Myofunctional Therapy in Open Bite - RCT

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

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Key information

Conditions

Open Bite Behavior Malocclusion Motor Activity Stomatognathic Diseases Tooth Diseases

Age range

6 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Myofunctional therapy (+)

Procedure

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

Myofunctional therapy (-)

Procedure

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

Primary outcomes

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

Secondary outcomes

Swallowing pattern

Time frame: 12 months

swallowing pattern (infant, adult or mixed)
Articulation

Time frame: 12 months

articulation of l,n,d,t,s sounds.

Sponsors and collaborators

Lead sponsor

Piotr Fudalej

Other

Registry information

Official study title

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

Acronym: Myofunctional

Important dates

Study start: 2024
Primary completion: 2027
Study completion: 2028
First posted: Aug 28, 2024
Registry last updated: Aug 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Not yet recruiting