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临床试验/CTRI/2025/04/084366
CTRI/2025/04/084366尚未招募3 期

Comparison of soft tissue nasal changes in unilateral cleft lip and palate with non-cleft lip and palate infants using 3-dimensional imaging

Abhishek Desai1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2025年4月20日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
24
试验地点
1
主要终点
Improvement in nasal shape following Primary Cheilorhinoplasty

研究概览

简要总结

Cleft lip and palate(CLP) is one of the most common congenital birth defects of the craniofacialregion. Unilateral cleft lipand palate infants (UCLP) have a distinct phenotype resulting in variousdegrees of nasolabial asymmetry due to structural deformity from nasolabialanomaly, asymmetrical vermillion border, deviation of nasal septum and a deficientmaxilla. Judgementof nasolabial aesthetics in cleft lip and palate (CLP) is a vital component ofassessment of treatment outcome. Nasoalveolar Moulding is one of the techniques used as a part of Pre surgical Infant Orthopedics, but it is not considered gold standard yet. In infants with cleft lip and palate, the primary lip closure surgery takes place around 3-6 months of age. The purpose of this study is to assess the shape and symmetry of the nose using 3D camera before and after the primary lip surgery in infants who have not undergone any treatment for the cleft lip and palate before the surgery. By evaluating the effectiveness of this approach, this study aims to contribute insights that could inform future strategies, ultimately formulating a treatment plan for patients with Cleft lip and palate right from the birth of these infants till adulthood.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
1.00 Day(s) 至 1.00 Month(s)(—)
性别
All

入选标准

  • Infants with Unilateral cleft lip and palate presenting for the first time to the department of Orthodontics and Dentofacial Orthopedics at KLE VK Institute of Dental Sciences, Belagavi
  • Infants with birth weight less than 2kg
  • Infants whose parents give written informed consent.

排除标准

  • Infants with Bilateral Cleft lip and palate
  • Infants over the age of 4 weeks when they first report to the department of Orthodontics
  • Infants with systemic diseases or syndromes.

结局指标

主要结局

Improvement in nasal shape following Primary Cheilorhinoplasty

时间窗: Baseline, at 6 months of age 1-2 days before surgery and 1-2 days after surgery

次要结局

  • Improvement in nasal symmetry following Primary Cheilorhinoplasty(Baseline, at 6 months of age 1-2 days before surgery and 1-2 days after surgery)

研究者

发起方
Abhishek Desai
申办方类型
Other [Self funded]

研究点 (1)

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