Evaluation of the Effect of Adenoid Hypertrophy on the Masseter Muscle in Children: A Comparative… (NCT07094581) | Clinical Trial Compass
RecruitingNot Applicable
Evaluation of the Effect of Adenoid Hypertrophy on the Masseter Muscle in Children: A Comparative Ultrasonographic Study
Turkey (Türkiye)72 participantsStarted 2024-07-20
Plain-language 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.
Who can participate
Age range
3 Years – 8 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Masseter Muscle Thickness and Internal Echogenic Bands Assessed by Ultrasonography