An observational study in Adenoid Hypertrophy, Masseter Muscle and Malocclusion, sponsored by Melis AKYILDIZ. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 3 Years to 8 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-29.
Sponsored by Melis AKYILDIZ · Observational
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:
Researchers will compare children diagnosed with adenoid hypertrophy and scheduled for adenoidectomy to healthy controls without adenoid hypertrophy.
Each participant will:
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:
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:
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.
323 studies on the registry are indexed under Malocclusion; 85 are open to participants now.
This study's planned enrollment of 72 is above the median of 63 across 74 observational studies indexed under Malocclusion.
Browse Malocclusion studies →Melis AKYILDIZ is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Children aged 3-8 years diagnosed with adenoid hypertrophy.
Diagnostic Test: USG
Healthy children aged 3-8 years without adenoid hypertrophy.
Diagnostic Test: USG
Masseter Muscle Thickness and Internal Echogenic Bands Assessed by Ultrasonography
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)
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)
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)
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)
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)
Number of Carious, Missing and Filled Teeth in Children With and Without Adenoid Hypertrophy
The number of carious, missing, and filled teeth will be determined through clinical and radiographic examination.
Time frame: At enrollment (single assessment)
Presence of Bruxism (Yes/No) in Children With and Without Adenoid Hypertrophy
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.
Time frame: At enrollment (single assessment)
Plan to share: No
Started Jul 2024 (actual). Primary completion is estimated for Feb 2026, 18 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Melis AKYILDIZ