Questionnaire Regarding the Effect of Wearing Face Masks on Oral Health

February 13, 2024 updated by: Philipp Kanzow, PD Dr. med. dent., Dr. rer. medic., University of Göttingen

During the current COVID-19 pandemic, the use of face masks is recommended / mandatory to prevent infection. Patients and students have reported to experience limitations in their oral health-related quality of life, especially with regard to the occurrence of dry mouth and halitosis, while wearing face masks.

Scientific studies regarding the effects of face masks have so far focused exclusively on medical staff. Studies among the general population are not yet available, but are of interest as dry mouth is a risk factor for dental diseases (e.g., caries, erosion).

Therefore, the present study aims at performing a questionnaire survey regarding self-perceived dry mouth and halitosis and the use of face masks (type, wearing time).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3750

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Lower Saxony
      • Göttingen, Lower Saxony, Germany, 37075
        • University Medical Center Goettingen, Dept. of Preventive Dentistry, Periodontology and Cariology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients, visitors, and staff members of the University Medical Center Goettingen

Exclusion Criteria:

  • N/A

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Questionnaire survey
Patients, visitors, and staff members of the University Medical Center Goettingen are invited to participate within our survey study. Study participation has no effect on any medical treatment.
Other: Invitation to participate
Patients, visitors, and staff members of the University Medical Center Goettingen are invited to participate within our survey study. Study participation has no effect on any medical treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-perceived dry mouth
Time Frame: During the 1 day of questionnaire survey
Questionnaire items based on the shortened Xerostomia Inventory
During the 1 day of questionnaire survey
Self-perceived halitosis
Time Frame: During the 1 day of questionnaire survey
Questionnaire items
During the 1 day of questionnaire survey

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Göttingen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2020

Primary Completion (Actual)

June 28, 2021

Study Completion (Actual)

June 28, 2021

Study Registration Dates

First Submitted

November 10, 2020

First Submitted That Met QC Criteria

November 16, 2020

First Posted (Actual)

November 17, 2020

Study Record Updates

Last Update Posted (Estimated)

February 14, 2024

Last Update Submitted That Met QC Criteria

February 13, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FaceMasks-OralHealth
  • 28/10/20 (Other Identifier: Local Ethics Commission)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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