Dry MouthNCT04632004
Questionnaire Regarding the Effect of Wearing Face Masks on Oral Health
A study testing Invitation to participate in people with Dry Mouth and Halitosis, run by University of Göttingen at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Invitation to participate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,750 participants
- Where
- 1 siteGermany
- Study dates
- 20 Nov 2020to 28 Jun 2021
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients, visitors, and staff members of the University Medical Center Goettingen
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Medical Center Goettingen, Dept. of Preventive Dentistry, Periodontology and Cariology
Göttingen, Lower Saxony, 37075
About this study
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).
- Being tested
- Invitation to participate
- Medical subject headings
- Xerostomia, Halitosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Invitation to participateOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Questionnaire survey | Other | 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. Receives: Other: Invitation to participate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-perceived dry mouth
Questionnaire items based on the shortened Xerostomia Inventory
Measured: During the 1 day of questionnaire survey
Self-perceived halitosis
Questionnaire items
Measured: During the 1 day of questionnaire survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2020
- Study start20 Nov 2020
- Primary completion28 Jun 2021
- Study completion28 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Dry MouthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 3,750 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Göttingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philipp Kanzow, PD Dr. med. dent., Dr. rer. medic., University Medical Center Goettingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04632004
- Sponsor's protocol ID
- FaceMasks-OralHealth
- Other IDs
- 28/10/20
- Status last verified
- Feb 2024
- First submitted
- 10 Nov 2020
- Last updated
- 14 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 32824564Rebmann 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 23768438Shenal 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 22168256Kanzow 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