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Effect of Wearing Face Masks on Salivary Parameters and Halitosis

U

University of Göttingen

Status

Completed

Conditions

Halitosis
Dry Mouth

Treatments

Device: DIY face mask
Other: Use of fluoridated toothpaste
Device: FFP2 respirator mask
Device: Surgical face mask
Other: Waiting for 4 hours without wearing a mask

Study type

Interventional

Funder types

Other

Identifiers

NCT04914208
FaceMasks-Halitosis
30/2/21 (Other Identifier)
2021-01521 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

40 participants in 2 patient groups

Wearing a face mask for 4 hours
Active Comparator group
Description:
Participants are wearing different kinds of face masks for 4 hours each. Masks are worn on different days and the order is randomly assigned.
Treatment:
Other: Use of fluoridated toothpaste
Device: Surgical face mask
Device: DIY face mask
Device: FFP2 respirator mask
4 hours without wearing a face mask
Other group
Description:
Participants do not wear any face mask for 4 hours.
Treatment:
Other: Use of fluoridated toothpaste
Other: Waiting for 4 hours without wearing a mask

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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