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临床试验/NCT06994754
NCT06994754招募中不适用

Evaluation of Maxillary Expansion Using Clear Aligners' Therapy in Patients With Cleft Lip and Palate at the Mixed Dentition Stage: A Pilot Study

Cairo University1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2025年4月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
10
试验地点
1
主要终点
Transverse dento-skeletal changes

研究概览

简要总结

The goal of this clinical trial is to learn if the aligners can expand upper dental arch in patients with cleft lip and palate at age of 6-8 years old to correct their collapsid archs. The main questions it aims to answer are:

Does aligners can achieve transverse dento-skeletal changes? Does aligners can achieve anteroposterior and vertical dento-skeletal changes?

Participants will:

Wear sequence of aligners (each for 10 days). Visit the clinic every month for checkups. 3D x-ray and intraoral scan will be taken after completion of the aligners set to evaluate the intervention.

详细描述

Cleft lip and palate (CLP) is the most prevalent among all craniofacial anomalies, affecting one in every 700 births and disturbing the quality of life of more than 7 million people around the world.

Cleft lip and palate are defined as malformations characterized by the non-union of the upper lip and/or palate, either separately or in conjunction with another syndrome. Its etiology is rather complex and definitely multifactorial, where complex interplay between genetic and environmental factors play a significant role in the incidence and cause of cleft.

Cleft lips can be unilateral or bilateral, and may involve the alveolus or palate. Unilateral cleft lip shows a 2:1 left predominance.

Lip and palate surgical repairs are performed in the first months and years of life respectively. As a consequence, the growth and development of the maxillary segments are compromised by scar tissues, presenting a significant maxillary transverse deficiency with medially collapsed cleft segments accompanied with anterior crossbite or both anterior and posterior crossbites. Most CLP patients present a narrower anterior than posterior maxillary arch frequently showing a crossbite in both canine and premolar areas and a normal occlusal transverse molar relationship.

Maxillary expansion is usually performed before the secondary alveolar bone grafting procedure. Expansion improves the maxillary arch morphology and causes the segmental alignment creating appropriate conditions for bone grafting surgery as well as correcting the posterior crossbites.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
6 Years 至 12 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Mixed dentition.
  • •Both males and females.
  • •Bilateral cleft lip and palate.
  • •Lip repair performed between 3 and 6 months of age and palate repair performed between 12and 24 months of age.
  • •Presence of maxillary constriction that needs maxillary expansion.
  • •Good periodontal health.
  • •No previous orthodontic treatment.

排除标准

  • •Syndromic cleft lip and palate patients.
  • •Taking medications that influence growth.

研究组 & 干预措施

Bilateral cleft lip and palate patients

Experimental

干预措施: clear aligners (Device)

结局指标

主要结局

Transverse dento-skeletal changes

时间窗: six months

Using pre and post treatment cone beam computed tomography (CBCT), 3D point identification and landmark development will be done. On the CBCT, skeletal transvers maxillary width, anterior, middle and posterior cleft width, intermolar, inter premolar and inter-canine widths will be measured.

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

mahmoud abdelsalam

Master degree candidate at Orthodontic Department

Cairo University

研究点 (1)

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