An interventional study of DIY face mask and Surgical face mask 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
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).
286 studies on the registry are indexed under Xerostomia; 51 are open to participants now.
This study's enrollment of 40 is close to the median of 44 across 235 interventional studies indexed under Xerostomia.
Browse Xerostomia studies →University of Göttingen is the lead sponsor of 37 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Participants are wearing different kinds of face masks for 4 hours each. Masks are worn on different days and the order is randomly assigned.
Device: DIY face mask · Device: Surgical face mask · Device: FFP2 respirator mask · Other: Use of fluoridated toothpaste
Participants do not wear any face mask for 4 hours.
Other: Waiting for 4 hours without wearing a mask · Other: Use of fluoridated toothpaste
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.
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.
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.
Participants do not wear any face mask for 4 hours (beginning between 8 and 9 a.m.).
Participants use fluoridated toothpaste.
Determination of unstimulated saliva flow rate
mL/min
Time frame: 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.
Determination of stimulated saliva flow rate
mL/min
Time frame: 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.
Determination of unstimulated and stimulated saliva pH
pH
Time frame: 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.
Determination of unstimulated and stimulated salivary buffer capacity
pH
Time frame: 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.
Determination of volatile sulphur compounds (VSC)
ppm
Time frame: 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.
Ran from Sep 2021 to primary completion in Apr 2022, 6 months.
Of 85 non-industry interventional studies with no phase under Xerostomia, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 33. This study's 6 months is below that.
Counting every sponsor, half of 101 studies reached it within 13 months; a quarter within 4 and three quarters within 33.
How these figures are worked out, and which studies are left out of them.
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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University of Göttingen