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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).

NCT07088055 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-07-28

No results posted yet for this study

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).

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Myo Munchee (Operations) Pty Ltd

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-08-20
Primary Completion
2027-06-30
Completion
2027-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07088055 on ClinicalTrials.gov