NCT07045779 Oral Myofunctional Pattern in Children With Anterior Open Bite
| NCT ID | NCT07045779 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Ghent |
| Condition | Orofacial Myofunctional Disorders |
| Study Type | INTERVENTIONAL |
| Enrollment | 33 participants |
| Start Date | 2023-02-22 |
| Primary Completion | 2026-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 33 participants in total. It began in 2023-02-22 with a primary completion date of 2026-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Kristiane Van Lierde, PhD
PRINCIPAL INVESTIGATOR
University Ghent
Frequently Asked Questions
Who can join the NCT07045779 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 12 Years, studying Orofacial Myofunctional Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07045779 currently recruiting?
Yes, NCT07045779 is actively recruiting participants. Contact the research team at Charis.vanderstraeten@ugent.be for enrollment information.
Where is the NCT07045779 trial being conducted?
This trial is being conducted at Ghent, Belgium.
Who is sponsoring the NCT07045779 clinical trial?
NCT07045779 is sponsored by University Ghent. The principal investigator is Kristiane Van Lierde, PhD at University Ghent. The trial plans to enroll 33 participants.