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Not yet recruitingNCT06574490MyofunctionalUpdated Aug 28, 2024

Myofunctional Therapy in Open Bite - RCT

An interventional study of Myofunctional therapy (+) and Myofunctional therapy (-) in Open Bite, sponsored by Piotr Fudalej. Not yet recruiting. Open to participants aged 6 Years to 10 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-28.

Sponsored by Piotr Fudalej · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
6 Years to 10 Years
Sex
All
01

Study 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

02

Conditions studied

  • Open Bite

Keywords

  • open bite
  • child
  • myofunctional
  • myotherapy
  • exercises
03

In context

Open Bite

34 studies on the registry are indexed under Open Bite; 8 are open to participants now.

This study's planned enrollment of 80 is above the median of 30 across 28 interventional studies indexed under Open Bite.

Browse Open Bite studies →

Lead sponsor

Piotr Fudalej is the lead sponsor of 4 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 10 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Myofunctional +

    A series of myofunctional exercises

    Procedure: Myofunctional therapy (+)

  • Active comparator
    Myofunctional -

    No exercises

    Procedure: Myofunctional therapy (-)

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

06

What researchers measure

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

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 28, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06574490
Lead sponsor
Piotr Fudalej
Responsible party
Piotr Fudalej (Professor, Jagiellonian University) — Sponsor-investigator
First posted
Aug 28, 2024
Start date
Oct 2024 (estimated)
Primary completion
Oct 2027 (estimated)
Completion
Oct 2028 (estimated)
Last update
Aug 28, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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