RecruitingNot ApplicableNCT07088055

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).

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).


Sponsor

Myo Munchee (Operations) Pty Ltd

Enrollment

48 participants

Start Date

Aug 20, 2025

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 3 YearsMax Age: 5 Years

Inclusion Criteria3

  • 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 Criteria13

  • 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

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Interventions

DEVICEChewing 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.

DEVICEMyo 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.

OTHEROral 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.


Locations(2)

Center for Svedhyaya Therapy Services

Chicago, Illinois, United States

Dentistry for Children

Chicago, Illinois, United States

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NCT07088055


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