Myofunctional Therapy in Open Bite - RCT

NCT ID: NCT06574490

Last Updated: 2024-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-31

Study Completion Date

2028-10-31

Brief Summary

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The goal of this clinical trial is to learn if myofunctional therapy in 6-10-year-old children with infant type of swallowing and open bite is effective.

Primary hypothesis: myofunctional therapy results in correction of open bite Researchers will compare a group in which myofunctional therapy is performed for 6 months to a group in which myoufunctional therapy will be delayed by 1 year.

Participants will exercise according to a pre-established regimen and schedule

Detailed Description

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Conditions

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Open Bite

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Myofunctional +

A series of myofunctional exercises

Group Type EXPERIMENTAL

Myofunctional therapy (+)

Intervention Type PROCEDURE

A series of myofunctional exercises performed in 10-20 sessions over 6 months

Myofunctional -

No exercises

Group Type ACTIVE_COMPARATOR

Myofunctional therapy (-)

Intervention Type PROCEDURE

NO exercises; A series of myofunctional exercises performed in 10-20 sessions over 6 months is delayed by 1 year

Interventions

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Myofunctional therapy (+)

A series of myofunctional exercises performed in 10-20 sessions over 6 months

Intervention Type PROCEDURE

Myofunctional therapy (-)

NO exercises; A series of myofunctional exercises performed in 10-20 sessions over 6 months is delayed by 1 year

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* generally healthy children aged 6-10 years,
* infant swallowing type,
* open anterior occlusion (i.e. no contact between the maxillary and mandibular medial incisors),
* mixed dentition

Exclusion Criteria

* finger sucking habit (or similar) occurring within the last 6 months,
* previous myofunctional therapy,
* upper airway obstruction,
* congenital craniofacial developmental disorder,
* connective tissue or muscle disease,
* macroglossia,
* ankyloglossia,
* mental retardation
Minimum Eligible Age

6 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Piotr Fudalej

OTHER

Sponsor Role lead

Responsible Party

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Piotr Fudalej

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Other Identifiers

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1072.6120.39.2024

Identifier Type: -

Identifier Source: org_study_id

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