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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age3-8
SponsorMelis AKYILDIZ

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Children aged between 3 and 8 years

Children diagnosed with adenoid hypertrophy

Children without any systemic disease

Disqualifiers

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

Trial population

Children aged 3 to 8 years, with or without adenoid hypertrophy. The adenoid hypertrophy group will include pediatric patients diagnosed by the Department of Otorhinolaryngology at Aydın Adnan Menderes University Faculty of Medicine and scheduled for surgery. The control group will include healthy children without systemic disease who present to the Department of Pedodontics at Aydın Adnan Menderes University Faculty of Dentistry for routine dental examination.

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

  • USG

    Diagnostic test

    Masseter Muscle Thickness and Internal Echogenic Bands Assessed by Ultrasonography

Treatment groups

72 Participants
are divided into 2 treatment groups
Group A: Adenoid Hypertrophy Group1 intervention
Group B: Healthy Control Group1 intervention

Trial outcomes

Primary outcomes

1

Masseter Muscle Thickness and Internal Echogenic Bands Assessed by Ultrasonography

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

Time frame
At enrollment (single assessment)

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

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.

Time frame
At enrollment (single assessment)
2

Overjet and Overbite in Children With and Without Adenoid Hypertrophy

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."

Time frame
At enrollment (single assessment)
3

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

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.

Time frame
At enrollment (single assessment)
4

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

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.

Time frame
At enrollment (single assessment)

Other outcomes

Sponsors and contacts

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Melis AKYILDIZ

Lead sponsor

Aydin Adnan Menderes University

Sponsor institution