Myo Munchee versus Oral Motor Therapy to improve upper-jaw growth and mouth muscle function in young children
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).
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 3 Years to 5 Years |
| Sex | All |
| Sponsor | Myo Munchee (Operations) Pty Ltd Industry-sponsored |
| Locations | 2 sites (Chicago, Illinois and 1 other locations) |
| Trial ID | NCT07088055 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Chicago, Illinois and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.