NCT05358665

Brief Summary

Various restrictions have been made all over the world due to coronavirus pandemics. In addition to situations such as social isolation and hygiene, the use of masks is among these rules. In addition to the protection it provides, the use of masks causes some negative situations in individuals. For this reason, the aim of our study is to examine the effects of long-term mask use on temporomandibular dysfunction, headache and fatigue.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
909

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2021

Shorter than P25 for all trials

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

May 1, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 28, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 3, 2022

Completed
Last Updated

May 3, 2022

Status Verified

April 1, 2022

Enrollment Period

4 months

First QC Date

April 28, 2022

Last Update Submit

April 28, 2022

Conditions

COVID-19

Keywords

masktemporomandibular joint disordersheadachefatigue

Outcome Measures

Primary Outcomes (1)

  • Temporomandibular Dysfunction

    According to the scores obtained from the scale, 0-15 points mean no temporomandibular dysfunction symptoms, 20-45 points mean mild temporomandibular dysfunction symptoms, 50-65 points mean moderate temporomandibular dysfunction symptoms, and 70-100 severe temporomandibular dysfunction symptoms.

    Baseline

Secondary Outcomes (5)

  • Mask Use Symptoms

    Baseline

  • Perceptions of Mask Use

    Baseline

  • Fatigue

    Baseline

  • Type of Headache

    Baseline

  • Trigger point of temporomandibular joint

    Baseline

Study Arms (3)

Group 1

There are individuals who use masks for less than 4 hours daily.

Other: mask use

Group 2

There are individuals who use masks for 4-8 hours daily.

Other: mask use

Group 3

There are individuals who use masks for more than 8 hours daily.

Other: mask use

Interventions

mask useOTHER

long term mask use

Group 1Group 2Group 3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

People using masks

You may qualify if:

  • Over 18 years
  • Able to read and understand
  • Volunteer to participate

You may not qualify if:

  • Malignity history
  • Head/Face surgery history

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Yildirim Beyazit University

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

COVID-19Temporomandibular Joint DisordersHeadacheFatigue

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesCraniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2022

First Posted

May 3, 2022

Study Start

May 1, 2021

Primary Completion

August 31, 2021

Study Completion

November 15, 2021

Last Updated

May 3, 2022

Record last verified: 2022-04

Locations

TU(1)