Temporomandibular Joint DisordersNCT06103851
Effect of Mask Use on Jaw Functionality
An observational study of Temporomandibular Joint Disorders, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Joint Disorders
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Sep 2021to 30 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Among the academicians working in our institution, healthy participants aged between 18-45 and volunteering to participate in the study.
Who may be able to join
- who voluntarily agreed to participate in the study
- who is able to wear N95 mask for 6 hours
Who cannot join
- Those with chronic jaw pain
- Those who have had Covid-19 (due to ongoing joint pain)
- Acute jaw trauma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effect of Mask Use on Temporomandibular Joint Functionality
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.
Read the detailed 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.
- Conditions
- Temporomandibular Joint Disorders
- Keywords
- Mask wearing, Temporomandibular joint disorder, TMJ, EMG
- Medical subject headings
- Temporomandibular Joint Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
surface EMG of masseter muscle
Masseter function with the VitalStim® Plus Electrotherapy System, the sEMG biofeedback activity of electrical impulses generated during the voluntary muscle contraction and relaxation cycle will be measured.
Measured: 6 weeks
Pain intensity
Pain on jaw region that felt after face mask usage Individuals' pain intensity will be evaluated using a numerical analog scale ranging from 0 to none at all and 10 to very severe pain.
Measured: 6 weeks
Secondary outcomes (3)
pressure pain threshold
to the most painful point on masseter and temporalis muscle, algometer applied vertically, 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.
Measured: 6 weeks
Jaw discomfort by face mask questionnaire
questionaire that collect demographic information of individuals and the complaints/discomforts that may occur with the mask usage around the jaw joint
Measured: 6 weeks
maximum mouth opening
Individual opens the mouth as much as possible and the distance between front teeth are measured.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start21 Sep 2021
- Primary completion10 Oct 2022
- Study completion30 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Joint DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, gizem ergezen, Istanbul Medipol University Hospital
- Investigators
- Sena Özdemir Görgü, PhD, Study chair, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06103851
- Sponsor's protocol ID
- E-10840098-772.02-4611
- Status last verified
- Oct 2023
- First submitted
- 5 Oct 2021
- Last updated
- 27 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Mask Use on Temporomandibular Joint Functionality
- ClinicalTrials.gov ID
- NCT06103851
- Acronym / sponsor ID
- E-10840098-772.02-4611
- Conditions
- Temporomandibular Joint Disorders
- Keywords
- Mask wearing, Temporomandibular joint disorder, TMJ, EMG
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 21 Sep 2021 (actual)
- Primary completion
- 10 Oct 2022 (actual)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 27 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Among the academicians working in our institution, healthy participants aged between 18-45 and volunteering to participate in the study.
Key inclusion criteria (2 listed)
- who voluntarily agreed to participate in the study
- who is able to wear N95 mask for 6 hours
Key exclusion criteria (3 listed)
- Those with chronic jaw pain
- Those who have had Covid-19 (due to ongoing joint pain)
- Acute jaw trauma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
surface EMG of masseter muscle
Time frame: 6 weeks
Masseter function with the VitalStim® Plus Electrotherapy System, the sEMG biofeedback activity of electrical impulses generated during the voluntary muscle contraction and relaxation cycle will be measured.
Pain intensity
Time frame: 6 weeks
Pain on jaw region that felt after face mask usage Individuals' pain intensity will be evaluated using a numerical analog scale ranging from 0 to none at all and 10 to very severe pain.
3 secondary outcomes
pressure pain threshold
Time frame: 6 weeks
Jaw discomfort by face mask questionnaire
Time frame: 6 weeks
maximum mouth opening
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sena Özdemir Görgü, PhD study chair
Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Temporomandibular Joint Disorders, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
surface EMG of masseter muscle (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2023.