Recruiting

Myo Munchee & OMT

Sponsor:

Myo Munchee (Operations) Pty Ltd

Code:

NCT07088055

Conditions

Orofacial Myofunctional Disorders

Myo Munchee

Oral Motor Therapy

Maxillary Deficiency

Eligibility Criteria

Sex: All

Age: 3 - 5

Healthy Volunteers: Accepted

Interventions

Chewing device only

Myo Munchee and Oral Motor Therapy Treatment

Oral Motor Therapy Treatment Arm

Study Details

Brief 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).

Conditions

Orofacial Myofunctional Disorders

Myo Munchee

Oral Motor Therapy

Maxillary Deficiency

Study ID

NCT07088055

Start date

Aug 20, 2025

Status verified date

Jul, 2025

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 5

Healthy Volunteers: Accepted

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

Study Design

Enrollment

48 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Control group

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.

experimental: Myo Munchee Only

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.

active comparator: Oral Motor Therapy Only

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.

active comparator: Myo Munchee and 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.

Interventions

Chewing device only

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 Treatment

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 Arm

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.

Primary outcome measure

  • Maxillary expansion [ Time Frame: 26 weeks ]

Central Contacts and Locations

Central contacts

Ignatius Bourke, Bachelor of Science (Hons)

+61 466 456 764ignatius@myomunchee.com

Locations

Center for Svedhyaya Therapy Services

Recruiting

Chicago, Illinois, United States, 60302

Contacts

Principal Investigator:

Jodi Walker, MA, CCC-SLP

Dentistry for Children

Recruiting

Chicago, Illinois, United States, 60614

Contacts

Kevin Bourke, M.D., D.D.S

312-523-8455kbo569@gmail.com

Principal Investigator:

Kevin Boyd, M.D., D.D.S

More Information

Sponsor

Myo Munchee (Operations) Pty Ltd

Last update posted

Jul 28, 2025

Last verified

Jul, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Myo Munchee (Operations) Pty Ltd on 2025-07-28.