Myofunctional Therapy in Open Bite - RCT

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

Status

Not yet recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06574490

Acronym

Myofunctional

Enrollment

Registered

2024-08-28

Start date

2024-10-31

Completion date

2028-10-31

Last updated

2024-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Open Bite

Keywords

open bite, child, myofunctional, myotherapy, exercises

Brief summary

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

Interventions

PROCEDUREMyofunctional therapy (+)

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

PROCEDUREMyofunctional therapy (-)

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

6 Years to 10 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Overbite	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

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026