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).

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).

Study Overview

Study Details

Study overview

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).

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).

Condition
Orofacial Myofunctional Disorders
Intervention / Treatment

-

Contacts and Locations

Chicago

Center for Svedhyaya Therapy Services, Chicago, Illinois, United States, 60302

Chicago

Dentistry for Children, Chicago, Illinois, United States, 60614

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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

Ages Eligible for Study

3 Years to 5 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Myo Munchee (Operations) Pty Ltd,

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

Study Record Dates

2027-06