NCT06113822

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2022

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, 2022

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

October 30, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 2, 2023

Completed
Last Updated

November 3, 2023

Status Verified

November 1, 2023

Enrollment Period

1.7 years

First QC Date

October 30, 2023

Last Update Submit

November 1, 2023

Conditions

Keywords

anxietybody mass indexmasseter muscleobesityultrasonography

Outcome Measures

Primary Outcomes (1)

  • BMI and anxiety

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

    2022

Study Arms (4)

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

Device: ultrasonography

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.

Device: ultrasonography

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

Device: ultrasonography

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.

Device: ultrasonography

Interventions

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 group2st working group3st working groupControl Group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Individuals in the Turkish population aged 18-45

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Firat University

Elâzığ, Elâzığ, 23000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety DisordersObesity

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Mental DisordersOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator, DDS

Study Record Dates

First Submitted

October 30, 2023

First Posted

November 2, 2023

Study Start

March 1, 2022

Primary Completion

October 30, 2023

Study Completion

October 30, 2023

Last Updated

November 3, 2023

Record last verified: 2023-11

Locations