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临床试验/NCT06856330
NCT06856330招募中不适用

Efficacy of Two Flap Palatoplasty (TFP) Versus Furlow With Buccinator Flap (FPBF) During Primary Palatoplasty on the Speech Development

Fayoum University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年3月25日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
1
主要终点
nasopharyngoscopic examination

研究概览

简要总结

About 20 patient will be collected according to the eligibility criteria and grouped into Group I : 10 patients were treated with furlow with buccinators flap Group II : 10 patients were treated with 2 flap palatoplasty All patients will be examined by an expert Phoniatrician by Recording of speech samples in Arabic language for the children in a soundproof room including repeated syllables, sentences with high-pressure sounds and counting from 1 to 10. The records will be analyzed to assess the degree of hypernasality, speech intelligibility and compensatory speech errors

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
3 Years 至 5 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •3-5 years old childreen with previous treated complete cleft lip and palate, nonsyndromic.
  • •lip and palate repair performed by one craniofacial surgeon

排除标准

  • •Patients with syndromic cleft lip.
  • •Redu cases
  • •Bilateral cleft lip
  • •Patient older 5years or younger 3 years.
  • •Associated Cardiac anomalies.
  • •Any systemic condition

结局指标

主要结局

nasopharyngoscopic examination

时间窗: through study completion, an average one week

this will be done through the nasopharyngoscopic examination of the cleft patients after repair with Furlow with buccinator flap versus two flap palatoplasty. it will assess the grade of velopharyngeal closure during speech

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shaimaa Mohsen

associate professor of oral and maxillofacial surgery

Fayoum University

研究点 (1)

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