- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06113822
Investigation of the Effect of Body Mass Index and Anxiety on Masseter Muscle Thickness on Ultrasonography
Investigation of The Effect of Body Mass Index and Anxiety on Masseter Muscle Thickness on Ultrasonography
Study Overview
Detailed Description
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Elazığ
-
Elazıg, Elazığ, Turkey, 23000
- Firat University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Control Group
Without Anxiety - Normal BMI 15 patient nonanxiety group (HAD scores ranging from 0 to 10) body mass index is normal between 18.5-24.9
|
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.
|
|
1st working group
High BMI & Anxiety Normal 19 Patient nonanxiety group (HAD scores ranging from 0 to 10) Those with a high body mass index are between 25 and 29.9.
|
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.
|
|
2st working group
Normal BMI & High Anxiety (15 patients) having anxiety group (HAD scores ranging from 11 to 21) body mass index is normal between 18.5-24.9
|
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.
|
|
3st working group
High BMI & High Anxiety (19 patients) having anxiety group (HAD scores ranging from 11 to 21) Those with a high body mass index are between 25 and 29.9.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
BMI and anxiety
Time Frame: 2022
|
Increased BMI and the presence of anxiety cause thickening of the masseter muscle.
|
2022
|
Collaborators and Investigators
Sponsor
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 (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FiratCerrahi
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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