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Oral Myofunctional Pattern in Children With Anterior Open Bite

Study acronym: OMBIT
StatusCompleted
PhaseNot applicable
Started
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Record History

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  1. Minor Trial completed Show 4 more changesShow less
    • Primary completion date changed from estimate of May 2026 to Jan 30, 2026
    • Start date: Feb 22, 2023 to Jan 9, 2023
    • Eligibility criteria expanded, about 7 words
    • Site details revised
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07045779
Lead Sponsor University Ghent
Collaborators: Research Foundation Flanders
Conditions
(from sponsor)
Orofacial Myofunctional Disorders, Anterior Open Bite Malocclusion
Enrollment 33 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov