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临床试验/NCT04975672
NCT04975672Unknown不适用

Efficacy of Myofunctional Therapy in Class II Patients With Functional Orthopedic Appliances. ECA

Fundación Universitaria CIEO0 个研究点目标入组 60 人开始时间: 2022年12月22日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
60
主要终点
41 / 5000 Resultados de traducción Efficacy of therapy / mandibular advancement

研究概览

简要总结

Randomized clinical trial , with a sample of 60 children with atypical swallowing, class II and with SN1 orthopedic appliances these patients were randomly divided into, group 1: 30 patients with SN1 orthopedic appliances and myofunctional therapy and group 2: 30 patients with SN1 orthopedic appliances and without myofunctional therapy.

详细描述

Randomized clinical trial with two parallel arms, on a sample of 60 children with atypical swallowing, class II and with SN1 orthopedic appliances, these patients were randomly divided into, group 1: 30 patients with SN1 orthopedic appliances and myofunctional therapy and group 2: 30 patients with SN1 orthopedic appliances and without myofunctional therapy for the study. Both groups carried out the evaluation of the protocol that included: 1) evaluation of the dental occlusion class and skeletal classification 2) swallowing function test using the Payne technique; 3) Mioscaner analysis to measure perioral forces, i.e. tongue extension force, lip pressure, masseter contraction force.

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)

盲法说明

The operator responsible for making measurements of tongue position, mandibular advancement, orofacial muscle contraction, chin muscle activity, will be blinded to the assignment. A previous training will be carried out with an instruction manual for the clinical evaluation process

入排标准

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

入选标准

  • the inclusion criteria the participants will be between
  • 8 and 10 years old
  • mixed dentition
  • canine class II diagnosis and 2 to 4 mm
  • molar according to Angle and overjet between 4 to 6 mm

排除标准

  • Patients with systemic involvement
  • congenital malformations
  • facial deformities
  • Open bite
  • oral breathing
  • finger sucking habit will be excluded

结局指标

主要结局

41 / 5000 Resultados de traducción Efficacy of therapy / mandibular advancement

时间窗: 9 months

It induces changes in the position of the mandibular bone towards a more advanced position

Therapy Efficacy / Tongue Position

时间窗: 9 months

Lingual projection force

Muscle contraction

时间窗: 9 months

Physiological process in which the muscles develop tension and are shortened or stretched by a stimulus

Contraction of the masseter muscles and muscle activity of the chin

时间窗: 9 months

101 / 5000 Resultados de traducción Physiological process in which the muscles develop tension and are shortened or stretched by a stimulus

次要结局

未报告次要终点

研究者

发起方
Fundación Universitaria CIEO
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sulma Milena Suarez

principal investigator

Fundación Universitaria CIEO

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