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临床试验/NCT06726005
NCT06726005招募中不适用

Impact of Functional Appliances on 3D Craniodentofacial Characteristics and Reported Sleep Related Breathing Disorders in Children

University of Rijeka2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年4月8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
20
试验地点
2
主要终点
Facial scan

研究概览

简要总结

Facial scans of the patients eligible for the functional appliance treatment (Twin Block appliance) will be taken prior to and after the end of treatment. Also, a facial scan of the predicted final outcome will be taken, and compared to the actual final outcome. Parents / caregivers will fill out the Pediatric Sleep Questionnaire (PSQ) prior to and upon the end of treatment to asses perceived influence on sleep related breathing problems in their children.

详细描述

The harmonious growth of the upper and lower jaw enables further favorable development of the orofacial region and the functions of breathing, chewing, swallowing and speaking, as well as the general growth and development of the child. Translation into Croatian and administration of the questionnaire for early detection of sleep disorders related to breathing in children (PSQ) will enable triage and early recognition of children with sleep disorders, which also affect general psycho-physical development. The impact of functional appliance therapy (FA) on changes in craniodentofacial characteristics, dimensions of the upper airway and sleep problems in children will be determined. The non-invasive three-dimensional representation of the face surface provides information about the surface and volume of the observed object, which is used for better diagnostics and therapy planning. Class II is a frequent malocclusion, characterized by a discrepancy of sagittal interjaw relationships. The diagnostic method, which helps in deciding on a therapeutic approach, is the so-called Fränkel maneuver (FM). By comparing the observation of the soft tissue profile of the subjects at rest and after the application of FM, a decision is made on the therapeutic approach. Previous research indicates the validity of using FM in making a decision about FN therapy, with high reliability and consistency. The analysis of latero-lateral (LL) X-ray cephalograms in numerous studies has provided a series of data, which is used, among other things, to assess the remaining growth in order to apply FN therapy in a timely manner, but also to expect a desirable response. The evaluation of the success of therapy based on FM don't exist, because a reliable 2D analysis through LL cephalogram would require additional radiation of the subjects. Research indicates that the analysis of scan surfaces is more appropriate than the analysis of anatomical points for detection of the area and amount of changes.

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
10 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • retrognathic mandible, increased overjet

排除标准

  • craniodentofacial deformities

结局指标

主要结局

Facial scan

时间窗: from enrollment and predicted outcome to the end of treatment at one year on average

Using stereophotographic camera, 3D facial scans will be taken, and superimposed to observe differences prior to and at the end of treatment. Also, predicted outcome (facial scan taken in Fraenkel manouver position (at start)) will be compared to the actual outcome after one year of treatment with functional appliance Twin Block.

PSQ questionnaire

时间窗: from enrollment to the end of treatment at one year on average

Parents / caregivers will fill out the PSQ questionnaire to assess influence of the functional appliance treatment on the sleep related breathing problems in their children.

次要结局

  • Latero-lateral cephalogram(from enrollment to the end of treatment at one year on average)

研究者

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

Visnja Katic

Associate Professor

University of Rijeka

研究点 (2)

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