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Status unknownNCT04975672Updated Aug 11, 2022

Efficacy of Myofunctional Therapy in Class II Patients

An interventional study of Myofuncional Therapy in Efficacy, Myofunctional Therapy and Orthopedics, sponsored by Fundación Universitaria CIEO. Status unknown. Open to participants aged 8 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-11.

Sponsored by Fundación Universitaria CIEO · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
8 Years to 12 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Efficacy
  • Myofunctional Therapy
  • Orthopedics

Keywords

  • Efficacy
  • Myofunctional Therapy
  • Dentofacial Orthopedics
03

In context

Lead sponsor

Fundación Universitaria CIEO is the lead sponsor of 12 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Patients with systemic involvement

    • congenital malformations
    • facial deformities
    • Open bite
    • oral breathing
    • finger sucking habit will be excluded
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • OtherMyofuncional 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

    Also known as: Orthopedics

06

What researchers measure

Primary outcomes

  1. Therapy Efficacy / Tongue Position

    Lingual projection force

    Time frame: 9 months

  2. 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

    Time frame: 9 months

  3. Muscle contraction

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

    Time frame: 9 months

  4. 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

    Time frame: 9 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Dec 2022; primary completion for Dec 2022, 0 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 1, 2021
First posted
Jul 23, 2021
StartEst.
Dec 22, 2022
Primary completionEst.
Dec 22, 2022
CompletionEst.
Dec 31, 2022
Last update
Aug 11, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 11, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04975672
Lead sponsor
Fundación Universitaria CIEO
Responsible party
Sulma Milena Suarez (principal investigator, Fundación Universitaria CIEO) — Principal investigator
First posted
Jul 23, 2021
Start date
Dec 22, 2022 (estimated)
Primary completion
Dec 22, 2022 (estimated)
Completion
Dec 31, 2022 (estimated)
Last update
Aug 11, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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