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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).
Sponsor: Myo Munchee (Operations) Pty Ltd
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).
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).
Key Details
Gender
All
Age Range
3 Years - 5 Years
Study Type
INTERVENTIONAL
Enrollment
48
Start Date
2025-08-20
Completion Date
2027-06
Last Updated
2025-07-28
Healthy Volunteers
Yes
Interventions
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.
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.
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.
Locations (2)
Center for Svedhyaya Therapy Services
Chicago, Illinois, United States
Dentistry for Children
Chicago, Illinois, United States