Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT06103851 |
| Other study ID # |
E-10840098-772.02-4611 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 21, 2021 |
| Est. completion date |
November 30, 2023 |
Study information
| Verified date |
October 2023 |
| Source |
Istanbul Medipol University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Due to COVID-19 pandemic the use of masks has been made mandatory to prevent contagion.
Individuals concluded that the use of masks has a negative effect on temporomandibular joint
functions. In our literature search, we did not find any study on this subject. The aim of
our study is to investigate the effect of mask use on temporomandibular joint function.
Female individuals between the ages of 18-45 will be included in the research. Before
participating in the study, individuals will be informed about the study and informed consent
will be obtained.
Evaluations will be made twice a day, in the morning without the use of a mask, in the
morning when using a mask, and in the evening (with the use of a mask for 6 hours,
approximately 6 hours after the first assessment). Each individual to be measured will use
the same brand and size N95 mask to be provided by us.
Evaluations: Individuals' m. masseter muscle activity with surface EMG, pain intensity felt
in the jaw area, the pain threshold on m. masseter and m.temporalis will be evaluated. The
questionnaire created by investigators also will be helded.
Description:
The COVID-19 pandemic was declared by the World Health Organization (WHO) in March 2019. Due
to the pandemic, the use of masks has been made mandatory to prevent contagion. We think that
the use of masks has a negative effect on temporomandibular joint functions. In our
literature search, we did not find any study on this subject. The aim of our study is to
investigate the effect of mask use on temporomandibular joint function.
Female individuals between the ages of 18-45 working at Istanbul Medipol University will be
included in the research. Before participating in the study, individuals will be informed
about the study and informed consent will be obtained.
Evaluations will be made twice a day, in the morning without the use of a mask, in the
morning when using a mask, and in the evening (with the use of a mask for 6 hours,
approximately 6 hours after the first assessment). Each individual to be measured will use
the same brand and size N95 mask to be provided by us.
Evaluations: Individuals' m. masseter muscle activity with surface EMG, pain intensity felt
in the jaw area, the pain threshold on m. masseter and m.temporalis will be evaluated. The
questionnaire created by investigators also will be helded.
Evaluation of Muscle Activity: M. masseter muscle activity will be recorded using the sEMG
feature of the VitalStim device. Electrodes will be placed on the area where the muscle is
swollen by maximizing the muscle contraction. The individual will be seated and rested for 5
minutes before sEMG recording and will be left for 1 minute without recording for the
acclimatization period after electrode placement.
Pain Severity Assessment: the pain intensity of the participants will be questioned with a
visual analog scale. On a ruler divided from 0 to 10 at equal intervals, the person will be
asked to mark the degree of pain he feels in his jaw. According to the VAS, 0 means "no pain"
and 10 means "as bad pain as possible".
Pressure Pain Threshold Assessment: Pressure pain threshold will be measured by the
physiotherapist with a hand algometer (Baseline FDK 10) over M. Temporalis and M. Masseter.
The algometer will be applied vertically to the most painful point, increasing the pressure
by 1 kg/cm2 every three seconds until the patient feels pain, and the pressure value at which
the pain begins will be recorded. 3 measurements will be made at 60 second intervals and the
average value will be considered as the pain threshold.
Evaluation of Mandibular Opening: Maximum mandibular opening will be measured with the help
of caliper at the final level of mouth opening, lateral deviation, protrusion and retrusion
movements.
Self Designed Survey: A questionnaire consisting of open-ended, multiple-choice and
likert-scale questions questioning the demographic information of individuals and the
complaints/discomforts that may occur with the mask in the jaw joint will be administered via
Google Forms, an online platform.
