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Myofunctional Therapy in Open Bite - RCT

ConditionOpen Bite
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-10
SponsorPiotr Fudalej

About this 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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

finger sucking habit (or similar) occurring within the last 6 months,

previous myofunctional therapy,

upper airway obstruction,

congenital craniofacial developmental disorder,

Trial design

Design model

Parallel

Treatments tested in this trial

  • Myofunctional therapy (+)

    Procedure/Surgery

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

  • Myofunctional therapy (-)

    Procedure/Surgery

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

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Myofunctional +Experimental treatment 1 intervention
Group B: Myofunctional -Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Overbite

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

Time frame
12months

Secondary outcomes

1

Swallowing pattern

swallowing pattern (infant, adult or mixed)

Time frame
12 months
2

Articulation

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

Time frame
12 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Piotr Fudalej

Lead sponsor

Jagiellonian University

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: