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RECRUITING
NCT07088055
NA

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

View on ClinicalTrials.gov

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

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.

Locations (2)

Center for Svedhyaya Therapy Services

Chicago, Illinois, United States

Dentistry for Children

Chicago, Illinois, United States