Oral Myofunctional Pattern in Children With Anterior 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: Orofacial myofunctional therapy - traditional, Orofacial myofunctional therapy - reduced, Vocal warm up.
- Who it may be relevant to
- Registry conditions: Orofacial Myofunctional Disorders, Anterior Open Bite Malocclusion. Basic parameters: 6 years — 12 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
- Belgium
- 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
The OMBIT Study: Oral Myofunctional Pattern in Children With Anterior Open Bite
Overview
Oral myofunctional disorders (OMD) are a key, internationally acknowledged environmental factor causing dental and skeletal malocclusion. For the past 15 years, research regarding the efficacy of orofacial myofunctional therapy (OMT) to reduce OMD and to contribute to the treatment of malocclusions has been significantly increased. Despite the growing interest, high-quality evidence is still lacking because studies show a lack of standardized assessment techniques, outcome measures, and inclusion criteria, important methodological limitations such as small sample sizes, a variety of content and service delivery models and a lack of long-term follow-up. The goal of this clinical trial is to evaluate the effects of structured OMT on anterior open bite (AOB) in children in early or intermediate mixed dentition. The main questions it aims to answer are: * Does a structured OMT program affect orofacial myofunctional patterns, dental occlusion, and oral health-related quality of life (OHRQoL) in children with AOB? * Are there differences in treatment outcomes between children receiving a traditional OMT program, a reduced OMT program, and a sham treatment? Participants will undergo baseline and follow-up assessments of dental occlusion, orofacial myofunctional patterns, and OHRQoL. They will follow a structured OMT protocol tailored to their assigned group and participate in weekly therapy sessions over a defined intervention period.
Interventions
- Behavioral Orofacial myofunctional therapy - traditional
Behavioral interventions, like orofacial myofunctional therapy (OMT), target brain reorganization and plasticity by establishing new motor patterns or re-establishing old ones. The aim of OMT is to correct pathological function and resting positions based on the equilibrium theory. A service model that is often used in OMT is the model provided by Garliner, which includes a 10 week OMT program with a frequency of one session of 45 minutes per week together with home practice. Treatment sessions - Behavioral Orofacial myofunctional therapy - reduced
Behavioral interventions, like orofacial myofunctional therapy (OMT), target brain reorganization and plasticity by establishing new motor patterns or re-establishing old ones. The aim of OMT is to correct pathological function and resting positions based on the equilibrium theory. A service model that is often used in OMT is the model provided by Garliner, which includes a 10 week OMT program with a frequency of one session of 45 minutes per week together with home practice. Treatment sessions - Behavioral Vocal warm up
The sham treatment program will include exercises from an evidence-based vocal warm up program, with exclusion of the exercises that include active involvement of the tongue or lips. Exercises that will be included are: open mouth approach, glottal fry, producing ascending and descending tones and the hand-over-mouth technique. These exercises aim to improve the dynamics of the extrinsic and intrinsic laryngeal muscles and therefore are expected not to interfere with the content of the OMT progr
Primary outcome measures
- Dental occlusion characteristics [Time frame: From enrollment until 12 months after conclusion of treatment]
- Orofacial myofunctional status [Time frame: From enrollment until 12 months after conclusion of treatment]
Secondary outcome measures (2)
- Oral health-related quality of life [Time frame: From enrollment until 12 months after conclusion of treatment]
- Orofacial strength [Time frame: From enrollment until 12 months after conclusion of treatment]
Eligibility criteria
Inclusion criteria
- Presence of anterior open bite (AOB)
- Early or intermediate mixed dentition phase
Exclusion criteria
- History of or active engagement in orofacial myofunctional therapy (OMT)
- History of or active engagement in orthodontic therapy
- Congenital abnormalities, syndromes, or surgical needs affecting the oral and maxillofacial region
- Disorders affecting motor or cognitive development
- Current or recent (< 3 months) non-nutritive sucking habits
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Belgium · 1 center
- Ghent University — Ghent
Identifiers
NCT: NCT07045779 · ONZ-2022-0135