- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06870084
Masseter Muscle Thickness and Craniofacial Skeletal Patterns
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Kutahya, Turkey, 43100
- Kutahya Health Science University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria: Patients who
- 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
Exclusion Criteria: Patients who
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Class I
Patients with ANB angle between 0-4 degrees were classified as class I.
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Standard lateral cephalometric radiographs were obtained from the patients.
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Class II
Patients with ANB angle greater than 4 degrees were classified as class II.
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Standard lateral cephalometric radiographs were obtained from the patients.
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Class III
Patients with ANB angle less than 0 degrees were classified as class III.
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Standard lateral cephalometric radiographs were obtained from the patients.
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Normodivergent
Patients with SN/GoGn angle between 28 and 36 were classified as normodivergent.
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Standard lateral cephalometric radiographs were obtained from the patients.
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Hyperdivergent
Patients with SN/GoGn angle greater than 36 degrees were classified as hyperdivergent.
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Standard lateral cephalometric radiographs were obtained from the patients.
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Hypodivergent
Patients with SN/GoGn angle less than 28 degrees were classified as hypodivergent.
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Standard lateral cephalometric radiographs were obtained from the patients.
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Brachyfacial
If the facial index value was less than 84%, it was classified as brachyfacial.
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Standard facial photographs were taken from a distance of 1.5 metres.
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Mesofacial
A facial index value between 84% and 88% was classified as mesofacial.
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Standard facial photographs were taken from a distance of 1.5 metres.
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Dolichofacial
If the facial index value was greater than 88%, it was classified as dolichofacial.
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Standard facial photographs were taken from a distance of 1.5 metres.
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Body Mass Index
The Body Mass Index is calculated by measuring with a standardised scale and height chart.
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The Body Mass Index is calculated by measuring with a standardised scale and height chart.
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Masseter muscle thickness
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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.
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The correlation between masseter muscle thickness and sagittal skeletal malocclusions
Time Frame: Just at the enrollment of the patients
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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.
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Just at the enrollment of the patients
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Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023/14-28
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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