Oral muscle therapy for children with front open bite
The OMBIT Study: Oral Myofunctional Pattern in Children With Anterior Open Bite
NA · University Hospital, Ghent · NCT07045779
This trial will test whether a structured program of orofacial myofunctional therapy helps children in early or intermediate mixed dentition who have an anterior open bite.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 33 (estimated) |
| Ages | 6 Years to 12 Years |
| Sex | All |
| Sponsor | University Hospital, Ghent (other) |
| Locations | 1 site (Ghent) |
| Trial ID | NCT07045779 on ClinicalTrials.gov |
What this trial studies
This interventional study delivers structured orofacial myofunctional therapy (OMT) to children with anterior open bite in the early or intermediate mixed dentition, comparing traditional and reduced OMT programs and including vocal warm-up components. Participants with prior OMT or orthodontic treatment, congenital craniofacial anomalies, motor or cognitive disorders, or recent non-nutritive sucking habits are excluded to create a more uniform sample. Outcomes include changes in orofacial myofunctional patterns, dental occlusion measures, and oral health-related quality of life using standardized assessment tools and scheduled follow-up visits. The trial aims to address prior methodological gaps by using defined inclusion criteria, standardized interventions, and planned outcome measures.
Who should consider this trial
Good fit: Ideal candidates are children in early or intermediate mixed dentition with an anterior open bite who have not previously received OMT or orthodontic treatment and have no relevant congenital or developmental disorders.
Not a fit: Children currently receiving orthodontic therapy or OMT, those with congenital craniofacial syndromes or motor/cognitive disorders, or those with recent non-nutritive sucking habits are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the program could help correct anterior open bite, improve oral muscle function, and enhance children's oral health-related quality of life.
How similar studies have performed: Previous studies have suggested potential benefits of OMT but results are limited by small samples, varied methods, and short follow-up, so the approach is promising but not yet definitively proven.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ghent
- Ghent University — Ghent, Belgium (RECRUITING)
Study contacts
- Principal investigator: Kristiane Van Lierde, PhD — University Ghent
- Study coordinator: Charis Van der Straeten
- Email: Charis.vanderstraeten@ugent.be
- Phone: +3293325471
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Orofacial Myofunctional Disorders, Anterior Open Bite Malocclusion