Oral Myofunctional Pattern in Children With Anterior Open Bite

NCT ID: NCT07045779

Last Updated: 2025-07-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-22
• Study Completion Date: 2026-05-31

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.

Conditions

Orofacial Myofunctional Disorders; Anterior Open Bite Malocclusion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Traditional OMT

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.

Group Type: EXPERIMENTAL

Orofacial myofunctional therapy - traditional

Intervention Type: BEHAVIORAL

Behavioral interventions, like orofacial myofunctional therapy (OMT), target brain reorganization and plasticity by establishing new motor patterns or re-establishing old ones. The aim of OMT is to correct pathological function and resting positions based on the equilibrium theory. A service model that is often used in OMT is the model provided by Garliner, which includes a 10 week OMT program with a frequency of one session of 45 minutes per week together with home practice. Treatment sessions will be used to introduce and practice new exercises, to monitor home practice and motivation of the patients. Additionally, the participant will be instructed to perform the same exercises from the treatment session at home daily. This intervention will consist of (1) creating awareness, (2) establishing nasal breathing, (3) labial seal and lip closure exercises, (4) tongue posture exercises, (5) lip and tongue strengthening, (6) practicing a physiological swallowing act.

Reduced OMT

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.

Group Type: EXPERIMENTAL

Orofacial myofunctional therapy - reduced

Intervention Type: BEHAVIORAL

Behavioral interventions, like orofacial myofunctional therapy (OMT), target brain reorganization and plasticity by establishing new motor patterns or re-establishing old ones. The aim of OMT is to correct pathological function and resting positions based on the equilibrium theory. A service model that is often used in OMT is the model provided by Garliner, which includes a 10 week OMT program with a frequency of one session of 45 minutes per week together with home practice. Treatment sessions will be used to introduce and practice new exercises, to monitor home practice and motivation of the patients. Additionally, the participant will be instructed to perform the same exercises from the treatment session at home daily. This intervention will consist of (1) creating awareness, (2) establishing nasal breathing, (3) labial seal and lip closure exercises, (4) tongue posture exercises.

Sham treatment

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.

Group Type: SHAM_COMPARATOR

Vocal warm up

Intervention Type: BEHAVIORAL

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. Exercises that will be included are: open mouth approach, glottal fry, producing ascending and descending tones and the hand-over-mouth technique. These exercises aim to improve the dynamics of the extrinsic and intrinsic laryngeal muscles and therefore are expected not to interfere with the content of the OMT program. 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.

Interventions

Orofacial myofunctional therapy - traditional

Behavioral interventions, like orofacial myofunctional therapy (OMT), target brain reorganization and plasticity by establishing new motor patterns or re-establishing old ones. The aim of OMT is to correct pathological function and resting positions based on the equilibrium theory. A service model that is often used in OMT is the model provided by Garliner, which includes a 10 week OMT program with a frequency of one session of 45 minutes per week together with home practice. Treatment sessions will be used to introduce and practice new exercises, to monitor home practice and motivation of the patients. Additionally, the participant will be instructed to perform the same exercises from the treatment session at home daily. This intervention will consist of (1) creating awareness, (2) establishing nasal breathing, (3) labial seal and lip closure exercises, (4) tongue posture exercises, (5) lip and tongue strengthening, (6) practicing a physiological swallowing act.

Intervention Type: BEHAVIORAL

Orofacial myofunctional therapy - reduced

Behavioral interventions, like orofacial myofunctional therapy (OMT), target brain reorganization and plasticity by establishing new motor patterns or re-establishing old ones. The aim of OMT is to correct pathological function and resting positions based on the equilibrium theory. A service model that is often used in OMT is the model provided by Garliner, which includes a 10 week OMT program with a frequency of one session of 45 minutes per week together with home practice. Treatment sessions will be used to introduce and practice new exercises, to monitor home practice and motivation of the patients. Additionally, the participant will be instructed to perform the same exercises from the treatment session at home daily. This intervention will consist of (1) creating awareness, (2) establishing nasal breathing, (3) labial seal and lip closure exercises, (4) tongue posture exercises.

Intervention Type: BEHAVIORAL

Vocal warm up

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. Exercises that will be included are: open mouth approach, glottal fry, producing ascending and descending tones and the hand-over-mouth technique. These exercises aim to improve the dynamics of the extrinsic and intrinsic laryngeal muscles and therefore are expected not to interfere with the content of the OMT program. 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Research Foundation Flanders

OTHER

Sponsor Role: collaborator

University Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kristiane Van Lierde, PhD

Role: PRINCIPAL_INVESTIGATOR

University Ghent

Kim Bettens, PhD

Role: STUDY_CHAIR

University Ghent

Locations

Ghent University

Ghent, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Charis Van der Straeten

Role: CONTACT

Charis.vanderstraeten@ugent.be

+3293325471

Facility Contacts

Kristiane Van Lierde, PhD

Role: primary

Kristiane.VanLierde@UGent.be

+3293325471

Other Identifiers

ONZ-2022-0135

Identifier Type: -

Identifier Source: org_study_id