跳至主要内容
临床试验/CTRI/2024/04/066366
CTRI/2024/04/066366尚未招募4 期

Comparative Assessment of Volumetric Airway Changes in Unilateral Cleft Lip and Palate patients in Mixed Dentition treated for Maxillary Expansion using Aligners and Ni-Ti palatal expander: A 3-D CBCT Study

Dr. Riddhi Bansal1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2024年5月28日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
24
试验地点
1
主要终点
To compare the volumetric airway changes after maxillary expansion using aligners and Ni-Ti palatal expander in unilateral cleft lip and palate patients in mixed dentition palate patients in mixed dentition

研究概览

简要总结

One of the most prevalent congenital abnormalities of the craniofacial region, cleft lip and palate(CLP) accounts for about 15% of all congenital deformities globally. The accompanying facial traits of children with CLP include a retrognathic maxilla and midface hypoplasia, which leads to diminished upper airway dimensions that do not improve even with surgical treatment. In children, the primary cause of respiratory problems is the obstruction of upper airway which is relieved by Rapid Maxillary Expansion (RME) which is also frequently employed to address the transverse deficiency. However, comparative studies show that Slow Maxillary Expansion(SME) provide more controlled anterior expansion than RME and is also equally effective in increasing pharyngeal airway volume in growing patients. Both Ni-Ti palatal expander and Aligners effectively causes SME, but aligners provide an added advantage to improve the alignment of dentition simultaneously with expansion. In this study, we will be doing a comparative assessment of volumetric airway changes in cleft lip and palate patients when treated with aligners and Ni-Ti palatal expander.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
7.00 Year(s) 至 11.00 Year(s)(—)
性别
All

入选标准

  • Complete unilateral cleft lip and palate Both sexes Age group from 7 years to 11 years.

排除标准

  • Syndromic cleft lip and palate patients Individuals with systemic diseases affecting bone density Erupted permanent canines Bilateral cleft lip and palate patients.

结局指标

主要结局

To compare the volumetric airway changes after maxillary expansion using aligners and Ni-Ti palatal expander in unilateral cleft lip and palate patients in mixed dentition palate patients in mixed dentition

时间窗: T0- Before expansion | T1- After expansion

次要结局

  • To evaluate changes in questionnaire based assessment of OSA risk in UCLP patients treated with expansion appliances(T0- Before expansion)

研究者

发起方
Dr. Riddhi Bansal
申办方类型
Other [self-funded]
责任方
Principal Investigator
主要研究者

Dr Riddhi Bansal

Manav Rachna Dental College

研究点 (1)

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