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).

NCT07088055 | Recruiting FDA Device

• 1 other identifier: 0001
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Maxillary expansion

  1. Palatal transverse width (in mm) expansion. Measured using an intraoral 3D iTero scanner. 2. Palatal sagittal depth (in mm) expansion. Measured using an intraoral 3D iTero scanner. 3. 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 Outcomes (4)

• Resolution of dysfunctional resting mouth posture

  26 weeks

• Resolution of Oral Motor Development Sequence dysfunction

  26 weeks

• Improvement in patients sleep and behavior

  26 weeks

• Improvement in patients sleep and behavior

  26 weeks

Study Arms (4)

Control group

NO INTERVENTION

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.

Myo Munchee Only

EXPERIMENTAL

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

Oral Motor Therapy Only

ACTIVE COMPARATOR

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

Myo Munchee and Oral Motor Therapy

ACTIVE COMPARATOR

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

Interventions

Chewing device only DEVICE

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.

Also known as: Chewing device

Myo Munchee Only

Myo Munchee and Oral Motor Therapy Treatment DEVICE

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.

Also known as: Chewing device, Oral Motor Therapy

Myo Munchee and Oral Motor Therapy

Oral Motor Therapy Treatment Arm OTHER

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.

Also known as: Oral Motor Therapy

Oral Motor Therapy Only

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Myo Munchee (Operations) Pty Ltd: lead

Study Sites (2)

Center for Svedhyaya Therapy Services

Chicago, Illinois, 60302, United States

RECRUITING

Dentistry for Children

Chicago, Illinois, 60614, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 19304760 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Retrognathia

Condition Hierarchy (Ancestors)

Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic Diseases; Mandibular Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Ignatius Bourke, Bachelor of Science (Hons)

  Myo Munchee (Operations) Pty Ltd

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ignatius Bourke, Bachelor of Science (Hons)

CONTACT

+61 466 456 764; ignatius@myomunchee.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2025
• First Posted: July 28, 2025
• Study Start: August 20, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)