MasseterNCT06870084
Masseter Muscle Thickness and Craniofacial Skeletal Patterns
An observational study of Masseter and Ultrasonography, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
Facial morphology is influenced by hard and soft tissues, including bone and muscle. While numerous factors can lead to changes in bone tissue, soft tissues such as muscle also have an important influence. Read more about this study
- Who is it for?
- Ages 18 minutes and olderHealthy volunteers can take part
- Conditions the study is for
- Masseter, Ultrasonography, Malocclusions
- What is being tested?
- Ultrasonography, Lateral cephalometric radiography and Facial photograph
- How many people
- 101 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2024to 24 Feb 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 minutes and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Healthy patients with orthodontic malocclusion were included in the study.
Who may be able to join
- Patients who were 18 years of age or older,
- had skeletal malocclusion,
- were systemically healthy,
- were not taking any medication,
- had no missing teeth except for the third molars,
- had no history of congenital and/or acquired anomalies in the lips, mouth and facial regions,
- had not received orthodontic treatment before
Who cannot join
- were younger than 18 years of age
- were with systemic disease,
- used antidepressant drugs before,
- has bruxism habit,
- had orthodontic treatment or has active orthodontic treatment,
- had history of trauma and surgery in the maxillofacial region
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kutahya Health Science University
Kütahya, 43100
About this study
Official title: The Relationship Between Masseter Muscle Thickness and Different Craniofacial Skeletal Patterns
Facial morphology is influenced by hard and soft tissues, including bone and muscle. While numerous factors can lead to changes in bone tissue, soft tissues such as muscle also have an important influence. It is widely acknowledged that the function, shape and thickness of masticatory muscles have substantial effects on facial morphology and skeletal development, and are correlate with other anthropometric variables. Furthermore, a correlation has been observed between masseter muscle thickness and various characteristics of the dental arches, such as alveolar process thickness and intermaxillary width.
The evaluation of soft tissue in the region of the face is a more challenging process in comparison to that of hard tissue.The recent development of cone beam computed tomography has improved the analysis of three-dimensional skeletal morphology and jaw. However, the radiographic assessment of soft tissue remains more difficult.The thickness of masticatory muscles can be measured using computerised tomography; however, this has the disadvantage of exposing the patient to radiation. Magnetic resonance imaging (MRI) is an imaging technique that can be used to assess soft tissues. However, this technique is expensive and time-consuming. Furthermore, MRI is a static rather than a dynamic imaging technique, which makes it difficult to analyse during muscle contraction and relaxation. Ultrasound is a technique that provides dynamic imaging that can assess the masticatory muscles without the use of ionising radiation.
There are many publications in the literature that indicate that malocclusions in the vertical and sagittal dimensions can be assessed with measurements from lateral cephalometric radiographs.
- Conditions
- Masseter, Ultrasonography, Malocclusions, Cephalometry
- Being tested
- Ultrasonography, Lateral cephalometric radiography, Facial photograph, Weigth and Heigth, Electronic caliper
- Keywords
- masseter muscle, malocclusion, ultrasonography, cephalometry, maxillofacial development
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasonographyOther
The masseter muscle thickness measurements were performed in B mode of ultrasound, midline between the zygomatic arch and mandibular plane, parallel to the mandibular plane and perpendicular to the mandibular ramus. Prior to the examination being performed in the resting position, the patient was instructed to make minimal contact between the lips without the teeth touching each other.The first USG image was recorded in this position. The patient was then requested to clench their teeth as firmly as possible, after which a second USG image was recorded from the same area. The thickness of the muscles was measured again on second recorded images. To ensure the reliability of the measurements, these procedures were repeated by the same researcher after the patients rested for five minutes.
Lateral cephalometric radiographyOther
Standard lateral cephalometric radiographs were obtained from the patients.
Facial photographOther
Standard facial photographs were taken from a distance of 1.5 metres.
Weigth and HeigthOther
The Body Mass Index is calculated by measuring with a standardised scale and height chart.
Electronic caliperOther
The intermaxillary distance is measured from the cervical level of the palatal surfaces of the first permanent molars to their mesial corners using an electronic caliper.
| Study group | Role | What they receive |
|---|---|---|
| Class I | Patients with ANB angle between 0-4 degrees were classified as class I. Receives: Other: Lateral cephalometric radiography | |
| Class II | Patients with ANB angle greater than 4 degrees were classified as class II. Receives: Other: Lateral cephalometric radiography | |
| Class III | Patients with ANB angle less than 0 degrees were classified as class III. Receives: Other: Lateral cephalometric radiography | |
| Normodivergent | Patients with SN/GoGn angle between 28 and 36 were classified as normodivergent. Receives: Other: Lateral cephalometric radiography | |
| Hyperdivergent | Patients with SN/GoGn angle greater than 36 degrees were classified as hyperdivergent. Receives: Other: Lateral cephalometric radiography | |
| Hypodivergent | Patients with SN/GoGn angle less than 28 degrees were classified as hypodivergent. Receives: Other: Lateral cephalometric radiography | |
| Brachyfacial | If the facial index value was less than 84%, it was classified as brachyfacial. Receives: Other: Facial photograph | |
| Mesofacial | A facial index value between 84% and 88% was classified as mesofacial. Receives: Other: Facial photograph | |
| Dolichofacial | If the facial index value was greater than 88%, it was classified as dolichofacial. Receives: Other: Facial photograph | |
| Intermolar width | The intertermolar distance was measured in millimetres. This measurement was taken from the mesiopalatinal surfaces of two maxillary first permanent molars at the level of the cervical. The measurement was taken using an electronic caliper. Receives: Other: Electronic caliper | |
| Body Mass Index | The Body Mass Index is calculated by measuring with a standardised scale and height chart. Receives: Other: Weigth and Heigth | |
| Masseter muscle thickness | Not described Receives: Other: Ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
The correlation between masseter muscle thickness and sagittal skeletal malocclusions
The masseter muscle was measured in millimetres using ultrasound, while different skeletal malocclusions were classified using the angles between anatomical landmarks on lateral cephalometric radiographs. Intertermolar distance was measured in millimetres using an electronic caliper intraorally in the clinic. Facial index was calculated and classified using standard facial photographs, with millimetre measurements obtained using ImageJ software. The patients' height and weight were measured in centimetres and kilograms, respectively, and their body mass index was calculated.
Measured: Just at the enrollment of the patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start1 Mar 2024
- Primary completion10 Dec 2024
- Study completion24 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MasseterStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 101 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Halil Ayyıldız, Kutahya Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06870084
- Sponsor's protocol ID
- 2023/14-28
- Status last verified
- Dec 2023
- First submitted
- 5 Mar 2025
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Togninalli D, Antonarakis GS, Papadopoulou AK. Relationship between craniofacial skeletal patterns and anatomic characteristics of masticatory muscles: a systematic review and meta-analysis. Prog Orthod. 2024 Sep 9;25(1):36. doi: 10.1186/s40510-024-00534-2.
PubMed 39245691Kurt SS, Ayyildiz H. Evaluation of masseter muscle thickness in relation to sagittal skeletal pattern, intermolar width and masseter echogenicity: a prospective ultrasonographic and lateral cephalometric radiographic study. BMC Oral Health. 2026 Apr 9;26(1):976. doi: 10.1186/s12903-026-08234-5.
PubMed 41957744
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Masseter Muscle Thickness and Different Craniofacial Skeletal Patterns
- ClinicalTrials.gov ID
- NCT06870084
- Acronym / sponsor ID
- 2023/14-28
- Conditions
- Masseter, Ultrasonography, Malocclusions, Cephalometry
- Keywords
- masseter muscle, malocclusion, ultrasonography, cephalometry, maxillofacial development
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 10 Dec 2024 (actual)
- Study completion
- 24 Feb 2025 (actual)
- First posted
- 11 Mar 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.
Facial morphology is influenced by hard and soft tissues, including bone and muscle. While numerous factors can lead to changes in bone tissue, soft tissues such as muscle also have an important influence. It is widely acknowledged that the function, shape and thickness of masticatory muscles have substantial effects on facial morphology and skeletal development, and are correlate with other anthropometric variables. Furthermore, a correlation has been observed between masseter muscle thickness and various characteristics of the dental arches, such as alveolar process thickness and intermaxillary width.
The evaluation of soft tissue in the region of the face is a more challenging process in comparison to that of hard tissue.The recent development of cone beam computed tomography has improved the analysis of three-dimensional skeletal morphology and jaw. However, the radiographic assessment of soft tissue remains more difficult.The thickness of masticatory muscles can be measured using computerised tomography; however, this has the disadvantage of exposing the patient to radiation. Magnetic resonance imaging (MRI) is an imaging technique that can be used to assess soft tissues. However, this technique is expensive and time-consuming. Furthermore, MRI is a static rather than a dynamic imaging technique, which makes it difficult to analyse during muscle contraction and relaxation. Ultrasound is a technique that provides dynamic imaging that can assess the masticatory muscles without the use of ionising radiation.
There are many publications in the literature that indicate that malocclusions in the vertical and sagittal dimensions can be assessed with measurements from lateral cephalometric radiographs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| Class I | – | Other: Lateral cephalometric radiographyPatients with ANB angle between 0-4 degrees were classified as class I. |
| Class II | – | Other: Lateral cephalometric radiographyPatients with ANB angle greater than 4 degrees were classified as class II. |
| Class III | – | Other: Lateral cephalometric radiographyPatients with ANB angle less than 0 degrees were classified as class III. |
| Normodivergent | – | Other: Lateral cephalometric radiographyPatients with SN/GoGn angle between 28 and 36 were classified as normodivergent. |
| Hyperdivergent | – | Other: Lateral cephalometric radiographyPatients with SN/GoGn angle greater than 36 degrees were classified as hyperdivergent. |
| Hypodivergent | – | Other: Lateral cephalometric radiographyPatients with SN/GoGn angle less than 28 degrees were classified as hypodivergent. |
| Brachyfacial | – | Other: Facial photographIf the facial index value was less than 84%, it was classified as brachyfacial. |
| Mesofacial | – | Other: Facial photographA facial index value between 84% and 88% was classified as mesofacial. |
| Dolichofacial | – | Other: Facial photographIf the facial index value was greater than 88%, it was classified as dolichofacial. |
| Intermolar width | – | Other: Electronic caliperThe intertermolar distance was measured in millimetres. This measurement was taken from the mesiopalatinal surfaces of two maxillary first permanent molars at the level of the cervical. The measurement was taken using an electronic caliper. |
| Body Mass Index | – | Other: Weigth and HeigthThe Body Mass Index is calculated by measuring with a standardised scale and height chart. |
| Masseter muscle thickness | – | Other: Ultrasonography |
Who may qualify
- Ages
- 18 minutes and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Healthy patients with orthodontic malocclusion were included in the study.
Key inclusion criteria (7 listed)
- Patients who were 18 years of age or older,
- had skeletal malocclusion,
- were systemically healthy,
- were not taking any medication,
- had no missing teeth except for the third molars,
Key exclusion criteria (6 listed)
- were younger than 18 years of age
- were with systemic disease,
- used antidepressant drugs before,
- has bruxism habit,
- had orthodontic treatment or has active orthodontic treatment,
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 |
|---|---|---|
| UltrasonographyThe masseter muscle thickness measurements were performed in B mode of ultrasound, midline between the zygomatic arch and mandibular plane, parallel to the mandibular plane and perpendicular to the mandibular ramus. Prior to the examination being performed in the resting position, the patient was instructed to make minimal contact between the lips without the teeth touching each other.The first USG image was recorded in this position. The patient was then requested to clench their teeth as firmly as possible, after which a second USG image was recorded from the same area. The thickness of the muscles was measured again on second recorded images. To ensure the reliability of the measurements, these procedures were repeated by the same researcher after the patients rested for five minutes. | Other | Masseter muscle thickness |
| Lateral cephalometric radiographyStandard lateral cephalometric radiographs were obtained from the patients. | Other | Class I, Class II, Class III, Hyperdivergent, Hypodivergent, Normodivergent |
| Facial photographStandard facial photographs were taken from a distance of 1.5 metres. | Other | Brachyfacial, Dolichofacial, Mesofacial |
| Weigth and HeigthThe Body Mass Index is calculated by measuring with a standardised scale and height chart. | Other | Body Mass Index |
| Electronic caliperThe intermaxillary distance is measured from the cervical level of the palatal surfaces of the first permanent molars to their mesial corners using an electronic caliper. | Other | Intermolar width |
Primary outcome
The correlation between masseter muscle thickness and sagittal skeletal malocclusions
Time frame: Just at the enrollment of the patients
The masseter muscle was measured in millimetres using ultrasound, while different skeletal malocclusions were classified using the angles between anatomical landmarks on lateral cephalometric radiographs. Intertermolar distance was measured in millimetres using an electronic caliper intraorally in the clinic. Facial index was calculated and classified using standard facial photographs, with millimetre measurements obtained using ImageJ software. The patients' height and weight were measured in centimetres and kilograms, respectively, and their body mass index was calculated.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
- Results publication: PubMed 39245691Togninalli D, Antonarakis GS, Papadopoulou AK. Relationship between craniofacial skeletal patterns and anatomic characteristics of masticatory muscles: a systematic review and meta-analysis. Prog Orthod. 2024 Sep 9;25(1):36. doi: 10.1186/s40510-024-00534-2.
- Derived from this study: PubMed 41957744Kurt SS, Ayyildiz H. Evaluation of masseter muscle thickness in relation to sagittal skeletal pattern, intermolar width and masseter echogenicity: a prospective ultrasonographic and lateral cephalometric radiographic study. BMC Oral Health. 2026 Apr 9;26(1):976. doi: 10.1186/s12903-026-08234-5.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Masseter and Ultrasonography, run by Kutahya Health Sciences University 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 7 inclusion and 6 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: finished, as of the sponsor's last update on 14 Mar 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The correlation between masseter muscle thickness and sagittal skeletal malocclusions (time frame: Just at the enrollment of the patients). 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 NCT06870084, which also lists 2 linked publications.
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 14 Mar 2025.