EfficacyNCT04975672
Efficacy of Myofunctional Therapy in Class II Patients
A study testing Myofuncional Therapy in people with Efficacy and Myofunctional Therapy, run by Fundación Universitaria CIEO.
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… Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Efficacy, Myofunctional Therapy, Orthopedics
- What is being tested?
- Myofuncional Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 22 Dec 2022to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Patients with systemic involvement
- congenital malformations
- facial deformities
- Open bite
- oral breathing
- finger sucking habit will be excluded
About this study
Official title: Efficacy of Myofunctional Therapy in Class II Patients With Functional Orthopedic Appliances. ECA
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.
- Conditions
- Efficacy, Myofunctional Therapy, Orthopedics
- Being tested
- Myofuncional Therapy
- Keywords
- Efficacy, Myofunctional Therapy, Dentofacial Orthopedics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myofuncional TherapyOther
Also called Orthopedics
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Myofuncional Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Therapy Efficacy / Tongue Position
Lingual projection force
Measured: 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
Measured: 9 months
Muscle contraction
Physiological process in which the muscles develop tension and are shortened or stretched by a stimulus
Measured: 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
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2021
- Study start22 Dec 2022 (estimated)
- Primary completion22 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EfficacyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial with two parallel arms
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Universitaria CIEO
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sulma Milena Suarez, Fundación Universitaria CIEO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04975672
- Sponsor's protocol ID
- 111
- Status last verified
- Aug 2022
- First submitted
- 1 Mar 2021
- Last updated
- 11 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Myofunctional Therapy in Class II Patients With Functional Orthopedic Appliances. ECA
- ClinicalTrials.gov ID
- NCT04975672
- Acronym / sponsor ID
- 111
- Conditions
- Efficacy, Myofunctional Therapy, Orthopedics
- Keywords
- Efficacy, Myofunctional Therapy, Dentofacial Orthopedics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fundación Universitaria CIEOUniversity, hospital or other
- Study start
- 22 Dec 2022 (estimated)
- Primary completion
- 22 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 23 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized clinical trial with two parallel arms
| Arm | Type | Receives |
|---|---|---|
| Group 1, with myofunctional therapy and SN1 functional orthopedic appliances | Experimental | Other: Myofuncional TherapyThe 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 2, without myofunctional therapy and SN1 functional orthopedic appliances. | Experimental | Other: Myofuncional TherapyOnce the investigation is finished, the patient will decide whether or not to perform myofunctional therapy one every month, for 9 months. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- the inclusion criteria the participants will be between
Key exclusion criteria (6 listed)
- Patients with systemic involvement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Myofuncional TherapyAlso: OrthopedicsGroup 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 | Group 1, with myofunctional therapy and SN1 functional orthopedic appliances, Group 2, without myofunctional therapy and SN1 functional orthopedic appliances. |
Primary outcome
Therapy Efficacy / Tongue Position
Time frame: 9 months
Lingual projection force
41 / 5000 Resultados de traducción Efficacy of therapy / mandibular advancement
Time frame: 9 months
It induces changes in the position of the mandibular bone towards a more advanced position
Muscle contraction
Time frame: 9 months
Physiological process in which the muscles develop tension and are shortened or stretched by a stimulus
Contraction of the masseter muscles and muscle activity of the chin
Time frame: 9 months
101 / 5000 Resultados de traducción Physiological process in which the muscles develop tension and are shortened or stretched by a stimulus
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Myofuncional Therapy in people with Efficacy and Myofunctional Therapy, run by Fundación Universitaria CIEO.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Therapy Efficacy / Tongue Position (time frame: 9 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2022.