Effect of Wearing Face Masks on Salivary Parameters and Halitosis

Study Overview
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Brief Summary
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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).

Official Title
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Effect of Wearing Face Masks on Oral Health

Conditions
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Dry Mouth, Halitosis

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Wearing a face mask for 4 hours<br>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<br>* 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.<br>Device: Surgical face mask<br>* 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.<br>Device: FFP2 respirator mask<br>* 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.<br>Other: Use of fluoridated toothpaste<br>* Participants use fluoridated toothpaste.<br>|
| Other: 4 hours without wearing a face mask<br>Participants do not wear any face mask for 4 hours. | Other: Waiting for 4 hours without wearing a mask<br>* Participants do not wear any face mask for 4 hours (beginning between 8 and 9 a.m.).<br>Other: Use of fluoridated toothpaste<br>* Participants use fluoridated toothpaste.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of unstimulated saliva flow rate | mL/min | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of stimulated saliva flow rate | mL/min | 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 | 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 | 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 | 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. |