Dry Mouth, Halitosis
Conditions
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 measuring the effect of wearing different face masks on salivary parameters (unstimulated and stimulated saliva flow rate, pH, buffer capacity) and halitosis (volatile sulphur compounds).
Interventions
DEVICEDIY face mask
Participants are wearing a DIY face mask for 4 hours (beginning between 8 and 9 a.m.). The correct fit of the face mask is checked by the study officials and corrected if necessary.
DEVICESurgical face mask
Participants are wearing a surgical face mask for 4 hours (beginning between 8 and 9 a.m.). The correct fit of the face mask is checked by the study officials and corrected if necessary.
DEVICEFFP2 respirator mask
Participants are wearing a FFP2 respirator mask for 4 hours (beginning between 8 and 9 a.m.). The correct fit of the face mask is checked by the study officials and corrected if necessary.
OTHERWaiting for 4 hours without wearing a mask
Participants do not wear any face mask for 4 hours (beginning between 8 and 9 a.m.).
Participants use fluoridated toothpaste.
Sponsors
University of Göttingen
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Oral healthy adult volunteers who are able to give written consent
Exclusion criteria
* Non-fulfillment of the inclusion criteria * Denied access to the University Medical Center Goettingen at the Corona screening * Exemption from wearing a face mask for medical reasons * Medical reasons hindering participants from refraining eating and drinking prior (except for water) or during the visits * Hyposalivation / xerostomia (unstimulated saliva \< 0.3 mL/min, stimulated saliva \< 0.7 mL/min) * Refusal to use fluoridated toothpastes * Smoking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determination of unstimulated saliva flow rate | Each day, prior (between 8 and 9 a.m.) and after wearing a face mask for 4 hours or 4 hours without wearing any mask. Saliva samples are collected for 5 min each. | mL/min |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Determination of stimulated saliva flow rate | Each day, prior (between 8 and 9 a.m.) and after wearing a face mask for 4 hours or 4 hours without wearing any mask. Stimulated saliva samples are collected for 5 min while chewing a paraffin pellet. | mL/min |
| Determination of unstimulated and stimulated saliva pH | Each day, prior (between 8 and 9 a.m.) and after wearing a face mask for 4 hours or 4 hours without wearing any mask. Saliva samples are collected for 5 min each. Stimulated saliva samples are collected while chewing a paraffin pellet. | pH |
| Determination of unstimulated and stimulated salivary buffer capacity | Each day, prior (between 8 and 9 a.m.) and after wearing a face mask for 4 hours or 4 hours without wearing any mask. Saliva samples are collected for 5 min each. Stimulated saliva samples are collected while chewing a paraffin pellet. | pH |
| Determination of volatile sulphur compounds (VSC) | Each day, prior (between 8 and 9 a.m.) and after wearing a face mask for 4 hours or 4 hours without wearing any mask. | ppm |
Countries
Germany
Outcome results
None listed