Effect of Mask Use on Jaw Functionality

NCT06103851 | Unknown

• 1 other identifier: E-10840098-772.02-4611
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Temporomandibular Joint Disorders

Keywords

Mask wearing; Temporomandibular joint disorder; TMJ; EMG

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  6 weeks

Secondary Outcomes (3)

• pressure pain threshold

  6 weeks

• Jaw discomfort by face mask questionnaire

  6 weeks

• maximum mouth opening

  6 weeks

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Among the academicians working in our institution, healthy participants aged between 18-45 and volunteering to participate in the study.

You may qualify if:

• who voluntarily agreed to participate in the study
• who is able to wear N95 mask for 6 hours

You may not qualify if:

• Those with chronic jaw pain
• Those who have had Covid-19 (due to ongoing joint pain)
• Acute jaw trauma

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Gizem Ergezen

Istanbul, Beykoz, 34810, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Study Officials

• Sena Özdemir Görgü, PhD

  Medipol University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assist. prof.

Study Record Dates

• First Submitted: October 5, 2021
• First Posted: October 27, 2023
• Study Start: September 21, 2021
• Primary Completion: October 10, 2022
• Study Completion: November 30, 2023
• Last Updated: October 27, 2023

Record last verified: 2023-10

Locations

TU (1)