Adenoid HypertrophyNCT07094581
Evaluation of the Effect of Adenoid Hypertrophy on the Masseter Muscle in Children: A Comparative Ultrasonographic Study
An observational study of Adenoid Hypertrophy and Masseter Muscle, run by Melis AKYILDIZ at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Adenoid Hypertrophy, Masseter Muscle, Malocclusion
- What is being tested?
- USG
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jul 2024to 28 Feb 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- Children aged between 3 and 8 years
- Children diagnosed with adenoid hypertrophy
- Children without any systemic disease
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Aydın Adnan Menderes University
Aydin, Efeler
Melis Akyıldız, phd, 905387970703, baharmeliss@hotmail.com
Melis Akyıldız, phd
About this study
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.
Read more
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.
Read the detailed description
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:
- Transversely: Parallel to the inferior mandibular border along a line connecting the oral commissure and the tragus.
- Longitudinally: Perpendicular to the mandibular body.
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:
- Type 1: Clear visibility of thin transverse bands.
- Type 2: Thickened bands with reduced echogenicity.
- Type 3: Disappearance or reduction in the number of bands.
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.
- Conditions
- Adenoid Hypertrophy, Masseter Muscle, Malocclusion
- Being tested
- USG
- Keywords
- Adenoid Hypertrophy, Ultrasonography, Masseter Muscle
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
USGDiagnostic test
Masseter Muscle Thickness and Internal Echogenic Bands Assessed by Ultrasonography
| Study group | Role | What they receive |
|---|---|---|
| Adenoid Hypertrophy Group | Children aged 3-8 years diagnosed with adenoid hypertrophy. Receives: Diagnostic Test: USG | |
| Healthy Control Group | Healthy children aged 3-8 years without adenoid hypertrophy. Receives: Diagnostic Test: USG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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.
Measured: 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."
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At enrollment (single assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start20 Jul 2024
- Primary completion9 Feb 2026 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adenoid HypertrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Melis AKYILDIZ
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Melis AKYILDIZ, Aydin Adnan Menderes University
- Investigators
- Melis Akyıldız, phd, Principal investigator, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07094581
- Sponsor's protocol ID
- 2023/37
- Status last verified
- Jul 2025
- First submitted
- 22 Jul 2025
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 15356473
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Adenoid Hypertrophy on the Masseter Muscle in Children: A Comparative Ultrasonographic Study
- ClinicalTrials.gov ID
- NCT07094581
- Acronym / sponsor ID
- 2023/37
- Conditions
- Adenoid Hypertrophy, Masseter Muscle, Malocclusion
- Keywords
- Adenoid Hypertrophy, Ultrasonography, Masseter Muscle
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Melis AKYILDIZUniversity, hospital or other
- Study start
- 20 Jul 2024 (actual)
- Primary completion
- 9 Feb 2026 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 30 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Transversely: Parallel to the inferior mandibular border along a line connecting the oral commissure and the tragus.
- Longitudinally: Perpendicular to the mandibular body.
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:
- Type 1: Clear visibility of thin transverse bands.
- Type 2: Thickened bands with reduced echogenicity.
- Type 3: Disappearance or reduction in the number of bands.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adenoid Hypertrophy Group | – | Diagnostic Test: USGChildren aged 3-8 years diagnosed with adenoid hypertrophy. |
| Healthy Control Group | – | Diagnostic Test: USGHealthy children aged 3-8 years without adenoid hypertrophy. |
Who may qualify
- Ages
- 3 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- Children aged between 3 and 8 years
- Children diagnosed with adenoid hypertrophy
- Children without any systemic disease
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| USGMasseter Muscle Thickness and Internal Echogenic Bands Assessed by Ultrasonography | Diagnostic test | Adenoid Hypertrophy Group, Healthy Control Group |
Primary outcome
Masseter Muscle Thickness and Internal Echogenic Bands Assessed by Ultrasonography
Time frame: At enrollment (single assessment)
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
6 secondary outcomes
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
Time frame: At enrollment (single assessment)
Overjet and Overbite in Children With and Without Adenoid Hypertrophy
Time frame: At enrollment (single assessment)
Adenoid Hypertrophy Grade in Children Diagnosed With Adenoid Hypertrophy and Scheduled for Surgery
Time frame: At enrollment (single assessment)
Presence of Mouth Breathing (Yes/No) in Children With and Without Adenoid Hypertrophy
Time frame: At enrollment (single assessment)
Number of Carious, Missing and Filled Teeth in Children With and Without Adenoid Hypertrophy
Time frame: At enrollment (single assessment)
Presence of Bruxism (Yes/No) in Children With and Without Adenoid Hypertrophy
Time frame: At enrollment (single assessment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Background: PubMed 15356473Ariji 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Melis Akyıldız, phd principal investigator
Aydin Adnan Menderes University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adenoid Hypertrophy and Masseter Muscle, run by Melis AKYILDIZ at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melis Akyıldız, phd (+905387970703, baharmeliss@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Masseter Muscle Thickness and Internal Echogenic Bands Assessed by Ultrasonography (time frame: At enrollment (single assessment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07094581, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2025; AzTrials last refreshed its copy on 8 Nov 2026.