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
- Are there results?
- None posted in the registry
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
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Questionnaire Regarding the Effect of Wearing Face Masks on Oral Health
- ClinicalTrials.gov ID
- NCT04632004
- Acronym / sponsor ID
- FaceMasks-OralHealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,750 participants (actual)
- Lead sponsor
- University of GöttingenUniversity, hospital or other
- Study start
- 20 Nov 2020 (actual)
- Primary completion
- 28 Jun 2021 (actual)
- Study completion
- 28 Jun 2021 (actual)
- First posted
- 17 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients, visitors, and staff members of the University Medical Center Goettingen are invited to participate within the survey study.
| Arm | Type | Receives |
|---|---|---|
| Questionnaire survey | Other | Other: Invitation to participatePatients, 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients, visitors, and staff members of the University Medical Center Goettingen
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Invitation to participatePatients, 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 | Questionnaire survey |
Primary outcome
Self-perceived dry mouth
Time frame: During the 1 day of questionnaire survey
Questionnaire items based on the shortened Xerostomia Inventory
Self-perceived halitosis
Time frame: During the 1 day of questionnaire survey
Questionnaire items
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
- Background: PubMed 32824564Farronato 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.
- Background: PubMed 23768438Rebmann 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.
- Background: PubMed 22168256Shenal 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 publication: PubMed 34501768Kanzow 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Invitation to participate in people with Dry Mouth and Halitosis, run by University of Göttingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-perceived dry mouth (time frame: During the 1 day of questionnaire survey). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04632004, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2024.