NCT06870084

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 24, 2025

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

March 5, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 11, 2025

Completed
Last Updated

March 14, 2025

Status Verified

December 1, 2023

Enrollment Period

9 months

First QC Date

March 5, 2025

Last Update Submit

March 11, 2025

Conditions

Keywords

masseter musclemalocclusionultrasonographycephalometrymaxillofacial development

Outcome Measures

Primary Outcomes (1)

  • 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.

    Just at the enrollment of the patients

Study Arms (12)

Class I

Patients with ANB angle between 0-4 degrees were classified as class I.

Other: Lateral cephalometric radiography

Class II

Patients with ANB angle greater than 4 degrees were classified as class II.

Other: Lateral cephalometric radiography

Class III

Patients with ANB angle less than 0 degrees were classified as class III.

Other: Lateral cephalometric radiography

Normodivergent

Patients with SN/GoGn angle between 28 and 36 were classified as normodivergent.

Other: Lateral cephalometric radiography

Hyperdivergent

Patients with SN/GoGn angle greater than 36 degrees were classified as hyperdivergent.

Other: Lateral cephalometric radiography

Hypodivergent

Patients with SN/GoGn angle less than 28 degrees were classified as hypodivergent.

Other: Lateral cephalometric radiography

Brachyfacial

If the facial index value was less than 84%, it was classified as brachyfacial.

Other: Facial photograph

Mesofacial

A facial index value between 84% and 88% was classified as mesofacial.

Other: Facial photograph

Dolichofacial

If the facial index value was greater than 88%, it was classified as dolichofacial.

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.

Other: Electronic caliper

Body Mass Index

The Body Mass Index is calculated by measuring with a standardised scale and height chart.

Other: Weigth and Heigth

Masseter muscle thickness

Other: Ultrasonography

Interventions

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.

Masseter muscle thickness

Standard lateral cephalometric radiographs were obtained from the patients.

Class IClass IIClass IIIHyperdivergentHypodivergentNormodivergent

Standard facial photographs were taken from a distance of 1.5 metres.

BrachyfacialDolichofacialMesofacial

The Body Mass Index is calculated by measuring with a standardised scale and height chart.

Body Mass Index

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.

Intermolar width

Eligibility Criteria

Age18 Minutes+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Healthy patients with orthodontic malocclusion were included in the study.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kutahya Health Science University

Kütahya, 43100, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 39245691BACKGROUND

MeSH Terms

Conditions

Malocclusion

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof.

Study Record Dates

First Submitted

March 5, 2025

First Posted

March 11, 2025

Study Start

March 1, 2024

Primary Completion

December 10, 2024

Study Completion

February 24, 2025

Last Updated

March 14, 2025

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations