跳至主要内容
临床试验/NCT04627389
NCT04627389Enrolling By Invitation不适用

Esthetic Outcomes Evaluation of Unilateral Cleft Lip Repaired by Orbicularis Oris Z-plasty Modification of Modified Millard Technique Versus Modified Millard Technique. A Randomized Clinical Trail.

Fayoum University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
40
试验地点
1
主要终点
lip legth

研究概览

简要总结

This study aimed to evaluate the effect of orbicularis oris muscle z-plasty modification of modified Millard technique on the esthetic outcome and length of the repaired lip

详细描述

forty patients with a unilateral cleft lip will be enrolled in this randomized comparative study. The patients will be divided into two groups, the control (group A) who treated with the modified Millard technique and the study group who repaired by orbicularis oris muscle Zplasty modification of modified Millard technique (group B).

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
3 Months 至 6 Months(Child)
性别
All
接受健康志愿者

入选标准

  • non-syndromic cleft lip patients.
  • Primary, unilateral, complete or incomplete cleft lip.
  • The patient's age is younger than six months.
  • lip repair performed by one craniofacial surgeon
  • Exclusion Criteria
  • syndromic cleft lip.
  • Secondary lip treatment (previously operated cases)
  • Bilateral cleft lip
  • Patients are older than six months. Associated Cardiac anomalies. Any systemic condition

排除标准

  • 未提供

结局指标

主要结局

lip legth

时间窗: immediate postoperative

evaluate the lip length of the cleft side changes from preoperative at immediate postoperative

次要结局

  • Philtral ridge length symmetry index assessment(6months)
  • Scar width assessment by photograph(6months)
  • scar width by ultrasound(6months)
  • scar elascitity(6months)

研究者

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

Shaimaa Mohsen

lecturer,oral surgery

Fayoum University

研究点 (1)

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