跳至主要内容
临床试验/NCT06792513
NCT06792513已完成不适用

The Effectiveness of Acrylic and Clear Aligners in the Treatment of Anterior Crossbite in Children and Evaluatıon of the Effects of These Treatments on Quality of Life

Ozge Gungor2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年6月10日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
2
主要终点
Changes in Cephalometric Measurements Before and After Treatment Assessed Using Dolphin Imaging Software (Version 11.95)

研究概览

简要总结

To evaluate the treatment efficacy, treatment duration, and cephalometric changes, as well as the impact on quality of life, of clear aligners and labiolingual spring Hawley appliances in the treatment of pediatric patients with anterior crossbite.

详细描述

Two groups were treated with clear aligners and labiolingual springs Hawley and the study consisted of 30 patients, 15 patients in each group. Cast analysis and cephalometric analysis were performed at pretreatment and posttreatment. Quality of life was assessed at the end of treatment for both groups.

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
Single (Participant)

入排标准

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

入选标准

  • In the mixed dentition phase, aged between 7-12 years
  • With a dental Class I molar relationship according to Angle's classification
  • ANB within the normal range i.e. (the crossbite will be diagnosed as dental)
  • Exhibiting anterior crossbite (AC) in at least one permanent incisor in the sagittal plane
  • No prior orthodontic treatment for any reason
  • No history of maxillofacial trauma
  • No systemic diseases or syndromes that may interfere with treatment
  • Able to attend regular appointments and cooperate with instructions throughout the treatment process

排除标准

  • Patients with functional anterior crossbite associated with mandibular functional shift
  • Patients with clinically evident retrognathia or prognathia of the maxilla or mandible
  • Patients with severe gingivitis or periodontitis
  • Patients with known allergies to the materials to be used in the treatment
  • Patients with severe dental anomalies (e.g., supernumerary teeth, missing teeth, dental malformations)
  • Patients with serious emotional or psychological issues that may hinder treatment compliance

结局指标

主要结局

Changes in Cephalometric Measurements Before and After Treatment Assessed Using Dolphin Imaging Software (Version 11.95)

时间窗: 3 months

Comparison of cephalometric measurements (e.g., ANB, FMA, U1-NA angle, overjet, and overbite) between the two groups at pre-treatment and post-treatment periods. Measurements will be performed using Dolphin Imaging Software version 11.95, with units reported in degrees and millimeters as applicable.

Changes in Oral Health-Related Quality of Life Assessed Using the Child Oral Health Impact Profile-Short Form 19 (COHIP-SF-19)

时间窗: 3 months

COHIP-SF-19 scores will be assessed at the end of the treatment period to evaluate changes in oral health-related quality of life. The scale ranges from 0 to 76, with higher scores indicating worse oral health-related quality of life.

次要结局

  • Changes in Analogue Cast Model Measurements Before and After Treatment(3 months)
  • 3D model measurements(3 months)

研究者

发起方
Ozge Gungor
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ozge Gungor

PhD, DDS, Clinical Associate Professor of Pedodontics

Akdeniz University

研究点 (2)

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