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).

What this Trial Is About

Researchers are evaluating the effects of Myo Munchee therapy and Oral Motor Therapy (OMT) in children aged 3 to 5 years who have maxillary deficiency and orofacial myofunctional dysfunction (OMD). This trial aims to study these treatments, which focus on improving the development of the upper jaw and oral muscles, potentially enhancing health and wellbeing in this young population. The study is conducted across multiple centers and is randomized and controlled over six months. Participants are divided into four groups: a control group with no intervention; a group using the Myo Munchee device with a specific protocol; a group following an Oral Motor Therapy program; and a group receiving both Myo Munchee and Oral Motor Therapy. All groups undergo clinical assessments and complete questionnaires at the start, week 10, and week 26 of the study. The Myo Munchee is a small handheld device designed to help with issues like drooling, mouth breathing, and teeth grinding, while Oral Motor Therapy is delivered by speech-language pathologists to support feeding and swallowing difficulties. During the 26-week study, participants will be regularly evaluated through clinical and questionnaire measurements to track improvements in maxillary expansion, resting mouth posture, oral motor function, and sleep and behavior. The study monitors these outcomes to understand the therapies' effects and safety. Total participation lasts approximately six months, with visits scheduled at baseline, mid-study, and study completion to assess progress and treatment impact.

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).