Skeletal, Dental and Upper Airway Changes in Skeletal Class II Division 1 Patients With the Constricted Maxilla (8-14 Years Old) Treated With Twin Block and Hyrax, Evaluated Through Pressure Drop Experimental Analysis.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Airflow
研究概览
简要总结
Breathing is a crucial function for everyone. Breathing impairment in children could lead to behavioral and cognitive problems at least. But what if orthodontic treatment could help those patients to breathe better, with less effort? This research proposal aims to find out if the increase in the upper airway volume seen in some research results can be related to a decrease in respiratory effort and an improvement in the breathing capacity of those patients. In other words, if a tube shape is changed or if a tube is enlarged, would the airflow passing inside the tube change in velocity? Or would there be more air? Therefore, investigating the pressure/airflow, volume/lumen relation and its possible changes after mandibular repositioning and maxillary expansion in children will lead to a better understanding of how orthodontics could potentially affect the upper airway. Previous studies have reported a link between mandibular advancement appliances and maxillary appliances to an increase in the upper airway volume. However, more studies are needed to evaluate the relationship between the changes in the upper airway volume and actual airflow and respiratory capability. The airway volume measurement is important to, preliminary, state if there is an increase in the upper airway after orthodontic treatment.
However a change in shape, even with the same volume, can affect the pressure and airflow. In this sense, the pressure drop analysis will allow an answer to those questions
详细描述
Our hypotheses are:
- There is an increase in upper airway volume and minimal cross-sectional area after maxillary expansion and mandible repositioning in class II malocclusion children using Hyrax and Twin-block.
- There is a larger increase in the airway dimensions and a larger decrease in the air resistance (in the pressure drop analysis) in the group started with the mandibular advancement device.
- There is a change in the shape of the upper airway after maxillary expansion and mandible repositioning in class II malocclusion children using Hyrax and Twin-block.
- There is a correlation between the increase in airway volume, the change in shape and an increase in airflow using in vitro simulated airway experiments.
- There is an increase in respiratory capability when evaluated with in-home portable PSG (after maxillary expansion and mandible repositioning).
- There is a positive correlation to the in-home portable Polysomnography (PSG) with the results acquired by volume, shape, airflow and pressure drop.
Methods
The inclusion criteria are children between the ages 8-14 years old (8-12 years old girls and 9-14 years old boys), presenting skeletal class II division 1 malocclusion with maxillary constriction. The study design is a randomized crossover controlled trial. 90 patients will be randomly allocated into three groups:
Group 1: 30 patients will immediately undergo to Hyrax/Twin-block treatment, the patients will have the maxillary expansion treatment (Part I) before the mandibular repositioning (Part II).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
When data will be analyzed, data will be coded to keep confidentiality for time and type of treatment.
入排标准
- 年龄范围
- 8 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •children between the ages 8-14 years old (8-12 years old girls and 9-14 years old boys), presenting skeletal class II division 1 malocclusion with maxillary constriction
排除标准
- •syndromic patients, previous ortho history, non-compliance, severe oral health issues (cavities, poor oral hygiene)
研究组 & 干预措施
Twin Block then Hyrax
Patients will undergo mandibular advancement prior to maxillary expansion using Twin block prior to Hyrax
干预措施: Twin block then Hyrax (Other)
Hyrax then Twin block
Patients will undergo maxillary expansion prior to mandibular advancement using Hyrax prior to Twin block
干预措施: Hyrax then Twin block (Other)
Control
Patients will wait 1,5 years before the start of treatment
结局指标
主要结局
Airflow
时间窗: 3 years
Airflow of the upper airway using pressure drop experimental analyzed using the CBCTs scans to print out the models of the upper airway.
次要结局
- Skeletal changes(3 years)
- Dental changes(3 years)