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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04632004
Other study ID # FaceMasks-OralHealth
Secondary ID 28/10/20
Status Completed
Phase N/A
First received
Last updated
Start date November 20, 2020
Est. completion date June 28, 2021

Study information

Verified date February 2024
Source University of Göttingen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 3750
Est. completion date June 28, 2021
Est. primary completion date June 28, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients, visitors, and staff members of the University Medical Center Goettingen Exclusion Criteria: - N/A

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Germany University Medical Center Goettingen, Dept. of Preventive Dentistry, Periodontology and Cariology Göttingen Lower Saxony

Sponsors (1)

Lead Sponsor Collaborator
University of Göttingen

Country where clinical trial is conducted

Germany, 

References & Publications (4)

Farronato M, Boccalari E, Del Rosso E, Lanteri V, Mulder R, Maspero C. A Scoping Review of Respirator Literature and a Survey among Dental Professionals. Int J Environ Res Public Health. 2020 Aug 17;17(16):5968. doi: 10.3390/ijerph17165968. — View Citation

Kanzow P, Dylla V, Mahler AM, Hrasky V, Rodig T, Barre F, Scheithauer S, Wiegand A. COVID-19 Pandemic: Effect of Different Face Masks on Self-Perceived Dry Mouth and Halitosis. Int J Environ Res Public Health. 2021 Aug 31;18(17):9180. doi: 10.3390/ijerph1 — View Citation

Rebmann T, Carrico R, Wang J. Physiologic and other effects and compliance with long-term respirator use among medical intensive care unit nurses. Am J Infect Control. 2013 Dec;41(12):1218-23. doi: 10.1016/j.ajic.2013.02.017. Epub 2013 Jun 12. — View Citation

Shenal BV, Radonovich LJ Jr, Cheng J, Hodgson M, Bender BS. Discomfort and exertion associated with prolonged wear of respiratory protection in a health care setting. J Occup Environ Hyg. 2012;9(1):59-64. doi: 10.1080/15459624.2012.635133. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Self-perceived dry mouth Questionnaire items based on the shortened Xerostomia Inventory During the 1 day of questionnaire survey
Primary Self-perceived halitosis Questionnaire items During the 1 day of questionnaire survey
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