Oral Myofunctional Pattern in Children With Anterior Open Bite (OMBIT)

University Ghent

Status: Enrolling

Conditions: Anterior Open Bite Malocclusion; Orofacial Myofunctional Disorders

Treatments: Behavioral: Vocal warm up; Behavioral: Orofacial myofunctional therapy - reduced; Behavioral: Orofacial myofunctional therapy - traditional

Study type: Interventional

Funder types: Other

Identifiers

NCT07045779

ONZ-2022-0135

Details and patient eligibility

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.

Enrollment: 33 estimated patients

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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33 participants in 3 patient groups

Traditional OMT

Experimental group

Description:

Participants who are randomly assigned to this arm, will receive traditional orofacial myofunctional therapy (OMT), consisting of interventions targeting orofacial strength, orofacial differentiation, breathing pattern, orofacial resting postures, and swallowing pattern.

Treatment:

Behavioral: Orofacial myofunctional therapy - traditional

Reduced OMT

Experimental group

Description:

Participants who are randomly assigned to this arm, will receive reduced orofacial myofunctional therapy (OMT), consisting of interventions targeting orofacial differentiation, breathing pattern, and orofacial resting postures.

Treatment:

Behavioral: Orofacial myofunctional therapy - reduced

Sham treatment

Sham Comparator group

Description:

Participants who are randomly assigned to this arm, will receive a sham treatment. This active control intervention will not include any of the exercises included in the experimental treatment arms. 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. Furthermore, exercises regarding body posture (no focus on articulators), relaxation and voice onset will be included. This sham treatment program will be provided by the same speech-language pathologist with comparable motivation techniques as those applied in the real OMT programs. Patients and parents will initially not be informed about the actual purpose of this sham treatment. A debriefing will take place after the follow-up phase.

Treatment:

Behavioral: Vocal warm up