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Compares treatment options for Orofacial Myofunctional Disorders
Official title 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).
ClinicalTrials.gov ID: NCT07088055
What this study is testing
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 to 5. Healthy volunteers may be eligible.
You may be able to join if
- 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)
You likely can't join if
- A patient must be considered healthy to be included in this study. Definition of health: the patient does not have ongoing treatment, medication or...
- 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...
- Patients with any known syndromic conditions to affect oral motor function, including but not limited to syndromes that involve craniofacial...
- 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...
- History of prescription for therapeutic gum chewing and/or use of edibles in treatment program
See the full eligibility 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)
- 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...
- 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 3 years to 5 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.