Efficacy of Myofunctional Therapy in Class II Patients

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Efficacy; Orthopedics; Myofunctional Therapy
• Intervention / Treatment: Other: Myofuncional Therapy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 12 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Patients with systemic involvement

  • congenital malformations
  • facial deformities
  • Open bite
  • oral breathing
  • finger sucking habit will be excluded

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group 1, with myofunctional therapy and SN1 functional orthopedic appliances; The participant will receive a session of myofunctional therapy every month, for 9 months. In this group, a series of procedures and techniques are carried out to create and mechanize muscular and orofacial patterns at rest and in function, eliminate habits, correct muscular imbalance, improve the aesthetics of the patient and normalize the functions of the stomatognathic system.	Other: Myofuncional Therapy; Group 1, with myofunctional therapy and SN1 functional orthopedic appliances The participant underwent a myofunctional therapy session every month, for 9 months. In this group, a series of procedures and techniques are carried out to create and mechanize muscular and orofacial patterns at rest and in function, eliminate habits, correct muscular imbalance, improve the aesthetics of the patient and normalize the functions of the stomatognathic system. The myofunctional therapy performed will be by an expert speech therapist; Other Names: Orthopedics
EXPERIMENTAL: Group 2, without myofunctional therapy and SN1 functional orthopedic appliances.; Once the investigation is finished, the patient will decide whether or not to perform myofunctional therapy one every month, for 9 months.	Other: Myofuncional Therapy; Group 1, with myofunctional therapy and SN1 functional orthopedic appliances The participant underwent a myofunctional therapy session every month, for 9 months. In this group, a series of procedures and techniques are carried out to create and mechanize muscular and orofacial patterns at rest and in function, eliminate habits, correct muscular imbalance, improve the aesthetics of the patient and normalize the functions of the stomatognathic system. The myofunctional therapy performed will be by an expert speech therapist; Other Names: Orthopedics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Therapy Efficacy / Tongue Position	Lingual projection force	9 months
41 / 5000 Resultados de traducción Efficacy of therapy / mandibular advancement	It induces changes in the position of the mandibular bone towards a more advanced position	9 months
Muscle contraction	Physiological process in which the muscles develop tension and are shortened or stretched by a stimulus	9 months
Contraction of the masseter muscles and muscle activity of the chin	101 / 5000 Resultados de traducción Physiological process in which the muscles develop tension and are shortened or stretched by a stimulus	9 months

Collaborators and Investigators

• Sponsor: Fundación Universitaria CIEO

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): December 22, 2022
• Primary Completion (ANTICIPATED): December 22, 2022
• Study Completion (ANTICIPATED): December 31, 2022

Study Registration Dates

• First Submitted: March 1, 2021
• First Submitted That Met QC Criteria: July 14, 2021
• First Posted (ACTUAL): July 23, 2021

Study Record Updates

• Last Update Posted (ACTUAL): August 11, 2022
• Last Update Submitted That Met QC Criteria: August 10, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Efficacy; Myofunctional Therapy; Dentofacial Orthopedics
• Other Study ID Numbers: 111

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No