Efficacy of Myofunctional Therapy in Class II Patients

NCT ID: NCT04975672

Last Updated: 2022-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-22

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Efficacy Myofunctional Therapy Orthopedics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized clinical trial with two parallel arms
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
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

Study Groups

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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.

Group Type EXPERIMENTAL

Myofuncional Therapy

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

Myofuncional Therapy

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Other Intervention Names

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Orthopedics

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

8 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fundación Universitaria CIEO

OTHER

Sponsor Role lead

Responsible Party

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Sulma Milena Suarez

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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111

Identifier Type: -

Identifier Source: org_study_id

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