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临床试验/NCT03004300
NCT03004300Unknown不适用

Maxillary Expansion Effects in the Facial Structures of Children With Upper Airway Obstruction: a Randomized Clinical Trial

Universidade Federal de Goias2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年7月13日最近更新:
适应症
干预措施

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

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

Active Comparator

Patients with atresic maxilla without upper airway obstruction submitted to rapid maxillary expansion

干预措施: Rapid maxillary expansion (Procedure)

group 2

Experimental

Patients with atresic maxilla and adenotonsillar hypertrophy submitted to rapid maxillary expansion before adenotonsillectomy

干预措施: Rapid maxillary expansion (Procedure)

group 2

Experimental

Patients with atresic maxilla and adenotonsillar hypertrophy submitted to rapid maxillary expansion before adenotonsillectomy

干预措施: Adenotonsillectomy (Procedure)

group 3

Experimental

Patients with atresic maxilla and adenotonsillar hypertrophy submitted to rapid maxillary expansion after adenotonsillectomy

干预措施: Rapid maxillary expansion (Procedure)

group 3

Experimental

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

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

José Valladares Neto

PHD Professor

Universidade Federal de Goias

研究点 (2)

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