Back to resultsQuestionnaire Regarding the Effect of Wearing Face Masks on Oral Health
Primary Purpose
Dry Mouth, Halitosis
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Invitation to participate
Sponsored by
About this trial
This is an interventional prevention trial for Dry Mouth
Eligibility Criteria
Inclusion Criteria:
- Patients, visitors, and staff members of the University Medical Center Goettingen
Exclusion Criteria:
- N/A
Sites / Locations
- University Medical Center Goettingen, Dept. of Preventive Dentistry, Periodontology and Cariology
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Questionnaire survey
Arm Description
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.
Outcomes
Primary Outcome Measures
Self-perceived dry mouth
Questionnaire items based on the shortened Xerostomia Inventory
Self-perceived halitosis
Questionnaire items
Secondary Outcome Measures
Full Information
NCT ID
NCT04632004
First Posted
November 10, 2020
Last Updated
September 27, 2021
Sponsor
University of Göttingen
1. Study Identification
Unique Protocol Identification Number
NCT04632004
Brief Title
Questionnaire Regarding the Effect of Wearing Face Masks on Oral Health
Official Title
Questionnaire Regarding the Effect of Wearing Face Masks on Oral Health
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
November 20, 2020 (Actual)
Primary Completion Date
June 28, 2021 (Actual)
Study Completion Date
June 28, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Göttingen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Mouth, Halitosis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
3750 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Questionnaire survey
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Invitation to participate
Intervention Description
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.
Primary Outcome Measure Information:
Title
Self-perceived dry mouth
Description
Questionnaire items based on the shortened Xerostomia Inventory
Time Frame
During the 1 day of questionnaire survey
Title
Self-perceived halitosis
Description
Questionnaire items
Time Frame
During the 1 day of questionnaire survey
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients, visitors, and staff members of the University Medical Center Goettingen
Exclusion Criteria:
N/A
Facility Information:
Facility Name
University Medical Center Goettingen, Dept. of Preventive Dentistry, Periodontology and Cariology
City
Göttingen
State/Province
Lower Saxony
ZIP/Postal Code
37075
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32824564
Citation
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.
Results Reference
background
PubMed Identifier
23768438
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.
Results Reference
background
PubMed Identifier
22168256
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.
Results Reference
background
PubMed Identifier
34501768
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/ijerph18179180.
Results Reference
result
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Questionnaire Regarding the Effect of Wearing Face Masks on Oral Health
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