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Not yet recruiting NCT06574490

Myofunctional Therapy in Open Bite - RCT

No phase Interventional Open Bite

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Myofunctional therapy (+), Myofunctional therapy (-).
Who it may be relevant to
Registry conditions: Open Bite. Basic parameters: 6 years — 10 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • Procedure Myofunctional therapy (+)
    A series of myofunctional exercises performed in 10-20 sessions over 6 months
  • Procedure Myofunctional therapy (-)
    NO exercises; A series of myofunctional exercises performed in 10-20 sessions over 6 months is delayed by 1 year

Primary outcome measures

  • Overbite [Time frame: 12months]
Secondary outcome measures (2)
  • Swallowing pattern [Time frame: 12 months]
  • Articulation [Time frame: 12 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06574490 · 1072.6120.39.2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗