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CompletedNCT04632004Updated Feb 14, 2024

Questionnaire Regarding the Effect of Wearing Face Masks on Oral Health

An interventional study of Invitation to participate in Dry Mouth and Halitosis, sponsored by University of Göttingen. Completed at 1 site in Germany. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-14.

Sponsored by University of Göttingen · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
3,750
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Dry Mouth
  • Halitosis

Browse trials for

03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • N/A
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
3,750 participants (actual)

Study arms

  • 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

Interventions

  • OtherInvitation 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.

05

What researchers measure

Primary outcomes

  1. Self-perceived dry mouth

    Questionnaire items based on the shortened Xerostomia Inventory

    Time frame: During the 1 day of questionnaire survey

  2. Self-perceived halitosis

    Questionnaire items

    Time frame: During the 1 day of questionnaire survey

06

Study locations

1 site
  • University Medical Center Goettingen, Dept. of Preventive Dentistry, Periodontology and Cariology
    Göttingen, Lower Saxony 37075, Germany
07

References and documents

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):5968. doi: 10.3390/ijerph17165968. PubMed 32824564 ↗
  • 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. PubMed 23768438 ↗
  • 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. PubMed 22168256 ↗
  • 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. PubMed 34501768 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT04632004
Lead sponsor
University of Göttingen
Responsible party
Philipp Kanzow, PD Dr. med. dent., Dr. rer. medic. (Senior Dental Practitioner, University Medical Center Goettingen) — Principal investigator
First posted
Nov 17, 2020
Start date
Nov 20, 2020
Primary completion
Jun 28, 2021
Completion
Jun 28, 2021
Last update
Feb 14, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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