of age
- •Syndromic, malnourished and systemically ill infants.
- •Patients with bilateral cleft lip and palate.
- •Incomplete Cleft lip.
- •Medically compromised patients
- •Patient's/guardians who will be unwilling to go through the PNAM therapy
结局指标
主要结局
Parents' satisfaction
时间窗: 3 months
It will be measured by questionnaire
次要结局
- Changes in Nasal morphology( Height, width, angulation of columella(3 months)
- Changes in Interlabial gab(3 months)
- Changes in Maxillary arch dimension(3 months)
研究者
Khadega Ali Al Khateeb
Master student, faculty of oral and dental medicine, Cairo university
Cairo University