Efficacy of Myofunctional Therapy in Class II Patients

Sponsor
Fundación Universitaria CIEO (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04975672
Collaborator
(none)
60
Enrollment
2
Arms
9
Anticipated Duration (Days)

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Other: Myofuncional Therapy
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized clinical trial with two parallel armsRandomized clinical trial with two parallel arms
Masking:
Single (Outcomes Assessor)
Masking Description:
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
Primary Purpose:
Treatment
Official Title:
Efficacy of Myofunctional Therapy in Class II Patients With Functional Orthopedic Appliances. ECA
Anticipated Study Start Date :
Dec 22, 2021
Anticipated Primary Completion Date :
Dec 22, 2021
Anticipated Study Completion Date :
Dec 31, 2021

Arms and Interventions

ArmIntervention/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
  • Outcome Measures

    Primary Outcome Measures

    1. Therapy Efficacy / Tongue Position [9 months]

      Lingual projection force

    2. 41 / 5000 Resultados de traducción Efficacy of therapy / mandibular advancement [9 months]

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

    3. Muscle contraction [9 months]

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

    4. Contraction of the masseter muscles and muscle activity of the chin [9 months]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    8 Years to 12 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Fundación Universitaria CIEO

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sulma Milena Suarez, principal investigator, Fundación Universitaria CIEO
    ClinicalTrials.gov Identifier:
    NCT04975672
    Other Study ID Numbers:
    • 111
    First Posted:
    Jul 23, 2021
    Last Update Posted:
    Oct 20, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Sulma Milena Suarez, principal investigator, Fundación Universitaria CIEO

    Study Results

    No Results Posted as of Oct 20, 2021