跳至主要内容
临床试验/NCT07465939
NCT07465939进行中(未招募)不适用

Dento-skeletal Effects of Quadhelix Versus Mini-hyrax Expanders in Patients With Cleft Lip and Palate at the Mixed Dentition Stage: A Randomized Clinical Trial

Cairo University1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2025年5月29日最近更新:
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
24
试验地点
1
主要终点
Anterior transverse dento-skeletal effects measured by linear distance tool between deciduous upper canines on CBCT and digital models (axial view)

研究概览

简要总结

Regarding expansion in cleft lip and palate patients, very few clinical trials were found after searching literature and fewer randomized trials. This means that no enough evidence in literature is tackling expansion in cleft lip and palate patients.

To the best of our knowledge, this study will represent the first RCT to compare the dentoskeletal effects of mini-hyrax vs quadhelix. Since cleft cases usually need greater anterior than posterior expansion, both appliances are capable of anterior expansion. Nevertheless, no other study compared how much anterior expansion could be accomplished by either appliance.

详细描述

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. An important treatment objective in cleft cases is to achieve greater anterior than posterior maxillary expansion since there is a greater anterior than posterior maxillary constriction in most of those patients. Variable appliances have been used for maxillary arch expansion in cleft patients.

  • Hyrax expanders exert parallel forces to the alveolar bones and the maxillary complex, generating similar amounts of anterior as well as posterior expansion and might be indicated for patients with overall maxillary transverse deficiency. While with patients of greater anterior constriction, Hyrax expander must be frequently interrupted before the full correction of the anterior transverse deficiency in order to avoid the occurrence of a posterior buccal crossbite.
  • Fan-shape expanders and mini-hyrax (supported on the first premolars and associated to a transpalatal arch cemented to the first molars) enhanced expansion in the maxillary anterior region and restricted posterior expansion.
  • Mini-hyrax (supported on the first permanent molars) can expand anteriorly as well as posteriorly and was found comparable to hyrax.

I this study we are comparing the dentoskeletal effects of quadhelix versus mini-hyrax utilizing CBCT and digital models performed before and after expansion.

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
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

入选标准

  • Mixed dentition.
  • Both males and females.
  • Unilateral cleft lip and palate
  • Presence of maxillary constriction that needs maxillary expansion prior to secondary alveolar bone grafting.
  • Erupted first permanent maxillary molars.
  • Good periodontal health.
  • No previous orthodontic treatment

排除标准

  • Syndromic cleft lip and palate patients.
  • Previous secondary alveolar bone grafting.
  • Taking medications that influence growth.
  • Absence of teeth to support the expansion appliance

研究组 & 干预措施

Quadhelix Group

Experimental

CLP pts with quadhelix expander

干预措施: Quadhelix Expander (Device)

Minihyrax Group

Active Comparator

CLP pts with minihyrax expander

干预措施: Minihyrax Expander (Device)

结局指标

主要结局

Anterior transverse dento-skeletal effects measured by linear distance tool between deciduous upper canines on CBCT and digital models (axial view)

时间窗: 6 months

Digital models and CBCTs are used to compare dentoskeletal effects before and after expansion

次要结局

  • Maxillary and mandibular anteroposterior measurements measured by linear distance tool and angle measurement tool on CBCT and digital models (sagittal view)(6 months)
  • Vertical skeletal measurements measured by angle measurement tool (y-axis angle - SnMp) on CBCT (sagittal view)(6 months)
  • Dentoskeletal Effects measured by angle measurement tool on CBCT (Coronal view)(6 months)

研究者

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

Mahmoud Sherif

Demonstrator of orthodontics at faculty of dentistry

Cairo University

研究点 (1)

Loading locations...

相似试验