Actively Recruiting

Phase Not Applicable
Age: 6Years - 12Years
All Genders
NCT07045779

Oral Myofunctional Pattern in Children With Anterior Open Bite

Led by University Ghent · Updated on 2025-07-01

33

Participants Needed

1

Research Sites

166 weeks

Total Duration

On this page

Sponsors

U

University Ghent

Lead Sponsor

R

Research Foundation Flanders

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Oral Myofunctional Pattern in Children With Anterior Open Bite

Who Can Participate

Age: 6Years - 12Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Presence of anterior open bite (AOB)
  • Early or intermediate mixed dentition phase
  • Age between 6 and 12 years
Not Eligible

You will not qualify if you...

  • History of or current orofacial myofunctional therapy (OMT)
  • History of or current orthodontic therapy
  • Congenital abnormalities, syndromes, or surgical needs affecting the oral and maxillofacial region
  • Disorders affecting motor or cognitive development
  • Current or recent (less than 3 months) non-nutritive sucking habits

AI-Screening

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Trial Site Locations

Total: 1 location

1

Ghent University

Ghent, Belgium, 9000

Actively Recruiting

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Research Team

C

Charis Van der Straeten

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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