Efficacy of Myofunctional Therapy in Class II Patients

NCT04975672 | Unknown

• 1 other identifier: 111
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Efficacy; Myofunctional Therapy; Orthopedics

Keywords

Efficacy; Myofunctional Therapy; Dentofacial Orthopedics

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Group 1, with myofunctional therapy and SN1 functional orthopedic appliances

EXPERIMENTAL

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 2, without myofunctional therapy and SN1 functional orthopedic appliances.

EXPERIMENTAL

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

Interventions

Myofuncional Therapy 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

Also known as: Orthopedics

Group 1, with myofunctional therapy and SN1 functional orthopedic appliances; Group 2, without myofunctional therapy and SN1 functional orthopedic appliances.

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Fundación Universitaria CIEO: lead

MeSH Terms

Interventions

Orthopedic Procedures

Intervention Hierarchy (Ancestors)

Therapeutics; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: Randomized clinical trial with two parallel arms

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: July 23, 2021
• Study Start: December 22, 2022
• Primary Completion: December 22, 2022
• Study Completion: December 31, 2022
• Last Updated: August 11, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share