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

NCT07094581 | Recruiting

• 1 other identifier: 2023/37
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Malocclusion; Adenoid Hypertrophy; Masseter Muscle

Keywords

Adenoid Hypertrophy; Ultrasonography; Masseter Muscle

Outcome Measures

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

  At enrollment (single assessment)

Secondary Outcomes (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

  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)

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

  At enrollment (single assessment)

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

  At enrollment (single assessment)

Study Arms (2)

Adenoid Hypertrophy Group

Children aged 3-8 years diagnosed with adenoid hypertrophy.

Diagnostic Test: USG

Healthy Control Group

Healthy children aged 3-8 years without adenoid hypertrophy.

Diagnostic Test: USG

Interventions

USG DIAGNOSTIC_TEST

Masseter Muscle Thickness and Internal Echogenic Bands Assessed by Ultrasonography

Adenoid Hypertrophy Group; Healthy Control Group

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• Children aged between 3 and 8 years
• Children diagnosed with adenoid hypertrophy
• Children without any systemic disease

You may not qualify if:

• 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

Sponsors & Collaborators

• Melis AKYILDIZ: lead

Study Sites (1)

Aydın Adnan Menderes University

Aydin, Efeler, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• 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 BACKGROUND

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Melis Akyıldız, phd

  Aydin Adnan Menderes University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melis Akyıldız, phd

CONTACT

+905387970703; baharmeliss@hotmail.com

Esra Dişcioğlu Candemir, dds

CONTACT

+905073341496; Esra.discioglu@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 22, 2025
• First Posted: July 30, 2025
• Study Start: July 20, 2024
• Primary Completion: February 9, 2026
• Study Completion: February 28, 2026
• Last Updated: December 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)