Myo Munchee vs Oral Motor Therapy for Orofacial Myofunctional Disorder

Recruiting at 1 trial location

Overseen By Ignatius Bourke, Bachelor of Science (Hons)

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Myo Munchee (Operations) Pty Ltd

Must not be taking: Nasal sprays, Sleeping medication

Disqualifiers: Sleep disorder, Genetic conditions, Overweight, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 26 weeks

48 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two treatments—Myo Munchee therapy and Oral Motor Therapy—to assist young children with jaw and mouth muscle development issues. The goal is to determine which treatment, or combination, more effectively improves conditions like maxillary deficiency and orofacial myofunctional dysfunction. Children aged 3 to 5 years with specific dental issues and challenges in mouth and facial muscle functions may be suitable candidates for this trial. As an unphased trial, it offers families a unique opportunity to explore innovative therapies that could significantly benefit their child's oral health and development.

Do I have to stop taking my current medications for the trial?

The trial requires participants to be healthy, meaning they should not be on ongoing treatment or medication for any condition. If you are currently using medications for a sleep or behavioral disorder, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Earlier studies on Myo Munchee therapy have shown good results in improving swallowing and oral health, with no major side effects, indicating the treatment is generally safe for children.

Research on Oral Motor Therapy (OMT) has also demonstrated positive outcomes. Approximately 80% of participants improved their tongue position, and all showed better lip control. No serious side effects were reported, suggesting it is safe for children.

Overall, these findings suggest that both Myo Munchee and Oral Motor Therapy are safe for young children and are generally well-tolerated without major negative effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Myo Munchee and Oral Motor Therapy for treating Orofacial Myofunctional Disorder because they offer unique approaches compared to traditional treatments like speech therapy and orthodontics. Myo Munchee Therapy is distinct because it involves using a small chewing device that helps strengthen jaw muscles and improve oral posture with a hands-on approach. Oral Motor Therapy focuses on exercises to enhance muscle control and coordination in the mouth and face. Combining both therapies could potentially offer a comprehensive solution by addressing muscle function and improving oral habits, which is why researchers are keen to explore their combined effectiveness.

What evidence suggests that this trial's treatments could be effective for orofacial myofunctional disorder?

This trial will compare Myo Munchee therapy with Oral Motor Therapy (OMT) for treating orofacial myofunctional disorder. Research has shown that Myo Munchee therapy can greatly improve sleep, breathing, teeth alignment, and speech. One study found significant improvement in swallowing after just five weeks of using a device like the Myo Munchee. Participants in this trial may receive Myo Munchee therapy alone or combined with OMT. For OMT, 86% of main studies reported good results, though the quality of these studies varies. Some research found that OMT helps with tongue position and certain speech sounds, but the best studies did not show direct improvements in speech. When used together, these therapies might work better, but specific data on their combined use is limited. ^{1 2 4 6 7}

Who Is on the Research Team?

Ignatius Bourke, Bachelor of Science (Hons)

Principal Investigator

Myo Munchee (Operations) Pty Ltd

Are You a Good Fit for This Trial?

This trial is for children aged 3-5 with orofacial myofunctional disorder, which can include issues like a recessed chin or maxillary deficiency. It's also relevant for those who may benefit from speech therapy. Children must not have mumps to participate.

Inclusion Criteria

My child is between 3 and 5 years old and won't turn 6 before the study ends.

My dentist found I have at least two types of jaw misalignment.

I have been diagnosed with an OMD trait by a speech therapist.

Exclusion Criteria

I do not have conditions like muscular dystrophy or cerebral palsy that affect my mouth and speech.

My child does not have their second molars at 3 years old.

I have been prescribed gum or edibles for treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Myo Munchee Therapy and/or Oral Motor Therapy over a 26-week period

26 weeks

3 visits (in-person) at the beginning, week 10, and week 26

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Myo Munchee Therapy
• Oral Motor Therapy

Trial Overview The study compares Myo Munchee therapy—a chewing device—with Oral Motor Therapy (OMT), and a combination of both, to see which is more effective in treating jaw and facial muscle dysfunction in young kids.

How Is the Trial Designed?

Group I: Myo Munchee Only Experimental Treatment 1 Intervention

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.

Group II: Oral Motor Therapy Only Active Control 1 Intervention

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.

Group III: Control group Active Control 1 Intervention

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.

Group IV: Myo Munchee and Oral Motor Therapy Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Myo Munchee (Operations) Pty Ltd

Lead Sponsor

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07088055

Trial to Compare the Effects of Myo Munchee Therapy and ... This study is intended for 3-5 year old children who have a deficiency in their maxillary, dental and oral muscle development.

2. mdpi.com mdpi.com/2694-2526/50/1/2

A Myofunctional Chewing Device as an Early Intervention ... Throughout the treatment period, the patient demonstrated significant improvements in her sleep, breathing, dental occlusion, speech, and overall confidence.

3. pilotfeasibilitystudies.biomedcentral.com pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-022-01148-3

Myofunctional device use in oral care and swallowing The results indicated that swallowing function significantly improved for those in the intervention group immediately following 5 weeks of ...

4. withpower.com withpower.com/trial/phase-orofacial-myofunctional-disorders-7-2025-cc3b9

Myo Munchee vs Oral Motor Therapy for Orofacial ... Multi-center, 6-month, randomized, and controlled trial to compare the effects of Myo Munchee therapy and Oral Motor Therapy (OMT) in pediatric patients ...

5. pubs.asha.org pubs.asha.org/doi/pdf/10.1044/2022_PERSP-22-00145

Use of Myofunctional Devices in Therapy Programs While positive outcomes targeting a range of areas. (swallowing, oral behaviors, oral hygiene, and speech) were identified, the assessment and therapy protocols ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9388991/

Myofunctional device use in oral care and swallowing The outcomes from this study of feasibility and efficacy for the use of a myofunctional device in improving in oral health and dysphagia in an ...

7. trialx.com trialx.com/clinical-trials/listings/310076/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/

Trial to Compare the Effects of Myo Munchee Therapy and ... Multi-center, 6-month, randomized, and controlled trial to compare the effects of Myo Munchee therapy and Oral Motor Therapy (OMT) in pediatric ...