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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04975672
Other study ID # 111
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date December 22, 2022
Est. completion date December 31, 2022

Study information

Verified date August 2022
Source Fundación Universitaria CIEO
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date December 31, 2022
Est. primary completion date December 22, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 8 Years to 12 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Fundación Universitaria CIEO

Outcome

Type Measure Description Time frame Safety issue
Primary Therapy Efficacy / Tongue Position Lingual projection force 9 months
Primary 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
Primary Muscle contraction Physiological process in which the muscles develop tension and are shortened or stretched by a stimulus 9 months
Primary 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
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