Orofacial Myofunctional DisordersOMBITNCT07045779
Oral Myofunctional Pattern in Children With Anterior Open Bite
A study testing Orofacial myofunctional therapy - traditional, Orofacial myofunctional therapy - reduced and Vocal warm up in people with Orofacial Myofunctional Disorders and Anterior Open Bite Malocclusion, run by University Ghent at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Orofacial Myofunctional Disorders, Anterior Open Bite Malocclusion
- What is being tested?
- Orofacial myofunctional therapy - traditional, Orofacial myofunctional therapy - reduced and Vocal warm up
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteBelgium
- Study dates
- 9 Jan 2023to 30 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Presence of anterior open bite (AOB)
- Early or intermediate mixed dentition phase
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: The OMBIT Study: Oral Myofunctional Pattern in Children With Anterior Open Bite
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:
Read more
- 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.
- Being tested
- Orofacial myofunctional therapy - traditional, Orofacial myofunctional therapy - reduced, Vocal warm up
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orofacial myofunctional therapy - traditionalBehavioural
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.
Orofacial myofunctional therapy - reducedBehavioural
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.
Vocal warm upBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Traditional OMT | Experimental | 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. Receives: Behavioral: Orofacial myofunctional therapy - traditional |
| Reduced OMT | Experimental | 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. Receives: Behavioral: Orofacial myofunctional therapy - reduced |
| Sham treatment | Sham comparator | 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. Receives: Behavioral: Vocal warm up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dental occlusion characteristics
Measurement of dental occlusion characteristics (overbite, overjet, palatal surface area, palatal volume) will be based on 3D digital intraoral scans. The chief among which, anterior open bite, will be measured by vertical gap measurement (mm), i.e. the vertical distance between the incisal edge of the maxillary and mandibular central incisors when in occlusion.
Measured: From enrollment until 12 months after conclusion of treatment
Orofacial myofunctional status
Orofacial myofunctional status will be evaluated using the Orofacial Myofunctional Evaluation with Scores (OMES) protocol, a validated measure quantifying orofacial myofunctional behavior (with a lower score indicative of a more impaired orofacial function). Additionally, submandibular ultrasonography will be used to verify tongue posture at rest and swallowing pattern.
Measured: From enrollment until 12 months after conclusion of treatment
Secondary outcomes (2)
Oral health-related quality of life
OHRQoL will be assessed using the Childrens Oral Health Impact Profile (COHIP) (a higher score is indicative of a better OHRQoL).
Measured: From enrollment until 12 months after conclusion of treatment
Orofacial strength
Maximal strength and endurance of tongue and lips will be assessed using the Iowa Oral Performance Instrument (IOPI).
Measured: From enrollment until 12 months after conclusion of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start9 Jan 2023
- Primary completion30 Jan 2026
- Study completion30 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orofacial Myofunctional DisordersStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Research Foundation Flanders
- Responsible party
- Sponsor
- Investigators
- Kristiane Van Lierde, PhD, Principal investigator, University GhentKim Bettens, PhD, Study chair, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07045779
- Sponsor's protocol ID
- ONZ-2022-0135
- Acronym
- OMBIT
- Status last verified
- Sep 2026
- First submitted
- 23 Jun 2025
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The OMBIT Study: Oral Myofunctional Pattern in Children With Anterior Open Bite
- ClinicalTrials.gov ID
- NCT07045779
- Acronym / sponsor ID
- OMBIT / ONZ-2022-0135
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- Research Foundation Flanders
- Study start
- 9 Jan 2023 (actual)
- Primary completion
- 30 Jan 2026 (actual)
- Study completion
- 30 Jan 2026 (actual)
- First posted
- 1 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Traditional OMT | Experimental | Behavioral: Orofacial myofunctional therapy - traditionalParticipants 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. |
| Reduced OMT | Experimental | Behavioral: Orofacial myofunctional therapy - reducedParticipants 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. |
| Sham treatment | Sham comparator | Behavioral: Vocal warm upParticipants 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. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Presence of anterior open bite (AOB)
- Early or intermediate mixed dentition phase
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Orofacial myofunctional therapy - traditionalBehavioral 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. | Behavioural | Traditional OMT |
| Orofacial myofunctional therapy - reducedBehavioral 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. | Behavioural | Reduced OMT |
| Vocal warm upThe 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. | Behavioural | Sham treatment |
Primary outcome
Dental occlusion characteristics
Time frame: From enrollment until 12 months after conclusion of treatment
Measurement of dental occlusion characteristics (overbite, overjet, palatal surface area, palatal volume) will be based on 3D digital intraoral scans. The chief among which, anterior open bite, will be measured by vertical gap measurement (mm), i.e. the vertical distance between the incisal edge of the maxillary and mandibular central incisors when in occlusion.
Orofacial myofunctional status
Time frame: From enrollment until 12 months after conclusion of treatment
Orofacial myofunctional status will be evaluated using the Orofacial Myofunctional Evaluation with Scores (OMES) protocol, a validated measure quantifying orofacial myofunctional behavior (with a lower score indicative of a more impaired orofacial function). Additionally, submandibular ultrasonography will be used to verify tongue posture at rest and swallowing pattern.
2 secondary outcomes
Oral health-related quality of life
Time frame: From enrollment until 12 months after conclusion of treatment
Orofacial strength
Time frame: From enrollment until 12 months after conclusion of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristiane Van Lierde, PhD principal investigator
University Ghent
Kim Bettens, PhD study chair
University Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orofacial myofunctional therapy - traditional, Orofacial myofunctional therapy - reduced and Vocal warm up in people with Orofacial Myofunctional Disorders and Anterior Open Bite Malocclusion, run by University Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dental occlusion characteristics (time frame: From enrollment until 12 months after conclusion of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.