Evaluation of the Effect of Adenoid Hypertrophy on the Masseter Muscle in Children: A Comparative Ultrasonographic Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Masseter Muscle Thickness and Internal Echogenic Bands Assessed by Ultrasonography
研究概览
简要总结
The goal of this observational study is to evaluate the effect of adenoid hypertrophy on the masseter muscle in children aged 3 to 8 years. The primary objectives are:
- To assess whether adenoid hypertrophy affects the thickness or structure of the masseter muscle.
- To determine whether there is a measurable difference in masseter muscle characteristics between children with and without adenoid hypertrophy.
Researchers will compare children diagnosed with adenoid hypertrophy and scheduled for adenoidectomy to healthy controls without adenoid hypertrophy.
Each participant will:
- Undergo ultrasonographic examination of the masseter muscle using a 9L linear probe (6-15 MHz), and
- Have their occlusal relationship, dental findings, age, sex, and adenoid hypertrophy grade recorded.
详细描述
Hypotheses
H0 (Null Hypothesis): There is no difference in masseter muscle thickness or the visibility of internal echogenic bands between children with adenoid hypertrophy and healthy controls.
H1 (Alternative Hypothesis): There is a difference in masseter muscle thickness or the visibility of internal echogenic bands between children with adenoid hypertrophy and healthy controls.
Sample Size Calculation No prior studies were identified comparing masseter muscle thickness between children with adenoid hypertrophy and healthy controls. The sample size was calculated using G*Power software. Assuming a medium effect size (0.6), an alpha level of 0.05, and a power of 0.80, the required total sample size was determined to be 72 participants.
Ultrasound Evaluation of the Masseter Muscle
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 3 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged between 3 and 8 years
- •Children diagnosed with adenoid hypertrophy
- •Children without any systemic disease
排除标准
- •Children with a history of surgery for adenoid hypertrophy
- •Children who are uncooperative during clinical examination
- •Children with syndromes involving the maxillofacial region
- •Children with multiple missing teeth
结局指标
主要结局
Masseter Muscle Thickness and Internal Echogenic Bands Assessed by Ultrasonography
时间窗: At enrollment (single assessment)
The masseter muscles of both groups will be evaluated using a LOGIQ S8 R4 ultrasound device with a 9L linear probe. All participants will be examined in the supine position. The probe will be placed: Transversely: Along a line extending from the oral commissure to the ear tragus Longitudinally: Perpendicular to the mandibular body The thickness of the right and left masseter muscles will be measured in millimeters, both at rest and during maximum clenching, from the thickest region of the muscle. Internal echogenic bands will be classified into three types: * Type 1: Clear, thin transverse bands * Type 2: Thickened bands with reduced echogenicity * Type 3: Disappearance or reduction in the number of bands
次要结局
- Presence of Bruxism (Yes/No) in Children With and Without Adenoid Hypertrophy(At enrollment (single assessment))
- Primary Molar Occlusion (Mesial Step, Distal Step, Flush Terminal Plane) or Angle's Classification (Class I-III) of Permanent Molars in Children With and Without Adenoid Hypertrophy(At enrollment (single assessment))
- Presence of Mouth Breathing (Yes/No) in Children With and Without Adenoid Hypertrophy(At enrollment (single assessment))
- Overjet and Overbite in Children With and Without Adenoid Hypertrophy(At enrollment (single assessment))
- Adenoid Hypertrophy Grade in Children Diagnosed With Adenoid Hypertrophy and Scheduled for Surgery(At enrollment (single assessment))
- Number of Carious, Missing and Filled Teeth in Children With and Without Adenoid Hypertrophy(At enrollment (single assessment))
研究者
Melis AKYILDIZ
Assistant Professor
Aydin Adnan Menderes University