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NCT Number: NCT07094581

Evaluation of the Effect of Adenoid Hypertrophy on the Masseter Muscle in Children: A Comparative Ultrasonographic Study

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.

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Key information

Age range

3 year–8 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Aydın Adnan Menderes University

Aydin, Efeler, Turkey (Türkiye)

Location status: Recruiting

Location contact

Esra Dişcioğlu Candemir, dds

SUB_INVESTIGATOR

Melis Akyıldız, phd

CONTACT

[email protected]

905387970703

Melis Akyıldız, phd

PRINCIPAL_INVESTIGATOR

Selin Yeşiltepe, dds,msd

SUB_INVESTIGATOR

Sunay Hoşgör, dds

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

USG

Diagnostic Test

Masseter Muscle Thickness and Internal Echogenic Bands Assessed by Ultrasonography

Primary outcomes

  1. Masseter Muscle Thickness and Internal Echogenic Bands Assessed by Ultrasonography

    Time frame: 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

Secondary outcomes

  1. 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)

    Evaluations will be conducted with children in maximum intercuspation. Primary molar occlusion (mesial step, distal step, flush terminal plane) will be recorded in children with primary dentition. Angle's classification (Class I-III) will be used in children with fully erupted permanent first molars.

    Primary occlusal classification will be based on the distal surfaces of the second primary molars. In a mesial step, the distal surface of the mandibular second primary molar is mesial to that of the maxillary molar. In a distal step, it is distal. In a flush terminal plane, the distal surfaces are aligned.

    Angle's classification will be recorded as follows: Class I, the mesiobuccal cusp of the mandibular first permanent molar aligns with the mesiobuccal groove of the maxillary molar; Class II, the cusp is distal to the groove; Class III, the cusp is mesial to the groove.

  2. Overjet and Overbite in Children With and Without Adenoid Hypertrophy

    Time frame: At enrollment (single assessment)

    Participants will be seated in an upright position, with the head aligned parallel to the Frankfort horizontal plane. Measurements will be performed in maximum intercuspation.

    Overjet (Horizontal Measurement): The distance will be measured by drawing a perpendicular line from the incisal edge of the upper central incisor to the labial surface of the lower central incisor. A periodontal probe will be used, and the values will be recorded in millimeters (mm).

    Overbite (Vertical Measurement): The vertical distance between the incisal edges of the upper and lower central incisors will be measured along the labial surface of the lower incisor using a periodontal probe and recorded in millimeters (mm).

    If the upper or lower central incisors are missing or severely malpositioned, the measurements will be recorded as "not assessable."

  3. Adenoid Hypertrophy Grade in Children Diagnosed With Adenoid Hypertrophy and Scheduled for Surgery

    Time frame: At enrollment (single assessment)

    The adenoid hypertrophy grade will be determined according to the degree of nasopharyngeal airway obstruction observed during otorhinolaryngological examination at Aydın Adnan Menderes University Faculty of Medicine, Department of Otorhinolaryngology, and will be classified into four grades. The participants with adenoid hypertrophy will consist of patients who were examined at the same department and scheduled for surgery. The degree of nasopharyngeal airway obstruction by the adenoid tissue will be assessed using endoscopic examination.

    Grade 1: Adenoid tissue occupies 0-25% of the nasopharyngeal airway; airway mostly patent, minimal or no obstruction.

    Grade 2: Occupies 26-50%; mild obstruction possible, nasal breathing generally intact.

    Grade 3: Occupies 51-75%; moderate obstruction, mouth breathing and snoring may occur.

    Grade 4: Occupies 76-100%; severe obstruction, marked mouth breathing, possible sleep-disordered breathing.

  4. Presence of Mouth Breathing (Yes/No) in Children With and Without Adenoid Hypertrophy

    Time frame: At enrollment (single assessment)

    Mouth breathing will be assessed through both clinical observation and parental reporting. During clinical observation, children will be evaluated in an upright position at rest. The principal investigator will assess whether the child maintains lip closure and whether breathing occurs through the mouth. In addition, parents will be asked whether their child usually breathes through the mouth or nose during both wakefulness and sleep.

    Mouth breathing present (Yes): If the child breathes through the mouth at rest or if parents report that the child predominantly breathes through the mouth.

    Mouth breathing absent (No): If the child breathes through the nose at rest and parents do not report mouth breathing.

  5. Number of Carious, Missing and Filled Teeth in Children With and Without Adenoid Hypertrophy

    Time frame: At enrollment (single assessment)

    The number of carious, missing, and filled teeth will be determined through clinical and radiographic examination.

  6. Presence of Bruxism (Yes/No) in Children With and Without Adenoid Hypertrophy

    Time frame: At enrollment (single assessment)

    Bruxism will be assessed based on both parental reporting and clinical examination. Parents will be asked whether they have observed their child grinding or clenching their teeth during sleep or while awake. Clinical indicators such as abnormal tooth wear, masticatory muscle tenderness, and soft tissue signs (e.g., linea alba) will also be recorded to support the diagnosis.

    Bruxism present (Yes): If either parental report or clinical signs are observed.

    Bruxism absent (No): If neither parental reporting nor clinical signs are present.

Study contacts

Contact information is provided by the study sponsor or research team.

Esra Dişcioğlu Candemir, dds

CONTACT

[email protected]

+905073341496

Melis Akyıldız, phd

CONTACT

[email protected]

+905387970703

Sponsors and collaborators

Lead sponsor

Melis AKYILDIZ

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 30, 2025
Registry last updated
Dec 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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