Myofunctional Therapy in Open Bite - RCT (Myofunctional)

August 25, 2024 updated by: Piotr Fudalej

Effectiveness of Myofunctional Therapy in Children With Open Bite - a Randomized Clinical Trial

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Myofunctional +
A series of myofunctional exercises
Procedure: Myofunctional therapy (+)
A series of myofunctional exercises performed in 10-20 sessions over 6 months
Active Comparator: Myofunctional -
No exercises
Procedure: Myofunctional therapy (-)
NO exercises; A series of myofunctional exercises performed in 10-20 sessions over 6 months is delayed by 1 year

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overbite
Time Frame: 12months
presence positive vertical (i.e. the upper teeth overlap the lower teeth) and horizontal (i.e. the upper teeth are positioned in front of the lower teeth) occlusion
12months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Swallowing pattern
Time Frame: 12 months
swallowing pattern (infant, adult or mixed)
12 months
Articulation
Time Frame: 12 months
articulation of l,n,d,t,s sounds.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Piotr Fudalej

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2024

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2028

Study Registration Dates

First Submitted

August 13, 2024

First Submitted That Met QC Criteria

August 25, 2024

First Posted (Actual)

August 28, 2024

Study Record Updates

Last Update Posted (Actual)

August 28, 2024

Last Update Submitted That Met QC Criteria

August 25, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1072.6120.39.2024

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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