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Completed

NCT Number: NCT06113822

Investigation of the Effect of Body Mass Index and Anxiety on Masseter Muscle Thickness on Ultrasonography

The aim of this study is to determine the effect of body mass index (BMI) and anxiety on masseter muscle thickness by using ultrasonography.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Firat University

Elâzığ, 23000, Turkey (Türkiye)

About this study

The aim of this study is to determine the effect of body mass index (BMI) and anxiety on masseter muscle thickness by using ultrasonography.

A total of 68 patients were included in this study. Height and weight of the patients were measured. BMI was calculated. The Control Group Without Anxiety - Normal BMI (15 patients) was composed of patients in general. Working groups were formed as High BMI & Anxiety Normal (19 patients), Normal BMI & High Anxiety (15 patients), and High BMI & High Anxiety (19 patients). The Hospital Anxiety Depression Scale (HADS) was applied to the participants. Muscle thickness measurements were first measured by using the high-frequency linear scanning probe of an ultrasound device to measure the contraction and relaxation of the right masseter muscle. Then, the contraction and relaxation of the left masseter muscle was measured.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The study group consisted of individuals between the ages of 18 and 45 who, according to an examination of the masseter muscles under the 'Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD),' had the presence of pain in at least one region in the palpation made from three regions (origin, center, attachment zone) or had pain in chewing muscles in the preceding month.

Exclusion criteria

  • Exluded from the study where those who had experienced any systemic discomfort from the study group, those who had undergone acute temporomandibular joint trauma, those who had experienced early occlusion of the teeth, those who were using any moving dental prosthesis, those with clenching habits, those who use cigarette-alcohol, those with temporomandibular joint discomfort, and those with unilateral chewing habits.

Treatment and study plan

Ultrasonography

Device

We used ultrasonography to measure the patients' masseter muscle thickness. Measurements were performed simultaneously for both the right and left sides using a high frequency linear scanning probe (13-6 MHz) of an ultrasound device (Fujifilm Sonosite Edge II). In order to prevent possible artifacts and oblique imaging, the probe was kept perpendicular to the skin surface, and the distance between the location of the hyperechoic linear appearance of the mandibular and temporal bone in the transverse section and the muscular fascia were measured.

Primary outcomes

  1. BMI and anxiety

    Time frame: 2022

    Increased BMI and the presence of anxiety cause thickening of the masseter muscle.

Sponsors and collaborators

Lead sponsor

Oguzhan Deveci

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 2, 2023
Registry last updated
Nov 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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