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临床试验/NCT06510881
NCT06510881招募中不适用

Single Stage Versus Multiple Staged Repair of Nasal & Alveolar Deformities in Patients With Cleft Lip and Palate

Assiut University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年7月20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
40
试验地点
2
主要终点
Evaluation of SCHNOS criteria in both groups for evaluation of both cosmetic and functional improvement . The patients will be assessed on the scale and compared between the obtained pre and post operative results after 6 months of surgery .

研究概览

简要总结

Cleft lip and palate patients are commonly seen among maxillofacial patients. Patients with cleft lip and palate have evident cosmetic nasal deformities. The interrupted insertion of orbicularis oris muscle into the columella on the noncleft side forces the premaxilla, columella and caudal nasal septum towards that side. At the same time, as the orbicularis oris inserts into the alar base on the cleft side, the base is pulled laterally, inferiorly and posteriorly. The malformed lower lateral cartilage on the side of the cleft contributes majorly to the deformity of the nasal tip, causing it to be more blunt. A shorter medial crus and longer lateral crus on the cleft side results in a horizontally wider and displaced nostril on the cleft side. In addition, those patients have alveolar bone defect which results in both cosmetic and dental problems. Repair of the deformed nose along with the reconstruction of the alveolar defect may have an advantage over the staged repair in:- decrease the surgical burden on the patient , correction of the facial asymmetry by redeeming the maxillary bony support , peri-alar augmentation and accordingly obtaining faster and better socio-cosmetic benefit .

详细描述

Patients are assigned randomly into two groups; group (1) for combined rhinoplasty and alveolar repair , and group (2) for alveolar repair alone and a planned rhinoplasty in an upcoming session .

Pre-operative evaluation:

History taking:

Personal history; name, age, gender and occupation . Patient's complaint(s); as dental problems related to cleft alveolus and both cosmetic and obstructive problems related to nasal deformities .

Clinical examination :

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
5 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with unilateral cleft lip and palate deformities with evident nasal and cleft lip and palate aged between 5 - 18 years.

排除标准

  • * Patients with bilateral complete cleft palate .
  • Patients with only cleft lip.
  • Patients with cleft secondary palate.
  • Patients non fit for surgery.
  • Patients refuse the consent.

结局指标

主要结局

Evaluation of SCHNOS criteria in both groups for evaluation of both cosmetic and functional improvement . The patients will be assessed on the scale and compared between the obtained pre and post operative results after 6 months of surgery .

时间窗: 6 months after surgery

1. Having a blocked or obstructed nose 2. Getting air through my nose during exercise 3. Having a congested nose 4. Breathing through my nose during sleep 5. Decreased mood and self-esteem due to my nose 6. The shape of my nasal tip 7. The straightness of my nose 8. The shape of my nose from the side 9. How well my nose suits my face 10. The overall symmetry of my nose

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

Youssef Saleh

Assistant Lecturer

Assiut University

研究点 (2)

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