Maxillary Expansion Effects in the Facial Structures of Children With Upper Airway Obstruction: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Airway Volume
研究概览
简要总结
The most frequent causes of mouth breathers are the adenotonsillar hypertrophy. Adenotonsillectomy is the main choice for the elimination of the obstruction. However, this surgical treatment does not have its effect well elucidated and apnea has been cited in the literature as a residual outcome. Other types of supporting treatment may also been involved such as the use of corticosteroids, physiotherapy and orthodontic-orthopedic treatment, among them rapid maxillary expansion (RME).
RME corrects the morphological constriction of the upper arch caused by buccal breathing and also reduce the airway resistance. Despite reports of RME influencing volume enhancement in pharyngeal airway, there are still few three-dimensional studies following the post-expansion effects. In addition, these changes are doubtful due postural changes of the tongue during the tomography exam. Conflicts of results are also present for changes in the nasal septum of children. The main alteration mentioned is the increase in the length of the lower third of the septum.
The investigators propose a randomized, prospective, controlled clinical trial in patients with atresic maxilla with or without adenotonsillar hypertrophy. The patients will be treated with RME and adenotonsillectomy when the obstruction is present. The purpose of this study is elucidate if there is different outcomes considering the moment of RME treatment before or after the adenotonsillectomy.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 9 Years(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children (boys and girls) between 5 and 9 years of age.
- •Atresic maxilla.
- •Skeletal Class I
- •With or without Adenotonsillar hypertrophy
- •Parents or tutors sign Informed Consent.
排除标准
- •Craniofacial syndromes or neurologic disease diagnosis.
- •History of adenotonsillectomy and orthodontic treatment
- •History of facial trauma
- •Morbid obesity
- •Premature loss of posterior teeth
研究组 & 干预措施
group 1
Patients with atresic maxilla without upper airway obstruction submitted to rapid maxillary expansion
干预措施: Rapid maxillary expansion (Procedure)
group 2
Patients with atresic maxilla and adenotonsillar hypertrophy submitted to rapid maxillary expansion before adenotonsillectomy
干预措施: Rapid maxillary expansion (Procedure)
group 2
Patients with atresic maxilla and adenotonsillar hypertrophy submitted to rapid maxillary expansion before adenotonsillectomy
干预措施: Adenotonsillectomy (Procedure)
group 3
Patients with atresic maxilla and adenotonsillar hypertrophy submitted to rapid maxillary expansion after adenotonsillectomy
干预措施: Rapid maxillary expansion (Procedure)
group 3
Patients with atresic maxilla and adenotonsillar hypertrophy submitted to rapid maxillary expansion after adenotonsillectomy
干预措施: Adenotonsillectomy (Procedure)
结局指标
主要结局
Airway Volume
时间窗: 7 months
cone beam computed tomography
次要结局
- Quality of life before and after maxillary expansion:(1 and 7 months)
- Pediatric Quality of Life(1 and 7 months)
- Sleep Disturbance for Children(1 and 7 months)
- Nasal septum morphology(7 months)
- Dental arch distances(7 months)
- Airway obstruction(7 months)
- Bruxism(7 months)
研究者
José Valladares Neto
PHD Professor
Universidade Federal de Goias
