NCT07088055

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).

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Myo Munchee (Operations) Pty Ltd · Industry
• Sex: All
• Age: 3 Years – 5 Years
• Healthy volunteers: Accepted

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).

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).

Conditions

• Orofacial Myofunctional Disorders
• Myo Munchee
• Oral Motor Therapy
• Maxillary Deficiency

Interventions

Type	Name	Description
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.
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	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.

Timeline

• Start date: 2025-08-20
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2025-07-28
• Last updated: 2025-07-28

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study