How enlarged adenoids affect the masseter (chewing) muscle in children using ultrasound
Evaluation of the Effect of Adenoid Hypertrophy on the Masseter Muscle in Children: A Comparative Ultrasonographic Study
Using ultrasound, researchers will see if enlarged adenoids change the thickness or internal bands of the masseter muscle in children aged 3 to 8.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 72 (estimated) |
| Ages | 3 Years to 8 Years |
| Sex | All |
| Sponsor | Aydin Adnan Menderes University Academic / other |
| Locations | 1 site (Aydin, Efeler) |
| Trial ID | NCT07094581 on ClinicalTrials.gov |
What this trial studies
This is an observational, case-control comparison of children aged 3–8 with diagnosed adenoid hypertrophy scheduled for adenoidectomy versus healthy controls. Each child will receive bilateral ultrasound measurements of masseter muscle thickness and visibility of internal echogenic bands at rest and during maximum clench, using a high-frequency linear probe, and researchers will record dental occlusion, age, sex, and adenoid grade. The planned sample size is 72 participants based on a calculated medium effect size, with exclusions for prior adenoid surgery, syndromes affecting the maxillofacial region, multiple missing teeth, or inability to cooperate. Results will compare thickness (mm) and band visibility categories between groups to see if adenoid hypertrophy is associated with measurable muscle differences.
Who should consider this trial
Good fit: Children aged 3 to 8 years with diagnosed adenoid hypertrophy who are cooperative, have no systemic disease, and are scheduled for adenoidectomy are ideal candidates.
Not a fit: Children outside the 3–8 age range, those with prior adenoid surgery, maxillofacial syndromes, multiple missing teeth, or who cannot cooperate with the exam are excluded and unlikely to benefit from this comparison.
Why it matters
Potential benefit: If a link is found, the results could help clinicians recognize how enlarged adenoids relate to changes in chewing muscle structure and guide earlier dental or surgical referrals.
How similar studies have performed: Direct comparisons of masseter thickness in children with adenoid hypertrophy versus healthy controls appear novel, although ultrasound is a commonly used and validated tool for assessing muscle structure.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Aydin, Efeler
- Aydın Adnan Menderes University — Aydin, Efeler, Turkey (Türkiye) (Recruiting)
Study contacts
- Principal investigator: Melis Akyıldız, phd — Aydin Adnan Menderes University
- Study coordinator: Melis Akyıldız, phd
- Email: baharmeliss@hotmail.com
- Phone: +905387970703
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.