NCT07088055 · Myo Munchee (Operations) Pty Ltd
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).
What this study is about
Multi-center, 6-month, randomly assigned, and controlled trial to compare the effects of Myo Munchee therapy and taken by mouth Motor Therapy (OMT) in pediatric patients (aged 3-5 years) to treat maxillary deficiency and orofacial myofunctional dysfunction (OMD).
View original scientific description
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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Chicago, Illinois
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 28, 2025 · Source of record for eligibility and locations