Evaluation of the Effect of Adenoid Hypertrophy on the Masseter Muscle in Children: A Comparative Ultrasonographic Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: USG.
- Who it may be relevant to
- Registry conditions: Adenoid Hypertrophy, Masseter Muscle, Malocclusion. Basic parameters: 3 years — 8 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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
Masseter muscle thickness and the visibility of internal echogenic bands will be assessed bilaterally at rest and during maximum clenching (intercuspal position). Evaluations will be performed with participants in the supine position. The ultrasound probe will be placed:
* Transversely: Parallel to the inferior mandibular border along a line connecting the oral commissure and the tragus. * Longitudinally: Perpendicular to the mandibular body.
Thickness measurements (mm) will be taken from the thickest part of the muscle in both positions. Visibility of internal echogenic bands will be classified as follows:
* Type 1: Clear visibility of thin transverse bands. * Type 2: Thickened bands with reduced echogenicity. * Type 3: Disappearance or reduction in the number of bands.
Evaluations will be performed by the investigator (SY) at the Department of Oral and Maxillofacial Radiology, Faculty of Dentistry, Aydın Adnan Menderes University.
Clinical Examination The principal investigator (BMA) will record each participant's age, sex, adenoid hypertrophy grade, occlusion type, molar relationship classification, overjet, overbite, number of carious, missing, and filled teeth, and the presence of mouth breathing and bruxism.
Statistical and Analytical Methods Data will be analyzed using SPSS version 19.0 (IBM Corp.). The Kolmogorov-Smirnov test will be used to assess normality of distribution. Categorical variables will be expressed as frequencies and percentages; continuous variables will be presented as means and standard deviations. The independent samples t-test will be used to compare measurement data between groups. The chi-square test will be used to evaluate associations between categorical variables and adenoid hypertrophy.
Interventions
- Diagnostic test USG
Masseter Muscle Thickness and Internal Echogenic Bands Assessed by Ultrasonography
Primary outcome measures
- Masseter Muscle Thickness and Internal Echogenic Bands Assessed by Ultrasonography [Time frame: At enrollment (single assessment)]
Secondary outcome measures (6)
- 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 [Time frame: At enrollment (single assessment)]
- Overjet and Overbite in Children With and Without Adenoid Hypertrophy [Time frame: At enrollment (single assessment)]
- Adenoid Hypertrophy Grade in Children Diagnosed With Adenoid Hypertrophy and Scheduled for Surgery [Time frame: At enrollment (single assessment)]
- Presence of Mouth Breathing (Yes/No) in Children With and Without Adenoid Hypertrophy [Time frame: At enrollment (single assessment)]
- Number of Carious, Missing and Filled Teeth in Children With and Without Adenoid Hypertrophy [Time frame: At enrollment (single assessment)]
- Presence of Bruxism (Yes/No) in Children With and Without Adenoid Hypertrophy [Time frame: At enrollment (single assessment)]
Eligibility criteria
Inclusion criteria
- Children aged between 3 and 8 years
- Children diagnosed with adenoid hypertrophy
- Children without any systemic disease
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
Turkey (Türkiye) · 1 center
- Aydın Adnan Menderes University — Aydin
Publications
- Ariji Y, Sakuma S, Izumi M, Sasaki J, Kurita K, Ogi N, Nojiri M, Nakagawa M, Takenaka M, Katsuse S, Ariji E. Ultrasonographic features of the masseter muscle in female patients with temporomandibular disorder associated with myofascial pain. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2004 Sep;98(3):337-41. doi: 10.1016/j.tripleo.2004.06.068. PMID 15356473
Identifiers
NCT: NCT07094581 · 2023/37