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.
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
- 否
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
排除标准
- •syndromic cleft lip.
- •Secondary lip treatment (previously operated cases)
- •Bilateral cleft lip
- •Patients are older than six months. Associated Cardiac anomalies. Any systemic condition
研究组 & 干预措施
study arm
20 patients with a unilateral cleft lip will be repaired with orbicularis oris muscle Z-plasty modification of modified Millard technique
干预措施: orbicularis oris muscle Z- plasty modification of modified millard technique (Procedure)
controlled arm
20 patients with a unilateral cleft lip will be repaired with modified Millard technique
干预措施: modified millard technique (Procedure)
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
Shaimaa Mohsen
lecturer,oral surgery
Fayoum University