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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).
This study is intended for 3-5 year old children who have a deficiency in their maxillary, dental and oral muscle development. They are at the ideal age for undertaking preventative dental and Oral Motor Therapy to improve their orofacial (referring to structures in the mouth, jaw, lips and cheeks) development, which will likely improve their health and wellbeing. The therapies being used are Oral Motor Therapy and Myo Munchee Therapy. Oral Motor Therapy is a type of therapy used by Speech-Language Pathologists to help patients with feeding, chewing and swallowing difficulties. The Myo Munchee, is a small handheld medical device that fits within the mouth. It is intended for children that have issues with (a) dribbling and drooling, mouth breathing in the daytime or during sleep, (c) messy eating, (d) misaligned teeth, (e) ear and sinus congestion, and (f) teeth clenching and grinding. Both of these therapies are clinically effective and safe. They are low-cost and minimally invasive treatments to resolve OMD's (referring to abnormal patterns of movement, function or positioning of the muscles of the mouth, face, and jaw that interfere with normal growth, development or function) and likely improve maxillary deficiency (referring to the underdevelopment or abnormality of the upper jaw).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No 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. | |
| Myo Munchee Only | Experimental | 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. |
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| Oral Motor Therapy Only | Active Comparator | 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. |
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| Myo Munchee and Oral Motor Therapy | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Maxillary expansion |
| 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Resolution of dysfunctional resting mouth posture | Resting mouth posture outcome will be considered resolved if the below measurements are no longer present at the final evaluation. To assess this outcome, the Speech-Language Pathologist (SLP) will assess if:
If any of these parameters is present at the first evaluation and then resolved at the final evaluation (i.e. no longer present), this will be consider a completed secondary outcome. |
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Inclusion Criteria:
Exclusion Criteria:
Of particular consideration:
Ongoing care from a sleep physician or respiratory physician Current use of Continuous Positive Airway Pressure (CPAP), nasal sprays, sleeping or behavioral medication to treat diagnosed sleep disorder or behavioral disorder Adenectomy or tonsillectomy within last 12 months
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ignatius Bourke, Bachelor of Science (Hons) | Contact | +61 466 456 764 | ignatius@myomunchee.com |
| Name | Affiliation | Role |
|---|---|---|
| Ignatius Bourke, Bachelor of Science (Hons) | Myo Munchee (Operations) Pty Ltd | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Svedhyaya Therapy Services | Recruiting | Chicago | Illinois | 60302 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19304760 | Background | Thilander B. Dentoalveolar development in subjects with normal occlusion. A longitudinal study between the ages of 5 and 31 years. Eur J Orthod. 2009 Apr;31(2):109-20. doi: 10.1093/ejo/cjn124. |
| Label | URL |
|---|---|
| Myo Munchee Homepage | View source |
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The individual participant data will only be shared with those researchers involved in the study. Specifically, the clinicians who will be taking the measurements and administering the therapy will have access to the de-identified data. The Principal Investigator will also have access to the de-identified data. No other person or persons will have access to the de-identified data.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 25, 2025 | Jun 26, 2025 |
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|
| 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. |
|
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| 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. |
|
|
| 26 weeks |
| Resolution of Oral Motor Development Sequence dysfunction | Oral Motor Development Sequence dysfunction will be determined by the SLP against 6 parameters, which is expected of a child to be able to do by 36 months of age:
The above criteria will be measured during the initial evaluation and determined if they have dysfunction in any of the domains (1-6). They will then be reassessed at 26 weeks during the final evaluation and assess if they have been resolved after completing the study's intervention. | 26 weeks |
| Improvement in patients sleep and behavior | Improvement in sleep and behavior as evaluated with the Children's General Airway Screening Protocol (C-GASP) Questionnaire. | 26 weeks |
| Improvement in patients sleep and behavior | Improvement in sleep and behavior as evaluated with the Sleep Disorders Inventory for Students-Revised (SDIS-R) by Child Uplift, Inc | 26 weeks |
| Dentistry for Children | Recruiting | Chicago | Illinois | 60614 | United States |
|
| Myo Munchee Educational Material | View source |
| Oral Motor Therapy Exercises | View source |
| Prot_000.pdf |
| ID | Term |
|---|---|
| D063173 | Retrognathia |
| ID | Term |
|---|---|
| D007569 | Jaw Abnormalities |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D019767 | Maxillofacial Abnormalities |
| D019465 | Craniofacial Abnormalities |
| D009139 | Musculoskeletal Abnormalities |
| D009057 | Stomatognathic Diseases |
| D008336 | Mandibular Diseases |
| D018640 | Stomatognathic System Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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