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Questionnaire Regarding the Effect of Wearing Face Masks on Oral Health

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ClinicalTrials.gov Identifier: NCT04632004
Recruitment Status : Enrolling by invitation
First Posted : November 17, 2020
Last Update Posted : November 25, 2020
Sponsor:
Information provided by (Responsible Party):
Philipp Kanzow, Dr. med. dent., Dr. rer. medic., University Medical Center Goettingen

Study Description
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Brief Summary:

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).


Condition or disease Intervention/treatment Phase
Dry Mouth Halitosis Other: Invitation to participate Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3000 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Patients, visitors, and staff members of the University Medical Center Goettingen are invited to participate within the survey study.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Questionnaire Regarding the Effect of Wearing Face Masks on Oral Health
Actual Study Start Date : November 20, 2020
Estimated Primary Completion Date : May 1, 2021
Estimated Study Completion Date : July 1, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Self-perceived dry mouth [ Time Frame: During the 1 day of questionnaire survey ]
    Questionnaire items based on the shortened Xerostomia Inventory

  2. Self-perceived halitosis [ Time Frame: During the 1 day of questionnaire survey ]
    Questionnaire items


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • N/A
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04632004


Locations
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Germany
University Medical Center Goettingen, Dept. of Preventive Dentistry, Periodontology and Cariology
Göttingen, Lower Saxony, Germany, 37075
Sponsors and Collaborators
University of Göttingen
More Information
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Publications:

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Responsible Party: Philipp Kanzow, Dr. med. dent., Dr. rer. medic., Assistant, University Medical Center Goettingen
ClinicalTrials.gov Identifier: NCT04632004    
Other Study ID Numbers: FaceMasks-OralHealth
First Posted: November 17, 2020    Key Record Dates
Last Update Posted: November 25, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Halitosis
Signs and Symptoms, Digestive