Questionnaire Regarding the Effect of Wearing Face Masks on Oral Health

• Sponsor: University of Göttingen (Other)
• Overall Status: Completed
• CT.gov ID: NCT04632004
• Collaborator: (none)
• Enrollment: 3,750
• Location: 1
• Arm: 1
• Actual Duration (Months): 7.2
• Patients Per Site Per Month: 518.8

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 3750 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.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: Nov 20, 2020
• Actual Primary Completion Date: Jun 28, 2021
• Actual Study Completion Date: Jun 28, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Self-perceived dry mouth [During the 1 day of questionnaire survey]

   Questionnaire items based on the shortened Xerostomia Inventory

2. Self-perceived halitosis [During the 1 day of questionnaire survey]

   Questionnaire items

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

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

Exclusion Criteria:

• N/A

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Medical Center Goettingen, Dept. of Preventive Dentistry, Periodontology and Cariology	Göttingen	Lower Saxony	Germany	37075

Sponsors and Collaborators

• University of Göttingen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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). pii: E5968. doi: 10.3390/ijerph17165968. Review.
• 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.
• 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.

• Responsible Party: Philipp Kanzow, PD Dr. med. dent., Dr. rer. medic., Senior Dental Practitioner, University Medical Center Goettingen
• ClinicalTrials.gov Identifier: NCT04632004
• Other Study ID Numbers: FaceMasks-OralHealth; 28/10/20
• First Posted: Nov 17, 2020
• Last Update Posted: Oct 4, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Halitosis

Study Results

No Results Posted as of Oct 4, 2021