Myo Munchee versus Oral Motor Therapy to improve upper-jaw growth and mouth muscle function in young children
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).
Run by Myo Munchee (Operations) Pty Ltd · NCT07088055 · Data updated 2026-11-12
This will see if the Myo Munchee mouth device works better than standard oral motor therapy to improve upper-jaw development and mouth muscle function in children ages 3 to 5.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 3 Years to 5 Years |
| Sex | All |
| Enrollment | 48 (estimated) |
| Sponsor | Myo Munchee (Operations) Pty Ltd Industry-sponsored |
| Locations | 2 sites (Chicago, Illinois and 1 other locations) |
| Status | Recruiting |
| Started | August 20, 2025 |
| Main results expected | June 2027 |
| Study ends | June 2027 |
| Registry record updated | July 28, 2025 |
| Trial ID | NCT07088055 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are otherwise healthy children aged 3–5 who have at least two maxillary skeletal-dental malocclusion traits and at least one orofacial myofunctional dysfunction trait and can attend clinic visits.
✕Probably not a fit
Children receiving ongoing specialty medical care (for example active respiratory or sleep physician management), those outside the 3–5 age range, or those with major craniofacial syndromes may not benefit from these low-intensity therapies.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a multi-center, 6-month, randomized controlled comparison of the Myo Munchee chewing device and standard Oral Motor Therapy in children aged 3–5 with maxillary underdevelopment and orofacial myofunctional dysfunction. Participants are randomized to receive the Myo Munchee device protocol or an oral motor therapy program delivered by speech-language pathologists. Outcomes include dental and skeletal measures of the maxilla and clinical measures of orofacial muscle function assessed by dentists and SLPs. The study enrolls otherwise healthy children who meet specified malocclusion and OMD criteria and excludes those with ongoing specialty medical care.
Why it matters
Potential benefit: If successful, the intervention could improve upper-jaw growth, reduce drooling and mouth breathing, and decrease feeding and dental problems that often require more invasive treatment later.
How similar studies have gone: Oral motor therapy has prior clinical support for improving feeding and orofacial function, while the Myo Munchee device has more limited published randomized evidence and is less well studied.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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) Exclusion Criteria: * 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 * 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
Where it's running
-
Center for Svedhyaya Therapy Services
Chicago, Illinois, United States Recruiting -
Dentistry for Children
Chicago, Illinois, United States Recruiting
Study contacts
- Principal investigator: Ignatius Bourke, Bachelor of Science (Hons) — Myo Munchee (Operations) Pty Ltd
- Study coordinator: Ignatius Bourke, Bachelor of Science (Hons)
- Email: ignatius@myomunchee.com
- Phone: +61 466 456 764
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Single-surgery Bone Ring Technique for Sinus Lift and Dental Implant in the Back of the Upper Jaw
This study tests a one-step Bone Ring Technique to lift the sinus and place a dental implant in patients with very thin upper jaw bone.
-
Orofacial muscle training for children with obstructive sleep apnea
This trial will test whether 12 weeks of orofacial muscle exercises help children aged 6–12 with obstructive sleep apnea (AHI > 1) sleep better and feel better during the day.
-
Orofacial muscle therapy for children with Down syndrome or Prader–Willi syndrome and obstructive sleep apnea
We will test whether 20 weeks of orofacial myofunctional therapy can reduce obstructive sleep apnea and improve sleep-related quality of life in children with Down syndrome or Prader–Willi syndrome.
-
Using clear aligners to expand the upper dental arch in children with cleft lip and palate
This study is testing if clear aligners can help expand the upper jaw in children aged 6-8 with cleft lip and palate.
-
Impact of flapless piezoincision on periodontal health during orthodontic treatment
This study is testing if a new technique for orthodontic treatment without cutting the gums can improve gum health better than two types of grafting in adults with dental issues.
-
Comparing two ways to widen the upper jaw: MARPE versus SARME
The team will test whether mini‑screw–assisted expansion (MARPE) or surgically‑assisted expansion (SARME) better widens the upper jaw and how each method changes nasal and sinus structures in people aged 15 and older with maxillary transverse deficiency.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.