Effect of Wearing Face Masks on Salivary Parameters and Halitosis

University of Göttingen40 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Dry Mouth Halitosis

Interventions

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.

Surgical face maskDEVICE

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.

FFP2 respirator maskDEVICE

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.

Waiting for 4 hours without wearing a maskOTHER

Participants do not wear any face mask for 4 hours (beginning between 8 and 9 a.m.).

Use of fluoridated toothpasteOTHER

Participants use fluoridated toothpaste.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University Medical Center Goettingen, Dept. of Preventive Dentistry, Periodontology and Cariology

Göttingen, Lower Saxony, Germany

Outcomes

Primary Outcomes

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.

Secondary Outcomes

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

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

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.

Data from ClinicalTrials.gov

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