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).
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 4
- 主要终点
- Maxillary expansion
研究概览
简要总结
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).
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Maxillary expansion
时间窗: 26 weeks
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)
Maxillary expansion
时间窗: 26 weeks
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)
次要结局
- Resolution of dysfunctional resting mouth posture(26 weeks)
- Resolution of Oral Motor Development Sequence dysfunction(26 weeks)
- Improvement in patients sleep and behavior(26 weeks)
- Resolution of dysfunctional resting mouth posture(26 weeks)
- Resolution of Oral Motor Development Sequence dysfunction(26 weeks)
- Improvement in patients sleep and behavior(26 weeks)