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).

Myo Munchee (Operations) Pty Ltd48 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Interventions

Chewing device onlyDEVICE

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.

Myo Munchee and Oral Motor Therapy TreatmentDEVICE

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.

Oral Motor Therapy Treatment ArmOTHER

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.

Eligibility

Sex: ALLMin age: 3 YearsMax age: 5 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Aged between 36 - 60 (3-5 yrs) months old and will not turn 6 years of age before the study completion * Diagnosed with having at least two maxillary skeletal-dental malocclusion traits as determined by the dentist * At least one of the identified Orofacial Myofunctional Dysfunction (OMD) traits determined by the Speech-Language Pathologist (CCC-SLP) Exclusion Criteria: * A patient must be considered healthy to be included in this study. Definition of health: the patient does not have ongoing treatment, medication or specialized assessments (more than routine follow up exams) with health care providers regarding a condition. If they have had treatment for a condition (e.g. treated by respiratory physician for acute asthma hospitalization), it must have been 12 months or more since their last appointment with a health provider related to that condition. 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 * Any previous or current tumors or traumas in the head, neck and jaw region Patients with any known genetic or congenital conditions that impair oral motor muscle function, oral motor coordination, or speech articulation, such as but not limited to muscular dystrophy, cerebral palsy, will be excluded from the study. * Patients with any known syndromic conditions to affect oral motor function, including but not limited to syndromes that involve craniofacial anomalies, neuromuscular disorders, or developmental delays affecting oral motor muscle control, speech articulation, or swallowing, such as Down Syndrome, Pierre Robin sequence, or Moebius syndrome. * Children that do not have their 2nd molars by 36 months of age * Overweight, Z-scores Body Mass Index (BMI) above 85th percentile (z score of 1) Boys: https://www.cdc.gov/growthcharts/data/extended-bmi/BMI-Age-percentiles-BOYS-Z-Scores.pdf Girls: https://www.cdc.gov/growthcharts/data/extended-bmi/BMI-Age-percentiles-GIRLS-Z-Scores.pdf * History of prescription for therapeutic gum chewing and/or use of edibles in treatment program * Previous tongue tie releases (frenuloplasty and frenectomy) * Any therapeutic oral device treatment * Previous or current treatment from any other dental, Oral Motor Therapy (OMT) or orthodontic provider * Gross neglect of patient's oral health and presence of dental caries * Grade 4 tonsils on Brodsky scale

Outcomes

Primary Outcomes

Maxillary expansion

1. Palatal transverse width (in mm) expansion. Measured using an intraoral 3D iTero scanner. 2. Palatal sagittal depth (in mm) expansion. Measured using an intraoral 3D iTero scanner. 3. Palatal vault height (in mm) expansion. Intraoral measurements taken using an intraoral 3D iTero scanner, which is used to print a 3D model of the intraoral maxilla. The palatal height will then be measured using a GPM \& Holtain Palatometer (Model no. 215)

Time frame: 26 weeks

Secondary Outcomes

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: 1. Lips open when the child is resting 2. Mouth breathing during the day and night as mentioned by parent 3. Tongue rests on the floor of the mouth. The SLP will gently pull down the chin at rest and again look to see where the tongue is once the lips have opened. This is performed after movement, eating and while the patient is sitting. 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.

Time frame: 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: 1. Internal jaw stabilization 2. Tongue-tip elevation for swallowing 3. Appropriate jaw grading for biting and chewing 4. Gradual refinement of tongue movements 5. Circular rotary chew patterns 6. Mature swallow pattern 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.

Time frame: 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.

Time frame: 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

Time frame: 26 weeks

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).

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts