Myofunctional Therapy in Open Bite - RCT

NCT06574490 — Not applicable, Not yet recruiting, 80 participants, Piotr Fudalej

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

Registry	NCT06574490, acronym Myofunctional
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	80 (Estimated)
Sponsor	Piotr Fudalej (Other)
Conditions	Open Bite
Interventions	Myofunctional therapy (+), Myofunctional therapy (-) (Procedure)
Dates	start 2024-10-01 (estimated), primary completion 2027-10-01 (estimated), completion 2028-10-01 (estimated), first posted 2024-08-28, last updated 2024-08-28

-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

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+Arms and interventions

Arm	Type	Interventions	Description
Myofunctional +	Experimental	Procedure: Myofunctional therapy (+)	A series of myofunctional exercises
Myofunctional -	Active comparator	Procedure: Myofunctional therapy (-)	No exercises

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

+Outcome measures

Primary outcomes

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 outcomes

Swallowing pattern [12 months]: swallowing pattern (infant, adult or mixed)
Articulation [12 months]: articulation of l,n,d,t,s sounds.

+Eligibility

Sex: All, ages: 6 Years to 10 Years, accepts healthy volunteers

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

My Notes

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