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).

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).

Study Overview

• Status: Recruiting
• Conditions: Maxillary Deficiency; Orofacial Myofunctional Disorders; Myo Munchee; Oral Motor Therapy
• Intervention / Treatment: Device: Chewing device only; Other: Oral Motor Therapy Treatment Arm; Device: Myo Munchee and Oral Motor Therapy Treatment

Detailed Description

This study is intended for 3-5 year old children who have a deficiency in their maxillary, dental and oral muscle development. They are at the ideal age for undertaking preventative dental and Oral Motor Therapy to improve their orofacial (referring to structures in the mouth, jaw, lips and cheeks) development, which will likely improve their health and wellbeing. The therapies being used are Oral Motor Therapy and Myo Munchee Therapy. Oral Motor Therapy is a type of therapy used by Speech-Language Pathologists to help patients with feeding, chewing and swallowing difficulties. The Myo Munchee, is a small handheld medical device that fits within the mouth. It is intended for children that have issues with (a) dribbling and drooling, mouth breathing in the daytime or during sleep, (c) messy eating, (d) misaligned teeth, (e) ear and sinus congestion, and (f) teeth clenching and grinding. Both of these therapies are clinically effective and safe. They are low-cost and minimally invasive treatments to resolve OMD's (referring to abnormal patterns of movement, function or positioning of the muscles of the mouth, face, and jaw that interfere with normal growth, development or function) and likely improve maxillary deficiency (referring to the underdevelopment or abnormality of the upper jaw).

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ignatius Bourke, Bachelor of Science (Hons); Phone Number: +61 466 456 764; Email: ignatius@myomunchee.com

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60302
      • Recruiting
      • Center for Svedhyaya Therapy Services
      • Contact: Jodi Walker, MA, CCC-SLP; Phone Number: 917-620-7916; Email: jodiwalkerspeech@gmail.com
      • Principal Investigator: Jodi Walker, MA, CCC-SLP
    • Chicago, Illinois, United States, 60614
      • Recruiting
      • Dentistry for Children
      • Contact: Kevin Bourke, M.D., D.D.S; Phone Number: 312-523-8455; Email: kbo569@gmail.com
      • Principal Investigator: Kevin Boyd, M.D., D.D.S

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: 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.; Other Names: Chewing device
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.	Other: 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.; Other Names: Oral Motor Therapy
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.	Device: 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.; Other Names: Chewing device; Oral Motor Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maxillary expansion	Palatal transverse width (in mm) expansion. Measured using an intraoral 3D iTero scanner.; Palatal sagittal depth (in mm) expansion. Measured using an intraoral 3D iTero scanner.; Palatal vault height (in mm) expansion. Intraoral measurements taken using an intraoral 3D iTero scanner, which is used to print a 3D model of the intraoral maxilla. The palatal height will then be measured using a GPM & Holtain Palatometer (Model no. 215)	26 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resolution of dysfunctional resting mouth posture	Resting mouth posture outcome will be considered resolved if the below measurements are no longer present at the final evaluation. To assess this outcome, the Speech-Language Pathologist (SLP) will assess if: Lips open when the child is resting; Mouth breathing during the day and night as mentioned by parent; Tongue rests on the floor of the mouth. The SLP will gently pull down the chin at rest and again look to see where the tongue is once the lips have opened. This is performed after movement, eating and while the patient is sitting. If any of these parameters is present at the first evaluation and then resolved at the final evaluation (i.e. no longer present), this will be consider a completed secondary outcome.	26 weeks
Resolution of Oral Motor Development Sequence dysfunction	Oral Motor Development Sequence dysfunction will be determined by the SLP against 6 parameters, which is expected of a child to be able to do by 36 months of age: Internal jaw stabilization; Tongue-tip elevation for swallowing; Appropriate jaw grading for biting and chewing; Gradual refinement of tongue movements; Circular rotary chew patterns; Mature swallow pattern The above criteria will be measured during the initial evaluation and determined if they have dysfunction in any of the domains (1-6). They will then be reassessed at 26 weeks during the final evaluation and assess if they have been resolved after completing the study's intervention.	26 weeks
Improvement in patients sleep and behavior	Improvement in sleep and behavior as evaluated with the Children's General Airway Screening Protocol (C-GASP) Questionnaire.	26 weeks
Improvement in patients sleep and behavior	Improvement in sleep and behavior as evaluated with the Sleep Disorders Inventory for Students-Revised (SDIS-R) by Child Uplift, Inc	26 weeks

Collaborators and Investigators

• Sponsor: Myo Munchee (Operations) Pty Ltd
• Investigators: Principal Investigator: Ignatius Bourke, Bachelor of Science (Hons), Myo Munchee (Operations) Pty Ltd

Publications and helpful links

General Publications

• Thilander B. Dentoalveolar development in subjects with normal occlusion. A longitudinal study between the ages of 5 and 31 years. Eur J Orthod. 2009 Apr;31(2):109-20. doi: 10.1093/ejo/cjn124.

Helpful Links

• Myo Munchee Homepage
• Myo Munchee Educational Material
• Oral Motor Therapy Exercises

Study record dates

Study Major Dates

• Study Start (Estimated): August 20, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: June 26, 2025
• First Submitted That Met QC Criteria: July 19, 2025
• First Posted (Actual): July 28, 2025

Study Record Updates

• Last Update Posted (Actual): July 28, 2025
• Last Update Submitted That Met QC Criteria: July 19, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Jaw Diseases; Jaw Abnormalities; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Micrognathism
• Other Study ID Numbers: 0001 (Researcher)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The individual participant data will only be shared with those researchers involved in the study. Specifically, the clinicians who will be taking the measurements and administering the therapy will have access to the de-identified data. The Principal Investigator will also have access to the de-identified data. No other person or persons will have access to the de-identified data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No