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

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

Eligibility Criteria

Sex

ALL

Age

3 Years - 5 Years

Healthy Volunteers

Accepted

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.
• 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.
• 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.

Study Details

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 Dates

Start date

Aug 20, 2025

Status verified

Jul 2025

Primary completion

Jun 30, 2027

Completion

Jun 30, 2027

Study Design

Enrollment

48 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• No Intervention: Control group
  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.
• Experimental: Myo Munchee 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.
• Active Comparator: Oral Motor Therapy Only
  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.
• Active Comparator: Myo Munchee and Oral Motor Therapy
  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.

Primary Outcome Measure

Maxillary expansion [ Time Frame: 26 weeks ]

Central Contacts

• Ignatius Bourke, Bachelor of Science (Hons)
  +61 466 456 764
  [email protected]

Locations (2)

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