Orofacial Myofunctional DisordersNCT07088055
Trial to Compare the Effects of Myo Munchee Therapy and Oral Motor Therapy (OMT) in Pediatric Patients to Treat Maxillary Deficiency and Orofacial Myofunctional Dysfunction (OMD).
A study testing Chewing device only, Myo Munchee and Oral Motor Therapy Treatment and Oral Motor Therapy Treatment Arm in people with Orofacial Myofunctional Disorders and Myo Munchee, run by Myo Munchee (Operations) Pty Ltd at 2 sites in United States.
Trial summary
Multi-center, 6-month, randomized, and controlled trial to compare the effects of Myo Munchee therapy and Oral Motor Therapy (OMT) in pediatric patients (aged 3-5 years) to treat maxillary deficiency and orofacial myofunctional dysfunction (OMD). Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Orofacial Myofunctional Disorders, Myo Munchee, Oral Motor Therapy
- What is being tested?
- Chewing device only, Myo Munchee and Oral Motor Therapy Treatment and Oral Motor Therapy Treatment Arm
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Aug 2025to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 3 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Aged between 36 - 60 (3-5 yrs) months old and will not turn 6 years of age before the study completion
- Diagnosed with having at least two maxillary skeletal-dental malocclusion traits as determined by the dentist
- At least one of the identified Orofacial Myofunctional Dysfunction (OMD) traits determined by the Speech-Language Pathologist (CCC-SLP)
Who cannot join
- A patient must be considered healthy to be included in this study. Definition of health: the patient does not have ongoing treatment, medication or specialized assessments (more than routine follow up exams) with health care providers regarding a condition. If they have had treatment for a condition (e.g. treated by respiratory physician for acute asthma hospitalization), it must have been 12 months or more since their last appointment with a health provider related to that condition.
- Of particular consideration:
- Ongoing care from a sleep physician or respiratory physician Current use of Continuous Positive Airway Pressure (CPAP), nasal sprays, sleeping or behavioral medication to treat diagnosed sleep disorder or behavioral disorder Adenectomy or tonsillectomy within last 12 months
- Any previous or current tumors or traumas in the head, neck and jaw region Patients with any known genetic or congenital conditions that impair oral motor muscle function, oral motor coordination, or speech articulation, such as but not limited to muscular dystrophy, cerebral palsy, will be excluded from the study.
- Patients with any known syndromic conditions to affect oral motor function, including but not limited to syndromes that involve craniofacial anomalies, neuromuscular disorders, or developmental delays affecting oral motor muscle control, speech articulation, or swallowing, such as Down Syndrome, Pierre Robin sequence, or Moebius syndrome.
- Children that do not have their 2nd molars by 36 months of age
Show all 13Show fewer
- Overweight, Z-scores Body Mass Index (BMI) above 85th percentile (z score of 1) Boys: https://www.cdc.gov/growthcharts/data/extended-bmi/BMI-Age-percentiles-BOYS-Z-Scores.pdf Girls: https://www.cdc.gov/growthcharts/data/extended-bmi/BMI-Age-percentiles-GIRLS-Z-Scores.pdf
- History of prescription for therapeutic gum chewing and/or use of edibles in treatment program
- Previous tongue tie releases (frenuloplasty and frenectomy)
- Any therapeutic oral device treatment
- Previous or current treatment from any other dental, Oral Motor Therapy (OMT) or orthodontic provider
- Gross neglect of patient's oral health and presence of dental caries
- Grade 4 tonsils on Brodsky scale
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Center for Svedhyaya Therapy Services
Chicago, Illinois, 60302
Jodi Walker, MA, CCC-SLP, 917-620-7916, jodiwalkerspeech@gmail.com
Jodi Walker, MA, CCC-SLP
- Recruiting
Dentistry for Children
Chicago, Illinois, 60614
Kevin Bourke, M.D., D.D.S, 312-523-8455, kbo569@gmail.com
Kevin Boyd, M.D., D.D.S
About this study
Official title: Multi-center, 6-month, Randomized, and Controlled Trial to Compare the Effects of Myo Munchee Therapy and Oral Motor Therapy (OMT) in Pediatric Patients (Aged 3-5 Years) to Treat Maxillary Deficiency and Orofacial Myofunctional Dysfunction (OMD).
Multi-center, 6-month, randomized, and controlled trial to compare the effects of Myo Munchee therapy and Oral Motor Therapy (OMT) in pediatric patients (aged 3-5 years) to treat maxillary deficiency and orofacial myofunctional dysfunction (OMD).
Read the detailed description
This study is intended for 3-5 year old children who have a deficiency in their maxillary, dental and oral muscle development. They are at the ideal age for undertaking preventative dental and Oral Motor Therapy to improve their orofacial (referring to structures in the mouth, jaw, lips and cheeks) development, which will likely improve their health and wellbeing. The therapies being used are Oral Motor Therapy and Myo Munchee Therapy. Oral Motor Therapy is a type of therapy used by Speech-Language Pathologists to help patients with feeding, chewing and swallowing difficulties. The Myo Munchee, is a small handheld medical device that fits within the mouth. It is intended for children that have issues with (a) dribbling and drooling, mouth breathing in the daytime or during sleep, (c) messy eating, (d) misaligned teeth, (e) ear and sinus congestion, and (f) teeth clenching and grinding. Both of these therapies are clinically effective and safe. They are low-cost and minimally invasive treatments to resolve OMD's (referring to abnormal patterns of movement, function or positioning of the muscles of the mouth, face, and jaw that interfere with normal growth, development or function) and likely improve maxillary deficiency (referring to the underdevelopment or abnormality of the upper jaw).
- Being tested
- Chewing device only, Myo Munchee and Oral Motor Therapy Treatment, Oral Motor Therapy Treatment Arm
- Medical subject headings
- Retrognathia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chewing device onlyDevice
Also called Chewing device
This group will be administered the Myo Munchee and be given a protocol to follow over the 26-week study period. They will also have the clinical and questionnaire measurements taken at the beginning, week 10 and week 26 of the study.
Myo Munchee and Oral Motor Therapy TreatmentDevice
Also called Chewing device, Oral Motor Therapy
This group will be administered an Oral Motoro Therapy program as well as a Myo Munchee protocol to follow over the 26-week study period. They will also have the clinical and questionnaire measurements taken at the beginning, week 10 and week 26 of the study.
Oral Motor Therapy Treatment ArmOther
Also called Oral Motor Therapy
This group will be administered an Oral Motor Therapy program to follow over the 26-week study period. They will also have the clinical and questionnaire measurements taken at the beginning, week 10 and week 26 of the study.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | There will be no intervention administered to this group. This group will have their clinical and questionnaire measurements taken at the beginning, week 10 and week 26 of the study. |
| Myo Munchee Only | Experimental | This group will be administered the Myo Munchee and be given a protocol to follow over the 26-week study period. They will also have the clinical and questionnaire measurements taken at the beginning, week 10 and week 26 of the study. Receives: Device: Chewing device only |
| Oral Motor Therapy Only | Active comparator | This group will be administered an Oral Motor Therapy program to follow over the 26-week study period. They will also have the clinical and questionnaire measurements taken at the beginning, week 10 and week 26 of the study. Receives: Other: Oral Motor Therapy Treatment Arm |
| Myo Munchee and Oral Motor Therapy | Active comparator | This group will be administered an Oral Motoro Therapy program as well as a Myo Munchee protocol to follow over the 26-week study period. They will also have the clinical and questionnaire measurements taken at the beginning, week 10 and week 26 of the study. Receives: Device: Myo Munchee and Oral Motor Therapy Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maxillary expansion
- Palatal transverse width (in mm) expansion. Measured using an intraoral 3D iTero scanner.
- Palatal sagittal depth (in mm) expansion. Measured using an intraoral 3D iTero scanner.
- Palatal vault height (in mm) expansion. Intraoral measurements taken using an intraoral 3D iTero scanner, which is used to print a 3D model of the intraoral maxilla. The palatal height will then be measured using a GPM \& Holtain Palatometer (Model no. 215)
Measured: 26 weeks
Secondary outcomes (4)
Resolution of dysfunctional resting mouth posture
Resting mouth posture outcome will be considered resolved if the below measurements are no longer present at the final evaluation. To assess this outcome, the Speech-Language Pathologist (SLP) will assess if:
- Lips open when the child is resting
- Mouth breathing during the day and night as mentioned by parent
- Tongue rests on the floor of the mouth. The SLP will gently pull down the chin at rest and again look to see where the tongue is once the lips have opened. This is performed after movement, eating and while the patient is sitting.
If any of these parameters is present at the first evaluation and then resolved at the final evaluation (i.e. no longer present), this will be consider a completed secondary outcome.
Measured: 26 weeks
Resolution of Oral Motor Development Sequence dysfunction
Oral Motor Development Sequence dysfunction will be determined by the SLP against 6 parameters, which is expected of a child to be able to do by 36 months of age:
- Internal jaw stabilization
- Tongue-tip elevation for swallowing
- Appropriate jaw grading for biting and chewing
- Gradual refinement of tongue movements
- Circular rotary chew patterns
- Mature swallow pattern
The above criteria will be measured during the initial evaluation and determined if they have dysfunction in any of the domains (1-6). They will then be reassessed at 26 weeks during the final evaluation and assess if they have been resolved after completing the study's intervention.
Measured: 26 weeks
Improvement in patients sleep and behavior
Improvement in sleep and behavior as evaluated with the Children's General Airway Screening Protocol (C-GASP) Questionnaire.
Measured: 26 weeks
Improvement in patients sleep and behavior
Improvement in sleep and behavior as evaluated with the Sleep Disorders Inventory for Students-Revised (SDIS-R) by Child Uplift, Inc
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start20 Aug 2025 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Orofacial Myofunctional DisordersStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Myo Munchee (Operations) Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ignatius Bourke, Bachelor of Science (Hons), Principal investigator, Myo Munchee (Operations) Pty Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07088055
- Sponsor's protocol ID
- 0001
- Status last verified
- Jul 2025
- First submitted
- 26 Jun 2025
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: The individual participant data will only be shared with those researchers involved in the study. Specifically, the clinicians who will be taking the measurements and administering the therapy will have access to the de-identified data. The Principal Investigator will also have access to the de-identified data. No other person or persons will have access to the de-identified data.
Publications
Thilander B. Dentoalveolar development in subjects with normal occlusion. A longitudinal study between the ages of 5 and 31 years. Eur J Orthod. 2009 Apr;31(2):109-20. doi: 10.1093/ejo/cjn124.
PubMed 19304760
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, 6-month, Randomized, and Controlled Trial to Compare the Effects of Myo Munchee Therapy and Oral Motor Therapy (OMT) in Pediatric Patients (Aged 3-5 Years) to Treat Maxillary Deficiency and Orofacial Myofunctional Dysfunction (OMD).
- ClinicalTrials.gov ID
- NCT07088055
- Acronym / sponsor ID
- 0001
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Myo Munchee (Operations) Pty LtdIndustry (pharma, biotech, devices)
- Study start
- 20 Aug 2025 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 28 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.
Multi-center, 6-month, randomized, and controlled trial to compare the effects of Myo Munchee therapy and Oral Motor Therapy (OMT) in pediatric patients (aged 3-5 years) to treat maxillary deficiency and orofacial myofunctional dysfunction (OMD).
Detailed description
This study is intended for 3-5 year old children who have a deficiency in their maxillary, dental and oral muscle development. They are at the ideal age for undertaking preventative dental and Oral Motor Therapy to improve their orofacial (referring to structures in the mouth, jaw, lips and cheeks) development, which will likely improve their health and wellbeing. The therapies being used are Oral Motor Therapy and Myo Munchee Therapy. Oral Motor Therapy is a type of therapy used by Speech-Language Pathologists to help patients with feeding, chewing and swallowing difficulties. The Myo Munchee, is a small handheld medical device that fits within the mouth. It is intended for children that have issues with (a) dribbling and drooling, mouth breathing in the daytime or during sleep, (c) messy eating, (d) misaligned teeth, (e) ear and sinus congestion, and (f) teeth clenching and grinding. Both of these therapies are clinically effective and safe. They are low-cost and minimally invasive treatments to resolve OMD's (referring to abnormal patterns of movement, function or positioning of the muscles of the mouth, face, and jaw that interfere with normal growth, development or function) and likely improve maxillary deficiency (referring to the underdevelopment or abnormality of the upper jaw).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –There will be no intervention administered to this group. This group will have their clinical and questionnaire measurements taken at the beginning, week 10 and week 26 of the study. |
| Myo Munchee Only | Experimental | Device: Chewing device onlyThis group will be administered the Myo Munchee and be given a protocol to follow over the 26-week study period. They will also have the clinical and questionnaire measurements taken at the beginning, week 10 and week 26 of the study. |
| Oral Motor Therapy Only | Active comparator | Other: Oral Motor Therapy Treatment ArmThis group will be administered an Oral Motor Therapy program to follow over the 26-week study period. They will also have the clinical and questionnaire measurements taken at the beginning, week 10 and week 26 of the study. |
| Myo Munchee and Oral Motor Therapy | Active comparator | Device: Myo Munchee and Oral Motor Therapy TreatmentThis group will be administered an Oral Motoro Therapy program as well as a Myo Munchee protocol to follow over the 26-week study period. They will also have the clinical and questionnaire measurements taken at the beginning, week 10 and week 26 of the study. |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Aged between 36 - 60 (3-5 yrs) months old and will not turn 6 years of age before the study completion
- Diagnosed with having at least two maxillary skeletal-dental malocclusion traits as determined by the dentist
- At least one of the identified Orofacial Myofunctional Dysfunction (OMD) traits determined by the Speech-Language Pathologist (CCC-SLP)
Key exclusion criteria (13 listed)
- A patient must be considered healthy to be included in this study. Definition of health: the patient does not have ongoing treatment, medication or specialized assessments (more than routine follow up exams) with health care providers regarding a condition. If they have had treatment for a condition (e.g. treated by respiratory physician for acute asthma hospitalization), it must have been 12 months or more since their last appointment with a health provider related to that condition.
- Ongoing care from a sleep physician or respiratory physician Current use of Continuous Positive Airway Pressure (CPAP), nasal sprays, sleeping or behavioral medication to treat diagnosed sleep disorder or behavioral disorder Adenectomy or tonsillectomy within last 12 months
- Any previous or current tumors or traumas in the head, neck and jaw region Patients with any known genetic or congenital conditions that impair oral motor muscle function, oral motor coordination, or speech articulation, such as but not limited to muscular dystrophy, cerebral palsy, will be excluded from the study.
- Patients with any known syndromic conditions to affect oral motor function, including but not limited to syndromes that involve craniofacial anomalies, neuromuscular disorders, or developmental delays affecting oral motor muscle control, speech articulation, or swallowing, such as Down Syndrome, Pierre Robin sequence, or Moebius syndrome.
- Children that do not have their 2nd molars by 36 months of age
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 |
|---|---|---|
| Chewing device onlyAlso: Chewing deviceThis group will be administered the Myo Munchee and be given a protocol to follow over the 26-week study period. They will also have the clinical and questionnaire measurements taken at the beginning, week 10 and week 26 of the study. | Device | Myo Munchee Only |
| Myo Munchee and Oral Motor Therapy TreatmentAlso: Chewing device, Oral Motor TherapyThis group will be administered an Oral Motoro Therapy program as well as a Myo Munchee protocol to follow over the 26-week study period. They will also have the clinical and questionnaire measurements taken at the beginning, week 10 and week 26 of the study. | Device | Myo Munchee and Oral Motor Therapy |
| Oral Motor Therapy Treatment ArmAlso: Oral Motor TherapyThis group will be administered an Oral Motor Therapy program to follow over the 26-week study period. They will also have the clinical and questionnaire measurements taken at the beginning, week 10 and week 26 of the study. | Other | Oral Motor Therapy Only |
Primary outcome
Maxillary expansion
Time frame: 26 weeks
1. Palatal transverse width (in mm) expansion. Measured using an intraoral 3D iTero scanner. 2. Palatal sagittal depth (in mm) expansion. Measured using an intraoral 3D iTero scanner. 3. Palatal vault height (in mm) expansion. Intraoral measurements taken using an intraoral 3D iTero scanner, which is used to print a 3D model of the intraoral maxilla. The palatal height will then be measured using a GPM \& Holtain Palatometer (Model no. 215)
4 secondary outcomes
Resolution of dysfunctional resting mouth posture
Time frame: 26 weeks
Resolution of Oral Motor Development Sequence dysfunction
Time frame: 26 weeks
Improvement in patients sleep and behavior
Time frame: 26 weeks
Improvement in patients sleep and behavior
Time frame: 26 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
- Background: PubMed 19304760Thilander B. Dentoalveolar development in subjects with normal occlusion. A longitudinal study between the ages of 5 and 31 years. Eur J Orthod. 2009 Apr;31(2):109-20. doi: 10.1093/ejo/cjn124.
- Myo Munchee HomepageLink provided by the sponsor.
- Myo Munchee Educational MaterialLink provided by the sponsor.
- Oral Motor Therapy ExercisesLink provided by the sponsor.
- Individual participant dataSharing planned: No. The individual participant data will only be shared with those researchers involved in the study. Specifically, the clinicians who will be taking the measurements and administering the therapy will have access to the de-identified data. The Principal Investigator will also have access to the de-identified data. No other person or persons will have access to the de-identified data.
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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.
Ignatius Bourke, Bachelor of Science (Hons) principal investigator
Myo Munchee (Operations) Pty Ltd
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chewing device only, Myo Munchee and Oral Motor Therapy Treatment and Oral Motor Therapy Treatment Arm in people with Orofacial Myofunctional Disorders and Myo Munchee, run by Myo Munchee (Operations) Pty Ltd at 2 sites in United States.
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 3 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ignatius Bourke, Bachelor of Science (Hons) (+61 466 456 764, ignatius@myomunchee.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maxillary expansion (time frame: 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07088055, which also lists 1 linked publication.
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 28 Jul 2025.