Myofunctional Therapy in Open Bite - RCT
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 →
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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