Actively Recruiting
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).
Led by Myo Munchee (Operations) Pty Ltd · Updated on 2025-07-28
48
Participants Needed
2
Research Sites
92 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
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).
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 36 and 60 months (3-5 years) and will not turn 6 before study completion
- Diagnosed with at least two maxillary skeletal-dental malocclusion traits by a dentist
- Has at least one Orofacial Myofunctional Dysfunction (OMD) trait identified by a Speech-Language Pathologist (CCC-SLP)
You will not qualify if you...
- Not considered healthy, meaning ongoing treatment, medication, or specialized assessments for any condition
- Ongoing care from a sleep or respiratory physician
- Current use of CPAP, nasal sprays, or medications for sleep or behavioral disorders
- Adenectomy or tonsillectomy within the last 12 months
- Previous or current tumors or trauma in head, neck, or jaw region
- Known genetic or congenital conditions impairing oral motor function or speech articulation (e.g., muscular dystrophy, cerebral palsy)
- Known syndromic conditions affecting oral motor function or speech, including Down Syndrome, Pierre Robin sequence, or Moebius syndrome
- Does not have 2nd molars by 36 months of age
- Overweight with BMI above 85th percentile (z score of 1)
- History of therapeutic gum chewing prescription or use of edibles in treatment
- Previous tongue tie release surgery
- Any previous therapeutic oral device treatment
- Previous or current dental, Oral Motor Therapy, or orthodontic treatment
- Gross neglect of oral health and presence of dental caries
- Grade 4 tonsils on Brodsky scale
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Center for Svedhyaya Therapy Services
Chicago, Illinois, United States, 60302
Actively Recruiting
2
Dentistry for Children
Chicago, Illinois, United States, 60614
Actively Recruiting
Research Team
I
Ignatius Bourke, Bachelor of Science (Hons)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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