RECRUITING

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).

Conditions

Orofacial Myofunctional Disorders Myo Munchee Oral Motor Therapy Maxillary Deficiency

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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).

Quick Facts

Study Start:2025-08-20

Study Completion:2027-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07088055

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:3 Years to 5 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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)	* 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. * 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

Inclusion Criteria

Exclusion 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)

* 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.
* 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

Contacts and Locations

Study Contact

Ignatius Bourke, Bachelor of Science (Hons)

CONTACT

+61 466 456 764

ignatius@myomunchee.com

Principal Investigator

Ignatius Bourke, Bachelor of Science (Hons)

PRINCIPAL_INVESTIGATOR

Myo Munchee (Operations) Pty Ltd

Study Locations (Sites)

Center for Svedhyaya Therapy Services

Chicago, Illinois, 60302

United States

Dentistry for Children

Chicago, Illinois, 60614

United States

Collaborators and Investigators

Sponsor: Myo Munchee (Operations) Pty Ltd

Ignatius Bourke, Bachelor of Science (Hons), PRINCIPAL_INVESTIGATOR, Myo Munchee (Operations) Pty Ltd

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-20

Study Completion Date2027-06

Study Record Updates

Study Start Date2025-08-20

Study Completion Date2027-06

Terms related to this study

Additional Relevant MeSH Terms

Orofacial Myofunctional Disorders
Myo Munchee
Oral Motor Therapy
Maxillary Deficiency